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The Cannulated Compression Device System is indicated for fracture fixation of small and long bones. The system is not intended for spinal use.

The Cannulated Compression Device System is used to aid in the alignment and stabilization of bone fractures. The system consists of the following parts:

• A cannulated compression device body with distal threads for bone engagement and distal portals that allow passage of deployable integral anchors to achieve stabilization distally within the bone. The anchors may be retracted for removal of the device if and when it is necessary. The device will be provided in a pre-assembled condition with the deployable anchors and a distal end cap already installed. The device will be available in a variety of lengths.
• A compression nut will be provided separately in various configurations, including both threaded and non-threaded versions. The compression nut has a proximal head and internal threads. The proximal head engages the bone fragment. The internal threads allow engagement to the cannulated compression device body. As the compression nut is tightened onto the device body compression is achieved across the bone fragments. The rate of compression varies based on the proximal head configuration selected.
  ODi-NA will manufacture the implants from implant grade titanium allov (Ti-6AL-4V-ELI) per ASTM F136. The implants will be offered in both sterile (steam) and non-sterile packaging configurations and are intended for single-use.

The provided text is a 510(k) summary for the Cannulated Compression Device System. It describes the device, its indications for use, and a comparison to predicate devices, along with performance data. However, it does not contain the information required to fill in the table and answer all the questions about acceptance criteria and a study proving a device meets them, particularly in the context of an AI/ML algorithm.

This document describes a physical medical device (cannulated compression device for bone fracture fixation), not an AI/ML algorithm or software. Therefore, many of the requested fields are not applicable to the content provided (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance).

Here's what can be extracted and what cannot:

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

Note: The document states that the device was "evaluated" and "tested" against these standards and criteria, and that it "meets the specified endotoxin limit." Specific numerical results of these evaluations and tests are not provided in this summary. The "acceptance criteria" here refers to the standards used for mechanical and biological testing of the physical hardware, not the performance of an AI/ML system.

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 / Not provided. The study described is for a physical medical device, involving mechanical and biological testing according to ASTM standards. There is no "test set" in the context of software/AI data, nor "data provenance." The tests would involve physical samples of the device and biological samples for pyrogen testing.

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 / Not provided. This information is relevant for AI/ML studies where human experts establish ground truth for image interpretation or diagnosis. For a physical device, ground truth is established by measured physical properties or biochemical assays against established standards.

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

• Not applicable / Not provided. Adjudication methods are used in AI/ML studies to resolve disagreements among human experts when establishing ground truth. This is not relevant for the mechanical and biological testing of a physical device.

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 / Not provided. MRMC studies are specific to evaluating AI/ML systems, particularly in medical imaging, to compare human performance with and without AI assistance. This document describes a physical bone fixation device.

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

• Not applicable / Not provided. This pertains to the performance of an AI/ML algorithm without human intervention. The device in question is a physical surgical implant.

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

• For the mechanical tests (torsional strength, driving torque, pullout strength, bend strength), the "ground truth" would be the measured physical properties of the device, compared against the specifications defined by the ASTM standards (F543-17 and F1264-16).
• For the pyrogen testing, the "ground truth" is the measured endotoxin level compared against the specified limit of 20.0 USP Endotoxin Units per device, as per ANSI/AAMI ST72 using the Limulus amebocyte lysate (LAL) test.

8. The sample size for the training set

• Not applicable / Not provided. This is relevant for AI/ML algorithms.

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

• Not applicable / Not provided. This is relevant for AI/ML algorithms.

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The Asnis® III Cannulated Screw System intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
The Asnis® PRO Cannulated Screw System intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.

The Asnis® III Cannulated Screw System, previously cleared in K000080, K024060, consists of self-tapping cannulated screws and the corresponding washers. All devices in the system are provided sterile and non-sterile. The thread diameters are 4.0, 5.0. 6.5, and 8.0 mm. They are either fully or partially threaded. All screws are self-drilling and self-tapping. There are corresponding washers to the 4.0 and 5.0 mm screws respectively and one washer fitting for both diameters, 6.5 and 8.0 mm. Screws and washers are made of stainless steel and titanium alloy.
The Asnis® PRO Cannulated Screw System consists of self-tapping cannulated screws. All devices in the system are provided sterile and non-sterile. The thread diameters are 6.5, and 8.0 mm. They are either fully or partially threaded. All screws are self-drilling and self-tapping. Screws are made of stainless steel and titanium alloy.
The subject of this bundled traditional submission is to introduce minor design specification changes; MRI Labeling, shelf-life update of existing package to 10 years, and re-branding Ø6.5/8.0 mm long screws (130-180 mm to Asnis® PRO Cannulated Screw System) to the Asnis® III Cannulated Screw System, cleared in K000080 and K024060 and to introduce a new system Asnis® PRO Cannulated Screw System.

