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The DHS/DCS Plate System is intended for use in treating fractures of femoral head (Dynamic Hip Plates) and condylar part of the femur (Dynamic Condylar Plates).

Specific indications, which are dependent on the angle of the plate, include:

130°-135°: fractures of the trochanter region, simple and multifragmentary pertrochanteric, intertrochanteric.

95°: distal and intercondylar fractures of the femur.

The Auxein's DHS/DCS Plate System offers a variety of treatment options depending on the fracture site and the patient. The DHS/DCS Plate System is composed of plates, compression screw and bone screws. The devices are made from either Stainless Steel as per ASTM F138-19 or Titanium alloy as per ASTM F136-13(2021)e1.

These implants will be available either in sterile or non-sterile state.

Note- Non sterile products have to be sterilized before use.

The system is indicated for use in skeletally mature patients only. All implants are for single use only.

The provided document is a 510(k) summary for Auxein Medical Private Limited's DHS/DCS Plate System. This summary details the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence.

It's crucial to understand that a 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct performance against specific predetermined acceptance criteria through a clinical study for a new device on the market. Performance is typically demonstrated through non-clinical bench testing, material characterization, and comparison to the predicate.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria is interpreted within the context of a 510(k) submission, specifically focusing on the non-clinical testing performed to establish substantial equivalence. A 510(k) does not typically include a clinical study with human patients demonstrating effectiveness in the same way a PMA (Pre-Market Approval) would, nor does it typically involve human expert readers evaluating AI performance in the way described in the prompt.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines applicable product standards considered for non-clinical standards as the de facto acceptance criteria for mechanical performance and biocompatibility. The "reported device performance" is the conclusion that the device complies with these standards and that test results were similar to those of predicates.

Regarding the "Study that proves the device meets the acceptance criteria":

The "study" in this context refers to non-clinical bench testing and comparison to predicates, not a clinical trial or an AI performance study as implied by some of the prompt's more specific questions.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not explicitly stated in terms of a "test set" as one might refer to a data set for an AI algorithm. For mechanical testing, this refers to the number of physical samples tested. This information is typically detailed in the full test reports, which are not included in this summary.
• Data Provenance: The tests are bench tests performed on manufactured devices. The manufacturing country is India (Auxein Medical Private Limited). The tests themselves are laboratory-based, not based on patient data (retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This question is not applicable to this type of device submission (510(k) for an orthopedic implant) or the non-clinical studies performed. Ground truth for mechanical properties is established by adherence to defined ASTM and ISO standards, not by expert consensus from radiologists or other medical professionals.

4. Adjudication Method for the Test Set:

This question is not applicable. Adjudication methods are relevant in studies involving human interpretation or AI output, where discrepancies need to be resolved. For mechanical and biocompatibility testing, results are quantitative and compared against established limits defined by the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size of Human Improvement with AI vs. Without AI Assistance:

This question is not applicable. This device is a physical orthopedic implant (DHS/DCS Plate System), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI assistance are irrelevant to its evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This question is not applicable. This refers to AI algorithm performance without human interaction. The device is a physical implant.

7. The Type of Ground Truth Used:

For the non-clinical testing performed:

• Mechanical Performance: Ground truth is established by the specified limits and methodologies defined within the applicable ASTM and ISO standards (e.g., ASTM F384-17 for bone plates). The "truth" is whether the device's measured mechanical properties fall within the acceptable range or perform similarly to the predicate devices as per the standard's requirements.
• Biocompatibility: Ground truth is established by compliance with ISO 10993 standards, indicating the material's safety for biological contact.
• Material Composition: Ground truth is established by adherence to specified material standards (e.g., ASTM F138-19, ASTM F136-13(2021)e1).

8. The Sample Size for the Training Set:

This question is not applicable. There is no "training set" in the context of a 510(k) submission for a physical orthopedic implant. This question is relevant for machine learning model development.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable for the same reason as point 8.

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Wise-Lock Tibia & Fibula System The Wise-Lock Tibia & Fibula System plates are intended for fracture fixations for the plates included in the system as follows:

3.5mm Wise-Lock Medial Distal Tibia Plate: Medial distal tibia plates are indicated for treating fractures of the tibia.

3.5mm Wise-Lock Proximal Tibia Plate:

3.5mm Wise-Lock Proximal Tibia Plate indicated for treating fractures of the tibia.

3.5mm Wise-Lock Medial Proximal Tibia Plate:

The 3.5mm Wise-Lock Medial Proximal Tibia Plates are indicated to buttress metaphyseal fractures of the medial tibia plateau, split type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia.

3.5mm Wise-Lock Posterior Medial Proximal Tibia Plate:

3.5mm Wise-Lock Posterior Medial Proximal Tibia Plates are indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal, distal, and metaphyseal areas of the tibia.

3.5mm Wise-Lock Anterolateral Distal Tibia Plate: 3.5mm Wise-Lock Anterolateral Distal Tibia Plate indicated for treating fractures of the tibia.

3.5mm Wise-Lock Medial Distal Tibia Plate, Without Tab: The 3.5mm Wise-Lock Medial Distal Tibia Plate, Without Tab is indicated for fixation of complex intra-and extraarticular fractures and osteotomies of the distal tibia.

3.5mm Wise-Lock Low Profile Medial Distal Tibia Plate, Without Tab: The 3.5mm Wise-Lock Low Profile Medial Distal Tibia Plate, Without Tab is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.

3.5mm Wise-Lock Lateral Distal Fibula Plate:

The 3.5mm Wise-Lock Lateral Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula.

3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia:

The 3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia is indicated for fractures, and non-unions of the metaphyseal and diaphyseal region of the distal fibula.

3.5mm Wise-Lock Pilon Plate:

The 3.5mm Wise-Lock Pilon Plate is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.

3.5mm Wise-Lock Pilon Plate, Cruciform:

3.5mm Wise-Lock Pilon Plate, Cruciform is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.

