(477 days)
OSUNG INSTRUMENT CASSETTE (EFCCL1-F) is intended to hold instruments and accessories during storage and steam sterilization. This case cassette is intended to be used with a sterilized wrap in order to maintain sterility.
This case cassette is intended to be used with an FDA cleared sterilization wrap in order to maintain sterility.
Validated sterilization parameters:
| Cycle Type | Temperature | Exposure Time | Dry Time |
|---|---|---|---|
| Gravity Steam | 132℃ (270°F) | 15 minutes | 30 minutes |
The OSUNG INSTRUMENT CASSETTE is designed to handle reusable dental instruments for sterilization and storage. This device is intended to hold instruments and accessories during storage and steam sterilization, and to be used with a sterilized wrap in order to maintain sterility.
The OSUNG INSTRUMENT CASSETTE is comprised of a base, lid, silicone mat/rail, holders, and spring lock system.
The internal insert cassette has the ability to hold individualized pieces and accessories which include scissors, needle, elevators, forceps, pincers, retractors, mallets etc.
The provided text does not describe an AI/ML powered device, but rather a medical device for sterilization—an "Instrument Cassette." Therefore, many of the requested fields (such as MRMC study, effect size of human improvement with AI, training set size, etc.) are not applicable and cannot be found in the document.
However, I can extract information related to the acceptance criteria and the study that proves the device meets them based on the provided text.
Acceptance Criteria and Device Performance for Instrument Cassette (EFCCL1-F)
1. A table of acceptance criteria and the reported device performance
| Performance Test / Acceptance Criteria | Reported Device Performance |
|---|---|
| Half cycle sterilization validation at 132°C (per ISO 17665-1, ISO 17665-2) | No growth at half cycle. |
| Dry Time Validation (per ANSI/AAMI ST79 & A1, A2, A3, A4) | The minimum weight difference was -0.05% (Pass). |
| Cleaning Validation (per AAMI TIR 30) | Results are not explicitly stated in the summary table but implied to be compliant with "All of tests demonstrated compliance to both safety and effectiveness requirements that apply to the device." |
| Limits of Reuse (per FDA Guideline: "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" & AAMI TIR12, AAMI TIR30) | Results are not explicitly stated in the summary table but implied to be compliant with "All of tests demonstrated compliance to both safety and effectiveness requirements that apply to the device." |
| Overall Safety and Effectiveness | Demonstrated compliance to both safety and effectiveness requirements, including sterilization performance, maintenance of sterility, and reusability. |
| Substantial Equivalence | Substantially equivalent to the predicate device, Miltex Thompson Cassettes (K101653), based on intended use, indications for use, technological characteristics, and performance data. |
| Validated Sterilization Parameters | Gravity Steam: 132°C (270°F) temperature, 15 minutes exposure time, 30 minutes dry time. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for the performance tests (e.g., number of cassettes tested, number of cycles performed). Data provenance is also not detailed regarding country of origin or whether studies were retrospective or prospective, beyond stating "Validation test for steam sterilization of ultrasonic cleaning and limit of reuse test for the OSUNG INSTRUMENT CASSETTE (EFCCL1-F) has been carried out as the results were shown by test reports."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical instrument cassette requiring performance testing against standards, not expert interpretation of outputs to establish ground truth like in an AI/ML context.
4. Adjudication method for the test set
Not applicable. There is no mention of adjudication for establishing ground truth, as the performance tests are objective measurements against established standards.
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-powered device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI-powered device.
7. The type of ground truth used
The "ground truth" or acceptance criteria for this device are based on established industry standards and FDA guidelines for sterilization, cleaning validation, and reusability of medical devices. Specifically, the following standards were used:
- ISO 17665-1(2006)
- ISO 17665-2(2009)
- ANSI/AAMI ST79(2010) & A1(2010) & A2(2011) & A3(2012) & A4(2013)
- AAMI TIR 30 (2011)
- FDA Guideline: "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (2011)"
- AAMI TIR12(2010)
8. The sample size for the training set
Not applicable. This is not an AI-powered device subject to machine learning training.
9. How the ground truth for the training set was established
Not applicable. This is not an AI-powered device subject to machine learning 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).