The provided document is a 510(k) Summary for the Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System. It outlines the reasons for the submission and compares the new devices to predicates. However, it explicitly states there was no clinical data or clinical trials needed for this device submission. The changes made (minor design specification changes, MRI labeling, shelf-life update, and re-branding) did not create a new "worst case" scenario that would necessitate mechanical testing beyond what was already performed for the predicate device.

Therefore, the following information regarding acceptance criteria and studies to prove device performance cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance: No new performance data is presented, as the document states "No mechanical testing was deemed necessary."
2. Sample size used for the test set and the data provenance: No new test set was used for mechanical performance, and no clinical data was collected.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no test set requiring expert ground truth.
4. Adjudication method for the test set: Not applicable.
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 a medical device (screws), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

What the document does state regarding performance:

• Performance Data (Nonclinical):
  • "No mechanical testing was deemed necessary as the design modifications and the new system introduction do not create a new worst case. All bench tests performed in accordance with ASTM F543 and previously presented in Asnis® III Cannulated Screw System (K024060), remain true and accurate."
  • Tests performed to establish compatibility with a magnetic resonance environment:
    • Magnetically Induced Displacement per ASTM F2052
    • Magnetically Induced Torque per ASTM F2213
    • RF Heating per ASTM F2182
    • Image Artifacts per ASTM F 2119
• Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device."

In summary, this 510(k) submission relies on the substantial equivalence to its predicate devices and the existing non-clinical performance data for those predicates (K000080, K024060, and K140891), along with new MRI compatibility testing for the modified/new devices. No new trials or studies to establish performance against acceptance criteria in a traditional sense (e.g., diagnostic accuracy, clinical outcomes) were conducted or deemed necessary for this submission.

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AxSOS 3 Ti is intended for long bone fracture fixation

Indications include:

• Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
• Non-unions and malunions
• Normal and osteopenic bone
• Osteotomies
• Periprosthetic fractures of the femur and proximal tibia.

The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of:

• Periprosthetic fractures
• Diaphyseal and metaphyseal areas of long bones in pediatric patients

The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis

The AxSOS 3 Ti system (also referred to as the AxSOS 3 Ti Locking Plate system) is a system used for internal fixation applications. The system includes anatomically contoured monoaxial locking plates, as well as screws and blind screws (limited to waisted compression plates) . The plates have been designed with holes that can accommodate either locking or non-locking screws, and also include holes for suture and Kirschner wires (K-wires). The screws come in 3 types (locking, cortical, and cancellous) and are available in several different diameters. All implantable components are available sterile and non-sterile and are manufactured from titanium alloy (Ti6Al4V-ELI) per ASTM F136.

The AxSOS 3 Ti 5.0mm Cable Plug is categorized as permanent, direct bone/tissue patient contacting implant with contact duration >30 days. It is manufactured from titanium alloy (ASTM F136, Ti6Al4V-ELI) and is Type II anodized. It is designed to be used in combination with the 5.0mm AxSOS 3 Ti system. It is an aid for internal fixation component used in conjunction with the AxSOS 3 Ti 5.0mm distal lateral femur, broad compression and narrow compression plates. The Cable Plug is threaded or clicked into a 5.0mm universal locking hole of the AxSOS 3 Ti plates and provides a positioning point for a cerclage cable.

The provided text is related to a 510(k) premarket notification for a medical device (AxSOS 3 Ti) and focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a study demonstrating the device meets specific acceptance criteria through AI/ML performance.

The document discusses:

• Device Name: AxSOS 3 Ti
• Regulation Number and Name: 21 CFR 888.3030 (Single/Multiple Component Metallic Bone Fixation Appliances And Accessories) and 21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener).
• Regulatory Class: Class II
• Product Code: HRS, HWC
• Indications for Use: Long bone fracture fixation, including various types of fractures, non-unions, malunions, normal and osteopenic bone, osteotomies, and periprosthetic fractures. Also specific indications for Waisted Compression Plates in pediatric patients and for the scapula and pelvis.
• Predicate Devices: AxSOS 3 Ti (K153379 & K162439) and Dall-Miles Homogenous Vitallium Cable (K961283).
• Reference Devices: Fixos Screw System (K133451) and Asnis III Cannulated Screw System (K000080).
• Non-Clinical Testing: Performed to ASTM standards for pull-out, dynamic compression, and MR compatibility (magnetically induced displacement force, torque, heating, and image artifacts).
• Clinical Testing: Not required for this submission.

