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The Extremity Medical Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.

The Extremity Medical Calcaneal Osteotomy Device is a bone fixation device consisting of a bracket and lag screws and a set of instruments used for implant site preparation and delivery. The bracket is offered in height sizes of 6mm to 13mm. The Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.

The provided document describes the FDA 510(k) premarket notification for the Extremity Medical Calcaneal Osteotomy Device. This device is a bone fixation device, not an AI/ML medical device, and therefore the concepts of acceptance criteria, device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable in the context of AI regulatory submissions.

The document indicates that the device's substantial equivalence was based on non-clinical testing, specifically bench testing for static and dynamic bending, which was performed and compared to a predicate device. No clinical testing was performed.

The relevant information regarding this device's "acceptance criteria" (though not explicitly stated as such in the AI/ML context) would be its ability to demonstrate substantial equivalence to legally marketed predicate devices through its design, material mechanical properties, indications for use, and performance in these non-clinical bench tests.

To answer your request based on the provided document and keeping in mind it's for a physical bone fixation device:

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Implied): Substantial equivalence to predicate device in terms of design, material mechanical properties, indications for use, and performance in static and dynamic bending bench tests.
   • Reported Device Performance: "Bench testing static and dynamic bending were performed and compared to the predicate device." (Specific numerical performance data is not provided in this summary document.)

2. Sample size used for the test set and the data provenance: Not applicable as this is a physical device and no "test set" in the context of data for AI/ML is mentioned. The testing refers to physical bench tests.

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 AI/ML models is not relevant here.

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: No, this is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI algorithm.

7. The type of ground truth used: Not applicable. The "ground truth" for this physical device's performance would be its mechanical properties measured in bench tests and compared to the predicate device.

8. The sample size for the training set: Not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

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The Speed™, Speed Shift™, Speed Titan™ and Speed ArcTM are indicated for:

• Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
• Fixation of proximal tibial metaphysis osteotomy. ●
• Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
• Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.

The Speed™ product family consists of nitinol staple implants offered in a range of sizes for bone fixation. The Speed™ product family consists of Speed™, Speed Shift™, Speed Arc™, and Speed Titan™ with the primary difference being the shape of the bridge. The bridges range from flat (Speed™ and Speed Titan™), arched (Speed Arc™), and stepped (Speed Shift™) to conform to patient and osteotomy anatomy.

All of the Speed™ implants are delivered to the operating room with the legs parallel in a constraining plastic inserter. The implant is then released from the inserter and transformed by ambient and body heat after insertion so that the legs converge. The implants do not require any external heating; they are completely transformed at typical operating room temperatures or body heat.

The difference between the Speed™ implant staples and the primary predicate implant staples are their heat activating temperature as well as bridge shape (stepped or curved). The predicate BME OSStaple™ requires an external heating unit to warm the staples and activate the compression function. The bundled implant staples are activated at typical operating room temperatures or body temperature, and provide active compression without an external heating requirement.

The provided document describes the safety and performance of "Speed™," "Speed Shift™," "Speed Titan™," and "Speed Arc™" bone staples through various bench tests, comparing them to predicate devices. It does not contain information about studies involving human readers or AI.

Here's a breakdown of the available information regarding acceptance criteria and device performance:

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

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

The document does not provide specific sample sizes for the test sets in any of the performance bench tests. The data provenance is controlled laboratory testing, not medical data from patients.

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

Not applicable. These are bench tests on physical devices, not assessments requiring expert interpretation of medical data.

4. Adjudication method for the test set

Not applicable. This is not a study involving human readers or adjudication.

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 MRMC comparative effectiveness study was done. This document focuses on the physical performance of bone staples, not AI-assisted diagnosis or human reader performance.

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

This is not applicable, as the device is a physical bone staple, not an algorithm.

7. The type of ground truth used

The ground truth for these tests is based on the established material science and mechanical engineering standards (ASTM standards) that define the test methods and the expected performance for such medical devices. For example, "superior pull-out resistance" is a direct measurement against a standard and comparison to a predicate, not an expert opinion or pathology.

8. The sample size for the training set

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

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

Not applicable.

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