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The FLASH™ Facet Fusion Instruments are intended to be used during spinal surgery to assist the surgeon in precisely locating and preparing anatomical structures, specifically the lumbar facet joints, in either open or minimally invasive procedures. The FLASH™ Facet Fusion Instruments are specifically designed for use with the 7D Surgical System™, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure can be identified.

The IsoTis® Facet Fusion Instruments are intended to be used during spinal surgery to assist the surgeon in precisely locating and preparing anatomical structures, specifically the lumbar facet joints, in either open or minimally invasive procedures. The IsoTis® Facet Fusion Instruments are specifically designed for use with the 7D Surgical System™, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure can be identified.

The FLASH™ Facet Fusion Instruments are a manually operated disposable instrument set to be used with the 7D Surgical System to assist the surgeon in precise site preparation during open or minimally invasive spinal surgery. The FLASH™ Facet Fusion Instruments consist of a Lumbar Inserter, a Navigation T-Handle, an Array Adaptor, a Lumbar Tamp and Lumbar Facet Drill. The product is provided sterile in a ready-to-use, single patient use container. The subject instruments are made of a combination of stainless steel and medical grade plastics commonly used in orthopedic procedures. The surgical instruments are intended for use as an adjunct to established posterior lumbar fixation procedures, where the Instrumentation enables the location and preparation of a facet joint defect with or without the use of Navigation and delivery of bone graft into the defect.

The provided FDA 510(k) clearance letter and summary for the FLASH™ Facet Fusion Instruments (K243659) do not contain information about acceptance criteria or a detailed study proving the device meets those criteria, particularly not in the context of an AI/algorithm-driven device performance evaluation.

The document states:

• "Clinical Testing: A clinical trial was not required to demonstrate the safety and effectiveness of FLASH™ Facet Fusion Instruments. Clinical validation is unnecessary as FLASH™ Facet Fusion Instruments does not introduce new indications for use, and device features are substantially equivalent to the previously cleared predicate device identified. The clinical safety and effectiveness of image guided surgery systems are historically accepted for both the predicate and subject device."

This indicates that the clearance was based on substantial equivalence to predicate devices, and the testing performed was primarily non-clinical bench performance testing, sterilization and packaging validation, and compliance conformity assessments. The device itself is described as a "manually operated disposable instrument set" used with a surgical system, not an AI or algorithm-driven diagnostic or assistive technology in the way implied by the question's requirements (e.g., MRMC studies, standalone algorithm performance, AI assistance effect size).

Therefore, based solely on the provided text, I cannot fulfill the request for information related to acceptance criteria and a study proving an AI/algorithm-driven device meets them. The document does not describe such studies or acceptance criteria because the device is not an AI/algorithm device that would typically undergo such evaluations.

Response based on the provided document:

1. A table of acceptance criteria and the reported device performance:
* Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for device output as would be seen for an AI/algorithm. The criteria were based on functional verification ("design outputs meet design inputs") and compatibility.
* Reported Device Performance:
* "The functionality of the new or modified features was tested to ensure that system requirements and user needs were met as defined."
* "Specifically, the navigation compatibility of the subject tool with the 7D Surgical System and facet decortication capability were verified and validated through testing."
* "The results show that the subject device is substantially equivalent to the cleared predicates."
* "non-clinical performance data demonstrate that the FLASH™ Facet Fusion Instruments perform as expected and in a manner that is substantially equivalent to its predicate devices."

2. Sample sized used for the test set and the data provenance:
* Not applicable/Not provided. The testing described is bench performance testing of mechanical instruments, not an evaluation of an AI algorithm on a data set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable/Not provided. Ground truth in the context of AI/algorithms is not relevant for this device's described testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable/Not provided.

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: "A clinical trial was not required to demonstrate the safety and effectiveness of FLASH™ Facet Fusion Instruments." This type of study is for AI-assisted diagnostic or decision support systems, which this device is not.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* No. This is a manually operated surgical instrument set, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not applicable/Not provided. The "ground truth" for this device would relate to its mechanical function and compatibility with the surgical system, verified through engineering tests, not medical expert consensus on patient data.

8. The sample size for the training set:
* Not applicable/Not provided. This device is not an AI/ML algorithm that requires a training set.

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

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