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Intrafix Tibial Sheath is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee.

The proposed Intrafix System consists of two components, a non-absorbable Intrafix Expansion Sheath and a non-absorbable Intrafix Expansion Screw. Also included within the system is the instrumentation to place devices and establish the tunnel. The device functions by establishing the tunnel and placing the expansion Sheath into the tibial tunnel by the use of Sheath Inserter. This is followed by screwing an Expansion Screw into the Sheath expanding the Sheath which compresses the graft against the tunnel and creating fixation.

The document provided is a 510(k) summary for a medical device called the "Intrafix Tibial Sheath." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for establishing novel performance criteria through a study with the specified details. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable or available in this document.

The submission focuses on comparing the new device to existing predicate devices based on design and material characteristics, and verification activities rather than clinical trials with extensive performance metrics against pre-defined acceptance criteria, especially not in the context of an AI/ML device.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not present:

Acceptance Criteria and Study Details for the Intrafix Tibial Sheath

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

The document does not specify formal, quantitative acceptance criteria for device performance in the manner you've requested (e.g., sensitivity, specificity, accuracy for an AI device). Instead, the "acceptance criteria" for a 510(k) submission like this are generally satisfied by demonstrating substantial equivalence to predicate devices. The "performance" assessment is based on verification activities rather than clinical outcomes with an established ground truth.

2. Sample sized used for the test set and the data provenance

• Test set sample size: Not specified. The document mentions "Verification activities, such as, Insertion Torque, Pullout Strength, Displacement Test were performed on the implant and its predicate device," but does not provide the number of units tested.
• Data provenance: Not specified, but these are likely laboratory-based mechanical tests performed by the manufacturer (DePuy Mitek, Inc. in Raynham, MA, USA). The context indicates nonclinical, laboratory testing rather than data from human subjects or clinical settings.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The "ground truth" for this type of mechanical device is typically established by engineering specifications and standard test methods (e.g., for torque, pullout strength, displacement), rather than expert consensus on a clinical diagnosis or interpretation.

4. Adjudication method for the test set

Not applicable. There is no mention of adjudication, as the tests are mechanical and quantitative, not qualitative assessments requiring expert review.

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 mechanical orthopedic implant, not an AI/ML algorithm or imaging device that would involve human readers or AI assistance.

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

Not applicable. This device is a mechanical orthopedic implant, not an algorithm.

7. The type of ground truth used

For the nonclinical testing ("Insertion Torque, Pullout Strength, Displacement Test"), the ground truth would be established by the physical properties measured according to standardized engineering test protocols and specifications for the device and its predicate.

8. The sample size for the training set

Not applicable. This device is a mechanical orthopedic implant, not an AI/ML algorithm that requires a training set.

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

Not applicable. There is no training set for this type of device.

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