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The Apyx is intended for attaching sutures to ligaments of the pelvic floor.

The Apyx device is indicated for anchoring sutures to ligaments of the pelvic floor. The device consists of an implantable nitinol anchor with 4 prongs configured with either non-absorbable or resorbable suture. The anchor-suture assembly is contained within a cartridge, wherein the anchor / suture assembly is deployed to the target site from the cartridge with an applicator. An optional use retriever may be used to remove the anchor in the event of sub-optimal placement of an Anchor during the index procedure. The Apyx also includes an optional securement element which may be used as a suture retention device to distribute suture tension over a larger tissue area and aid in wound healing.

The Apyx device is a single use device which is supplied sterile.

The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria in the typical format of a clinical or performance study with specific metrics like sensitivity, specificity, or AUC, as these would be associated with diagnostic or AI-powered devices.

However, based on the information provided, here's a breakdown of what can be extracted regarding performance and testing:

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

The document mentions various tests conducted, generally implying that the device met the requirements of these tests to demonstrate safety and effectiveness. Since specific numerical acceptance criteria (e.g., "pull-out strength > X N") and the exact reported performance values are not explicitly stated, I will infer the acceptance as "Met requirements" based on the conclusion of substantial equivalence.

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

• Sample size for test set: The "Cadaver Testing" section does not specify the number of cadavers or the number of anchors tested. It uses general phrasing like "users," "all anchor delivery and retrieval procedures," and "All anchors."
• Data provenance: Not explicitly stated, but cadaver testing implies a controlled laboratory environment. The country of origin of the data is not mentioned. It is prospective testing carried out for regulatory submission.

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

• This information is not provided. The cadaver testing describes the actions of "users" (implying medical professionals) who delivered and retrieved anchors, but doesn't mention independent expert assessment or ground truth establishment in a formalized way for outcomes like accuracy or safety observed during the testing. The "ground truth" here is the observed outcome of the procedure itself (e.g., successful placement, no damage).

4. Adjudication method for the test set

• Not applicable/Not described. The cadaver testing describes qualitative observations of successful delivery, retrieval, and proper fixation. There's no mention of an adjudication process for resolving disagreements between multiple observers, as might be seen in diagnostic studies.

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 device is a surgical instrument (fixation device), not an imaging or AI-assisted diagnostic tool. Therefore, an MRMC study and AI-related effectiveness are not relevant or discussed.

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

• No. This device is a manual instrument for surgical use, not an algorithm.

7. The type of ground truth used

• For the cadaver testing, the ground truth was the direct observation of the physical outcome and success of the procedure (e.g., "anchors were accurately delivered," "no damage observed," "properly fixed"). This is akin to direct experimental observation and physical verification rather than consensus, pathology, or outcomes data in a clinical trial.

8. The sample size for the training set

• Not applicable. This device is a physical medical instrument, not a machine learning algorithm, so there is no "training set."

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

• Not applicable, as there is no training set for a physical medical instrument.

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The Apyx is intended for attaching sutures to ligaments of the pelvic floor.

The Apyx device is indicated for anchoring sutures to ligaments of the pelvic floor. The device consists of an implantable nitinol anchor with 4 prongs configured with either non-absorbable or resorbable suture. The anchor-suture assembly is contained within a cartridge, wherein the anchor/suture assembly is deployed to the target site from the cartridge with an applicator. An optional retriever can be used to remove the anchor in the event of sub-optimal placement of an Anchor during the index procedure. The Apyx device is a single use device which is supplied sterile.

The provided text describes a 510(k) submission for the Apyx device, which is intended for attaching sutures to ligaments of the pelvic floor. The submission claims substantial equivalence to the predicate device, POP Medical Solutions, NeuGuide (K160569). However, the document does not contain a table of acceptance criteria and reported device performance or information about a specific study proving the device meets acceptance criteria related to efficacy metrics for an AI/ML algorithm.

The information provided is primarily related to the mechanical and biocompatibility testing of the Apyx device as a medical instrument, not an AI/ML system. Therefore, I cannot fulfill the request for information on acceptance criteria and a study proving an AI/ML device meets them, as those details are not present in the provided text.

Based on the available text, I can only extract general performance data categories and a cadaver study description for the mechanical device as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with specific numerical targets for performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/ML device. It lists general performance data categories for the Apyx medical device (a mechanical fixation device), along with a summary of cadaver testing.

The subsequent questions (2-9) are specifically tailored to the evaluation of an AI/ML-based medical device. Since the provided document describes a mechanical medical instrument (Apyx) and not an AI/ML product, these questions are not applicable to the information given. The text does not mention any AI/ML components, software algorithms, or their performance evaluation. Therefore, I cannot answer questions 2 through 9 based on the provided input.

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