3.5mm Wise-Lock Z-type Distal Medial Tibial Plate: The 3.5mm Wise-Lock Z-type Distal Medial Tibial Plate is indicated for temporary internal fixation of osteotomies and fractures, including: Comminuted fractures Supracondylar fractures Intra-articular and extra-articular condylar fractures Non-unions, and

Malunions

3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate:

The 3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate is intended for fixation of fractures and osteotomies involving the tibia. The plate is indicated for the the follow:

Treatment of non-unions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and fractures with associated shaft fractures.

To buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau.

The fixation of fractures of the distal tibia including, but not limited to, ankle fractures, intra articular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.

4.5/5.0mm Wise-Lock Proximal Lateral Tibia Plate:

The 4.5/5.0mm Wise-Lock Proximal Lateral Tibia Plate is indicated for treatment of nonunions, tibial osteotomies (4.5mm plate only), and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.

4.5/5.0mm Wise-Lock Medial Proximal Tibia Plate:

The 4.5/5.0mm Wise-Lock Medial Proximal Tibia Plates are indicated to buttress metaphyseal fractures of the medial tibia plateau, split type fractures of the medial tibia plateau, medial split fractures with associated deplit or depression fractures of the medial tibia plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. The 4.5mm version may also be used for fixation of nonunions and malunions of the medial proximal tibia shaft, as well as opening and closing wedge tibial osteotomies.

4.5/5.0mm Wise-Lock Proximal Tibia Plate:

4.5/5.0mm Wise-Lock Proximal Tibia Plate is indicated for treatment of non-unions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.

AV-Wise Lock Ankle System

The AV-Wise Lock Ankle System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused. Indications for plates included in the system are as follows:

Medial and Anteromedial Distal Tibia Plates are indicated for fixation of osteotomies, nonunions, nalunions, and replantations of bones and bone fragments of the diaphyseal regions of the distal tibia,

Distal Tibia T Plates and Distal Tibia L Plates are indicated to buttress partial articular fragments of the distal tibia, and

Lateral Distal Fibula Plates are indicated for fixation of osteotomies, malunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.

AV-Wise Lock Proximal Tibia Plates

The AV-Wise Lock Proximal Tibia Plates are indicated to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused including: simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. Plates can also be used for treatment of nonunions, malunions, tibial osteotomies.

The Tibia and Fibula System consists of three types of bone Plates system i.e. Wise-Lock Tibia & Fibula Plates, AV-Wise Lock Ankle Plates, AV-Wise Lock Proximal Tibia Plate and screws for implantation in the tibia and fibula bone to treat tibia and fibula bone fractures. The bone plates are available in Stainless steel and Titanium material and also in left and right directional configuration. There are 16 types of bone plates in Wise-lock tibia and fibula bone plates in AV-Wise Lock Ankle bone plates and 2 bone plates in AV-Wise Lock Proximal Tibia bone plate system. There are 25 types of bone screws associated with these bone plates.

These implants are sold in both non-sterile and sterile conditions.

Note- Non sterile products have to be sterilized before use. The system is indicated for use in adult patients only. All implants are for single use only.

The provided text is a 510(k) Premarket Notification for a medical device called the "Tibia and Fibula System." This type of document is submitted to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. The information required for your request (acceptance criteria and detailed study information) is typically not extensively detailed in a 510(k) summary, as the primary goal is to show equivalence.

However, based on the provided text, I can extract the following information concerning the acceptance criteria and the types of studies performed to show equivalence, rather than a detailed performance study proving efficacy against acceptance criteria. The document states that the new device is "substantially equivalent" to predicate devices, meaning it has the same intended use, technological characteristics, and performs as safely and effectively.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly defined by the material and performance standards the device claims to meet, and the "reported device performance" is the statement that the device conforms to these standards and exhibits equivalent performance to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical studies with patients or data. The testing mentioned is bench testing on the physical devices (plates and screws). Therefore, the concept of data provenance (country, retrospective/prospective) and sample size in the traditional sense of medical image analysis or clinical trials is not applicable here. The "sample" would refer to the number of devices tested in the lab, which is not detailed in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this 510(k) summary. The ground truth in this context is defined by international and national standards for material properties and mechanical performance, not by expert medical assessment of cases.

4. Adjudication Method for the Test Set

This information is not applicable as there is no human adjudication of a test set in the methods described. The "adjudication" of performance is done by comparing test results against established engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes bench testing for mechanical properties and material equivalence, not human reader performance with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done

No, a standalone (algorithm only) performance study was not done. This device is a physical medical implant (bone plate and screw system), not a software algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on established engineering standards (e.g., ASTM F382, ASTM F543, material standards like ASTM F136, ASTM F138, ASTM F899) and biological safety standards (e.g., ISO 10993-3 for biocompatibility, USP for bacterial endotoxin). This is a technical ground truth, not a clinical one derived from pathology or outcomes data in patients.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this device is a physical implant, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As stated above, there is no training set for this type of device.

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1. AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor

The AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor are indicated for attachment of soft tissue to bone. This product is intended for the following indications:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair.

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;

Hip: Capsular Repair, Acetabular Labral Repair.

2. AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor

The AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor are indicated for attachment of soft tissue to bone. This product is intended for the following indications:

Shoulder: Rotator Cuff Repair, Acromicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.

Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.

The AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor and AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor are non-absorbable threaded suture anchor manufactured in PEEK Material. Generally, it is indicated for the attachment of soft tissue to the bone.

The anchor comes preloaded on a disposable inserter assembly and is intended for fixation of size 2 suture to bone. The suture options may include needles to facilitate suture passage through tissue.

AUXILOCK® PEEK OPTIMA Screw-In Suture anchor is a fully threaded suture anchor featuring dual threads to maximize cortical and cancellous fixation. AUXILOCK® PEEK OPTIMA Screw-In Suture anchor has a flat tip to protect the sutures and to facilitate the insertion. The anchor is particularly suitable for repairing rotator cuff and associated pathologies. AUXILOCK® PEEK OPTIMA Screw-In Suture anchor is available in diameter of 4.5, 5.5 and 6.5mm. This anchor is available with two or three BioBraid suture. The anchors are also available with needles which are ideal for mini-open rotator cuff repair procedures.

AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchors are fully threaded knotless anchors. These anchors are designed to be used with sutures or tapes for rotator cuff repair employing the 'bridge' technique. Moreover, the 'knotless' technique consists of passing sutures or tapes of the medial row anchors through the tissue. They are finally inserted into the bone socket once they're loaded through the Rotador anchor eyelet. This technique eliminates possible complications caused by knots compared to other conventional anchors. The anchor is available in 4.75, 5.5 and 6.25mm diameter with PEEK OPTIMA anchor body and eyelet.

These implants are sold in sterile conditions (Ethylene Oxide Sterilization).

The system is indicated for use in adult patients only. All implants are for single use only.

The AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor and AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor consists of Peek OPTIMA (Grade LT1) as per ASTM F2026-17 implantable Class II, Anchors, UHMWPE (Ultra-High Molecular Weight Polyethylene) Suture as per ASTM F2848-17.

This document is a 510(k) Premarket Notification from Auxein Medical Private Limited for two suture anchors: AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor and AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor. It seeks to demonstrate substantial equivalence to legally marketed predicate devices.

Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

The document describes a submission for Class II medical devices (AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor and AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor) under the regulation 21 CFR 888.3040 for "Smooth or threaded metallic bone fixation fastener" (Product Code MBI). The primary intention of this 510(k) submission is to demonstrate substantial equivalence to existing predicate devices, not to prove clinical superiority or a novel mechanism of action requiring robust, comparative clinical trials with human subjects.

Therefore, the "acceptance criteria" and "study" described are primarily focused on bench testing and material compliance to demonstrate that the new device performs equivalently to the predicate devices and meets relevant industry standards for safety and fundamental function. There is no mention of an AI algorithm, human-in-the-loop performance, MRMC studies, or complex ground truth establishment for diagnostic accuracy as would be typical for AI/ML-based medical devices or diagnostic tools.

1. A table of acceptance criteria and the reported device performance:

The document does not present a formal table of "acceptance criteria" for clinical performance against a specific standard endpoint (e.g., diagnostic accuracy, sensitivity, specificity). Instead, it focuses on demonstrating equivalence in terms of design, material, operating principle, indications for use, sterilization, shelf-life, and mechanical properties compared to the predicate devices. The "performance" reported is primarily in the context of meeting various ASTM and ISO standards for materials, biocompatibility, sterilization, and mechanical integrity.

Here's a summary of the comparative criteria and implied performance from the document:

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Auxilock GFS Mini, GFS II Large, GFS Ultimate Mini and GFS Ultimate Large are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

The Auxilock GFS Mini, GFS II Large & GFS Ultimate are a range of devices design for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. Each device is made from a medical grade titanium alloy, Ti-6Al-4V ELI, grade 5 as per ASTM F136 and also includes an UHMWPE polyblend suture component as per ASTM F2848-17. These implants are sold in sterile conditions (Ethylene Oxide Sterilization). The system is indicated for use in adult patients only. All implants are for single use only.

I am sorry, but the provided text does not contain detailed information about acceptance criteria and study proving device meets the acceptance criteria. The document is a 510(k) Premarket Notification for a medical device (Auxilock Graft Fixation System) and primarily focuses on establishing substantial equivalence to a predicate device through comparison of technological characteristics and non-clinical bench testing.

Specifically, the text does not include:

• A table of acceptance criteria and reported device performance. While a comparison table between the subject and predicate devices is present, it focuses on general parameters like product code, regulation number, and material standards, rather than specific performance metrics with acceptance thresholds.
• Sample size used for a test set, data provenance, or details about patient data.
• Information about experts used to establish ground truth, their qualifications, or adjudication methods.
• Any mention of a multi-reader, multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Standalone algorithm performance or human-in-the-loop performance details, as this is not an AI/ML medical device.
• The type of ground truth used (e.g., pathology, outcomes data) for clinical validation, as clinical studies involving such ground truth are not detailed.
• Training set sample size or how ground truth for a training set was established.

The document primarily states that "Bench tests were conducted to verify that the subject device met all design specifications" and that "The results of this testing indicate that the Auxilock Graft Fixation System is equivalent to a predicate device." The "performance tests" mentioned are "Tensile Static and Pull out following cyclic loading test." However, the specific acceptance criteria for these tests (e.g., minimum tensile strength, maximum pull-out force) and the detailed results showing the device met these criteria are not provided in this summary.

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Specific Indications:

1. 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate
   2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate is intended for treating of Intraarticular Fracture of the distal humerus, Supracondylar fractures of the distal humerus and Non-unions of the distal humerus.
2. 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate with Lateral Support
   2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate with Lateral Support is intended for treating of Intraarticular fractures of the distal humerus, Supracondylar fractures of the distal humerus and Non-unions of the distal humerus.
3. 2.7/3.5mm Wise-Lock Dorsolateral Medial Distal Humerus Plate
   2.7/3.5mm Wise-Lock Dorsolateral Medial Distal Humerus Plate are indicated for treating of Intraarticular fractures of the distal humerus, Supracondylar fractures of the distal humerus and Non-unions of the distal humerus.
4. 3.5mm Wise-Lock Extra-Articular Distal Humerus Plate
   3.5mm Wise-Lock Extra-Articular Distal Humerus Plate are indicated for fractures of the distal humerus.
5. PHEELOS-3.5mm Wise-Lock Proximal Humerus Plate, Short
   PHEELOS Short Indications

• · Dislocated two-, three-, and four-fragment fractures of the proximal humerus
• · Pseudarthroses in the proximal humerus
• · Osteotomies in the proximal humerus

