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The DART-FIRE EDGE Cannulated Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of foot and ankle bones appropriate for the device. Screws gre intended for single use only.

The DART-FIRE EDGE Cannulated Screw System contains partially and fully threaded, cannulated screws offered in a variety of diameters and lengths. The screws are manufactured from titanium alloy (ASTM F136).

Here's a summary of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

Not applicable. The study was non-clinical and involved performance testing of the device itself rather than a test set of data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This was a non-clinical study based on engineering performance tests.

4. Adjudication Method for Test Set

Not applicable. There was no test set requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This was a non-clinical study for a bone fixation device, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical medical implant, not an algorithm. The performance described is for the device's physical properties.

7. Type of Ground Truth Used

The ground truth or benchmark for performance was the performance of the legally marketed predicate device (K082320: Wright Compression Screws, K080850: DARCO Headless Compression Screw, K183696: PERFORM Reverse). The study aimed to demonstrate "substantial equivalence" to these devices through various mechanical and MR Safety tests.

8. Sample Size for Training Set

Not applicable. This was a non-clinical study for a physical device, not an AI model.

9. How Ground Truth for Training Set Was Established

Not applicable. There was no training set in the context of this device.

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OsteoBullet Compression Screw is intended to maintain alignment and fixation of bone fractures, non-unions, osteotomies, or arthrodeses of small bones in the hand and foot.

The OsteoBullet Compression Screw has a wide range of diameters and lengths for use in a variety of fracture treatments. Implants are available as cannulated or non-cannulated and made from Titanium 6AL-4V ELI (ASTM F136) or Zeniva™ ZA-500 PEEK (ASTM F2026) and range in size from Ø3 to 7 mm in diameter and 16 to 105 mm in length. Implants are provided sterile and are for single use only. The system includes instrumentation to aid in delivery of the implants including drill guides, guide wires, depth gauge, manual drills, manual stop drills, taps, and drivers.

Below is a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

The document does not specify the exact sample sizes (number of screws or tests) used for the performance testing. The data provenance is described as "Documentation was provided" and relates to in vitro mechanical testing of the device itself, rather than human data. There is no mention of country of origin for the data or if it was retrospective or prospective, as these are not relevant for this type of mechanical testing.

3. Number of Experts and Qualifications for Ground Truth:

This section is not applicable. The study described is not a clinical study involving human patients or expert interpretation of medical data. It is a benchtop (mechanical) performance study comparing a new medical device (OsteoBullet Compression Screw) to existing predicate devices based on objective engineering standards (ASTM F543-13 and ASTM F1264-14). Therefore, there is no "ground truth" to be established by experts in the context of diagnostic accuracy or treatment outcomes.

4. Adjudication Method:

This section is not applicable for the same reasons as point 3. Benchtop mechanical testing does not involve adjudication.

5. Multi-reader Multi-case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic algorithms or imaging devices with human readers. The document describes mechanical performance testing of a physical implant (bone screw).

6. Standalone (Algorithm Only) Performance:

No, a standalone (algorithm only) performance study was not done. The device is a physical bone fixation screw, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this study is defined by established engineering standards and specifications for mechanical performance of bone fixation fasteners (ASTM F543-13 and ASTM F1264-14), and the performance characteristics of the legally marketed predicate devices. The performance metrics (e.g., axial pushout, torque to failure, bending strength) are quantitatively measured according to these standards.

8. Sample Size for the Training Set:

This section is not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

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

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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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APTUS® Cannulated Compression Screws 5.0, 7.0 are intended for the treatment of fractures, osteotomies and arthrodeses of bones with the appropriate screw size.

APTUS® Cannulated Compression Screws 5.0, 7.0 are headless screws intended for the treatment of fractures, osteotomies and arthrodeses of bones. The design of the screw, incorporating various diameters, threads on the head and tip, provides compression of the bone segments upon insertion of the screw. The submission includes the associated Kwires, intended to be used for internal fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of the implants.

APTUS Cannulated Compression Screws 5.0, 7.0 are available in two diameters (5.0 mm and 7.0 mm) and come in partially-threaded or fully-threaded designs. The 5.0 mm screws are provided in overall lengths ranging from 30 to 70 mm. The 7.0 mm screws are provided in overall lengths ranging from 40 to 140 mm. The 5.0 and 7.0 mm screws are used with the 1.6 and 2.2 mm diameter K-wires, respectively.

APTUS® Cannulated Compression Screws 5.0, 7.0 are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and the K-wires are made of stainless steel conforming to ASTM F138 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673).

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and study proving device performance:

This 510(k) summary is for a medical device (APTUS® Cannulated Compression Screws 5.0, 7.0), not an AI/software device. Therefore, many of the typical acceptance criteria and study aspects related to AI (e.g., sample size for test set, data provenance, ground truth experts, MRMC studies, standalone performance, training set) are not applicable.

The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical data, primarily engineering and mechanical testing. Clinical data was explicitly not submitted.

1. Table of Acceptance Criteria and Reported Device Performance

Note: Since this is a hardware device submission, the "acceptance criteria" are related to mechanical performance and regulatory standards, not diagnostic accuracy or AI model performance.

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

• Test set sample size: Not applicable in the context of AI/software performance. For mechanical testing, the specific number of screws tested is not detailed in this summary, but it would typically involve a statistically relevant number of samples to demonstrate compliance with ASTM F543.
• Data provenance: Not applicable in the context of data used for AI training/testing. The tests were performed on the physical device.

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 defined for AI (e.g., expert consensus on medical images) is not relevant for mechanical testing of bone screws. The "ground truth" here is compliance with established engineering and material standards.

4. Adjudication method for the test set

• Not applicable. No expert adjudication process as understood in AI performance evaluations. Mechanical tests have pass/fail criteria based on standards.

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. This is a hardware device, not an AI-assisted diagnostic tool.

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

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

7. The type of ground truth used

• Engineering and material standards compliance: The "ground truth" for this device revolves around its conformance to established material specifications (e.g., ASTM F136 for titanium alloy, ASTM F138 for stainless steel) and mechanical performance standards (ASTM F543 for metallic bone screws). The tests demonstrated that the device performs equivalently to previously cleared predicate devices when subjected to these standards.

8. The sample size for the training set

• Not applicable. This is a hardware device; there is no "training set" in the AI sense.

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

• Not applicable. This is a hardware device.

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