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510(k) Data Aggregation
(215 days)
The J Tac is intended for use to fixate and stabilize bioresorbable and non-resorbable barrier membranes used for regeneration of tissue in the oral cavity or in dental situations that require membrane use or fixation.
The J - Tac is a metal device intended to stabilize a barrier membrane. It is made of Titanium Alloy and supplied non-sterile.
The J-Tac device is a metal device designed to stabilize barrier membranes in oral and dental procedures. Its acceptance criteria and performance were evaluated through non-clinical bench testing.
1. Table of acceptance criteria and the reported device performance:
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Compression Force | Unspecified, but tested to demonstrate safe and effective physical properties. | Met the requirements of pre-defined acceptance criteria. |
| Torsion Test | Unspecified, but tested to demonstrate safe and effective physical properties. | Met the requirements of pre-defined acceptance criteria. |
2. Sample size used for the test set and the data provenance:
The document does not specify the exact sample size for the bench tests (compression force and torsion tests). The data provenance is non-clinical bench testing conducted by Jeil Medical Corporation.
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 was established through engineering tests (compression and torsion tests) against pre-defined physical property requirements, not through expert consensus on medical outcomes.
4. Adjudication method for the test set:
Not applicable. The evaluation was based on objective physical property measurements against pre-defined engineering requirements, not on subjective 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 physical medical device (membrane fixation pin), not an AI-assisted diagnostic or treatment tool. Therefore, an MRMC study and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used:
The ground truth for the device's performance was established through engineering requirements and specifications for physical properties, specifically compression force and torsion strength.
8. The sample size for the training set:
Not applicable. This is a physical medical device, and the evaluation involved non-clinical bench testing, not a training set for an algorithm.
9. How the ground truth for the training set was established:
Not applicable, as there was no training set for an algorithm. The "ground truth" for the device's functionality was based on established engineering principles and pre-defined acceptable ranges for its physical properties to ensure safe and effective use.
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