6. PHEELOS-3.5mm Wise-Lock Proximal Humerus Plate, Long
   • As for PHEELOS Short, but for fractures extending to the shaft or without medial support.
7. 3.5mm Wise-Lock Proximal Humerus Plate
   The 3.5mm Wise-Lock Proximal Humerus Plate is intended for fractures and fracture dislocations, and nonunions of the proximal humerus.
8. 3.5mm Wise-Lock Periarticular Proximal Humerus Plate
   3.5mm Wise-Lock Periarticular Proximal Humerus Plate are indicated for fracture dislocations, osteotomies, and nonunions of the proximal humerus.
9. 3.5mm Wise-Lock Olecranon Plate
   3.5mm Wise-Lock Olecranon Plate is indicated for fixation of fractures and non-unions of the olecranon.
10. 3.5mm Wise-Lock Hook Plate
    3.5mm Wise-Lock Hook Plate is indicated for fractures, osteotomies of small bones including the ulna, radius, tibia and fibula.
11. 2.7mm Wise-Lock Screw, Self-Tapping (Hex Head)
    This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
12. 3.5mm Wise-Lock Screw, Self-Tapping (Hex Head)
    This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
13. 3.5mm Wise-Lock Screw, Self-Drilling, (Hex Head)
    This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
14. 3.5mm Wise-Lock Cancellous Screw, Full Thread, Self-Tapping, (Hex Head) This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
15. 3.5mm Wise-Lock Cancellous Screw, Short Thread, Self-Tapping, (Hex Head) This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
16. 3.5mm Cortical Screw, Self-Tapping, (Hex Head)
    This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
17. 4.0mm Cancellous Screw, Short Thread
    This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
18. 4.0mm Cancellous Screw, Full Thread
    This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
19. 2.7mm Cortical Screw, Self-Tapping, (Hex Head)
    This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.

The Humerus and Ulna System consists of various types of bone plates, Screws for implantation in the humerus and ulna bone to treat humerus and ulna bone fractures.
The Humerus and Ulna System consists of medial and postero-lateral distal humerus plates of various lengths and 2.7 mm locking screws. The plates are pre-contoured to match the anatomy of the distal humerus with a limited contact low profile design. The plate features locking compression holes which accept 2.4, 3.5, & 4.0 mm cortex screws, 2.4, 2.7 & 3.5 mm locking screws, and 4.0 mm cancellous screws. The System is available in Stainless Steel and Titanium.
These implants are sold in both non-sterile and sterile conditions.
Note- Non sterile products have to be sterilized before use.
The system is indicated for use in adult patients only. All implants are for single use only.
The humerus and Ulna System contains several plates and each plate has its intended uses.

The provided 510(k) summary describes a medical device, the "Humerus & Ulna System" by Auxein Medical Private Limited, which consists of various bone plates and screws for humerus and ulna bone fracture fixation. The document states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain information related to software or AI/ML components. Therefore, it is impossible to extract the acceptance criteria for an algorithm, the details of a study proving a device meets those criteria, or other AI/ML-specific information like sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies.

The document primarily focuses on demonstrating substantial equivalence through:

• Comparison of technological characteristics: Product code, regulation number, regulatory class, indications for use, material, performance standards, sterilization, shelf-life, single use/reuse, operating principle, and dimensional verification are compared to predicate devices.
• Non-clinical (bench) testing: This includes material standards (ASTM F136/ISO 5832-3, ASTM F899-12, ASTM F138/ISO 5832-1), biocompatibility (ISO 10993), and mechanical performance (ASTM F382 for plates, ASTM F543 for screws, including driving torque, torsion, and axial pull-out tests).
• Sterilization, shelf-life, and packaging standards: (ISO 11137 series, ISO 17665 series, ISO 11140-1, ISO 11737 series, ISO 11607 series, ASTM F1980, ASTM F88, ASTM F1929).
• Bacterial Endotoxin testing: (USP , USP ).

All of these tests are standard for orthopedic implants and confirm the physical and biological safety and performance of the hardware, but they do not involve any AI/ML algorithm evaluation.

Therefore, based solely on the provided text, I cannot answer the specific questions related to acceptance criteria and studies for an AI/ML component. The device described is a physical implant system, not a software-driven diagnostic or treatment planning tool that would typically involve the type of AI/ML evaluation metrics requested.

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The Auxein's Varixis Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused.

Specifically,

Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, malunions and non-unions of the distal humerus.

Olecranon and Proximal ulna plates are indicated for fractures, malunions and non-unions of the olecranon and proximal ulna.

The Auxein Varixis Elbow System contains plates intended to treat fractures of the distal humerus and proximal ulna. A variety of plate configurations are included in the system to allow for fixation of multiple fracture patterns. Specifically, the system includes several plate configurations for fixation of the distal humerus which are intended to be used in a two-plate construct where plates are positioned medially and laterally. Additionally, the system includes plates for fixation of the olecranon and proximal ulna. Proximal ulna Plates enables the surgeon to address the specific biomechanical requirements of each fracture pattern while minimizing irritations of the adjacent soft tissue.

These implants are sold in both non-sterile and sterile conditions.

Note- Non sterile products have to be sterilized before use. All implants are for single use only.

This document is a 510(k) Premarket Notification for the Varixis Elbow System, a set of metallic bone fixation appliances. It focuses on demonstrating the substantial equivalence of the Varixis Elbow System to a legally marketed predicate device (Synthes Variable Angle LCP Elbow System, K120070).

The document does not describe a study involving an AI/ML device where acceptance criteria are set for diagnostic performance metrics (e.g., sensitivity, specificity, AUC) and then proven through clinical studies with human readers or standalone algorithm performance. Instead, it describes a medical device, the Varixis Elbow System, which is a physical implant used for fracture fixation.

Therefore, the requested information regarding acceptance criteria for device performance (like sensitivity, specificity), sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, ground truth types, and training set details are not applicable to this submission as it pertains to a mechanical orthopedic implant, not an AI/ML diagnostic or assistive device.

The "performance" referred to in this document relates to mechanical properties (e.g., static and fatigue strength of plates, driving torque, torsion, and axial pull-out of screws), material biocompatibility, and sterilization effectiveness.

Here's an analysis of the document in the context of your request, highlighting what is present and what is absent:

Acceptance Criteria and Proof of Device Meeting Criteria (for a mechanical implant)

The acceptance criteria for this device are demonstrated through a comparison to a predicate device and adherence to recognized industry standards for mechanical testing and material properties. The 'proof' is the declaration of substantial equivalence based on these comparisons and test results.

