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The subject device can be used with the TRIGEN META-TAN Trochanteric Antegrade Nailing System, TRIGEN TAN FAN Trochanteric Antegrade and Femoral Antegrade Nailing System, and the TRIGEN META-NAIL Retrograde Femoral Nail System therefore the indications for use for all three systems are applicable to the subject TRIGEN Stable Lock Nut & Washer.

TRIGEN META-TAN Trochanteric Antegrade Nailing System

The TRIGEN META-TAN Trochanteric Antegrade Nail is indicated for fixation of fractures that occur in and between the proximal third and distal fourth of the femur including simple long bone fractures, severely comminuted, spiral, and segmental fractures, and supracondylar fractures.

In addition, TRIGEN META-TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; and intracapsular fractures.

TRIGEN TAN FAN Trochanteric Antegrade and Femoral Antegrade Nailing System

Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted spiral, large oblique and segmental fractures; and nonunions. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures and intertrochanteric fractures.

TRIGEN META-NAIL Retrograde Femoral Nail System

The TRIGEN META-NAIL Retrograde Femoral Nail is indicated for fractures of the femur including stable and unstable distal metaphyseal fractures, diaphyseal fractures, intra-articular fractures, and peri-prosthetic fractures.

The device in scope of this submission is the TRIGEN Stable Lock Nut & Washer.

The TRIGEN Stable Lock Nut & Washer is intended to be used as an aid to normal fracture healing for fractures that occur in and between the proximal third and distal fourth of the femur including simple long bone fractures, severely comminuted, spiral, and segmental fractures, and supracondylar fractures; simple long bone fractures; severely comminuted spiral, large oblique and segmental fractures; nonunions; for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated; and for fractures of the femur that include stable and unstable distal metaphyseal fractures, diaphyseal fractures, intra-articular fractures, and peri-prosthetic fractures. The TRIGEN Stable Lock Nut & Washer is made from Ti-6Al-4V material. The device is Gamma sterilized and intended for single-use only.

The provided FDA 510(k) Clearance Letter for the TRIGEN Stable Lock Nut & Washer does not pertain to an Artificial Intelligence (AI) or machine learning (ML) device. Instead, it describes a mechanical bone fixation appliance.

Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device (e.g., sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment for training and test sets) cannot be extracted or inferred from this document.

The clearance letter focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical bench testing:

• Acceptance Criteria and Reported Device Performance: This document does not present quantitative acceptance criteria or performance metrics in a table format that would be typical for an AI/ML device validating its inferential accuracy (e.g., sensitivity, specificity, AUC). Instead, for this mechanical device, the performance is implicitly demonstrated by the successful completion of the following non-clinical tests:

  • Theoretical Failure Analysis
  • Torque to Failure/Insertion/Extraction Torque Testing and Analysis
  • MR Compatibility per ASTM F2182-19e2, ASTM F2052-15, ASTM F2213-2017, and ASTM F2119-07(2013)

• Study That Proves the Device Meets Acceptance Criteria: The study that proves the device meets acceptance criteria consists of the non-clinical bench tests listed above. The conclusion states: "The results of the equivalence testing demonstrate that the differences in design of the subject device does not raise any difference in safety or effectiveness as compared to the predicate devices." This implies that the 'acceptance criteria' were met if these tests demonstrated performance comparable to, or better than, the predicate devices without compromising safety or effectiveness.

In summary, as this is a traditional mechanical medical device, the concepts of acceptance criteria, test sets, ground truth, and study methodologies related to AI/ML device validation are not applicable here.

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TRIGEN MAX Tibial Nail System:

The TRIGEN MAX Tibial Nail is indicated for stable and unstable fractures that occur in and between the proximal and distal third of the tibia, including the shaft.

INTERTAN MAX Hip Fracture Nail System:

The INTERTAN MAX Nails are indicated for fractures of the femur including:

· Fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, and segmental shaft fracture; subtrochanteric fractures; intertrochanteric fractures;

ipsilateral femoral shaft/neck fractures; and intracapsular fractures

• · Polytrauma and multiple fractures
• · Prophylactic nailing of impending pathologic fractures
• · Reconstruction following tumor resection and grafting.

