(135 days)
DetachaTip® III Plus Multi-Use Instrument Tray (REF 3-4343) is a reusable sterilization tray intended for pre-vacuum steam sterilization, organization, transportation, and storage of enclosed, reusable medical devices. DetachaTip® III Plus Multi-Use Instrument Tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments.
DetachaTip® III Plus Multi-Use Instrument Tray is intended for use with DetachaTip® III instruments and ConMed reusable medical devices meeting challenge conditions defined in Table 1. The MAXIMUM recommended load is: 25 lb [11.3 kg].
The ConMed DetachaTip® III Plus Multi-Use Instrument Tray (REF 3-4343) is used to retain reusable instruments during steam sterilization. The tray consists of a perforated tray base and lid made from polypheny sulfone (Radel®). Latches securely hold the tray base, and handles are provided for transportation. A perforated silicone mat protects instruments placed in the bottom of the tray. A Radel® instrument rack separates and secures the DetachaTip® III instruments throughout sterilization processing and/or storage. The tray is not intended to maintain sterility. The instrument tray is to be used with an FDA cleared sterilization wrap.
DetachaTip® III Plus Multi-Use Instrument Tray is designed to fit a standard autoclave, comprised of materials resistant to corrosion, and able to withstand repeat steam sterilization cycles. The tray is designed to withstand repeated use. It is not designed to be serviced or repaired. The materials comprising the tray are biocompatible and will not contaminate reusable medical devices.
The provided document describes a 510(k) summary for the ConMed DetachaTip® III Plus Multi-Use Instrument Tray. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance metrics for a novel medical device like an AI algorithm.
Therefore, many of the requested categories for describing an AI study's acceptance criteria and performance cannot be directly extracted from this document, as it pertains to a physical sterilization tray.
Here's an attempt to answer the questions based on the available information, with clear indications where information is not available or not applicable to this type of device submission.
Acceptance Criteria and Device Performance (as much as applicable)
| Feature / Criteria (Derived from ANSI/AAMI ST77:2006/(R)2010 and device description) | Reported Device Performance (as stated in submission) |
|---|---|
| I. Intended Use Match (Sterilization of instruments) | Intended for pre-vacuum steam sterilization, organization, transportation, and storage of enclosed, reusable medical devices (DetachaTip® III instruments and ConMed reusable medical devices). |
| II. Physical Design Compatibility (Autoclave Fit) | Designed to fit a standard autoclave. |
| III. Material Properties (Corrosion Resistance) | Comprised of materials resistant to corrosion. |
| IV. Material Properties (Withstand Repeat Sterilization) | Able to withstand repeat steam sterilization cycles. |
| V. Material Properties (Biocompatibility) | Materials are biocompatible and will not contaminate reusable medical devices. |
| VI. Durability (Withstand Repeated Use) | Designed to withstand repeated use. |
| VII. Load Capacity | MAXIMUM recommended load: 25 lb [11.3 kg]. |
| VIII. Compatibility with Sterilization Parameters (Pre-vacuum Steam wrapped) | Temperature: 270°F (132°C) |
| Exposure Time: 4 minutes | |
| Dry Cycle Time: 30 minutes. | |
| IX. Grounding in Standards | Meets requirements of ANSI/AAMI ST77:2006/(R)2010. |
| X. Substantial Equivalence to Predicate | Found to be substantially equivalent in intended use, device design, materials, performance, effectiveness, and safety to K092414. |
Study Details (Information not present in the document for an AI study)
- Sample size used for the test set and the data provenance: Not applicable. This is not an AI algorithm. The performance testing refers to physical tests on the sterilization tray. The details of these tests (e.g., number of cycles tested, specific load configurations) are not provided in this summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/diagnostic devices (e.g., expert consensus, pathology) is not relevant for a sterilization tray. Compliance with ANSI/AAMI ST77 and functional performance (e.g., ability to hold instruments, withstand sterilization) is the focus.
- Adjudication method for the test set: Not applicable. (See #2)
- 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 is a physical device, not an AI or diagnostic algorithm requiring human interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. (See #4)
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI. For this device, the "ground truth" equates to demonstrated performance against established industry standards and defined parameters for sterilization effectiveness and device durability. The predicate device serves as a benchmark for substantial equivalence.
- The sample size for the training set: Not applicable. There is no training set for a physical device like this.
- How the ground truth for the training set was established: Not applicable. (See #7)
Summary of what the document does provide regarding performance and equivalence:
The document states that the DetachaTip® III Plus Multi-Use Instrument Tray meets requirements of ANSI/AAMI ST77:2006/(R)2010 Containment devices for reusable medical device sterilization. It further asserts that "Based on the nonclinical performance testing, the subject device is as safe and effective as the legally marketed predicate device."
The comparison table (page 2) highlights that the performance testing for both the subject and predicate devices refers to ANSI/AAMI ST77:2006/(R)2010 Containment devices for reusable medical device sterilization. This standard outlines the specific tests and criteria that such devices must meet. While the specific numerical results of these tests are not included in this summary, the statement "meets requirements" implies successful completion of these tests.
In essence, the study (performance testing) mentioned for this device is the demonstration that it complies with the ANSI/AAMI ST77 standard and is substantially equivalent to a previously cleared device (K092414) in terms of its materials, design, and ability to perform its intended function of holding instruments during steam sterilization.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).