Therefore, we cannot answer your request based on the provided text because it does not contain information about:

• Acceptance criteria and reported device performance related to AI/ML. The device is a bone fixation system, not an AI/ML-driven diagnostic or therapeutic device.
• Sample size for a test set (in the context of AI/ML).
• Data provenance (country of origin, retrospective/prospective) for AI/ML data.
• Number of experts and their qualifications for establishing ground truth for AI/ML.
• Adjudication method for an AI/ML test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study for AI/ML.
• Standalone (algorithm only) performance for AI/ML.
• Type of ground truth (expert consensus, pathology, outcomes data) for AI/ML.
• Sample size for the training set (for AI/ML).
• How ground truth for the training set was established (for AI/ML).

The document is a regulatory approval letter for a conventional medical device based on engineering and materials testing, not an AI/ML performance study.

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The Shotel Ankle Arthrodesis Nail System is intended for the following:

• Charcot Foot
• Avascular necrosis of the talus
• Failed total ankle arthroplasty
• Trauma (malunited tibial pilon fracture)
• Severe deformity or instability as a result of talipes equinoivarus, cerebral vascular accident, paralysis or other neuromuscular disease
• Revision ankle arthrodesis
• Neuroarthropathy
• Rheumatoid arthritis
• Osteoarthritis
• Pseudoarthrosis
• Post-Traumatic arthrosis
• Previously infected arthrosis
• Severe end stage degenerative arthritis
• Severe defects after tumor resection
• Pantalar arthrodesis

The Shotel Ankle Arthrodesis Nail System is an implantable intramedullary system of fusion nails, bone screws, a nail cap and a set of instruments for primary ankle fusion. The curved fusion nail has 6 screw holes that can accommodate up to 6 bone screws and is available in seven (7) diameters in two configurations, left and right. The four (4) distal cross locking holes provide the surgeon with either a static or dynamic cross locking hole in alternative 90 degree orientation configurations. The 5mm fixation bone screws are offered in 27 lengths and the nail caps are available in two configurations; standard nail cap length and a plus 5 mm nail cap length affording the surgeon the ability to slightly adjust the final nail assembly length. All three implant components are manufactured from titanium Ti-6Al-4V and are single use only. Components are offered sterile and non-sterile.

This document is a 510(k) premarket notification for a medical device called the "Shotel Ankle Arthrodesis Nail System." It describes the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to legally marketed predicate devices.

Here's a breakdown of the requested information based on the provided text, with a strong caveat: This document is a regulatory submission for a medical implant (a nail system), not an AI/software as a medical device (SaMD) or diagnostic imaging device. Therefore, many of the requested elements (like acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable or not provided in the context of this type of device.

The "performance data" referred to in this document relates to mechanical and material performance of the implant, not diagnostic accuracy or AI performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. This is not a study assessing a diagnostic or AI device with a test set of data. The "testing" refers to physical and mechanical evaluation of the implant itself, not evaluation on patient data.
• Data Provenance: Not applicable in the context of diagnostic/AI data. The materials and mechanical tests were performed on the device components.

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

• Not applicable. Ground truth as typically understood for diagnostic/AI studies (e.g., expert consensus on images, pathology results) is not relevant for this mechanical device submission.

4. Adjudication method for the test set

• Not applicable. There is no "test set" in the diagnostic/AI sense to adjudicate.

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 a study involving human readers or AI assistance.

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

• Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used

• Not applicable in the diagnostic/AI sense. The "ground truth" for this device's performance would be established through engineering standards (e.g., ASTM F1264) and measurements comparing the device's physical properties to those standards and predicate devices.

8. The sample size for the training set

• Not applicable. There is no training set as understood for AI/machine learning.

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

• Not applicable. There is no training set for this device.

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The Large Screws range is intended for the fixation of bone fractures, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults.

The Large Screws range consists of screws designed for the fixation of bone fractures, pseudarthroses, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults. The Large Screws range will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. Materials: Titanium alloy Ti-6Al-4V ELI (conform to ASTM F 136-12a and/or ISO 5832-3). Function: The implants of the Large Screws range are indicated for the fixation of bone fractures, pseudarthroses, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults.