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents a comparison table (Section A.6) outlining the technological characteristics of the Auxein Varixis Elbow System and the predicate device. This indirectly serves as a basis for acceptance criteria by demonstrating similarity or conformity to established standards, which are the "acceptance criteria" for this type of device.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: The document does not specify exact sample sizes for the mechanical tests (e.g., how many plates or screws were tested for ASTM F382 or F543). It simply states that "Bench tests were conducted" and "The results of this testing indicate that the Varixis Elbow System is equivalent to the predicate device."
• Data Provenance: The tests are bench tests performed on the physical device. The company, Auxein Medical Private Limited, is based in India, so it's presumed the testing was conducted there or by affiliated, qualified labs. It is not "retrospective or prospective" in the clinical study sense, as it involves physical testing of the device itself.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not Applicable. This is a submission for a mechanical implant, not an AI/ML diagnostic tool. There is no concept of "ground truth" established by experts in the context of analyzing medical images or clinical data for diagnostic purposes. The "ground truth" for this device's performance is adherence to engineering standards and mechanical test results.

4. Adjudication Method for the Test Set:

• Not Applicable. As above, no medical image or clinical data interpretation by human experts requiring adjudication is involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. This type of study is typically done for diagnostic imaging devices or AI/ML tools to assess human reader performance with and without AI assistance. It is not relevant for a mechanical bone fixation system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not Applicable. This is not an AI/ML algorithm or software. It is a physical medical device.

7. The Type of Ground Truth Used:

• For mechanical performance: The ground truth is defined by established engineering and medical device standards (e.g., ASTM F382, ASTM F543) and material specifications (e.g., ASTM F136, ISO 5832). The device performance is compared against the requirements of these standards.
• For substantial equivalence: The ground truth is the performance and characteristics of the legally marketed predicate device (Synthes Variable Angle LCP Elbow System, K120070).

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. No training set is involved.

Summary of Relevant Information from the Document:

• Device Name: Varixis Elbow System
• Intended Use: Fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) where growth plates have fused.
• Basis for Clearance: Substantial equivalence to predicate device Synthes Variable Angle LCP Elbow System (K120070).
• Key Evidence for Substantial Equivalence:
  • Identical product codes, regulation numbers, regulatory class, and indications for use as the predicate device.
  • Identical materials (Titanium Alloy and Stainless Steel) as the predicate, meeting specific ASTM/ISO standards.
  • Performance testing (bench tests) on the subject device according to ASTM F382 (for plates: 4-Point Static Test, 4-Point Fatigue Test) and ASTM F543 (for screws: Driving Torque Test, Torsion Test, Axial Pull-out Test). The results "Conform" to these standards.
  • Compliance with various ISO and ASTM standards for biocompatibility (ISO 10993-3), sterilization (ISO 11137, ISO 17665, ISO 11140, ISO 11737, ISO 11607, ASTM F1980, ASTM F88/F88M, ASTM F1929), shelf-life (5 years, identical to predicate), and bacterial endotoxin (USP , USP ).
  • Identical operating principle and dimensional characteristics to the predicate device.

In conclusion, this document provides the necessary information for the FDA to confirm substantial equivalence for a mechanical orthopedic implant but does not contain information relevant to an AI/ML driven diagnostic device.

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The Auxilock Draw Tight Suture-Based Anchor is indicated for attachment of soft tissue to bone. This product is intended for the following indications:

Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, Superior Labrum, Anterior to Posterior Lesion Repair.

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.

Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Triangular Fibrocartilage Complex Tear.

AUXILOCK® Draw tight anchor is made with UHMWPE suture anchor body and PEEK OPTIMA eyelet tip. The Auxilock Draw Tight Anchors are designed for use in attachment of soft tissue to bone. The construct of the Draw Tight Anchors is such that when inserted into the bone and deployed via the included suture, a suture ball is created in the prepared socket that provides the necessary fixation. The Draw Tight Anchors are designed to accommodate both sliding and fixed sutures to be used for soft tissue fixation. The anchor is designed to deliver efficiency and promote ease of use. The anchor can be used for rotator cuff repair surgeries. The AUXILOCK® Draw tight suture based anchor provides a small footprint and also asserts subcortical fixation for anchor insertion. The Draw tight anchor is available in 1.8mm and 3.2mm diameter with various combination of BioBraid and suture tapes. The drill guide and anchor driver combination is well-designed to improve the performance and reliability. The Auxilock Draw Tight Suture-Based Anchor consists of the following types of implants:

• AUXILOCK® 1.8mm Draw Tight Suture-Based Anchor with One #2 BioBraid: White/Blue .
• AUXILOCK® 1.8mm Draw Tight Suture-Based Anchor with One 1.6mm Suture Tape: ● White/Blue
• AUXILOCK® 3.2mm Draw Tight Suture-Based Anchor with Two #2 BioBraid: White/Blue & ● White/Black
• AUXILOCK® 3.2mm Draw Tight Suture-Based Anchor with One #2 BioBraid And One 1.6mm Suture tape: White/Black & White/Blue
  The Auxilock Suture is a dyed or non-dyed braided suture construct made of UHMWPE. The proposed suture is braided flat with round ends, and is available in precut lengths in straight and loop configurations, and with or without needles. Suture ends are stiffened with cyanoacrylate. The Suture constructs meet USP standards for suture. The Suture is available in straight and loop configurations; and sizes #2 for suture, and 1.6mm (width) for tape.

AUXILOCK® BioBraid Suture

AUXILOCK® BioBraid Sutures are braided sterile sutures prepared from Ultra High Molecular Weight Polyethylene (UHMWPE). Sutures are non-absorbable and do not impose any significant changes in tensile strength retention known to occur in vivo. BioBraid sutures are available in a variety of colour combinations for easy suture management in complicated repairs.

Suture color additives

The UHMWPE sutures when made up of tracers can be with blue polypropylene (pigment ß-Cuphthalocyanine blue) or polyamide black (pigment hematein).