The Smith & Nephew TRIGEN MAX Tibial Nail and INTERTAN MAX Hip Fracture Nail systems consist of implant intramedullary nails, screws, nail caps, buttress plate, washers and their corresponding US Class II instrumentation. The TRIGEN MAX Tibial Nail system is designed to address fractures of the tibia and the INTERTAN MAX Hip Fracture Nail system is designed to address fractures of the proximal femur.

The provided text is an FDA 510(k) clearance letter and associated summary for the TRIGEN MAX Tibial Nail System and INTERTAN MAX Hip Fracture Nail System. This document does not describe a study involving an AI/software device that requires specific acceptance criteria for performance metrics like sensitivity, specificity, or AUC.

Instead, this clearance is for mechanical bone fixation appliances and accessories, which are physical medical devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical (benchtop) performance evaluations and biocompatibility testing to demonstrate substantial equivalence to predicate devices, not AI algorithm performance.

Therefore, I cannot provide a response with the requested information template (table of acceptance criteria with reported device performance, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, ground truth type, training set sample size, and ground truth establishment for training set) because those metrics and study types are relevant for AI/software medical devices, which this submission is not for.

The document explicitly states: "No clinical tests were performed to support safety and efficacy of the subject devices. The performance bench evaluations and tests were used as a basis for the determination of substantial equivalence. The results of each evaluation or test show that when compared to the predicate devices have demonstrated substantially equivalent performance."

The types of "acceptance criteria" for these devices are related to mechanical properties and material compatibility, derived from standards like ASTM and ISO. These are not presented in a quantitative performance table like for an AI device.

To summarize, based on the provided document:

• This submission is for physical metallic bone fixation appliances, not an AI/software device.
• Therefore, the requested information template for AI device performance and validation studies is not applicable.
• The "studies" performed were non-clinical benchtop tests (e.g., Finite Element Analysis, Insertion/Removal Torque, Fatigue Testing, Biocompatibility).
• The "acceptance criteria" are implied by meeting the requirements of the referenced ASTM and ISO standards for substantial equivalence to predicate devices.

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The TRIGEN INTERTAN Nails are indicated for fractures of the femur including:

• Fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, and segmental shaft fractures; subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures: and intracapsular fractures
• · Polytrauma and multiple fractures
• · Prophylactic nailing of impending pathologic fractures
• · Reconstruction following tumor resection and grafting

The TRIGEN INTERTAN 10S Nail System consists of metallic implants including femur nails, leg screw, compression screw, Subtrochanteric lag screw, locking screw, Set Screw, and nail caps.

TRIGEN INTERTAN 10S nail is designed to have a slightly different neck taper from the existing neck design of the predicate TRIGEN INTERTAN 10mm Nail (K040212, SE 02/20/2004). The neck taper of the subject devices has been modified to accommodate the different patient population.

The TRIGEN INTERTAN 10S system is intended to provide a solution for treatment of proximal femoral fractures with one nail product. The INTERTAN nail includes two interlocking screws near the proximal end that form a worm gear, which is designed to provide stability for hip fracture cases.

The subject TRIGEN INTERTAN 10S nails are made of Titanium-6 Aluminum-4 Vanadium (Ti-6Al-4V). The 10S nails are available in both long and short nails. The "S" stands for shey are the smallest diameter nails offered. Design wise, the small diameter and a change to the subject INTERTAN 10S Nail implants are avallable in the 10mm diameter size, with lengths from 18cm to 46cm in 2cm increments, in both 125° or 130° neck angle versions. The INTERTAN 10S nails are single-use and are Gamma sterilized.

The provided text is a 510(k) premarket notification FDA clearance letter for a medical device called the "TRIGEN INTERTAN 10S Nail System." This documentation focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study or an AI algorithm's standalone performance.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), or training set information for an AI/algorithm-driven device.

The document states:

• "No clinical tests were performed to support safety and effectiveness of the subject devices."
• "The performance bench tests were used as a basis for the determination of substantial equivalence."