The provided text describes a medical device (Large Screws range) and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria for a study, nor does it present the results of a study designed to meet specific acceptance criteria.

The document is a 510(k) summary, which is a premarket notification to the FDA demonstrating that a device is substantially equivalent to a legally marketed predicate device. This process typically relies on demonstrating equivalence through comparison of technological characteristics, materials, and non-clinical testing, rather than a study against specific performance acceptance criteria as one might see for a novel AI/software medical device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The document lists "Non-clinical Test Summary" items (Comparative torsional tests, Comparative pullout engineering analysis, Driving torque tests) but does not provide specific acceptance criteria or performance data for these tests. It also explicitly states "No clinical studies were performed."
2. Sample size used for the test set and the data provenance: Not applicable, as there's no clinical "test set" described. The non-clinical tests would have involved samples of the screws, but details on sample size, other than implied through "comparative", are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not relevant here as no clinical studies were performed.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical bone fixation fastener, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is for a physical medical device (bone screws) and focuses on demonstrating substantial equivalence through non-clinical testing and comparison to existing predicate devices, not on a study with specific acceptance criteria as would be typical for an AI/software medical device.

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The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.

The CrossRoads Screw System is comprised of bone screws having various features in a variety of diameters and lengths to accommodate differing patient anatomy.

This document describes the CrossRoads Screw System, a bone fixation fastener. The acceptance criteria and the study that proves the device meets those criteria are detailed below, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text describes "theoretical analysis" and "predicted performance" rather than physical testing on a 'test set' in the traditional sense of a clinical or laboratory study with a distinct sample size. The analysis appears to be computational/theoretical in nature.

• Sample Size: Not explicitly stated as a numerical sample size for a "test set" of physical devices. The analysis was performed on "worst case CrossRoads screws." This implies a selection of device configurations that are considered most challenging from an engineering perspective, rather than a random sample.
• Data Provenance: The study is described as "theoretical analysis." This suggests the data is derived from engineering calculations and modeling, rather than empirical data from human subjects or physical tests on manufactured devices that would have a country of origin.

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

Not applicable. The "ground truth" for this type of engineering performance study (torsional and pullout strength) is based on established engineering principles, material properties (ASTM F136 titanium alloy and ASTM F138 stainless steel), and calculation methods. It does not involve expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. The study relies on calculated engineering values.

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

No, an MRMC comparative effectiveness study was not done. This study focuses on the mechanical properties of a medical device (screws) through theoretical analysis, not on the interpretation of medical images or clinical effectiveness where human readers would be involved.

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

This question is typically relevant for AI/ML-based diagnostic devices. In the context of a mechanical device like a screw system, the "standalone" performance refers to its intrinsic mechanical properties as determined by the theoretical analysis. The study described is precisely a standalone performance assessment of the device's predicted mechanical characteristics (torsional and pullout strengths) without human intervention in the performance itself (though humans designed the device and conducted the analysis).

7. The Type of Ground Truth Used

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

• Established engineering principles and material science.
• Calculated values derived from theoretical models for torsional and pullout strengths.
• Performance of legally marketed predicate devices (K143039 CrossRoads Screw System, K000080 and K024060 Stryker Asnis III Screw System), which serve as a benchmark for "substantial equivalence."

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML study that uses a "training set." The study involves theoretical engineering analysis.

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

Not applicable, as there is no "training set" for this type of engineering performance study.

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The Stryker Fixos Screw System is a single use device intended for the fixation, correction or stabilization of small and long bones in adult and adolescent patients. Indications include:

Ø4.0mm Headless Screw:

• · Fractures of the tarsals and metatarsals
• · Fractures of the olecranon, distal humerus
• Fractures of the radius and ulna
• · Patella fractures
• · Distal tibia and pilon fractures
• Fractures of the fibula, medial malleolus, os calcis
• · Tarso-metatarsal and metatarsophalangeal arthrodesis
• · Metatarsal and phalangeal osteotomies
• · Osteochondritis dissecans
• · Fractures of the pelvic ring
• · Small cancellous fragments of the small and long bones

05.0mm Headless Screw:

• · Medial and lateral malleolar and pilon fractures
• · Proximal and distal humerus fractures
• · Fractures of the olecranon process
• · Tibial plateau fractures
• Os calcis, talar and patellar fractures
• Fractures of the pelvis and acetabulum
• · Arthrodesis of the tarsals

07.0mm Headless Screw:

• · Tibial plateau fractures
• · Ankle arthrodesis
• · Calcaneus osteotomies

The Fixos Screw System is an internal fixation device that consists of various types of screws to treat a number of different types of fractures in small and long bones. The subject components will be available sterile and non-sterile.

