(98 days)
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 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 49" (Model HC 800) .
- 26" x 26" x 61" (Model HC 1000) .
The provided text describes a steam sterilizer and its specifications rather than an AI/ML powered device. Therefore, typical acceptance criteria, study methodologies, and performance metrics associated with AI/ML devices (e.g., sensitivity, specificity, AUC, human reader improvement with AI assistance, ground truth establishment for training/test sets) are not applicable.
The document mainly focuses on the factory-programmed sterilization cycles, cycle values, and recommended load capacities for the STERIS Amsco Evolution Medium Steam Sterilizer Models HC-800 and HC-1000. It's a 510(k) summary for a conventional medical device seeking substantial equivalence to a predicate device.
However, I can extract the acceptance criteria (defined by the device's operational parameters) and the "study" that proves it meets these criteria based on the provided information, interpreting "performance" as the ability to achieve the specified sterilization cycles.
Here's the information re-framed for a non-AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are its ability to perform the specified sterilization cycles at defined temperatures, times, and dry times, with recommended load capacities. The reported device performance is that it is equipped with and capable of executing these cycles.
| Cycle Type | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load Performance (Examples) |
|---|---|---|---|---|
| Prevac (270°F) | 270°F (132°C) | 4 minutes | 30 minutes | Able to sterilize Double wrapped instrument trays (max 25 lbs (11.3 kg) each) and Fabric Packs; up to 12 wrapped instrument trays / 16 fabric packs (HC-800), 15/20 (HC-1000). |
| Prevac (270°F) | 270°F (132°C) | 4 minutes | 5 minutes | Able to sterilize Single Fabric Pack. |
| Gravity (250°F) | 250°F (121°C) | 30 minutes | 15 minutes | Able to sterilize Fabric Packs; up to 16 fabric packs (HC-800), 20 (HC-1000). |
| Liquid (250°F) | 250°F (121°C) | 45 minutes | N/A | Able to sterilize 3 containers with 1000 ml liquid each. (Non-patient contact use only). |
| DART | 270°F (132°C) | 3 ½ minutes | 1 minute | Able to perform Bowie-Dick Test Pack, DART Test Pack cycle. |
| SFPP (270°F) | 270°F (132°C) | 4 minutes | 30 minutes | Able to sterilize Double wrapped instrument trays (max 25 lbs (11.3 kg) each) and Fabric Packs; up to 12 wrapped instrument trays / 16 fabric packs (HC-800), 15/20 (HC-1000). |
| Other cycles listed for Prevacuum and SFPP models are similarly specified. | TBD | TBD | TBD | TBD |
Study to Prove Device Meets Acceptance Criteria:
The document is a 510(k) summary, which typically references underlying validation studies but does not provide details of the studies themselves. For a sterilizer, the "study" would be sterilization validation testing in accordance with recognized standards (e.g., AAMI, ISO) to demonstrate that the device consistently achieves sterility assurance levels (SAL) under its specified cycles and loading conditions. The summary states:
- "A summary of the technological characteristics of the device subject of this premarket notification in comparison to those of the predicate devices is included in Table 5-5." (Table 5-5 is not provided in the excerpt).
- The FDA's letter (Page 5) states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
This indicates that STERIS performed the necessary validation testing (e.g., biological indicator testing, physical parameter monitoring, microbial challenge testing) to demonstrate that the Amsco Evolution Steam Sterilizer could reliably achieve the specified sterilization parameters and sterilize the indicated loads. The results of these tests (summarized but not detailed here) were submitted to the FDA to support the claim of substantial equivalence to the predicate device.
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established
These questions are not applicable to this submission. The document describes a steam sterilizer, a non-AI/ML medical device. Therefore, concepts like "test set," "data provenance," "experts," "adjudication," "MRMC studies," "AI assistance," "standalone algorithm performance," "ground truth," and "training set" in the context of AI/ML are not relevant.
For a steam sterilizer, the "ground truth" would be the successful killing of microbial spores (demonstrating sterility) confirmed through laboratory methods (e.g., biological indicator results, microbial challenge tests), and the "test set" would be the series of sterilization cycles performed under various worst-case loading and operating conditions during validation. The number of 'samples' would refer to the number of sterilization cycles performed and the number of biological and physical indicators evaluated. However, those details are not present in this 510(k) summary.
§ 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).