The "acceptance criteria" referred to in the document relate to a pre-market clearance process demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, primarily through bench testing to show similar performance characteristics.

In the context of the provided document, the "study that proves the device meets the acceptance criteria" refers to non-clinical bench tests. These tests assess the mechanical and physical properties of the device, rather than its clinical performance or the performance of an AI algorithm.

Here's what can be extracted from the document, though it won't fulfill all aspects of your request:

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

The document mentions "performance bench tests" but does not provide a table of specific acceptance criteria (e.g., minimum tensile strength, fatigue cycles) or the exact reported device performance values. It generalistically states: "The results of these tests show that the substantially equivalent to the predicate device."

• Mentioned Bench Tests:
  • Proximal Shaft Fracture Construct Fatigue Testing
  • MR Compatibility per ASTM F2182-19e2, ASTM F2052-15, ASTM F2213-2017, and ASTM F2119-07(2013)

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

• Sample Size: Not specified for the bench tests.
• Data Provenance: Not applicable in the context of clinical data for a 510(k) of this nature. The "data" would be the results of mechanical and material tests conducted on the device components, typically in a lab setting.

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

• Not applicable. Ground truth in the context of mechanical bench testing refers to the physical measurements and standards of the materials and device. Expert consensus as you might see in image interpretation for AI is not relevant here.

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

• Not applicable. No human interpretation or adjudication method is described for generating "ground truth" for the bench tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No. The document explicitly states: "No clinical tests were performed to support safety and effectiveness of the subject devices." MRMC studies are clinical studies involving human readers, which were not conducted.

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

• No. This device is a physical orthopedic implant, not an AI/algorithm. No algorithm performance was assessed.

7. The type of ground truth used:

• Bench Test Results/Standard Specifications: The "ground truth" for demonstrating substantial equivalence for an orthopedic implant through bench testing is typically based on established industry standards (e.g., ASTM standards for mechanical properties) and comparison to the performance of the predicate device.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. No training set was used.

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NET BRAND Osteosynthesis Nailing System are provided non-sterile.

Tibial Nails are indicated for stabilization of fractures of proximal and distal tibial shaft, open and closed tibial shaft fractures, certain pre and postisthmic fractures, non-unions and malunions.

Femoral Nails are indicated for stabilization of femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.

The Elastic Nails are indicated for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or the flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in paediatric or small statured patients, the flexibility of the elastic intramedullary nailing allows it to be inserted at a point which avoids disruption of the bone growth plate.

All Implants are for single use only.

NET BRAND Osteosynthesis Nailing System consists of various shape and sizes of Nails and Screws, Locking Bolts.

The NET BRAND Osteosynthesis Nailing System are fabricated from Stainless Steel And Titanium.

The system contains several models based on the size of the device and application site such as fixation/reconstruction of Tibia and Femoral bones appropriate for the device. The Nail implants are available in many diameters and lengths.

These all are mainly divided into

• Tibia Nail
• Femoral Nail
• Elastic Nail
• Corresponding Screws and Locking Bolts for Fixations of These Nails.

These implants are supplied non-sterile, the products have to be sterilized prior to use.

The provided text is a 510(k) Premarket Notification for the "NET BRAND Osteosynthesis Nailing System." This document primarily focuses on demonstrating substantial equivalence to predicate devices based on material, performance standards, and dimensional verification, rather than presenting a standalone study with detailed acceptance criteria and performance data for the device itself.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not extensively provided or applicable in the context of this 510(k) submission.

However, I can extract the information that is present concerning performance standards and the comparison with predicate devices.

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

The document states that the performance standards used in both the Subject Device (NET Brand) and the predicate device are "Equivalent." This implies that the NET BRAND Osteosynthesis Nailing System is expected to meet the performance criteria defined by these standards, which were also met by the predicate devices.

Here's a table summarizing the performance standards the device was tested against:

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

The document does not explicitly state the sample sizes for the "side-by-side testing" that was performed. It only mentions that these tests were conducted. The data provenance is not specified beyond the fact that the tests were conducted as part of this 510(k) submission by Narang Medical LTD. in India.