This submission is for the Fixos Screw System, a bone fixation device, and does not involve AI or algorithms that would require a study with acceptance criteria as typically defined for AI/ML devices. Therefore, a table of acceptance criteria and reported device performance related to AI/ML is not applicable. Similarly, most of the requested points are not relevant to this type of medical device submission.

Here's an analysis based on the provided text, highlighting why most points are not pertinent:

1. Table of Acceptance Criteria and Reported Device Performance (AI/ML specific): Not Applicable
This product is a traditional medical device (bone screws), not an AI/ML diagnostic or therapeutic device. Acceptance criteria for such devices typically relate to engineering specifications, material properties, and mechanical performance, not AI-driven metrics like sensitivity, specificity, or F1-score. The document states "Testing demonstrated that Fixos Screw System is substantially equivalent to the predicate device currently cleared for marketing." This implies that the performance met the expected standards for a bone screw, which would be based on mechanical tests, not AI-specific metrics.

2. Sample Size for the Test Set and Data Provenance (AI/ML specific): Not Applicable
No "test set" in the context of AI/ML models was used. The non-clinical testing involved mechanical tests on the device components themselves.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications (AI/ML specific): Not Applicable
Ground truth established by experts is a concept relevant to AI model training and evaluation, particularly for image analysis or diagnostic tasks. This device is a physical implant, not a diagnostic tool requiring expert ground truth for its performance assessment.

4. Adjudication Method (AI/ML specific): Not Applicable
Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies in expert labeling or diagnoses, which is a process specific to establishing ground truth for AI model development and validation. This is not relevant to the mechanical testing of a bone screw.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (AI/ML specific): No
The document explicitly states "Clinical testing was not required for this submission." MRMC studies are typically used to evaluate the impact of AI on human reader performance in diagnostic tasks. Since this is a physical device and no clinical testing was performed, an MRMC study was not conducted.

6. Standalone (Algorithm Only) Performance (AI/ML specific): Not Applicable
This is a physical device, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. Type of Ground Truth Used (AI/ML specific): Not Applicable
Ground truth (expert consensus, pathology, outcomes data) is used to validate AI systems. For a bone screw, the "ground truth" for its performance would be its mechanical integrity and biocompatibility, assessed through laboratory testing and material science, not through these types of data.

8. Sample Size for the Training Set (AI/ML specific): Not Applicable
There is no "training set" for an AI model as this is a physical device.

9. How the Ground Truth for the Training Set Was Established (AI/ML specific): Not Applicable
Again, this product is a physical device, not an AI model, so there is no training set or ground truth in that context.

Summary Relevant to the Provided Document:

• Acceptance Criteria: For the Fixos Screw System, acceptance criteria were based on non-clinical laboratory testing demonstrating substantial equivalence to predicate devices in terms of mechanical performance. These tests included:

  • Insertion Torque Testing
  • Shear-off Testing
  • Pull-out Testing
    The success criteria for these tests would typically be that the new device's performance falls within a predefined range that is equivalent to or better than the predicate devices, ensuring its mechanical integrity and strength for its intended use. The document confirms that "Testing demonstrated that Fixos Screw System is substantially equivalent to the predicate device currently cleared for marketing."

• Study Proving Acceptance: The study involved non-clinical laboratory testing of the Fixos Screw System components. The study's conclusion was that the device is "substantially equivalent to the predicate device identified in this premarket notification." The specific details of the exact values or thresholds for "substantial equivalence" are not provided in this summary but would be part of the full 510(k) submission.

In essence, the Fixos Screw System is a traditional medical device, and its evaluation for market clearance followed the standard path for such devices by demonstrating substantial equivalence through non-clinical mechanical testing when compared to already cleared predicate devices. AI/ML-specific validation criteria and studies are not applicable here.

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The VariAx Elbow System Line Extension is intended for fracture fixation of long bones. Indications include distal humerus and proximal ulna.

The subject VariAx Elbow System is comprised of plates and screws, manufactured from Titanium alloy and Commercially Pure Titanium. The subject system was determined substantially equivalent in K073527. This Special 510(k) submission is intended to address the addition of the 7mm washer to the predicate VariAx Elbow System.

