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The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodeses, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

The Healix Compression Screw (HCS) System consists of 2.0mm to 8.5mm cannulated, solid titanium alloy, headless, headed screws and specialized instrumentation. The screw system has multiple lengths depending on diameter of the screws.

The provided text is related to a 510(k) premarket notification for the "Healix™ Compression Screw System." It describes the device, its intended use, and its substantial equivalence to predicate devices based on non-clinical testing.

However, the document does not contain information about:

• Acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) for a diagnostic or AI-driven device.
• A study that proves the device meets specific acceptance criteria in terms of clinical performance because this device is a bone fixation fastener, not an AI or diagnostic tool.
• Sample sizes used for test sets or training sets in the context of AI or diagnostic algorithms.
• Data provenance, expert qualifications, or adjudication methods for ground truth, which are relevant for AI/diagnostic studies.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• The type of ground truth used for AI/diagnostic algorithms.
• How ground truth for a training set was established.

Instead, the document focuses on non-clinical testing to demonstrate the safety and effectiveness of the bone fixation screw system, establishing its substantial equivalence to previously cleared predicate devices.

Here's what can be extracted and what is missing relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as pass/fail values for specific performances, but implied as meeting industry standards and being comparable to predicate devices. The tests performed are described.
• Reported Device Performance:
  • Torsion, driving torque, and axial pullout (per ASTM F543)
  • Static and dynamic bending (per ASTM F1264)

The "results of these tests, as well as engineering analysis of device characteristics, indicate that the HEALIX Compression Screw System is substantially equivalent to the predicate devices." This implies that the device met the performance expected for these tests and was found to be comparable to or better than the predicate devices, thereby satisfying the implicit acceptance criteria of substantial equivalence.

2. Sample Size for Test Set and Data Provenance: Not applicable in the context of this device and testing. The testing described is mechanical (physical properties of the screws), not clinical data-based.

3. Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth, in this context, refers to the reference standard for clinical performance in AI/diagnostic studies. Here, the "ground truth" is adherence to established mechanical testing standards and comparison to predicate devices, assessed by engineers and regulatory bodies.

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This is a mechanical device, not an AI or diagnostic reading system.

6. Standalone (Algorithm Only) Performance Study: No.

7. Type of Ground Truth Used: The ground truth for this device's evaluation is primarily based on engineering standards (ASTM F543, ASTM F1264) and comparison to the established performance of legally marketed predicate devices.

8. Sample Size for the Training Set: Not applicable. This document does not describe an AI/diagnostic device with a training set.

9. How the Ground Truth for the Training Set was Established: Not applicable.

In summary, the provided document describes a mechanical device (bone fixation fastener) and its regulatory clearance based on non-clinical physical testing and comparison to predicate devices, rather than a diagnostic or AI device and its clinical performance evaluation. Therefore, most of the requested information regarding acceptance criteria and studies that prove the device meets acceptance criteria for AI/diagnostic devices is not present.

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The Monster Screw System™ is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device.

The Monster Screw System™ is comprised of bone screws and washers. The Monster Screw is a threaded bone screw offered in 2.0mm to 9.5mm diameters (in 0.5 mm increments) having overall lengths from 8mm (for smaller diameters) thru 200mm (for larger diameters). The screws are offered having a variety of features with respect to head, thread, tip, cannulation and material. Size-matched washers are also available.

This document is a 510(k) summary for the Paragon 28 Monster Screw System™. It describes the device and its intended use, but it does not contain the kind of detailed performance study data you're asking for regarding acceptance criteria, sample sizes, ground truth (which is typically for diagnostic devices), or comparative effectiveness studies.

This submission is for a bone fixation fastener, which is a hardware device, not a diagnostic AI/ML device. Therefore, the questions about "acceptance criteria and study that proves the device meets the acceptance criteria" are typically addressed through mechanical testing and equivalence to predicate devices, rather than clinical performance metrics, ground truth established by experts, or AI-specific study designs like MRMC or standalone performance.

However, I can extract the information that is present and note where the requested information is not applicable or not provided in this type of document.

Here's the relevant information based on the provided text:

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

This document does not specify formal "acceptance criteria" in terms of clinical performance metrics, as would be common for diagnostic devices. Instead, the performance is demonstrated through theoretical comparisons to predicate devices for mechanical equivalence.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) summary for a mechanical device. The "test set" here refers to theoretical comparisons and bench testing, not a clinical study with a patient sample size.
• Data Provenance: Not applicable. The "theoretical comparisons" would be based on engineering principles and potentially prior testing data of predicate devices.

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. This is not a diagnostic device where "ground truth" would be established by experts interpreting images or clinical outcomes. The equivalence is based on engineering and material science.

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

• Not applicable. There is no adjudication needed for mechanical equivalence testing as described here.

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 hardware bone fixation device, not an AI-powered diagnostic tool. An MRMC study is not relevant.

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

• Not applicable. This is a hardware device; there is no algorithm or AI component.

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

• Not applicable. As noted, "ground truth" as typically defined for diagnostic performance is not relevant for this type of device submission. The "truth" is established through engineering specifications and mechanical testing to demonstrate equivalence.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set" or "ground truth" in this context.

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

This Special 510(k) submission is a line extension to address modifications to the Asnis™ III Cannulated Screw System. This line extension is to add additional sizes of screws to the system.

The provided text describes a Special 510(k) submission for a line extension of the Asnis™ III Cannulated Screw System, specifically to add additional sizes of screws. This type of submission relies on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than conducting extensive new clinical studies with established acceptance criteria as would be typical for novel devices.

Therefore, many of the standard elements you've requested regarding acceptance criteria and detailed study information are not applicable in this context. The primary "study" performed here is mechanical testing to prove the new screw sizes are as strong as the predicate devices.

Here's a breakdown of the information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: For a 510(k) submission, especially a line extension like this, the "acceptance criteria" are intrinsically tied to demonstrating substantial equivalence. The key performance metric is the mechanical strength of the new screw sizes compared to the legally marketed predicate devices. The submission asserts that this equivalence was met through mechanical testing. Specific numerical thresholds for "strength" are not provided in this summary but would have been part of the underlying test reports submitted to the FDA.

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

• Sample Size: Not explicitly stated in the provided summary. Mechanical testing typically involves a set number of samples for each size and material tested, but the exact count isn't given here.
• Data Provenance: Not explicitly stated, but mechanical testing is usually performed in a laboratory setting by the manufacturer or a contracted testing facility. Given the manufacturer (Howmedica Osteonics Corp.) is based in Mahwah, New Jersey, USA, the testing likely occurred in the US. The data is prospective in the sense that it was generated specifically for this submission.

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

• N/A. For mechanical testing of this nature, "experts" establishing a "ground truth" in the clinical sense (e.g., radiologists, pathologists) are not involved. The ground truth is established by standardized mechanical testing protocols and measurements, typically interpreted by engineering and quality control professionals.

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

• N/A. Adjudication methods like 2+1 or 3+1 are used for clinical reads (e.g., imaging studies) where human interpretation is involved. This submission focuses on objective mechanical testing.

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 mechanical device, not an AI or imaging device. Therefore, MRMC studies and concepts of human reader improvement with AI are not applicable.

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

• N/A. This is a mechanical device, not an algorithm.

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

• N/A (for clinical ground truth). The "ground truth" in this context is the objective measurement of mechanical properties (e.g., strength, stiffness) as defined by engineering standards and specifications. The performance of the new devices is compared against the measured performance of the predicate devices.

8. The sample size for the training set

• N/A. There is no "training set" as this is not an AI or machine learning device.

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

• N/A. There is no "training set" and thus no ground truth for it to be established.

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