Search Results

The Autoclavable Cassettes are used in healthcare facilities to organize surgical and prosthetic instruments during sterilization, storage, and transport during and after surgical uses. The Autoclavable Cassettes are not intended to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated sterilization wrap to maintain the sterility of the enclosed devices.

Sterilization parameters:

Pre-vacuum steam: 132°C (270°F) for 4 minutes with 30 minutes drying time.

Sterilization validations for the worst-case Autoclavable Cassette and instruments. The Autoclavable Cassettes are validated for a maximum load of 641 grams for Glided Surgical Kit, 476 grams for Glidewell HTTM Implant Surgical Kit. and 192 grams for Glidewell™ Prosthetic Kit.

The Autoclavable Cassettes are designed to store, organize, and protect various surgical and prosthetic instruments that are sterilized by the healthcare provider. The Autoclavable Cassettes are composed of three main components: a lid, a base, and a tray. The components are made of polyphenylsulfone PPSU. The tray has silicone rubber grommets to hold the instruments in place. The lid latches to the base holds the tray, and all three components are designed to secure the kit into a single unit. The cassette protects the interior components during sterilization and subsequent storage. The kits are perforated to allow for penetration of moist heat during steam sterilization and require the use of an FDA-cleared sterilization wrap to maintain sterility. To facilitate the surgical procedure and the correct use and the positioning of the instrument, the tray has instrument descriptions on the surface.

Surgical and prosthetic instruments of the Glidewell Implant System are intended to be placed in the Autoclavable Cassette. These surgical and prosthetic instruments which are the contents of the sterilization cassette are all Class 1 exempt as described in 21 CFR 872.3980 (Endosseous dental implant accessories).

The provided text describes the acceptance criteria and the results of the study conducted to demonstrate the safety and effectiveness of the Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific "sample size" in terms of number of individual units tested for each non-clinical test. However, it indicates:

• Worst-case cassettes were tested for performance based on critical impact factors including weight, vent to volume ratio, and worst-case instruments to be contained.
• Data Provenance: The study is reported as non-clinical testing conducted by the manufacturer, Prismatik Dentalcraft, Inc. The document doesn't specify the country of origin of the data, but it refers to international standards (e.g., ANSI/AAMI, ISO, ASTM). The nature of these tests suggests they are prospective in that they are performed specifically to validate the device's performance against predefined criteria.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided in the document. The tests performed are non-clinical, objective evaluations against established scientific and engineering standards (e.g., visual inspection for soil, chemical tests for residue, biological indicators for sterility, mechanical testing for durability). They do not involve human interpretation of medical images or expert consensus to establish a "ground truth" in the way a diagnostic AI device would.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document for the reasons stated above. Adjudication typically applies to studies where human interpretation or consensus is required to determine a reference standard.

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 applicable and not provided in the document. The device in question is an "Autoclavable Cassette" (sterilization wrap accessory), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is irrelevant to this device type.

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

This information is not applicable and not provided in the document. The device is a physical medical device (sterilization cassette), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not relevant.

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

The "ground truth" for the non-clinical tests is based on objective, measurable standards and criteria established by recognized regulatory and industry standards (e.g., SAL ≤10^-6 for sterility, specific chemical residue limits for cleaning, visual inspection for damage, cellular vitality percentages for biocompatibility). These are not based on expert consensus, pathology, or outcomes data in the usual sense of diagnostic or therapeutic devices.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. The device is a physical product and does not involve AI/machine learning, thus there is no "training set."

9. How the Ground Truth for the Training Set was Established

This information is not applicable and not provided in the document, as there is no training set for this type of device.

Ask a specific question about this device