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The Tenon Medical Catamaran Sacroiliac Joint Fixation System) is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Tenon Medical Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) was developed as a less invasive alternative to traditional open posterior surqical SIJ fusion. The Tenon Medical Catamaran Sacroillac Joint Fixation System (CAT SIJ Fixation System) includes the Catamaran SIJ Implant and associated surgical instruments: an Access Set, a Drill/Delivery and an Accessory Set and an Extraction Set. The titanium implant consists of two hollow barrels connected by a bridge. During the procedure, autologous bone graft material is placed in the barrel of the implant to facilitate stabilization. The Catamaran SIJ Implant is available in two (2) different barrel diameters (7.5mm and 10mm) and two implant lengths (30mm and 40mm) for a total of four sizing options to fit patient anatomy. The Catamaran SIJ Implant is intended for single-use only. The implants and associated components are provided clean and non-sterile and designed for routine steam sterilization prior to use.

This document describes the Tenon Medical Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System). It is a medical device for sacroiliac joint fusion. The information provided outlines the regulatory submission, but does not detail a study that defines acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or effect size, as would be typical for an AI/ML or diagnostic device.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through performance testing related to the device's physical and mechanical properties.

Here's an analysis based on the provided text, addressing your points where possible, and noting when information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide acceptance criteria in the form of specific performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical study or an AI/ML model. Instead, it states that "Performance testing, including biocompatibility, chemical characterization, mechanical static and dynamic shear testing, pull-out, cadaver and instrumentation testing was submitted to support the overall functionality and usability of the Tenon Medical Catamaran Sacroiliac Joint Fixation System."

Therefore, a table of acceptance criteria and reported device performance, as you've requested for a typical AI/ML or diagnostic device evaluation, cannot be extracted from this text. The "performance data" here refers to engineering and biocompatibility tests, not clinical efficacy or diagnostic performance.

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

This information is not provided in the document. The document refers to "performance testing" which includes mechanical and cadaver testing, but does not specify sample sizes for these tests or characterize them as "test sets" in the context of clinical or AI/ML evaluations. There is no mention of country of origin or whether data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided. The document describes a medical device for surgical fixation, not a diagnostic or AI/ML system that would typically require expert-established ground truth on a test set.

4. Adjudication Method

This information is not provided. As above, adjudication methods are typical for expert review in clinical or AI/ML studies, which is not the focus of this device's performance data.

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

This information is not provided. The device is a surgical implant, not a diagnostic tool that human readers would use in conjunction with AI. Therefore, an MRMC study related to AI assistance for human readers is not applicable to this device and is not mentioned.

6. Standalone (Algorithm Only) Performance Study

This information is not provided. The device is a physical implant, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and not mentioned.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic or AI/ML studies (e.g., expert consensus, pathology, outcome data) is not applicable or stated for the performance testing mentioned for this surgical implant. The "performance data" refers to engineering and biocompatibility tests, which would have their own established standards and reference methods for evaluation.

8. Sample Size for the Training Set

This information is not provided. This device is a physical implant, not an AI/ML model, so the concept of a "training set" is not relevant.

9. How Ground Truth for the Training Set Was Established

This information is not provided. As the device is not an AI/ML model, there is no training set or associated ground truth establishment.

Summary of what the document does provide regarding device evaluation:

The document is a 510(k) premarket notification letter for a Class II surgical implant (Catamaran Sacroiliac Joint Fixation System). The primary method of demonstrating its suitability for market is through substantial equivalence to existing predicate devices.

The "Performance Data" section indicates that the following types of testing were submitted:

• Biocompatibility: To ensure the implant is safe for interaction with biological tissues.
• Chemical Characterization: To understand the material composition.
• Mechanical Static and Dynamic Shear Testing: To evaluate the implant's strength and fatigue resistance under various loads.
• Pull-Out Testing: To assess the implant's resistance to being dislodged from bone.
• Cadaver Testing: Likely to evaluate surgical technique, implant placement, and initial stability in a simulated anatomical environment.
• Instrumentation Testing: To ensure the surgical tools function as intended.

These tests are standard for evaluating the safety and mechanical performance of orthopedic implants, demonstrating that the device is "capable of performing in accordance with its intended use" and "does not raise any new or different questions or concerns of safety or effectiveness as compared to commercially available predicate devices."

The document does not contain the details of a clinical study or an AI/ML model evaluation as implied by the structure of your request.

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