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The Jax-tcp granules may be used alone or can be mixed with the gel to create a cohesive mass that can be applied to the defect site. The gel is contradicted for use without the use of the granules. When used together, the granules and gel should be combined in a 1:1 ratio. JAX-tcp is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. JAX-tcp is indicated to be gently packed into bony voids or gaps of the skeletal system, (i.e., the extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. JAX-tcp provides a filler that is resorbed and is replaced with bone during the healing process.

JAX-tcp is a single-use bone void filler consisting of two components: surgical grade ßtricalcium phosphate granules and a hydrogel, used as a handling medium. The product is supplied sterile in quantities ranging from 1cc to 30cc.

The provided document is a 510(k) premarket notification for the JAX-tcp device, which is a bone void filler. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trials proving performance against specific acceptance criteria.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Here's a breakdown of why the information is not present and what is typically found in a 510(k) for such a device:

1. Table of acceptance criteria and reported device performance: This document explicitly states: "A review of the test data indicated that JAX-tcp is equivalent to other predicate calcium salt based bone void fillers currently used clinically." It does not present specific acceptance criteria or quantitative performance metrics for JAX-tcp itself. The "performance data" section is very brief and refers to equivalence, not meeting specific criteria.

2. Sample size used for the test set and the data provenance: Not applicable. There is no mention of a standalone study with a test set. The submission relies on demonstrating equivalence through "materials data, and testing results" without detailing specific clinical or device performance studies in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no specific test set or clinical study with ground truth establishment described.

4. Adjudication method for the test set: Not applicable.

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. JAX-tcp is a physical bone void filler, not an AI-assisted diagnostic or imaging device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as JAX-tcp is a physical bone void filler.

7. The type of ground truth used: Not applicable, as there's no specific test set or clinical study with ground truth establishment described.

8. The sample size for the training set: Not applicable. JAX-tcp is a physical medical device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The submission focuses on establishing substantial equivalence to existing predicate devices based on:

• Intended use: Bony voids or gaps not intrinsic to stability, in extremities, spine, and pelvis.
• Base material of the granules: Beta-tricalcium phosphate.
• Use of a hydrogel: As a handling medium, mixed 1:1 with granules.
• Select performance properties: While not explicitly detailed, these would typically include material properties, handling characteristics, and demonstration of resorption and bone replacement similar to predicate devices.

The document states: "The product is adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification." This implies that the full 510(k) submission contained more detailed technical and non-clinical performance data to support the equivalence claim, but this summary does not elaborate on these "testing results" or the specific criteria they met.

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