Search Results

The Jewel Precision Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used, for a maximum of 30 days.

Jewel Precision Reusable Rigid Sterilization Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization at 270°F (132°C) for 4 minutes with a drying time of 30 minutes.

Reusable containers, covers, filter holders, insert trays, and accessory items such as brackets of various configuration, dividers, caddies, and silicone nipple mats are intended to organize and secure the enclosed medical devices during sterilization and storage of the container.

Filter media allows ingress and egress of sterilant gas while providing a microbial barrier. Filter media is single use only.

The Jewel Precision Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used, for a maximum of 30 days.

The containers are suitable for dynamic air removal (pre-vacuum) steam sterilization when used as described in the instructions for use.

Reusable trays and accessory items such as brackets of various configuration, dividers, caddies, and silicone nipple mats are intended to organize and secure the enclosed medical devices during sterilization and storage of the container.

The Jewel Precision Reusable Rigid Sterilization Container System comprises a sealed sterilization container consisting of a base, cover, filter retainers, single use replaceable paper filters, and accessories consisting of inner trays, and support brackets. Support brackets are configured to securely support container contents, and are secured to inner trays with stainless steel screws and cap nuts. The container is designed to allow efficient exposure of the tray's contents to sterilant gas during the sterilization process, and to contain and protect reusable surgical instruments during sterilization, transport, and storage. The cover incorporates a sealing gasket, and is secured to the base with latches which lock in place. The latching mechanism places a load on the gasket, which is held in compression against the top surface of the container base, maintaining sterile integrity and preventing unwanted separation. The cover also incorporates an alignment flange along its perimeter, which ensures correct alignment of the cover with the container bottom. Provisions are made on the external container surfaces for the use of user provided Sterilizer Load Data Cards and user provided Tamper Evident Locks, through the incorporation of stainless steel Load Data Card Holders and stainless steel hasp and pin studs are designed to fit standard autoclaves, and are manufactured of materials capable of withstanding repeated steam sterilization cycles. The containers and accessories are manufactured from materials which are suitable for use with Pulsed Pre-Vacuum Steam Sterilization methods.

Filter media is Ahlstrom Reliance 335 WL11359D paper, FDA cleared under K800123, which allows ingress and egress of sterilant gas while providing a microbial barrier. The Filter media is single use only.

The Jewel Precision Reusable Rigid Sterilization Container System is used to organize, protect, and transport surgical instruments during steam sterilization and subsequent storage. The Jewel Precision Reusable Rigid Sterilization Container System maintains sterility of enclosed instruments, having been validated for a period of 30 days post sterilization, using containers previously subjected to more than 100 sterilization usage cycles. The Jewel Precision Reusable Rigid Sterilization Container System is intended for sterilization of non-porous and porous items, e.g. scissors, hooks, probes, extractors, suction instruments, drivers, rasps, obturators, etc. The container does not come into direct patient contact while in use.

The provided document describes the Jewel Precision Reusable Rigid Sterilization Container System and its performance validation for sterilization efficacy, dry time, and biocompatibility, rather than an AI/ML medical device. Therefore, the information needed to answer many of the specific questions about AI/ML acceptance criteria and studies (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, ground truth establishment for AI/ML) is not present in this document.

However, I can extract the relevant acceptance criteria and reported performance for the described medical device.

1. A table of acceptance criteria and the reported device performance

Based on the "Performance Data" and "Summary of Non-Clinical Tests Conducted for Determination of Substantial Equivalence" sections, the following acceptance criteria and device performance are reported:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide a specific sample size for "test sets" in the context of an AI/ML model. The testing performed is for a physical medical device (sterilization container). It mentions "containers previously subjected to more than 100 sterilization usage cycles" for the sterility maintenance claim, suggesting these cycles were part of the testing. No information on data provenance (country of origin, retrospective/prospective) is applicable or provided as it's not a data-driven AI/ML study.

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 section is not applicable as the device is a physical sterilization container, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable as the device is a physical sterilization container, not an AI/ML algorithm requiring expert adjudication. The "ground truth" for this device's performance is established through standardized laboratory and engineering tests (e.g., sterility testing, drying tests, biocompatibility).

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 section is not applicable. No MRMC study was done, as this is a physical medical device and not an AI/ML diagnostic aid intended to improve human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This section is not applicable. This is a physical medical device, not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this medical device's performance relies on objective, quantitative measurements and laboratory tests based on recognized standards for sterilization (e.g., 12 log reduction for sterility assurance level), drying (absence of visible moisture), and biocompatibility (cytotoxicity testing). It is not based on expert consensus, pathology, or outcomes data in the sense of a diagnostic AI/ML system.

8. The sample size for the training set

This section is not applicable as there is no AI/ML model for which a training set would be used.

9. How the ground truth for the training set was established

This section is not applicable as there is no AI/ML model or training set.

Ask a specific question about this device