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 is not applicable as the submission relies on adherence to engineering performance standards rather than human-interpreted ground truth from medical imaging or clinical outcomes.

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

This is not applicable as the evaluation method is based on mechanical performance testing against established standards, not human expert adjudication.

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 applicable; the device is an osteosynthesis nailing system (physical implant), not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable; the device is a physical medical implant.

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

The "ground truth" in this context refers to the defined performance requirements as outlined in the ASTM material and performance standards (ASTM F 136, ASTM F 139, ASTM F 1264, ASTM F 384, ASTM F 543). The device's performance was compared "side-by-side" with predicate devices against these technical specifications to demonstrate equivalence.

8. The sample size for the training set

This is not applicable as the device is a physical implant and does not involve AI/machine learning requiring a training set.

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

This is not applicable.

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The TRIGEN META-NAIL Retrograde Femoral Nail is indicated for fractures of the femur including stable and unstable distal metaphyseal fractures, diaphyseal fractures, intra-articular fractures, and peri-prosthetic fractures.

The TRIGEN META-NAIL Antegrade Tibial Nail is indicated for stable and unstable fractures of the proximal and distal third of the tibia, including the shaft.

The TRIGEN META-NAIL Nail Systems is designed to be used for internal fixation of long bones in skeletally mature patients. The Subject TRIGEN META-NAIL Systems include TRIGEN Retrograde Femoral, Supracondylar and Tibial Nails (K051557, 6/30/2005), TRIGEN Meta-Nail Retrograde Femoral and Tibial Nails and TRIGEN META-NAIL Nail Cap Set Screw (K061019, 6/6/2006). The subject Smith & Nephew TRIGEN META-NAIL Systems devices are identical in function, design features, materials, sterilization, manufacturing methods and operational principles to what was previously 510(k) cleared. These labeling updates do not affect the safety and effectiveness of the subject devices when used as labeled. The TRIGEN META Antegrade Tibial Nails and the TRIGEN META Retrograde Femoral Nails are intended for the internal fixation of long bones in skeletally mature patients. The TRIGEN META Antegrade Tibial Nails and the TRIGEN META Retrograde Femoral Nails have a round, cannulated geometry and are composed of biocompatible titanium alloy (Ti-6AI-4V complied to ASTM F1472/ISO 5832-3). The TRIGEN META-NAIL Antegrade Tibial & Retrograde Femoral Nails are provided preassembled with polyethylene sleeves, which are manufactured from ultra-high molecular weight polyethylene (UHMWPE)] conforming to ASTM F648 and ISO 5834-2. The TRIGEN META Antegrade Tibial Retrograde Femoral Nailing System also include nail cap set screws. The META Nail Cap Set Screw is also composed of the same Titanium alloy (TI-6Al-4V) as the nail implants. These implants are design to provide a solution for fracture fixation and are offered in a variety of diameters (8.5-13mm) and lengths (16-50cm). The implants within this system are single-use and are Gamma sterilized.

I am sorry, but based on the provided text, I cannot provide the detailed information you requested about acceptance criteria and a study proving device performance. The document is primarily a 510(k) premarket notification for a medical device (TRIGEN META-NAIL Nail System) and focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Here's why I cannot fulfill your request and what the document does say:

1. No Acceptance Criteria or Performance Data Presented: The document explicitly states: "These labeling updates do not affect the safety and effectiveness of the subject devices when used as labeled. Therefore, since there are no changes to the design features, materials, or manufacturing methods of the subject TRIGEN META-NAIL Nail System devices, no performance testing (bench, animal, clinical) was required." This means there is no new study or performance data presented in this particular submission to establish acceptance criteria or demonstrate performance.

2. Focus on Substantial Equivalence: The entire submission is built on the premise that the TRIGEN META-NAIL Nail System is "substantially equivalent" to predicate devices (K051557, K061019, K981529). Substantial equivalence means that the device has the same intended use as a predicate, and either has the same technological characteristics or, if it has different technological characteristics, the information submitted demonstrates that the device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness.