The color additive FD&C Blue 2, color additive Black logwood and color additive phtalocyanine are according to FDA and it is approved for use in medical applications (§74.3102 - FDA), (§73.1410 –FDA) and (§74.3045 – FDA) respectively.

AUXILOCK® BioBraid Suture Tape

AUXILOCK® BioBraid Suture Tape made from UHMPWE has a width of 1.6mm. The suture tape design accommodates the tape in the centre with a suture on the either sides of the tape.

These implants are sold in sterile conditions (EO Sterilization). The system is indicated for use in adult patients only. All implants are for single use only.

Surgical instrumentation is included in Auxilock Draw Tight Suture-Based Anchor to allow the placement and attachment of the Anchors with bone. Various drill, anchor driver, Awl, Threading device, Tray, Containers and other components are included with the Auxilock Draw Tight Suture-Based Anchor. These Instruments are made from Stainless steel (SS 304) Material.

The provided text is a 510(k) summary for a medical device (Auxilock Draw Tight Suture-Based Anchor), which is a premarket notification to the FDA for a device that is substantially equivalent to a legally marketed predicate device. This type of submission relies on demonstrating similarity to existing devices and does not involve an AI/ML component or clinical studies meeting the criteria outlined in your request (e.g., multi-reader multi-case studies, expert consensus ground truth for image data, training/test sets for an algorithm).

Therefore, I cannot provide the specific information requested about acceptance criteria and study proving a device meets them, especially pertaining to AI/ML performance. The document focuses on demonstrating substantial equivalence through:

• Material Standards: Conformance to ASTM F2026-17 (PEEK) and ASTM F2848-17 (UHMWPE) for the anchor and suture, respectively, and ASTM F899-12 (Stainless Steel) for instruments.
• Biocompatibility: Evaluation according to ISO 10993.
• Performance Standards: Bench testing (static and fatigue loading) of pull-out strength, with results compared side-by-side to the predicate device. The document explicitly states "no significant differences."
• Sterilization, Shelf-life, and Packaging: Conformance to various ISO and ASTM standards related to EO sterilization, microbial methods, packaging integrity, and accelerated aging for a 5-year shelf life.
• Bacterial Endotoxin: Testing performed according to USP and .

In summary, the provided text describes a submission for a physical medical device (suture-based anchor) that is not an AI/ML-driven diagnostic or assistive technology. Consequently, there are no details about AI/ML acceptance criteria, test set characteristics (sample size, provenance), expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details as you've requested.

The "performance standards" mentioned relate to the physical and mechanical properties of the anchor itself, not the diagnostic performance of an AI algorithm.

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The Auxilock Titanium Screw-In Suture Anchor is intended to be used with #2 Biobraid suture with white, blue, black colors for use for the reattachment of soft tissue to bone for the following indications:

Shoulder:
Bankart lesion repairs, SLAP lesion repairs, Acromiolavicular separation repairs, Rotator cuff tear repairs, Capsular shift or Capsutolabral reconstructions, Biceps tenodesis, and Deltoid Repairs, Anterior Shoulder Instability Repair.

Foot and Ankle:
Hallux valgus reconstruction, Medial or Lateral instability repairs/reconstructions, Achilles tendon repair/reconstructions, Mid-foot reconstruction, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy.

Elbow, Wrist and Hand:
Scapholunate ligament reconstruction, Unar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment, Tennis elbow repair.

Knee:
Extra-capsular repairs: Medial collateral ligament repair. Lateral ligament repair. Posterior oblique ligament. Iliotibial band tenodesis, Patellar tendon repair - Vastus medialis obliquous advancement.

Hip:
Capsular repair, Acetabular labral repair.

The Titanium Screw-In Suture Anchor is a threaded, tapered fastener for use in attachment of soft tissue to bone. The self-tapping AUXILOCK® Titanium screw-in suture anchor is mostly used as a medial row anchor in rotator cuff repair surgery, Bankart or SLAP surgeries. It is recommended for use in small and large-joint repairs without the need for tapping or drilling. AUXILOCK® Titanium screw-in anchors are available in diameter of 2.8mm, 3.5mm, 5.0mm and 6.5mm. The anchor design incorporates a cancellous thread with a tiny core diameter to maximize pull-out strength in cancellous or osteoporotic bone. The AUXILOCK® Titanium screw-in anchor is designed for ultimate mechanical properties (pull-out strength, tensile strength, etc.) and ease-of-use. The anchor design incorporates a cortical thread with a small core diameter to maximize pull-out strength in a cortical or hard bone. The drill guide and drill bit are provided in the instrument set for the accurate placement of the anchor. It in turn minimizes the anchor slippage or breakage during the surgery.

All of the Auxein's Non-Absorbable Suture Anchors are provided sterile, for single use only. All Non-Absorbable Suture Anchors are preassembled onto an inserter, sized appropriately to accommodate the indicated procedures. Auxein's Non-Absorbable Suture Anchors come in various configurations, including: with attached non-absorbable suture(s). In certain configurations, the Non-Absorbable Suture Anchors are packaged with a guide and awl. All configurations of the Non-Absorbable Suture Anchors are identical to the identified predicate devices.

The device is made from a Titanium alloy, Ti-6Al-4V (ASTM F136) as per grade 5.

Note: The #2 Biobraid Suture is not to be used as a stand-alone. It should be used only with the assembled implant.

These implants are sold in sterile conditions (Ethylene Oxide Sterilization). The system is indicated for use in adult patients only. All implants are for single use only.

The provided text is a 510(k) premarket notification for a medical device called "Auxilock Titanium Screw-In Suture Anchor." It details the device's characteristics, intended use, and a comparison to predicate devices to demonstrate substantial equivalence.

However, this document does not contain information about acceptance criteria and a study that proves the device meets those criteria, specifically concerning an AI/ML-based medical device performance study. The document focuses on demonstrating substantial equivalence for a physical implantable device based on material standards, sterilization, mechanical performance (insertion, pull-out tensile static/fatigue), dimensional verification, shelf-life, and biocompatibility.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance for an AI/ML device, as the provided text pertains to a traditional medical implant and lacks any mention of AI/ML components or associated performance studies.

