(102 days)
The Amsco Evolution Series Steam Sterilizer Models HC-3000 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 Amso Evolution Series Prevacum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-1):
Table 5-1. Amso Evolution Series Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values
| Cycles | Sterilize
Temperature | Sterilize
Time | Dry Time | Recommended Load |
|-----------------|--------------------------|-------------------|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each and
Fabric Packs. Refer to
Table 5-3 for recommended
quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to
Table 5-3 for recommended
quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 for
recommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each. Refer to
Table 5-3 for recommended
quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 45 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each. Refer to
Table 5-3 for recommended
quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 45 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each. Refer to
Table 5-3 for recommended
quantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to
Table 5-3 for recommended
quantities. |
| DART
Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3 ½ minutes | 1 minute | Bowie-Dick Test Pack,
DART Test Pack |
| Leak Test | N/A | N/A | N/A | N/A |
- The liquid cycle is for non-patient contact use only.
The Amsco Evolution Series Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-2):
| Cycles | Sterilize
Temperature | Sterilize
Time | Dry Time | Recommended Load |
|-----------------|--------------------------|-------------------|------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| SFPP | 270°F (132°C) | 4 minutes | 45 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each and Fabric
Packs. Refer to Table 5-3 for
recommended quantities. |
| SFPP | 275°F (135°C) | 3 minutes | 45 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each. Refer to
Table 5-3 for recommended
quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each and Fabric
Packs. Refer to Table 5-3 for
recommended quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table
5-3 for recommended
quantities. |
| SFPP | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each. Refer to
Table 4-3 for recommended
quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 45 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each. Refer to
Table 5-3 for recommended
quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 for
recommended quantities. |
| DART
Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3½ minutes | 1 minute | Bowie-Dick Test Pack,
DART Test Pack |
| Leak Test | N/A | N/A | N/A | N/A |
Table 5-2. Amso Evolution Series Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cycles and ycle values
*The liquid cycle is for non-patient contact use only.
The Amsco Evolution Floorloader Steam Sterilizer models HC-2000 and HC-3000 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 Floorloader Steam Sterilizer Models are as follows: - 26" x 61" x 49" (Model HC 2000) .
- 26'' x 61'' x 72'' (Model HC 3000)
The document describes the Amsco Evolution Floorloader Steam Sterilizer (HC-2000 and HC-3000) and its substantial equivalence to a predicate device. The information provided primarily focuses on the device's technical specifications, intended use, and the verification activities conducted for specific modifications. It does not contain a typical "study" proving device performance against acceptance criteria in the sense of a clinical trial or an AI algorithm's performance study with expert ground truth.
Instead, the "acceptance criteria" and "device performance" relate to engineering verification and validation activities for modifications made to an existing device.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Device Modification | Verification / Validation Activity | Acceptance Criteria | Results of Verification / Validation |
|---|---|---|---|
| Control replacement | Performance testing | Per ST8 | Pass |
| Electrical safety | Per IEC 61010-1 | Pass | |
| Door gasket replacement | Door operation check | Proper function and no alarms after multiple cycles | Pass |
| Software modifications | Software validation | Software shall be appropriately verified and validated | Pass |
| Vacuum pump replacement | Performance testing | Per ST8 | Pass |
| Printer replacement | Software validation | Software shall be appropriately verified and validated | Pass |
| Valve modifications | Performance testing | Per ST8 | Pass |
| Switch modification | Actuation | Proper actuation, no alarms | Pass |
| Door mounting bracket modification | Door operation check | Proper function after multiple cycles | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The verification activities described are typical engineering tests, not studies with "test sets" of data in the context of an AI/algorithm.
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)
This information is not provided. The acceptance criteria primarily refer to engineering standards (e.g., ST8, IEC 61010-1) and functional tests, not expert-derived ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As these are engineering verification tests, an adjudication method for a test set (as typically used in clinical studies) would not be applicable.
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
This information is not provided. This document pertains to a steam sterilizer, a medical device, but it is not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided. This device is not an algorithm or AI system, so the concept of standalone performance for an algorithm does not apply.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the verification activities appears to be based on established engineering standards and functional requirements. For example, "Per ST8" or "Per IEC 61010-1" explicitly states the standard utilized. For functional checks like "Door operation check," the ground truth is "Proper function and no alarms after multiple cycles." This is an objective functional outcome, not based on expert consensus, pathology, or outcomes data in a medical diagnostic sense.
8. The sample size for the training set
This information is not provided. This device is a steam sterilizer, not an AI or machine learning system that would have a "training set."
9. How the ground truth for the training set was established
This information is not provided and is not applicable to the device described.
§ 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).