3. Labeling Updates, Not Device Changes: The purpose of this 510(k) is specifically for "labeling updates which include indication updates in IFU/Package Insert." It states: "There are no significant changes in design, technological characteristics, function, sterilization and packaging of the devices, as a result of this submission."

Therefore, I cannot extract information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document does not contain the kind of study data you are asking for because none was required for this particular submission (a labeling update for an already cleared, substantially equivalent device).

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DePuy Synthes Tibial Nail Advanced System:

The Tibial Nail Advanced implants are intended for treatment of fractures in adolescents (12-21) in which the growth plates have fused. Specifically, the implants are indicated for:

• · Open and closed proximal and distal tibial fractures
• Open and closed tibial shaft fractures
• · Tibial malunions and nonunions

DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm:

DePuy Synthes Locking Screws are used for the static and dynamic interlocking of femoral, humeral and tibial nails.

DePuy Synthes Tibial Nail Advanced System:
The DePuy Synthes Tibial Nail Advanced System is a system comprised of intramedullary nails, locking screws, end caps implants, as well as system-specific insertion instruments. The Tibial Nail Advanced System is intended to be used for temporary fixation and stabilization of tibia. This system enables three different surgical approaches for the insertion of the nailing implant in the tibia: suprapatellar. parapatellar, and infrapatellar. The implants are manufactured from titanium alloys and provided in a range of dimensions to match individual patient anatomy. The intramedullary nailing implants are cannulated and can be inserted over a reaming rod. The nailing implants are offered in a range of proximal and distal shaft diameters and lengths to accommodate patient anatomy and surgical need related to the specific fracture patterns and locations. The nails will be manufactured from titanium alloy (Ti-6Al-4V) and polyetherketone (PEEK).

DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm:

The DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm have a diameter of 5 mm available in lengths ranging from 26 up to 120 mm and a diameter of 4 mm available in lengths ranging from 18 up to 80 mm. These implantable devices are fully threaded at the shaft and are self-tapping. The locking screws feature either a standard screw head or a low-profile screw head. The screws are made from titanium alloy (Ti-6Al-7Nb).

This appears to be a 510(k) summary for a medical device (DePuy Synthes Tibial Nail Advanced System and Locking Screws). These submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed studies with specific acceptance criteria, sample sizes, and expert adjudication for AI/software performance.

Therefore, the requested information regarding AI/software performance studies, acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, and MRMC studies is not present in the provided document.

This document describes a traditional medical device (implants and screws for bone fixation) and its non-clinical performance data (mechanical testing, biocompatibility, MRI safety), comparing it to predicate devices. There is no mention of any AI or software component in this device.

Table of Acceptance Criteria and Reported Device Performance:

Since this document describes a physical medical device (implants and screws) and not an AI/software device, the acceptance criteria and performance are based on non-clinical tests comparing it to predicate devices. The document states that the new device is "substantially equivalent" to predicate devices, meaning it performs at least as safely and effectively.

Regarding AI/Software specific questions:

1. Sample size used for the test set and the data provenance: Not applicable. This document does not describe an AI/software device or a test set of data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for an AI/software test set is mentioned.
3. Adjudication method for the test set: Not applicable. No adjudication for an AI/software test set is mentioned.
4. 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: Not applicable. No AI component is described.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No AI component is described.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for these devices would be established by physical measurements and engineering standards.
7. The sample size for the training set: Not applicable. No AI component is described.
8. How the ground truth for the training set was established: Not applicable. No AI component is described.

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Device Name: Auxein Nailing system

Indications for Use (Describe)

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

1. Expert Tibia Nailing System 2. Expert Femoral Nailing System 3. Ga-mma Nailing System 4. AJAX Advance nailing system 5. Elastic Nailing System 6. Humeral Nailing System 7. Retrograde Nailing System INDICATION FOR USE:

2. 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 the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non- unions.

3. 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.

4. 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, malunion 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.

5. 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.

6. 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 .

7. 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.

8. 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 turnor 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.

