(364 days)
Wire Sterilization Package with Indicators is intended to be used to enclose and package American Orthodontics' line of Orthodontic Arch Wires. These packages are shipped unsterile and for single-use only. This packaging offers the health provider (trained dental professional and/or Orthodontist) the option of sterilizing the enclosed arch wire using steam or ethylene oxide gas. The indicators will display a visual color change to steam or ethylene oxide gas and distinguish between processed and unprocessed wire.
American Orthodontics' Wire Sterilization Package with indicators is manufactured from bleached surgical paper and plastic film with external chemical process indicators. This packaging is a pouch that is enclosed on all four sides and contains a single arch wire. These packages are shipped unsterile and for single-use only. This packaging offers the health provider (trained dental professional and/or Orthodontist) the option of sterilizing the enclosed arch wire using steam or ethylene oxide gas. Upon completion of the sterilization process, the enclosed arch wire is intended to be used immediately.
This packaging is not offered as a stand-alone product, but is strictly used for the packaging of American Orthodontics' Arch Wires (Classification Code: DZC; 510(k) Exempt).
The bleached surgical paper conforms to the FDA 21CFR186.1673 and can be sterilized using steam or ethylene oxide gas.
The plastic film is sealed to the bleached surgical paper and conforms to 21CFR177.1630 (Polyester), 21CFR175.105 (Adhesive) and 21CFR177.1520 (Polypropylene).
The process indicators meet the performance requirements of AAMI/ANSI/ISO 11140-1:2014.
The given document is a 510(k) premarket notification for a medical device called "Wire Sterilization Package with Indicators." This document does not describe the acceptance criteria and study for an AI/ML device, but rather for a physical sterilization packaging with chemical indicators. Therefore, many of the requested categories are not applicable.
Here's the relevant information based on the provided text, adapted to the questions where possible:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Requirements) | Reported Device Performance |
|---|---|
| Sterilization Parameters for Ethylene Oxide (EO) Gas: | EO Indicator Performance: |
| EO Concentration: 725 mg/L | Color indicator changes from Blue to Cocoa Brown upon completion of the process. |
| Exposure Temperature: 130°F (55°C) | |
| Exposure Time: 1 hour | |
| Aeration Time: 8 hours | |
| Sterilization Parameters for Steam - Gravity: | Steam Indicator Performance: |
| Exposure Temperature: 270°F (132°C) | Color indicator changes from Blue to Black/Brownish Black upon completion of the process. |
| Exposure Time: 15 minutes | |
| Dry Time: 30 minutes | |
| Material Compatibility: | |
| No effect on material or functionality of arch wires after sterilization processes. | Material Compatibility Testing (following ISO 15841:2014) showed sterilization (Steam, Formaldehyde, EO) had no effect on the material or functionality of the arch wires. |
| Performance Testing (Sterility Assurance Level - SAL): | Processing at half cycle ensures desired Sterility Assurance Level (SAL). |
| Performance testing (placing spores in difficult locations, BIs removed after half cycle exposure, incubated) validated that cycles achieve desired SAL. | |
| Residual Testing: | |
| Meet reference guidelines for Ethylene Oxide Sterilization Residuals. | Residual testing (following ISO 10993-7:2008/(R) 2012) met reference guidelines. |
| Indicator Validation: | |
| Chemical indicators change to appropriate signal color under "Pass Cycle" conditions and meet "Pass Cycle" requirements for Class I process indicators. | Indicator Validation testing (following AAMI/ANSI ISO 11140-1) verified indicators changed to an appropriate signal color and met "Pass Cycle" requirements for Class I process indicators. |
| Biocompatibility/Leachability (Cytotoxicity - for archwires): | Archwires met USP and ISO 10993-5 requirements; all test samples PASSED. |
| Cytotoxicity Testing (after sterilization) following ISO 10993-5 and USP showed that the enclosed archwires met requirements and all test samples PASSED. (The packaging itself does not contact patients). | |
| Biocompatibility (Irritation and Sensitization - for archwires): | All test samples PASSED. |
| Biocompatibility testing for archwires (before sterilization) according to ISO 10993-5 and ISO 10993-10 showed all test samples PASSED. |
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 explicitly state specific sample sizes for each test in terms of number of units. It refers to "samples" being processed and tested. The data provenance (country of origin, retrospective/prospective) is not specified. It can be inferred that these are prospective bench tests conducted for the purpose of the 510(k) submission.
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)
Not applicable. This device is not an AI/ML diagnostic tool that requires human expert interpretation for ground truth. The "ground truth" for the indicators is defined by the chemical reaction and color change under specific sterilization parameters, which is a physical and chemical phenomenon, not a human interpretation. The validation was against established standards (e.g., AAMI/ANSI ISO 11140-1) and biological indicators.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML diagnostic device requiring adjudication of human readings. The performance of the chemical indicators is evaluated by observing a color change against defined criteria.
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 not an AI/ML diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device with an algorithm. The device is a physical product with chemical indicators.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the Wire Sterilization Package with Indicators is based on:
- Physical/Chemical Reaction: The color change of the chemical indicators, which is a direct physical and chemical response to specific sterilization conditions (temperature, time, chemical exposure).
- Biological Indicators (BIs): Used in performance testing to confirm that the sterilization cycles are effective in achieving the desired Sterility Assurance Level (SAL). BIs contain resistant microorganisms which, if killed, confirm effective sterilization.
- Standardized Test Methods: Adherence to established international and national standards such as AAMI/ANSI ISO 11140-1 for chemical indicators, ISO 15841 for dentistry wires, ISO 10993 for biocompatibility, and USP for cytotoxicity.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set or ground truth for training.
§ 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).