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The OSSIO™ Pin Product Family is indicated for maintenance of alignment and fixation of bone fractures, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

The OSSIO™ Pin Product Family is a fixation device made of degradable poly (L-lactide-co-D,Llactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the mineral fibers are made from materials that are incorporated into bone.

The OSSIO™ Pin Product Family implants are supplied sterile and are available in several sizes: 10-70 mm long and 2-4 mm nominal dimension, and with a circular, hexagonal crosssectional design.

The provided text describes a medical device, the OSSIO™ Pin Product Family, and its clearance through the FDA 510(k) process. This process focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing new acceptance criteria or conducting studies to prove the device meets specific acceptance criteria in the manner one might see for a novel AI algorithm or diagnostic tool.

Therefore, the information requested in the prompt, which is typically relevant for studies evaluating the diagnostic performance of a device against specific benchmarks (like sensitivity, specificity, or accuracy in an AI context), is largely not applicable to this 510(k) submission for a bone fixation pin.

The submission focuses instead on:

• Mechanical performance: Comparing the OSSIO™ Pin's strength and fixation properties to those of the predicate device.
• Degradation profile: Demonstrating appropriate degradation over time.
• Biocompatibility: Ensuring the material is safe for implantation.
• Substantial Equivalence: Showing that the device is as safe and effective as the predicate, despite minor material or design differences.

Here's a breakdown of why each requested point is not directly addressed in the provided document, or how it might loosely relate:

1. A table of acceptance criteria and the reported device performance: This document does not present specific acceptance criteria in the form of diagnostic metrics (e.g., sensitivity/specificity targets) with corresponding reported performance. Instead, it states that "mechanical testing demonstrated at least equivalent performance both initially and after in vitro degradation" compared to the predicate, and that biocompatibility testing showed "no new issues of safety and effectiveness." The specific numerical thresholds for "equivalent performance" are not detailed in this summary.

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 for this type of device submission. There isn't a "test set" of patient data in the diagnostic sense. The "performance data" refers to mechanical and biological testing of the device itself.

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. There is no ground truth, expert consensus, or diagnostic interpretation involved in the performance data described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of device.

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 device is a bone fixation pin, not a diagnostic tool or an AI-assisted interpretation system for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This describes a physical implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the mechanical testing, the "ground truth" would be the performance characteristics of the predicate device (Inion OTPSTM Biodegradable Pin) which the OSSIO™ Pin sought to match or exceed. For biocompatibility, the ground truth is established by well-accepted, standardized tests (ISO 10993). Clinical outcomes data is implied to be similar to the predicate device due to substantial equivalence, but wasn't a direct "ground truth" in this submission summary.

8. The sample size for the training set: Not applicable for a physical medical device; this is relevant for machine learning algorithms.

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

Summary based on the provided document and the nature of a 510(k) for an implantable device:

The document describes the OSSION™ Pin Product Family, a fixation device for bone fractures, arthrodesis, and bone grafts. The submission is a 510(k) premarket notification, which aims to demonstrate substantial equivalence to a predicate device, not necessarily to meet de novo acceptance criteria for novel performance claims.

1. Table of Acceptance Criteria and Reported Device Performance:

The remaining points (Items 2-9) are not applicable to the information provided in this 510(k) summary, as it details the clearance of a physical medical implant through substantial equivalence, rather than the performance evaluation of a diagnostic or AI-driven system.

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