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Gelita-Spon® Absorbable Gelatin Sponge, USP is indicated for use to control minimal bleeding by tamponade effect, blood absorption and platelet aggregation following ENT surgery and also to prevent adhesions in the nasal cavity.

Gelita-Spon® Absorbable Gelatin Sponge USP is a sterile absorbable gelatin sponge composed of highly purified pH neutral pharmaceutical gelatin of porcine origin with haemostatic effect suitable for the control of bleeding and as a packing material. It is able to absorb blood corresponding to about 50 times its own weight and when implanted in vivo, it is completely absorbed within approximately 3 weeks. Gelita-Spon is identical to the predicate device in components, composition, specification, manufacture and packaging. Additional testing to confirm compliance with all test criteria in the USP, specifically including certain biocompatibility tests the methodology of which are slightly different from ISO 10993, was performed following FDA guidance in order to append 'USP' to the product name.

The provided text describes a 510(k) premarket notification for a medical device called Gelita-Spon® Absorbable Gelatin Sponge, USP. This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with acceptance criteria and device performance metrics.

Therefore, many of the requested elements regarding acceptance criteria, study details, and performance metrics (especially those related to AI or comparative effectiveness studies) are not applicable or cannot be extracted from this type of regulatory document.

However, I can extract information related to the device's characteristics and the comparison to its predicate device. This submission is for a material, not a diagnostic device, so the data requested regarding ground truth, expert opinions, and AI performance is not relevant.

Here's the information that can be extracted:

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

The submission does not specify numerical "acceptance criteria" in the traditional sense of a performance study for a diagnostic or therapeutic device with measurable outcomes (e.g., sensitivity, specificity). Instead, substantial equivalence is demonstrated by comparing the new device's characteristics to those of a legally marketed predicate device. The "performance" is considered equivalent if the characteristics are the same or better.

The 510(k) summary concludes: "The information discussed above demonstrates that Gelita-Spon® Absorbable Gelatin Sponge, USP is as safe, as effective, and performs as well as or better than the predicate device, Gelita-Spon® Absorbable Gelatin Sponge."

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

This information is not provided in the 510(k) summary. The submission primarily relies on a comparison of technological characteristics and compliance with biocompatibility standards (ISO 10993 and USP), rather than a clinical performance study with a test set of subjects. The additional "biocompatibility tests" performed to append 'USP' are mentioned, but details on the sample size or provenance of these tests are not included.

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 is not a diagnostic device or a study involving interpretation by experts. Ground truth in this context refers to the chemical and physical properties of the material.

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

Not applicable, as there is no traditional test set requiring 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

Not applicable. This device is an absorbable gelatin sponge, not an AI-powered diagnostic tool.

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

Not applicable. This is not an algorithm-based device.

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

For the new device, the "ground truth" for its characteristics is established through compliance with recognized standards such as USP (United States Pharmacopeia) and ISO 10993 (Biological evaluation of medical devices), and by chemical and physical testing of the material for properties like absorbent qualities, resorption time, and material composition.

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.

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Gelita-Spon® Absorbable Gelatin Sponge is indicated for use to control minimal bleeding by tamponade effect, blood absorption and platelet aggregation following ENT surgery and also to prevent adhesions in the nasal cavity.

Gelita-Spon® Absorbable Gelatin Sponge is a sterile absorbable gelatin sponge composed of highly purified pH neutral pharmaceutical gelatin of porcine origin with haemostatic effect suitable for the control of bleeding and as a packing material. It is able to absorb blood corresponding to about 50 times its own weight and when implanted in vivo, it is completely absorbed within approximately 3 weeks.

The provided document focuses on the 510(k) summary for the Gelita-Spon® Absorbable Gelatin Sponge, establishing its substantial equivalence to predicate devices rather than presenting a study demonstrating its performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and AI-related aspects cannot be extracted from this document.

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

The document does not specify formal acceptance criteria with numerical targets. Instead, it demonstrates substantial equivalence by comparing the technological characteristics of Gelita-Spon® with two predicate devices (MeroPack™ Nasal Dressing and Sinus Stent and MeroGel™ Nasal Dressing and Sinus Stent).

A comparative table of these characteristics is provided:

The acceptance criteria implicitly are that the device's characteristics are comparable to or better than the predicate devices, particularly for features like absorbent qualities and biocompatibility.

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

This information is not provided in the document. The submission relies on comparative data with predicate devices and general performance characteristics of the gelatin sponge, not on a specific clinical test set with a defined sample size or data provenance.

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)

This information is not provided in the document. No expert review or ground truth establishment relevant to a clinical test set is mentioned.

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

This information is not provided in the document. No adjudication method is mentioned as there is no specific clinical test set 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

This information is not applicable/provided. The device is a physical medical device (absorbable gelatin sponge), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human readers and AI is irrelevant to this submission.

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

This information is not applicable/provided. The device is a physical medical device, not an algorithm.

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

This information is not provided in the document. The submission relies on the established science and performance characteristics of absorbable gelatin sponges and a comparison to legally marketed predicate devices, rather than a specific ground truth derived from expert consensus, pathology, or outcomes data from a new study for this device.

8. The sample size for the training set

This information is not provided in the document. No "training set" in the context of an algorithm is discussed.

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

This information is not provided in the document. No "training set" or its ground truth establishment is mentioned.

Ask a specific question about this device