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The HammerLock® 2 is indicated for: Small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.

The HammerLock® 2 is a nitinol implant that comes in a range of sizes to provide intramedullary fixation for fingers and toes. The HammerLock® 2 device is situated in the intramedullary space and the legs extend into the cancellous bone. After reaching body temperature, the legs fully deflect outward to create an anchoring force. The changes for the HammerLock® 2 system involve design changes to the implant and new disposable instrumentation.

The provided text describes a 510(k) premarket notification for a medical device called HammerLock® 2. This document focuses on demonstrating substantial equivalence to a predicate device through material and mechanical testing, rather than clinical study data involving AI or human interpretation. Therefore, many of the requested elements for AI/imaging studies are not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

For the remaining points, please note that this is a 510(k) summary for a mechanical medical device (implant) and not an AI or imaging diagnostic device. Therefore, many of the questions are not applicable to this document.

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: Not explicitly stated as a numerical sample size of "devices" in the same way a clinical trial would report patients. For mechanical testing, samples of the device (HammerLock® 2) and the predicate (K131640 HammerLock®) were used for each test. The ASTM standards (F382-99 for bending, F2129-08 for corrosion) would specify the minimum number of samples required for robust testing, but these numbers are not detailed in the summary.
   • Data Provenance: The data is generated from laboratory bench testing conducted in accordance with ASTM standards. The summary does not specify the country of origin of the lab or if it was prospective/retrospective; however, bench testing is inherently prospective in its execution (i.e., new tests are run for the new device).

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 describes mechanical testing of an orthopedic implant, not an diagnostic imaging device that requires interpretation by medical experts to establish ground truth.

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

   • Not Applicable. As above, this pertains to expert review of diagnostic results, which is not relevant to this device's testing. Mechanical testing results are objective measurements (e.g., stiffness values, corrosion rates), not subject to expert adjudication in this context.

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. No MRMC study was performed as this is a device for surgical implantation, not an AI or imaging diagnostic tool that assists human readers.

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

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

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

   • For Mechanical Testing: The "ground truth" is defined by the objective performance parameters (stiffness, strength, corrosion resistance) as measured against established ASTM standards and compared to a legally marketed predicate device. The "ground truth" for the predicate's performance is its previously characterized mechanical properties.
   • For Substantial Equivalence: The ultimate "ground truth" being demonstrated is that the HammerLock® 2 is as safe and effective as its predicate.

8. The sample size for the training set

   • Not Applicable. There is no "training set" as this is a physical medical device undergoing mechanical validation, not a machine learning model.

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

   • Not Applicable. See point 8.

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The HammerLock™ is indicated for small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.

The HammerLock™ is an addition to the OSSPlate™ line and is designed for use as an intramedullary bone fixation device. The OSSPlate™ is situated on the bone with the prongs extending through the cortex and in its final configuration the prongs are deflected inward to create a clamping force. With the HammerLock™ the device is situated in the intramedullary space with the prongs extending into the cancellous bone and in the final configuration the prongs are deflected outward to create a compressive force. Two models of the HammerLock™ are provided for physician choice, the HammerLock™ X-Type and HammerLock™ Loop. Both exhibit similar test results to the predicate devices. The HammerLock™ models transformed to their final configuration by body heat alone.

The provided text is a 510(k) summary for the OSSplate™ HammerLock™ Product. This document is related to a medical device for bone fixation, not a software or AI-based device, and therefore does not contain information about acceptance criteria or studies in the context of device performance metrics like sensitivity, specificity, or reader studies.

The document focuses on demonstrating substantial equivalence to a predicate device (Memometal Technologies (MMI-USA) SmartToe™) to classify it as a Class II medical device. This type of regulatory submission primarily relies on comparing the new device's technological characteristics, materials, and intended use to a legally marketed predicate device, rather than performance studies with defined acceptance criteria for diagnostics or AI.

Therefore, the requested information, which pertains to the performance evaluation of a diagnostic or AI device (e.g., acceptance criteria for metrics like sensitivity/specificity, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, ground truth establishment), is not present in the provided text.

The document states: "Both exhibit similar test results to the predicate devices." This is the closest it comes to mentioning performance, but it doesn't provide specific data, acceptance criteria, or details regarding those "similar test results."

In summary, none of the requested information regarding acceptance criteria and performance studies for a diagnostic or AI device can be extracted from this document because it describes a physical medical implant device's 510(k) submission based on substantial equivalence.

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