(407 days)
The instrument kits 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 is:
Pre-vacuum steam: 134 °C during 3 minutes with 16 minutes drying time
Anthogyr does not make any lumen claims for the instrument kits.
The Axiom range surgery kit represents the worst case validated load due to the number of components (34 instruments).
The cassettes are not intended to be stacked during sterilization process.
Instrument kits are cassettes used to enclose and hold surgical instruments and accessories in an organized manner during the sterilization process and subsequent storage. The cassettes by themselves do not maintain sterility. They are to be used with an FDA cleared steam sterilizable pouch.
The cassette is available in only one size (129x156x47.5 mm) marketed in different variations, including different number of tools.
The tools included in the kits are class I exempt or already have class II pre-market notification clearance.
The cassettes are reusable and made of the same materials as the predicate device (Radel R-5000 and R-5100 for tray and lid and medical grade silicone for circular brackets holding the tools).
The provided document is a 510(k) premarket notification for "Instrument Kits" by Anthogyr. It details performance testing related to cleaning, sterilization, and material compatibility, but it does not describe a study involving acceptance criteria for device performance in terms of clinical or algorithmic outcomes. Instead, it focuses on the device's ability to be cleaned and sterilized effectively.
Here's an analysis of the information, tailored to the request but acknowledging the different nature of this medical device (sterilization kits vs. a performance-based device like AI):
1. Table of Acceptance Criteria and Reported Device Performance
The device is an instrument kit designed for sterilization of dental tools. The "performance" in this context relates to its ability to be effectively cleaned and sterilized, and its material safety. There are no clinical performance metrics like sensitivity, specificity, or accuracy for this type of device.
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied/Direct) | Reported Device Performance |
|---|---|---|
| Cleaning Validation | Demonstrated effectiveness of cleaning for both manual and automatic methods (as per AAMI TIR 30, AAMI TIR 12, ISO 17665). | Cleaning validations were conducted and support the effectiveness of both manual and automatic cleaning. |
| Sterilization Validation | Achieves sterility when used with an FDA cleared steam sterilizable pouch, under specified pre-vacuum steam cycle (134 °C for 3 min with 16 min drying time) (as per ISO 17665). | Sterilization validation was performed on the most complete instrument kit (worst-case scenario) and validated the sterilization cycle. |
| Drying Time | Adequate drying time within the sterilization cycle. | Validated in the steam sterilization report according to ISO 17665. |
| Toxicological Properties | No cytotoxicity observed (as per ISO 10993-5). | Cytotoxicity tests were conducted and demonstrate safety. |
| Material Compatibility | Materials are compatible with the sterilization process. | Radel technical data sheet indicates material compatibility. |
| Vent/Volume Ratio | Sterilant penetration is demonstrated despite the vent/volume ratio being lower than the predicate device. | Sterilant penetration testing demonstrates safety and efficacy. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable in the traditional sense for this device. The "test sets" would be the actual instrument kits subjected to cleaning and sterilization validation.
- Test Set Description: The "Axiom range surgery kit" was identified as the "worst case validated load" due to having the highest number of components (34 instruments). This indicates the most challenging configuration for sterilization was tested.
- Sample Size: The document does not specify a numerical sample size (e.g., how many kits were tested, or how many cycles were performed). It states "Sterilization validation was performed [...] on the most complete instrument kit".
- Data Provenance: The studies were conducted as part of the regulatory submission process, implying they are prospective studies performed by the manufacturer/authorized labs. The manufacturer's location is France (Sallanches, France).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not applicable here as the "ground truth" is based on objective scientific standards for cleaning, sterilization, and material safety, not expert interpretation of outputs. The standards themselves (e.g., ISO 17665, AAMI TIR 30) are established by experts in the field of medical device sterilization.
4. Adjudication Method for the Test Set
Not applicable. The "ground truth" is determined by established physical and biological testing standards and results, not by human adjudication of nuanced interpretations.
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
Not applicable. This is a physical medical device (instrument kit), not an AI algorithm or a diagnostic tool that involves human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
The ground truth is based on:
- Scientific Standards: Adherence to recognized national and international standards for cleaning (AAMI TIR 30, AAMI TIR 12), sterilization (ISO 17665), and biocompatibility (ISO 10993-5).
- Biological Endpoints: Sterilization validation typically involves sterility testing (e.g., absence of microbial growth), while cleaning validation may involve residual soil detection.
- Material Properties: Technical data sheets for the materials (Radel) providing evidence of their properties.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device requiring a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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).