(101 days)
The Amsco Evolution Medium Steam Sterilizer Models HC-800 and HC-1000 are designed for sterilization of heat and moisturestable materials used in healthcare facilities and are available in two configurations:
- Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. .
- Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-. Dick) cycles.
The Amsco Evolution Medium Steam Sterilizer models HC-800 and HC-1000 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:
- Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and ● DART (Bowie-Dick) cycles.
- Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, ● Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
The chamber sizes of the proposed Amsco Evolution Medium Steam Sterilizer Models are as follows: - 26" x 26" x 42" (Model HC 800) ●
- 26" x 26" x 54" (Model HC 1000) .
The provided text is a 510(k) Premarket Notification for a STERIS Corporation steam sterilizer. It outlines the device's indications for use, its comparison to a predicate device, and verification activities. The document does not describe acceptance criteria or a study that proves a device meets acceptance criteria in the context of an AI/ML medical device, which would involve aspects like AUC, sensitivity, specificity, expert readers, and ground truth establishment.
Instead, the document pertains to a traditional medical device (steam sterilizer) and its modifications. The "acceptance criteria" and "verification activities" mentioned are related to the sterilizer's mechanical, electrical, and software functionality, ensuring it performs as expected for its sterilization function.
Therefore, I cannot provide the information requested in your prompt as it is not present in the provided text. The prompt's questions (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, type of ground truth, training set size) are characteristic of studies for AI/ML-based medical devices, which this document does not describe.
The "Acceptance Criteria" table in the document is for hardware and software modifications to the sterilizer itself, not for an AI/ML algorithm's performance.
To reiterate, the document contains the following:
- A table of "Acceptance Criteria" and "Reported Device Performance": This table (on page 11) is titled "Verification / Validation Activity" and lists modifications made to the steam sterilizer (e.g., control replacement, software modifications, vacuum pump replacement). The acceptance criteria are engineering/functional standards (e.g., "Per ST8", "Per IEC 61010-1", "Software shall be appropriately verified and validated"), and the results are simply "Pass." This is not an evaluation of an AI/ML algorithm's performance metrics (like sensitivity/specificity).
- Sample sizes: Not mentioned in the context of a dataset for AI/ML or expert review.
- Data provenance: Not mentioned, as it's a hardware device verification.
- Number of experts and qualifications: Not applicable/not mentioned.
- Adjudication method: Not applicable/not mentioned.
- MRMC comparative effectiveness study: Not applicable/not mentioned, as this is for a hardware sterilizer.
- Standalone performance: Not applicable/not mentioned, as there is no AI algorithm.
- Type of ground truth: Not applicable. The "ground truth" for a sterilizer is simply whether it successfully sterilizes according to pre-defined parameters, not a diagnostic finding.
- Sample size for training set: Not applicable, as there is no AI algorithm training.
- How ground truth for training set was established: Not applicable.
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).