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FORCYTE Autograft Harvest Kit is intended to harvest cancellous bone and bone marrow for combination with commercially available allograft or bone void fillers for filling bony voids or gaps that are not intrinsic to the stability of the bony structure.

The Subject device is a kit comprised of a bone and marrow harvesting needle, collection jar, suction tubing, drill-tip guide pin, and bone void filler hydration chamber. The FORCYTE system harvests autologous bone and marrow for use as a bone void filler.

Based on the provided FDA 510(k) clearance letter for the Forcyte Autograft Harvest Kit (K243407), the device is a Gastroenterology-Urology Biopsy Instrument. The letter explicitly states that "No clinical evaluations were conducted" for this device. This means that the 510(k) clearance relies solely on non-clinical (bench) testing, and therefore, it is not possible to provide acceptance criteria or a study description related to AI algorithm performance or diagnostic accuracy, human reader performance, or multi-reader multi-case (MRMC) comparative effectiveness studies from this document.

The information requested in the prompt (AI algorithm performance data, expert ground truth, MRMC studies, etc.) is typically associated with software as a medical device (SaMD) or AI/ML-enabled devices that perform diagnostic or prognostic functions based on image analysis, pattern recognition, etc. The Forcyte Autograft Harvest Kit, however, is a physical instrument for harvesting bone and bone marrow.

Therefore, many of the requested items are not applicable to the information provided in this 510(k) clearance letter. I will address the relevant points based on the document's content and explicitly state when information is not available.

Analysis of the Forcyte Autograft Harvest Kit (K243407) based on the Provided 510(k) Clearance Letter:

The Forcyte Autograft Harvest Kit (K243407) is a physical medical device, not an AI/ML-enabled device or software medical device. The 510(k) clearance for this device was based on non-clinical (bench) testing and substantial equivalence to a predicate device, not on clinical performance studies involving human readers or AI algorithms.

Therefore, most of the requested information regarding AI acceptance criteria, clinical study design (sample size, expert ground truth, MRMC), and training data is not applicable to this specific device and the provided document.

Here's an attempt to address each point based on the provided text, clarifying what information is present and what is absent:

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

Based on the document, the acceptance criteria and performance data are related to the physical characteristics and functionality of the harvesting kit, not diagnostic accuracy.

Acceptance Criteria and Reported Device Performance (Non-Clinical)

Note: The document states "All testing had satisfactory results" but does not provide specific numerical acceptance criteria or detailed numerical results for each test. The acceptance criteria are implicitly that the device performs as intended and meets safety requirements.

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 specified in terms of number of units or test runs for the bench tests. The document only states "bench testing including simulated use testing, tensile, compression, torque, flexural, and vacuum testing were conducted."
• Data Provenance (Country of Origin, Retrospective/Prospective): Not specified. As these are bench tests, the concept of "retrospective" or "prospective" data collection from patients is not applicable. The tests would have been performed in a laboratory setting. No geographical origin of the testing data is mentioned.

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 device is a biopsy instrument, not an imaging or diagnostic AI device requiring expert interpretation for ground truth establishment. Bench testing does not typically involve "experts" establishing a "ground truth" in the diagnostic sense; rather, it involves engineers and quality control personnel assessing physical performance against specifications.

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

• Not Applicable. As no expert interpretation or diagnostic "ground truth" was established, there was no need for an adjudication method. Bench testing results are typically assessed against pre-defined engineering and material specifications.

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. The document explicitly states: "No clinical evaluations were conducted." Therefore, no MRMC study, human reader improvement, or AI assistance was involved in the clearance. This type of study is irrelevant for a physical bone harvesting instrument.

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

• Not Applicable. This is a physical medical device, not an algorithm or software. There is no "standalone" algorithm performance to evaluate.

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

• Not Applicable in the diagnostic sense. For a physical device, "ground truth" is established by manufacturing specifications, engineering design, and material properties. The device's performance is measured against these established physical and functional parameters (e.g., tensile strength, proper vacuum seal, successful harvesting of material, biocompatibility).

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a "training set" of data.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for it.

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