Auxein Brand of Expert Tibia Nail system consists of various shape and sizes of nails featuring proximal & distal holes, End cap & 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 8 mm to 12 mm; the length varies from 255 mm to 375 mm.

The screw implants are in corresponding diameter of 4.4 mm & 4.8 mm diameters with lengths varying as per the requirements and minimum length: 18 mm to maximum length 90 mm.

Auxein Brand of Expert Femoral Nail system consists of various shape and sizes of nails featuring proximal & distal holes, End cap, 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 9 mm to 13 mm; the length varies from 320 mm to 440 mm.

The screw implants are in corresponding diameter of 4.8 mm, 6.4 mm diameters with lengths varying as per the requirements and minimum length: 25 mm to maximum length 130 mm.

Auxein Brand of Ga-mma Nailing system consists of various shape and sizes of nails featuring proximal & distal holes, End cap, Inner screw, locking bolts, Antirotation 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 9 mm to 13 mm; the length varies from 180 mm to 440 mm.

The screw implants are in corresponding diameter of 4.8 mm, 6.4mm & 10.5 mm diameters with lengths varying as per the requirements and minimum length: 26 mm to maximum length 120 mm.

Auxein Brand of Humeral Nailing system consists of various shape and sizes of nails featuring proximal & distal holes, End cap, 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 7mm to 9 mm; the length varies from 180 mm to 320 mm.

The screw implants are in corresponding diameter of 3.5 mm & 4.5 mm diameters with lengths varying as per the requirements and minimum length: 20 mm to maximum length 70mm.

Auxein Brand of AJAX Advance Nailing system consists of various shape and sizes of nails featuring proximal & distal holes, End cap, locking bolts, Cephalic screw, 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 9 mm to 12 mm; the length varies from 170 mmto 420 mm.

The screw implants are in corresponding diameter of 4.9 mm & 10.5 mm diameters with lengths varying as per the requirements and minimum length: 26 mm to maximum length 120 mm.

Auxein Brand of Elastic Nailing system consists of various shape and sizes of nails featuring end cap 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 1.5 mm to 4.0 mm; the total length of 440 mm.

The end caps are in corresponding diameter ranges from 1.5 mm to 4.0 mm diameters with length of 14 mm & 25 mm.

Auxein Brand of Retrograde Nailing system consists of various shape and sizes of nails featuring proximal & distal holes, End cap & 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 10 mm to 12 mm; the length varies from 180 mm to 360 mm.

The screw implants are in corresponding diameter of 5.0 mm diameters with lengths varying as per the requirements and minimum length: 32 mm to maximum length 80 mm.

These implants are sold non-sterile, the products have to be sterilized prior to use.

This document is a 510(k) Premarket Notification from Auxein Medical Private Limited for their "Auxein Nailing System". The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance criteria by comparing the proposed device against predicate devices and relevant ASTM standards. The reported performance is often stated as "Equivalent" to the predicate.

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

The document does not specify a sample size for a test set that would typically be associated with clinical performance or accuracy studies. This submission is for a medical device (intramedullary fixation rod) and relies heavily on bench testing (non-clinical testing) and substantial equivalence to predicate devices. The data provenance is primarily from bench tests conducted by Auxein Medical Private Limited, presumably in India where the manufacturing unit is located. There is no mention of retrospective or prospective clinical data for the new device.

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

This section is not applicable in the context of this 510(k) submission. The submission focuses on substantial equivalence for a physical medical device based on engineering and material standards, not an AI/software device requiring expert adjudication of outputs.

4. Adjudication Method for the Test Set:

This section is not applicable as the submission describes an intramedullary fixation rod, not an AI/software device that would involve human adjudication of results.

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

This section is not applicable. An MRMC study is relevant for evaluating the performance of AI-assisted systems where human readers interpret medical images or data. This submission is for a physical medical device.

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

This section is not applicable. This describes a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device is based on:

• Engineering and Material Standards: Compliance with ASTM F 136, ASTM F899-12b (material standards), and ASTM F 1264, ASTM F 384, ASTM F 543 (performance standards).
• Comparison to Predicate Devices: The dimensional and performance characteristics of the new device are compared to established predicate devices (which have already demonstrated safety and efficacy).