This 510(k) summary describes a line extension for the VariAx Elbow System, adding a 7mm washer. As such, the study primarily focuses on demonstrating the substantial equivalence of the new component to existing predicate devices, rather than establishing new performance criteria for a novel device.

Here's an analysis of the provided information, framed by your request:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a line extension for an existing bone fixation system, the "acceptance criteria" are intrinsically tied to demonstrating substantial equivalence for the added component. The primary acceptance criteria for this type of device extension would be:

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

The document states "Functional and mechanical testing" was performed. However, it does not specify the sample size for these tests for the new 7mm washer.

The data provenance is prospective in the sense that the testing was conducted specifically for this 510(k) submission to demonstrate equivalence. The country of origin of the data is not specified, but it can be inferred to be from the manufacturer (Howmedica Osteonics Corp.) in the USA.

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

This type of information is not applicable to this submission. The "ground truth" for mechanical testing is established by engineering standards and validated testing protocols, not by expert consensus. There are no clinical images or diagnostic interpretations requiring expert radiologists or other medical professionals for ground truth establishment.

4. Adjudication Method for the Test Set

This is not applicable. Mechanical testing results are objective measurements and do not require adjudication by human experts.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices that involve human interpretation of medical images. The VariAx Elbow System Line Extension is a mechanical implant, not an AI or diagnostic device.

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 is not an AI or software-only device.

7. The Type of Ground Truth Used

For the mechanical testing, the "ground truth" would be established by validated engineering principles and standards for bone fixation devices. This might include standards for fatigue strength, torsional strength, bending strength, etc., depending on the specific mechanical tests performed. The document implies that the "comparable mechanical & functional properties" were assessed against the predicate device, which would have itself been evaluated against such standards.

8. The Sample Size for the Training Set

There is no training set mentioned or implied because this is a mechanical device undergoing physical testing, not a machine learning model.

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

This is not applicable as there is no training set.

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The intended use of Störk Instrumente GmbH's Bone Wires is the fixation of bone fractures and / or to guide other implants during insertion to the skeletal system.

Due to their design and used materials, which is either Stainless Steel acc. ASTM F 138 / 139 (316 L) or Titanium Alloy acc. to ASTM F 136, Grade 5, these devices can be used as implants.

Störk Instrumente GmbH delivers all Bone Wires in Non-Sterile conditions. The user may sterilize these devices by using a validated and applicable sterilization process.

Störk Instrumente GmbH recommends to use a steam-sterilizer that uses a validated sterilization cycle of 134°C / 270°F, 3 bar, for 10 minutes.

Trade Name: Bone Wire Common Name: Kirschner Wire (K wire), Steinmann Wire, Bonell Wire (Pin), Cerclage Wire

The provided text is a 510(k) Summary for a medical device (Bone Wires), which primarily focuses on demonstrating substantial equivalence to existing predicate devices. It does not contain information about specific acceptance criteria, performance studies against those criteria, or clinical evaluation data that would typically be found in an AI/ML medical device submission.

Therefore, I cannot populate the requested table or answer most of the questions, as this document type does not involve such studies for this class of device.

Here's what I can extract based on the provided text, and what is missing:

Acceptance Criteria and Device Performance Table:

Detailed Response to Individual Questions:

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

   • See the table above. The "acceptance criteria" for a traditional 510(k) for a device like this are primarily based on material standards and substantial equivalence to legally marketed predicate devices, rather than a quantifiable performance metric derived from a specific study.

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

   • N/A. This document does not describe a "test set" in the context of performance testing or clinical studies. Substantial equivalence for this type of device is typically established through material property comparisons, design similarities, and intended use comparison with predicate devices, rather than a clinical performance study with a test set.

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)

   • N/A. There is no "ground truth" establishment described in this document, as it's not a study evaluating diagnostic accuracy or clinical outcomes.

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

   • N/A. No test set or 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

   • N/A. This device (Bone Wire) is a physical implant, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance is relevant.

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

   • N/A. This is not an algorithm or software device.

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

   • N/A. No ground truth is established as there is no performance study of this nature. The "truth" for this submission is adherence to material standards and functional equivalence to predicate devices.

8. The sample size for the training set

   • N/A. There is no "training set" as this is not an AI/ML device requiring training data.

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

   • N/A. No training set or ground truth for it is relevant or described.

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