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The KSEA Perforated Bioabsorbable Interference Screw MegaFix" is intended for use by qualified surgeons for tibial and femoral fixation (primary anchorage) of tendon grafts in human cruciate ligament reconstruction.

The KSEA Perforated Bioabsorbable Interference Screw MegaFix" is biocompatible and biodegradable.

This looks like a 510(k) premarket notification for a medical device: "KSEA Perforated Bioabsorbable Interference Screw MegaFix™". This type of document is used to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

Crucially, 510(k) summaries for devices like this one (bioabsorbable screws for orthopedic fixation) typically do NOT include detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or adjudication methods in the way that an AI/software device would. The assessment for these types of devices focuses on material biocompatibility, mechanical properties, and equivalence to existing devices.

Therefore, many of the requested categories are not applicable to the provided text.

Here's a breakdown of what can and cannot be found in the provided text:

1. Table of acceptance criteria and the reported device performance

• Not applicable/Not found. This 510(k) summary does not contain a table of acceptance criteria or reported device performance in the context of diagnostic accuracy, which is what these questions typically refer to for AI/software devices. The acceptance is based on demonstrating "substantial equivalence" to predicate devices, primarily through comparison of design, materials, and intended use, and sometimes supported by mechanical testing and biocompatibility data (though not detailed here).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not applicable/Not found. There is no mention of a "test set" in the context of evaluating diagnostic performance or an AI algorithm. The device is a physical implant.

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/Not found. Ground truth establishment by experts is not relevant for this type of device submission.

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

• Not applicable/Not found. No test set or adjudication method is described.

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/Not found. This is not an AI-assisted diagnostic device.

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

• Not applicable/Not found. This is not an algorithm.

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

• Not applicable/Not found. Ground truth in the context of diagnostic accuracy is not relevant here. The "ground truth" for this device would be its physical and chemical properties and its performance in a mechanical or biocompatibility test, which are not detailed in this summary.

8. The sample size for the training set

• Not applicable/Not found. No training set is mentioned as this is not an AI/ML device.

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

• Not applicable/Not found. No training set ground truth to establish.

Summary regarding the provided document:

The provided text is a 510(k) summary for a physical medical device (Perforated Bioabsorbable Interference Screw). Its clearance is based on "Substantial Equivalence" to legally marketed predicate devices, not on performance against specific diagnostic acceptance criteria related to an algorithm or AI. Therefore, most of the questions stemming from an AI/software device context are not applicable to this document. The document confirms the device's indications for use and states that it is substantially equivalent to predicate devices because its basic features and intended use are similar, and minor differences raise no new issues of safety and effectiveness.

Ask a specific question about this device

The KSEA Bioabsorbable Interference Screw MegaFix" is intended for use by qualified surgeons for tibial and femoral fixation (primary anchorage) of tendon grafts in human cruciate ligament reconstruction.

The KSEA Bioabsorbable Interference Screw MegaFix" is biocompatible and biodegradable.

I am sorry, but based on the provided document, there is no information about acceptance criteria, device performance tables, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth types.

The document is a 510(k) summary for a medical device (KSEA Bioabsorbable Interference Screw Megafix™), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study results or performance metrics in the way you've requested. It states that "The minor differences between the KSEA Bioabsorbable Interference Screw and the predicate devices raise no new issues of safety and effectiveness, as these minor differences have no effect on the performance, function or intended use of the device." This implies a comparison to existing devices, but the specific studies and acceptance criteria are not detailed here.

Ask a specific question about this device