(81 days)
The Xomed EpiFilm™ Otologic Lamina is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures. EpiFilm™ Otologic Lamina is indicated for use in myringoplastic and tympanoplastic surgical procedures.
Xomed EpiFilm Otologic Lamina is a biomaterial composed of HYAFF® an ester of hyaluronic acid, a naturally occurring constituent of the extracellular matrix. The transparent lamina has micro-perforations to allow permeability facilitating drainage of exudate at the surgical site.
This document is a 510(k) summary for the Xomed EpiFilm™ Otologic Lamina, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than strictly defining and meeting acceptance criteria through a standalone study with performance metrics in the way a novel AI/software medical device might.
Therefore, the requested information elements related to AI/software device performance criteria and studies are not directly applicable or available in this document. I will extract the information that is present and explain why other sections are not applicable.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the document in the format of acceptance criteria and performance metrics typically seen for AI/software devices (e.g., sensitivity, specificity thresholds). For a 510(k) for a material implant, the "acceptance criteria" are generally demonstrating substantial equivalence to a predicate device, which includes biocompatibility, intended use, and similar performance characteristics.
The document states:
- "The material has been demonstrated non-toxic and biocompatible according to ISO 10993 standards, and in clinical study has presented no new issues of safety or effectiveness for the intended use."
- "In conclusion, Xomed EpiFilm™ Otologic Lamina has the same intended use as the predicate devices and differs only in the material which has been shown as biocompatible, as based on the data in the submission, and raises no new issue of safety or effectiveness."
This suggests the "performance" demonstrated was biocompatibility and lack of new safety/effectiveness issues in comparison to predicate devices, rather than a specific performance metric.
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 summary. The document mentions "clinical study" but does not detail its design, sample size, or 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. This concept of "ground truth" and expert adjudication is more relevant to diagnostic AI/software devices. For a material implant, the safety and effectiveness would be evaluated through pre-clinical (biocompatibility) and clinical (e.g., patient outcomes, adverse events) studies, not typically by expert consensus on image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable to the type of device and submission.
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 provided and is not applicable to an implantable biomaterial device. MRMC studies are for evaluating diagnostic performance, often with AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided and is not applicable to an implantable biomaterial device. This type of study applies to AI/software algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for a material implant would primarily be derived from:
- Biocompatibility testing results (pre-clinical): Adherence to ISO 10993 standards for non-toxicity and biocompatibility.
- Clinical outcomes data: Absence of adverse events, successful healing, and performance comparable to predicate devices in surgical procedures.
The summary states: "The material has been demonstrated non-toxic and biocompatible according to ISO 10993 standards, and in clinical study has presented no new issues of safety or effectiveness for the intended use." This points to both pre-clinical data (ISO standards) and clinical outcomes data.
8. The sample size for the training set
This information is not provided and is not applicable. "Training set" refers to data used to train an AI algorithm. This device is a biomaterial, not an AI.
9. How the ground truth for the training set was established
This information is not provided and is not applicable.
§ 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.