The document instead describes:

• Device Type: Auxilock Titanium Screw-In Suture Anchor (a physical implant).
• Performance Tests per document:
  • Material Standards (ASTM F136, ASTM F2848-17, ASTM F899-20)
  • Biocompatibility (ISO 10993-3)
  • Mechanical Performance (Insertion Test, Pull-Out Tensile Static Test, Pull-Out Tensile Fatigue Test)
  • Sterilization (ETO Sterilization, ISO 11135, ISO 17665, ISO 11140-1, ISO 11737-1, ISO 11737-2)
  • Packaging integrity (ISO 11607-1, ISO 11607-2, ASTM F1980, ASTM F88/F88M, ASTM F1929)
  • Shelf-life (5 years based on stability study)
  • Bacterial Endotoxin testing (USP , USP , ANSI/AAMI ST72:2019)

None of these tests align with the detailed questions regarding AI/ML device performance (like MRMC studies, standalone algorithm performance, ground truth establishment for training/test sets, or expert adjudication).

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2.4mm Wise-Lock Distal Radius System:
2.4mm Wise-Lock Distal Radius System are used for displaced extra-articular distal radius fractures and corrective osteotomies of the distal radius.

2.4mm Wise-Lock Proximal Radius System:
2.4mm Wise-Lock Proximal Radius System are used for extra-articular fractures of Proximal radius and multifragmented radial neck fractures.

2.4mm Variable Angle Distal Radius System:
2.4mm Variable Angle Distal Radius System are used for displaced extra-articular and intra-articular distal radius fractures and corrective osteotomies of the distal radius.

The 2.4mm Radius System consists of various types of bone plates, screws for implantation in the radius bone to treat the radius bone fracture.

The provided text describes a 510(k) premarket notification for a medical device called the "2.4mm Radius System." This is a submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device, and thus does not require approval of a premarket approval application (PMA).

Crucially, this document focuses on demonstrating substantial equivalence based on design, materials, and mechanical performance tests against recognized standards, rather than clinical performance or diagnostic accuracy. Therefore, the concepts of acceptance criteria for diagnostic performance, test set characteristics, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable to this type of regulatory submission.

The "acceptance criteria" in this context refer to compliance with material standards, mechanical performance standards, and sterilization/packaging standards. The "study that proves the device meets the acceptance criteria" refers to the non-clinical bench testing conducted against these standards.

Here's a breakdown of the requested information based on the provided text, noting where certain categories are not applicable:

Acceptance Criteria and Study Details for the 2.4mm Radius System (K211324)

1. Table of Acceptance Criteria and Reported Device Performance

• ASTM F899-12: Standard Specification for Wrought Stainless Steels for surgical instruments.
• ASTM F138/ISO 5832-1: Standard Specification for Wrought-18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants. | - Compliance verified with Titanium Alloy (Ti-6Al-4V) Grade 5 as per ISO 5832-1/ASTM F136 for Titanium Implants.
• Compliance verified with Stainless Steel (Grade 316L) as per ISO 5832-3/ASTM F138 for Stainless Steel Implants.
• Compliance verified with Grade 304 of Stainless steel (SS 304) Material for instruments as per ASTM F899-12b. |
  | Mechanical Performance | - ASTM F382: Standard Specification and Test Method for Metallic Bone Plates.
• ASTM F543: Standard Specification and Test Method for Metallic Medical Bone Screws. | Plate Testing:
• 4-Point Static Test: Conforms
• 4-Point Fatigue Test: Conforms
  Screw Testing:
• Driving Torque Test: Conforms
• Torsion Test: Conforms
• Axial Pull-out Test: Conforms |
  | Biocompatibility | - ISO 10993-3 (General evaluation for raw materials) | Raw materials evaluated and found to comply with ISO 10993-3. |
  | Sterilization & Packaging | - ISO 11137-1, -2, -3 (Radiation sterilization)
• ISO 17665-1, -2, -3 (Moist heat sterilization)
• ISO 11140-1 (Chemical indicators)
• ISO 11737-1, -2 (Microbiological methods)
• ISO 11607-1, -2 (Packaging for sterile medical devices)
• ASTM F1980 (Accelerated Aging of Sterile Barrier Systems)
• ASTM F88/F88M (Seal strength)
• ASTM F1929 (Seal leaks by dye penetration) | Subject device and packaging validated against these standards for both Gamma Sterilization and non-sterile products. |
  | Bacterial Endotoxin | - USP Bacterial Endotoxin Test.
• USP Medical Devices-Bacterial Endotoxin and Pyrogen Tests. | Compliance with USP and for bacterial endotoxin and pyrogen tests. |
  | Dimensional Verification | Comparison to predicate device dimensions. | Same dimension as of Predicate device. |
  | Shelf-life | 5 Years | 5 Years (Same as predicate device) |
  | Use Type | Single Use | Single Use (Same as predicate device) |

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: The document describes bench testing for mechanical integrity and material compliance, not clinical or diagnostic performance on human or animal subjects. The "sample size" would refer to the number of test coupons or devices subjected to mechanical tests (e.g., how many plates for 4-point static test, how many screws for torsion test). This specific number is not explicitly stated in the provided text, but it is implied that a sufficient number was tested to meet the requirements of the ASTM standards.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): The data provenance here refers to the origin of the bench test results. These tests were conducted as part of the manufacturer's (Auxein Medical Private Limited, India) submission to the FDA. The tests likely involved physical samples of the manufactured devices. The data itself is prospective in the sense that the tests were performed specifically for this submission against established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This device is a bone fixation system (medical hardware), not a diagnostic algorithm that requires expert interpretation to establish a ground truth. The "ground truth" for this device relates to its material properties and mechanical performance, which are established by standardized laboratory testing methods and engineering specifications, not expert consensus on medical images or diagnoses.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable. As this is not a diagnostic performance study, there's no need for an adjudication method for establishing ground truth. The compliance with standards is determined by objective measurements during bench testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is a bone fixation device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a physical medical device (bone plate and screws), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for this device is defined by established engineering and material standards (e.g., ASTM F382, ASTM F543, various ISO and ASTM material standards). Compliance with these standards confirms the device's functional and material integrity.