Essentially, the "ground truth" is that the device meets the established performance and material specifications demonstrated by predicate devices and recognized consensus standards.

8. The Sample Size for the Training Set:

This section is not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

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

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

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WIN Flexible Nail System

WIN Nails (for use in pediatric patients) are to be used for treatment of long-bone fractures including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures.

This device is intended for osteosynthesis.

The WIN Flexible Nail System is to be used for treatment of long-bone fractures including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, distal third fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures.

The subject WIN Flexible Nail System is made of titanium alloy, which has been continuously made commercially available since the 1950s. This device is to be implanted by insertion into long bones for fixation of fractures.

This document is a 510(k) premarket notification for the "WIN Flexible Nail System" and focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in the context of AI/software performance.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, ground truth, and MRMC studies is not applicable to this type of submission.

Here's an analysis based on the provided document:

1. Table of acceptance criteria and the reported device performance

• Not Applicable. This document does not describe performance metrics for a diagnostic or AI device with specific acceptance criteria. It's for a physical medical device (bone fixation nails) and focuses on mechanical properties and material equivalence to a predicate.

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

• Not Applicable. No test set or data provenance details are relevant for this type of device submission. The submission relies on demonstrating equivalence through comparison of materials, design features, and intended use, rather than a clinical performance study.

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)

• Not Applicable. There is no "ground truth" establishment in the context of an AI/diagnostic device performance study mentioned in this document.

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

• Not Applicable. No adjudication method for a test set is discussed.

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

• Not Applicable. This is not an AI/software device, so no MRMC study was conducted or is relevant.

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

• Not Applicable. This is a physical orthopedic implant, not an algorithm.

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

• Not Applicable. There is no ground truth concept as defined for AI/diagnostic devices in this submission. The "ground truth" in this context is established by the known properties and clinical history of the predicate device and the materials used.

8. The sample size for the training set

• Not Applicable. No training set is involved as this is not a machine learning/AI device.

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

• Not Applicable. No training set or ground truth for it is relevant.

Information provided in the document related to the device and its assessment:

• Device Name: WIN Flexible Nail System
• Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories
• Regulatory Class: Class II
• Product Code: JDS
• Indications for Use: To be used for treatment of long-bone fractures (including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures) in pediatric patients.
• Predicate Device: Pediatric Fixation Rods (K000764) and 2mm Pediatric Flex Nail (K022531)
• Basis for Substantial Equivalence:
  • Intended Use: Identical to predicate
  • Indications for Use: Identical to predicate
  • Materials: Identical to predicate (titanium alloy, commercially available since the 1950s)
  • Design Features: Similar to predicate
  • Sterilization: Identical to predicate
• Non-Clinical Tests: "None provided" - The document explicitly states no non-clinical tests were provided in this section of the summary. This implies reliance on the equivalence to the predicate and the established properties of the materials.
• Clinical Tests: "None provided" - No clinical tests were provided for this submission.

Conclusion from document: The submission concludes that the differences between the subject device and the predicate do not raise new questions of safety and effectiveness, and the subject device is at least as safe and effective as the legally marketed predicate devices. This is a common approach for Class II devices demonstrating substantial equivalence.

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The Conventus Orthopaedics PHS™ System is indicated for the fixation of proximal humerus fractures except when there are too many fracture fragments to repair the articular surface.

The Conventus PHS™ is an intramedullary device intended to treat proximal humerus fractures. The PHS™ System is a self-expanding implant which is deployed into the medullary canal and provides a scaffold to which bone fragments are attached using fragment screws. The implant is made from titanium alloy (Ti-6Al-4V ELI) and Nitinol.

The provided text describes a medical device called the Conventus PHS™ System, an intramedullary device for fixing proximal humerus fractures. However, it does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of diagnostic or AI-assisted performance.

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through mechanical and biocompatibility testing. It outlines the device's physical properties and mechanical performance, not its diagnostic accuracy or the performance of any AI component.

Therefore, I cannot provide details for most of your requested information as it is not present in the provided text.

