(268 days)
The Biodesign Otologic Butterfly Graft is intended for use as an implant material to aid in the natural healing process in myringoplasty and tympanoplasty procedures.
The Biodesign Otologic Butterfly Graft is a self-securing butterfly-style graft structure with the same underlay component as the predicate device, attached to an external stabilizing component with an absorbable knotted thread, all made from the same SIS (small intestinal submucosa) ECM material as that of the predicate device. This self-securing structure maintains the location and close tissue approximation of the underlay component across the tympanic membrane (TM) defect as an implant material to aid in the natural healing process in myringoplasty and tympanoplasty procedures.
The provided text does not describe an acceptance criteria table or a study that specifically "proves" the device meets acceptance criteria in the typical sense of a single, definitive study with a direct comparison against a set of performance metrics. Instead, it describes a Substantial Equivalence (SE) determination for a new device, the "Biodesign Otologic Butterfly Graft," by comparing it to a legally marketed predicate device (K161000).
The concept of "acceptance criteria" here is implicitly tied to demonstrating that the new device is as safe and effective as the predicate, despite some design changes. The studies conducted are largely comparative, aiming to show that the changes do not introduce new risks or diminish performance relative to the predicate.
Here's an attempt to extract the requested information based on the provided text, acknowledging that some details might be inferred or not explicitly stated as they would be in a direct performance study against a predefined acceptance criterion.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document focuses on demonstrating substantial equivalence to a predicate device rather than meeting pre-defined numerical acceptance criteria for a novel device. The "acceptance criteria" for the animal study are explicitly stated and are the closest to what was requested.
| Acceptance Criterion (from Animal Study) | Reported Device Performance (from Animal Study) |
|---|---|
| Treated tympanic membranes must (1) appear visually healed, with no perforation observed via endoscopy at follow-up. | The animal study showed a healing/closure rate of 79% among the 14 tympanic membrane perforations implanted with the subject device (11/14). This rate is within the range of the clinical and animal data submitted in support of the predicate device (63-100%). Visual healing via endoscopy is implied in the "healing/closure rate" and "no perforation observed." |
| Treated tympanic membranes must (2) have a waveform on the tympanogram above the baseline perforated TM (i.e. Type A graph shape). | The animal study for the subject device "evaluated the status of TM closure through a functional tympanogram technique." While a direct percentage of "Type A graph shape" isn't given, the statement "This healing/closure rate is within the range of the clinical and animal data submitted in support of the predicate device (63-100%)" combined with the method of evaluation suggests this criterion was met for the healed cases. |
| Treated tympanic membranes must (3) histologically show healing in progress at follow-up, as determined by the Veterinary Pathologist's review of the histologic sections of the grafted/implanted tympanic membranes. | "Histological evaluation of the healed TM tissue showed a tri-laminar healed TM structure in the animal studies for both the predicate and subject device." This indicates successful histological healing equivalent to the predicate. |
| Implicit Acceptance Criteria for Substantial Equivalence (derived from the document's structure): | |
| Biocompatibility in accordance with ISO 10993 series. | Biocompatibility testing for the subject device was submitted under ISO 10993, addressing various parts including cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, implantation effects, chemical characterization, and EO residuals. It is implied these tests met the standard requirements to demonstrate safety equivalent to the predicate. |
| Mechanical performance for intended use (burst strength, joint strength). | Product verification testing for "mechanical performance of the subject device for its intended use" included burst strength and joint strength (specific to the new design elements). Visual inspection was also performed. The conclusion states the device "functions as intended during implantation and throughout the patient's natural healing process to locate and secure the underlay component." No specific numerical results are provided, but the statement implies successful performance meeting internal specifications. |
| Usability of device handling and implantation. | A Summative Usability Report utilizing "simulated-use testing... in a worst-case benchtop model" and leveraging GLP animal study data related to usability was conducted. The report verified "device handling and usability characteristics in a hydrated state." This implicitly met the usability requirements. |
| Packaging system adequacy for a 6-month shelf-life. | Non-clinical bench testing on accelerated-aged samples confirmed the packaging system is "adequate to support a 6-month shelf-life claim." |
| Sterilization effectiveness (SAL: 10-6). | The device undergoes Ethylene Oxide (EO) sterilization with a "Sterility Assurance Level (SAL): 10-6," established via an adoption analysis per AAMI TIR28:2016 for the predicate device. This implies the sterilization method and SAL are equivalent and effective. |
Summary of Comparative Equivalence: The overall "acceptance criterion" for the device, in the context of this 510(k) submission, is to demonstrate that its design changes do not introduce new questions of safety or effectiveness and that it performs as well as, or better than, the predicate device. The various studies and tests listed are all geared towards supporting this claim of substantial equivalence.
2. Sample size used for the test set and the data provenance
For the animal study:
- Sample Size: 14 tympanic membrane perforations implanted with the subject device.
- Data Provenance: Prospective GLP animal study in a chinchilla model. The location/country is not specified.
For bench testing (mechanical performance, usability, packaging/shelf-life): Specific sample sizes are not provided, only that "Product verification testing was performed," "Summative Usability Report which utilized simulated-use testing," and "Non-clinical bench testing was performed on accelerated-aged representative SHS conditioned packaging system samples."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
For the animal study:
- Number of Experts: At least one "Veterinary Pathologist."
- Qualifications: "Veterinary Pathologist's review of the histologic sections of the grafted/implanted tympanic membranes." No specific years of experience are mentioned.
For other testing, specific expert numbers or qualifications for ground truth establishment are not provided.
4. Adjudication method for the test set
For the animal study:
- The text mentions a "Veterinary Pathologist's review of the histologic sections." This implies a single expert's determination for the histological ground truth. It does not describe a multi-reader adjudication method (e.g., 2+1, 3+1).
- Visual healing was determined "via endoscopy," and functional healing by "typanogram technique." It's unclear if these assessments involved multiple readers or an adjudication process.
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, an MRMC comparative effectiveness study was not done. This document pertains to a medical device (graft) and its biological/mechanical performance, not an AI or imaging diagnostic device where MRMC studies involving human readers and AI assistance would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (graft), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the animal study:
- Pathology: Histological assessment by a Veterinary Pathologist.
- Clinical Observation: Visual assessment (no perforation observed via endoscopy).
- Physiological/Functional Data: Tympanogram waveform analysis.
8. The sample size for the training set
- Not applicable. This document describes the evaluation of a physical medical device. There is no concept of a "training set" in the context of an animal study for a medical implant like there would be for an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for this type of device evaluation, no ground truth was established for one.
§ 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.