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The intended use of the Intratunnel Tibial Fixation Fastener is for fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee.

The Innovasive Intratunnel Tibial Fixation Fastener consists of two components, an Expansion Sheath, and Expansion Screw. Also included with the system is the instrumentation to place the devices and establish the tunnel. The device functions by establishing the tibia-femoral tunnel and placing the Expansion Sheath into the tibial tunnel. 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 provided text describes a 510(k) premarket notification for a medical device called the Innovasive Devices Intratunnel Tibial Fixation Fastener. The information focuses on the device's description, intended use, comparison to a predicate device, and the type of performance data submitted.

However, the document does not contain specific acceptance criteria values or detailed results of the study that proves the device meets those criteria. It only states that "Bench Testing: Comparison of the static holding strength of the Intratunnel Tibial Fixation Fastener compared to the predicate device in a porcine model" was provided as performance data.

Therefore, many of the requested fields cannot be filled.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

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: Not specified.
• Data Provenance: Porcine model (animal study). No country of origin is mentioned for the data collection. It's a bench test (laboratory, not human clinical data).

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 was a bench test involving static holding strength in a porcine model, not a study requiring expert interpretation of medical images or diagnoses.

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

• Not Applicable. As above, this was a bench test and did not involve expert adjudication.

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. This is not relevant to a mechanical fixation device in a porcine model.

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

• Not Applicable. This is a mechanical device, not an AI or algorithmic system. The bench testing performed is essentially a "standalone" evaluation of the device's physical properties.

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

• The "ground truth" for this type of bench testing would be the measured static holding strength of the device and the predicate device in the porcine model. This is an objective measurement based on physical testing.

8. The sample size for the training set

• Not Applicable. This is not a machine learning device; therefore, there is no "training set."

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

• Not Applicable. As above, no training set was used.

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