(145 days)
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:
| Feature | Gelita-Spon® | MeroPack™ Nasal Dressing and Sinus Stent | MeroGel™ Nasal Dressing and Sinus Stent |
|---|---|---|---|
| Intended Use | Post-Op, help control minimal bleeding by tamponade effect, blood absorption and platelet aggregation following ENT surgery and also to prevent adhesions in the nasal cavity. | Post-Op, help control minimal bleeding and separate mucosal surfaces/adhesion prevention | Space occupying dressing and/or stent to separate mucosal surfaces, help control minimal bleeding and aid in the natural healing process in the middle and external ear canal |
| Material/Construction | Porcine-derived gelatin (derived from collagen) | Esterified hyaluronic acid and collagen | Esterified hyaluronic acid |
| Absorbent Qualities | 40 times weight of the device | In excess of 10 times weight of the device | In excess of 10 times weight of the device |
| Sterility | Gamma radiation | Gamma radiation | Gamma radiation |
| Resorption Time | Within 21 days | Within 14 days | Within 14 days |
| Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 |
| Method of Action | Hygroscopic, forms gelatinous mass in contact with fluids | Hygroscopic, forms gelatinous mass in contact with fluids | Hygroscopic, forms gelatinous mass in contact with fluids |
| Method of Removal | Gentle irrigation of residues or natural resorption | Gentle irrigation of residues or natural resorption | Gentle irrigation of residues or natural resorption |
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.
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.