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The Salvation™ Osteopenic Screw is indicated for the treatment of fracture fixation, osteotomies, and reconstruction/arthrodeses of small bones, as well as patients with osteopenic bone.

The SALVATION™ Osteopenic Screws are non-locking, fully threaded screws offered in various diameters and lengths. All described implants are manufactured from titanium alloy and have a solid core. The implants are single use only devices.

This 510(k) summary does not contain sufficient information to describe specific acceptance criteria and a study proving the device meets those criteria, as typically required for AI/ML-based medical devices. This document is for a mechanical medical device (an osteopenic screw), and thus the evaluation paradigm is different from an AI/ML device.

However, based on the provided text, I can infer the type of evidence presented and the regulatory conclusion:

General Information Regarding Device Acceptance for a Mechanical Device (Osteopenic Screw):

• Acceptance Criteria: For mechanical devices like the SALVATION™ Osteopenic Screw, acceptance criteria are typically related to:
  • Mechanical Performance: Strength, durability, fatigue resistance, torsional strength, pull-out strength, bending strength.
  • Biocompatibility: The material (titanium alloy) must be biocompatible.
  • Sterilization: The device must be able to be sterilized and remain sterile.
  • Design Characteristics: Manufacturing specifications, dimensions, geometry.
  • Clinical Equivalence: Performance should be at least as safe and effective as a legally marketed predicate device.
• Study Proving Acceptance: The overall "study" presented here is a premarket notification (510(k)) submission for substantial equivalence. The core "proof" comes from non-clinical (mechanical) testing and comparison to existing predicate devices.

Missing Information (Because this is not an AI/ML device submission):

Most of the specific numbered points (2-9) in your request are directly applicable to AI/ML device studies and are therefore not present in this document for a mechanical screw. There is no:

• Test set size, data provenance, or ground truth for an AI algorithm.
• Number of experts, adjudication methods, or MRMC studies.
• Standalone algorithm performance or training set details.

Based on the provided text, here's what can be extracted and inferred regarding the mechanical device:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable / Not Provided for an AI/ML context. For a mechanical device, this refers to the number of samples used in mechanical tests. The specific number of screws tested for torsion, bending, or pull-out is not disclosed in the provided summary. The data provenance would be the test lab environment.

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 document does not involve expert-established ground truth in the context of an AI/ML diagnostic or prognostic system. The "ground truth" for a mechanical screw is its physical performance measured against engineering standards and comparison to predicate devices, which is evaluated by engineers and regulatory bodies.

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

• Not Applicable. No human adjudication of results in the AI/ML sense is mentioned or relevant 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 mechanical 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 mechanical device.

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

• Mechanical Testing Standards & Predicate Device Performance: The "ground truth" for this device lies in its ability to meet established mechanical engineering standards (e.g., ISO, ASTM for bone screws) and to demonstrate comparable or superior mechanical properties (torsion, bending, pull-out) to its legally marketed predicate devices, ensuring it is at least as safe and effective for its intended use.

8. The sample size for the training set

• Not Applicable. No AI model to train.

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

• Not Applicable. No AI model to train.

Summary of Regulatory Conclusion:

The FDA determined that the SALVATION™ Osteopenic Screw is substantially equivalent to the predicate devices (K110670 and K090675). This determination was based on:

• Non-clinical evidence including torsion testing, and rationales for bending and pull-out strength.
• Comparison of design and material (titanium alloy) characteristics.
• The conclusion that the device does not raise any new questions of safety or effectiveness.
• No clinical evidence (studies on human patients) was required for this 510(k) submission.

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