8. The sample size for the training set

• Not Applicable. This device is not an AI/machine learning algorithm, so there is no concept of a "training set."

9. How the ground truth for the training set was established

• Not Applicable. As there is no training set, this question is not relevant.

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Device Name: Auxein Nailing System are categorized to the following system:

1. Expert Tibia Nailing System 2. Expert Femoral Nailing System 3. Gamma Nailing System 4. AJAX Advance nailing system 5. Elastic Nailing System 6. Humeral Nailing System 7. Retrograde Nailing System

INDICATION FOR USE:

1. AUXEIN Brand of Expert Tibia Nailing System- consists of variety of Bone nails and bone screws. Expert Tibia Nail System is intended to stabilize fractures of the proximal and distal tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non- unions.

2. AUXEIN Brand of Expert Femoral Nailing System -is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.

3. AUXEIN Brand of Gamma Nailing System -The Gamma Nail with Anti -Rotation Screw is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, including non-union and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections.

4. AUXEIN Brand of AJAX Advance Nailing System, end cap and screws is intended to treat stable and unstable proximal femoral fracture including Pertrochanteric fractures and High sub trochanteric fractures and combination of these fractures.

5. The AUXEIN MEDICAL's Elastic Intramedullary Nail System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the important. This includes upper extremity fractures in all patients and lower extremity fractures in children above the age of 6 years and any patient below 65 kg. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures.

6. AUXEIN Brand of Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures.

7. AUXEIN Brand of Retrograde Nailing System This nails are indicated for simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated.

An intramedullary rod, also known as an intramedullary nail (IM nail) or inter-locking nail is a metal rod forced into the medullary cavity of a bone. IM nails have long been used to treat fractures of long bones of the body.

The device is made from a Titanium alloy, Ti-6Al-4V ELI (ASTM F136).

Auxein Brand of Expert Tibia Nail system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps & locking bolts of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 8mm to 12mm; the length varies from 255mm. The screw implants are in corresponding diameter of 4.4mm & 4.8mm diameters with lengths varying as per the requirements and minimum length: 24mm to maximum length 90mm.

Auxein Brand of Expert Femoral Nail system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, locking screw & Anti-rotation screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones.The diameter of the nails varies from 9mm to 13mm; the length varies from 320mm to 440mm.The screw implants are in corresponding diameter of 4.8mm, 6.4mm & 10.5mm diameters with lengths varying as per the requirements and minimum length: 25mm to maximum length 130mm.

Auxein Brand of Ga-mma Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, Inner screw, locking bolts, Anti-rotation screw & Cephalic screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 9mm to 13mm; the length varies from 180mm. The screw implants are in corresponding diameter of 4.8mm, 6.4mm & 10.5mm diameters with lengths varying as per the requirements and minimum length: 26mm to maximum length 120mm.

Auxein Brand of Humeral Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, locking bolt, compression screw, and proximal screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 6mm to 9mm; the length varies from 180mm to 320mm. The screw implants are in corresponding diameter of 3.5mm & 4.5mm diameters with lengths varying as per the requirements and minimum length: 20mm to maximum length 70mm.

Auxein Brand of AJAX Advance Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, locking bolts, Cephalic screw, Ajax Blade, and inner screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 9mm to 12mm: the length varies from 170mm to 420mm.The screw implants are in corresponding diameter of 4.9mm & 10.5mm diameters with lengths varying as per the requirements and minimum length: 26mm to maximum length 120mm.

Auxein Brand of Elastic Nailing system consists of various shapes and sizes of sterile nails featuring end caps of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 1.5mm to 4.0mm; the total length of 440mm. The end caps are in corresponding diameter ranges from 1.5mm to 4.0mm diameters with length of 14mm & 25mm.

Auxein Brand of Retrograde Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps & locking bolts of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 9.5 to 12mm; the length varies from 180mm to 360mm. The screw implants are in corresponding diameter of 5.0mm diameters with lengths varying as per the requirements and minimum length: 32mm to maximum length 80mm.

Auxein Nailing System covered same products as of covered in K192003. In this addition Auxein Nailing System is offering sterile version of the nailing devices.

The device is made from a Titanium alloy, Ti-6Al-4V ELI (ASTM F136).

However, we are adding a new device i.e. Ajax Blade in this submission. The associated Instruments with the newly added device are tabulated below.

1. Inner Screwdriver, Hex 4.0mm
2. Inner Screw Holder, Hex 4.0mm
3. Container for AJAX Cephalic Screw Instrument Set

These implants will be supplied in Sterile State (Gamma Irradiation) Only.

The provided text is a 510(k) summary for the Auxein Nailing System, which is a medical device. This type of document is for premarket notification of a device to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. It focuses on comparing the new device to existing ones based on design, materials, and intended use, and generally does not contain information about clinical studies with human participants, AI algorithms, or detailed performance metrics like sensitivity/specificity derived from such studies.

Therefore, many of the requested items, which are typical for studies involving AI algorithms or comparative effectiveness of diagnostic devices, are not present in this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria for device performance beyond compliance with material and performance standards. The "performance" is demonstrated through adherence to these standards and comparison to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided. The testing described is non-clinical (material and mechanical), not involving human patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. "Ground truth" in the context of clinical expert consensus is not relevant to the non-clinical testing performed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not an AI device. No MRMC study was performed or is relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not an AI device. No standalone algorithm performance was assessed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical testing is compliance with established engineering and material standards (e.g., ASTM F136 for material composition, ASTM F543 for mechanical properties).

8. The sample size for the training set

This information is not applicable and not provided. There is no AI training set for this device.

9. How the ground truth for the training set was established

This information is not applicable and not provided. There is no AI training set for this device.

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