Here is what I can extract:

1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or performance metrics related to diagnostic accuracy or AI performance. The pre-clinical tests performed are mechanical and material characterization tests (e.g., static and cyclic axial/bend testing, screw pullout testing, corrosion testing, wear testing, biocompatibility testing, animal testing). The conclusion is simply that "The results demonstrate that the PHS™ System is substantially equivalent to the legally marketed predicate devices," without providing specific numerical acceptance criteria or performance values for these tests.

2. Sample size used for the test set and the data provenance
Not applicable. There is no "test set" in the context of diagnostic or AI performance evaluation described. The "testing" refers to mechanical and material characterization of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment for a diagnostic test set is described.

4. Adjudication method for the test set
Not applicable. No test set adjudication method is described.

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
No. An MRMC study or any study involving human readers or AI assistance is not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. There is no mention of an algorithm or AI performance.

7. The type of ground truth used
Not applicable. No ground truth for diagnostic or AI performance is established. The "ground truth" equivalent for the pre-clinical tests would be established engineering standards and material properties, but these are not for diagnostic performance.

8. The sample size for the training set
Not applicable. No training set for an AI or diagnostic algorithm is mentioned.

9. How the ground truth for the training set was established
Not applicable. No training set for an AI or diagnostic algorithm is mentioned.

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The China Nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures. The Smith & Nephew, Inc. China Nails are for single use only.

Subject devices of this submission are China Nails and Accessories. The implant components included in the system are described in the following table.

The implants are manufactured from titanium alloy (Ti-6Al-4V).

This document describes the Smith & Nephew China Nails and Accessories, an intramedullary nail system. The information provided is for a 510(k) premarket notification, which is a submission to the FDA demonstrating that the device is substantially equivalent to legally marketed predicate devices. Therefore, the "acceptance criteria" and "study" are framed within the context of demonstrating substantial equivalence through non-clinical performance testing rather than a clinical trial with specific performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set (for mechanical testing): The document does not specify the exact sample size for the fatigue testing and wear evaluation. It only states that "Mechanical testing was conducted." Given the nature of medical device premarket notifications, these tests typically involve a statistically relevant number of samples to demonstrate performance.
• Data Provenance: The data is from non-clinical bench testing conducted by the manufacturer, Smith & Nephew, Inc. There is no mention of human subject data, and the context indicates that clinical data was not needed for this submission. The testing would have been performed in a laboratory setting.

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

• Ground Truth for Test Set: Not applicable in the traditional sense for a clinical study. For bench testing, the "ground truth" is established by engineering principles, accepted test methods (e.g., ASTM or ISO standards for medical implants), and comparison against predicate device performance. The experts involved would be biomechanical engineers, material scientists, and regulatory specialists within Smith & Nephew responsible for designing, executing, and interpreting the mechanical tests. Their specific number and qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (like 2+1, 3+1) are used for clinical studies involving multiple human readers or evaluators to resolve discrepancies in diagnoses or assessments. This submission relies on non-clinical mechanical testing and comparison to predicate devices, where adjudication of subjective interpretations is not relevant.

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

• Not applicable. This is not an AI/software device and no MRMC study was conducted. The device is a physical orthopedic implant.

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

• Not applicable. This is not an algorithm or software. It is a physical medical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is based on:
  • Engineering Standards and Specifications: Adherence to established material properties and dimensional specifications.
  • Bench Test Results: Quantitative and qualitative data from fatigue testing and wear evaluation according to industry-accepted protocols.
  • Predicate Device Performance: The established performance characteristics and safety profile of the legally marketed predicate devices (Smith & Nephew TRIGEN InterTAN, Smith & Nephew SURESHOT TAN and Accessories, Smith & Nephew TRIGEN Low Profile Bone Screws). The China Nails and Accessories are considered "substantially equivalent" if their performance in these tests is comparable to the predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not a machine learning or AI model that requires a training set. The "training" for such a device involves product development, manufacturing processes, quality control, and adherence to design specifications based on engineering principles.

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

• Not applicable for the same reasons as point 8.

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