(84 days)
The Anthogyr Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility.
The cycle of sterilization, for Anthogyr INTEGRAL Guided Surgery Cassettes, uses pre-vacuum steam: 132 °C (270° F) during 4 minutes with 30 minutes drying time.
Anthogyr INTEGRAL Guided Surgery Cassettes have been validated for a maximum load of with the associated instrument. The worst-case recommended load is: 886 g.
The device dimension of Anthogyr INTEGRAL Guided Surgery Cassettes is 290x176x62 mm.
The cassettes are not intended to be stacked during sterilization process.
Anthoqyr cassettes are reusable rigid containers, comprising a case bottom (base), one or more removable inner tray base (tray) and a tray lid (lid). The trays are composed of brackets made of medical grade silicone, namely brackets used to maintain the Anthogyr dental instruments in place during the surgical or prosthetic procedure and during sterilization. The base and trays have markings and/or colors code to indicate either the surgical workflow, or the position of the instruments in the kit. The lid holds all the instruments securely in place during treatment. To facilitate the surgical procedure and the correct use and positioning of the instruments, the trays have instrument pictograms and/ or color-coded workflows printed on the surface. Surgical instruments of the Anthogyr Dental Implant System intended to be placed in the Anthogyr cassettes are used for bed preparation, placement, maintenance and explanation of the implants from Anthogyr Dental Implant System. These devices are all Class I exempt or already have class II pre-market notification clearance as described in 21 CFR 872.3980 (Endosseous dental implant accessories) and are not subject devices of this submission.
The provided text is a 510(k) Summary for the Anthogyr INTEGRAL Guided Surgery Cassettes. It does not describe a study involving an AI/software device that requires establishing ground truth by experts or evaluating human reader performance. Instead, it focuses on demonstrating substantial equivalence of a medical device (sterilization cassettes) to a predicate device through non-clinical performance testing.
Therefore, many of the requested criteria, such as "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "standalone (i.e. algorithm only) performance" are not applicable to this document.
However, I can extract the acceptance criteria and reported device performance for the non-clinical tests mentioned.
Here's a breakdown of the requested information based on the provided text, indicating "Not Applicable" (N/A) for criteria that do not fit the nature of this submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Standard or Test Method | Purpose of the Testing | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Custom | • Test Soil: Blood Soil (BLSO) | ||
| • Cleaning Method: Manual | |||
| • Residuals Tested: Hemoglobin and Protein | Visual Inspection: No Visible Soil | ||
| Hemoglobin Test: |
§ 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).