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The RigidFix™ Tibial ACL CrossPin System is indicated for tibial fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracilis).

The device described in this 510(k) is a sterile, disposable device designed for single patient use only. The crosspins are constructed of bioabsorbable Poly L-lactic Acid (PLA).

The provided text describes a medical device, the RigidFix™ Tibial Soft Tissue ACL Crosspin System, and its submission for FDA 510(k) clearance. However, it does not include detailed acceptance criteria or the specifics of a study proving the device meets those criteria in the way you've outlined for performance metrics (e.g., sensitivity, specificity, or improvement over human readers).

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on functional and integrity bench testing and biocompatibility testing. This is a common pathway for Class II medical devices in the US, where the aim is not to prove superiority, but rather that the new device is as safe and effective as a legally marketed predicate.

Here's an analysis based on the information provided, addressing your requested points as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria (e.g., specific tensile strength values, percentage reduction in failure rate) and corresponding reported device performance in the manner you'd expect for an AI/diagnostic device.

Instead, the "acceptance criteria" are implicitly met by:

Important Note: The document states, "Specifically, testing was performed to determine the initial fixation strength of the Tibial RigidFix CrossPin System when used for Hamstring Grafted ACL Reconstructions." However, it does not provide the specific numerical results of this testing or the pre-defined target values that would constitute "acceptance." The conclusion is that the data supported substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not specified. This would typically refer to the number of biological samples or specimens used in the bench testing.
• Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory environment, not on human subjects. Therefore, there is no country of origin for human data, and it is not retrospective or prospective in the clinical trial sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not applicable. For bench testing of initial fixation strength and biocompatibility, "experts" in the sense of clinical specialists establishing a "ground truth" for diagnostic purposes aren't typically involved. The "ground truth" is derived from engineering measurements and established biological safety standards.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods (like 2+1) are typically used in clinical studies or diagnostic performance evaluations involving human interpretation. For bench testing, results are usually objectively measured and compared against engineering specifications or established standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was it done?: No, an MRMC study was not done.
• Effect Size: Not applicable, as no MRMC study was performed. MRMC studies are relevant for evaluating the impact of AI on human reader performance, which is not the type of evaluation described for this device.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Was it done?: Essentially, yes. The "functional and integrity bench testing" and "biocompatibility testing" represent a standalone evaluation of the device's physical and biological properties. There is no "human-in-the-loop" component to how the device functions in these tests. The device's performance is measured directly (e.g., how much force it can withstand, its biological interaction with tissues).

7. Type of Ground Truth Used

• Ground Truth Type:
  • Bench Testing (Functional/Integrity): The ground truth is based on engineering measurements and biomechanical properties, compared against established performance characteristics of predicate devices or industry standards for fixation strength.
  • Biocompatibility Testing: The ground truth is based on biological safety standards as outlined in ODE Blue Book Memorandum #G95-1 (ISO-10933), which involves in-vitro and/or in-vivo tests to assess toxicity, irritation, sensitization, etc.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a physical implant, not an AI algorithm that requires a "training set" of data. The manufacturing process is validated, and the device itself is tested.

9. How Ground Truth for the Training Set Was Established

• Ground Truth Establishment: Not applicable, as there is no training set for this type of device.

In summary: The provided document is a 510(k) summary for a medical device (a crosspin system) seeking clearance based on substantial equivalence. The "acceptance criteria" and "study" described are focused on bench testing for physical performance and biocompatibility testing against established regulatory standards, rather than clinical efficacy trials or AI algorithm performance evaluations. The key outcome is that the testing data supported the claim of substantial equivalence to predicate devices.

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