(133 days)
Adaptain™ Soluble Implant Material is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.
Adaptain™ Soluble Implant Material is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired. Adaptain" Soluble Implant Material is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC PolymerBlend"). Adaptain" "Soluble Implant Material contains no other additives or colorants. Adaptain"" Soluble Implant Material is formed in bars and sheets of various sizes with weights ranging from 0.5 to 5 grams each. Adaptain™ Soluble Implant Material is provided sterile by irradiation and must not be resterilized.
This document describes the 510(k) submission for the Adaptain™ Soluble Implant Material, an ear, nose, and throat synthetic polymer material. The submission aims to demonstrate substantial equivalence to a predicate device, the Ceretene™ Soluble Implant Material (K081531).
Based on the provided text, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are not detailed in a quantitative, performance-based manner that would typically be seen for a diagnostic or AI-driven device. Instead, the submission relies on demonstrating substantial equivalence to an existing predicate device.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. The core "acceptance" is based on substantial equivalence, which implies the new device performs similarly to the predicate in all relevant aspects.
| Acceptance Criteria Category | Reported Device Performance (as demonstrated by comparison to predicate) |
|---|---|
| Indications for Use | Identical to predicate device |
| Intended Use | Identical to predicate device |
| Design | Identical to predicate device |
| Materials | Identical to predicate device (comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC PolymerBlend™), no other additives or colorants) |
| Sterilization | Identical to predicate device (provided sterile by irradiation) |
| Performance | Identical to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention a "test set" or a specific study involving patient data (clinical or otherwise) with a defined sample size for performance evaluation. The substantial equivalence argument is based on comparing device characteristics rather than clinical outcomes. Therefore, there is no information on data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as there is no "test set" and no "ground truth" establishment in the context of device performance in a clinical setting mentioned. The evaluation is based on a comparison of the device's characteristics to its predicate.
4. Adjudication Method for the Test Set
This information is not applicable as there is no "test set" for which adjudication would be required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence of the device itself, not on evaluating human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone "algorithm only" performance study was not done. The device is a physical implant material, not a software algorithm.
7. The Type of Ground Truth Used
This information is not applicable. The "ground truth" in this context is the established characteristics and performance of the predicate device, against which the new device is compared for "identicality." It's not a clinical "ground truth" like pathology or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above – no training set for an AI/ML model.
Summary of the document's approach to "acceptance criteria" and "study":
The acceptance criteria for the Adaptain™ Soluble Implant Material appear to be qualitative: to be "identical in design, materials, indications, performance and sterilization" to its predicate, Ceretene™ Soluble Implant Material (K081531). The "study" proving this is a non-clinical evaluation that directly compares these aspects between the new device and the predicate. The FDA's 510(k) clearance signifies agreement that this comparison demonstrates substantial equivalence, allowing the new device to be marketed. This is a common pathway for medical devices that are similar to already legally marketed devices.
§ 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.