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510(k) Data Aggregation
(77 days)
The Amsco Warming Cabinet is designed to raise the temperature of blankets, linens and sterile surgical irrigation solutions and IV solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications.
The Amsco Warming Cabinet is designed to store and warm sterile IV solutions, surgical irrigation solutions, linens and/or blankets to an acceptable level for hospital and surgical outpatient center applications. The mid-size model consists of a single chamber unit and is available in (4) saleable configurations all with premium features (24" deep, glass door, electronic door lock, data recording and 120 or 230Vac with or without option mobile base). Optional pull-out wire baskets can be interchangeable with the existing wire shelf. Each of the two wire baskets have a 30L maximum capacity. The external measurements are 36-3/8"H x 27-1/8"D x 30"W (without mobile base) and the internal heat compartment is 22-3/4"H x 22-7/8"D x 24"W (7.2 cu ft).
This document describes the acceptance criteria and the verification and validation study for the Amsco Warming Cabinet, Mid-size Model.
1. Table of acceptance criteria and the reported device performance
| Test Description | Acceptance Criteria | Results |
|---|---|---|
| Electrical Testing | • Achieve passing results through automated dielectric strength tester• Earth and Enclosure Leakage Current must not exceed requirements listed in UL 61010-1 clause 6.3.1b (must not exceed .5mA normal condition and 3.5mA single fault condition)• Ground bond must not exceed 0.1 ohm and maintain ground continuity.• The power input of equipment at rated voltage and steady state current shall not exceed the marked rating by 10%. | PASS |
| System Functions: Controls, Heating, Door Lock System Test | • Exhaust fans and blowers must operate continuously when the main power is set to the ON position• Opening or closing the doors shall not cause fans or blowers to turn off• Input current must be within 5.9 - 7.12 Amps for 120Vac unit.• Over-temp alarm must activate and displayed temperature flashes alternately with the error "Hi" when compartment temperature is more than 10°F above set point temperature• Warming cabinet must communicate with laptop or personal-computer to transfer stored temperature data to the computer• Numeric code entered on keypad must unlock the door within 4 seconds.• Door must remain locked when 40 pounds of force is applied | PASS |
| Spillage | • Pass dielectric strength test per UL 61010-1, section 6, clause 6.8• Voltage measurement of cabinet outer surfaces must not exceed test voltages per UL 61010-1, section 6, clause 6.3.2a. | PASS |
| Heating Performance (empty compartment) | • Temperature reading of each thermocouple must not vary from set-point temperature by more than ±3°F for temperature settings between 90-110°F and ±5°F for temperature settings between 110-160°F.• Normal system operation is maintained without over-temperature condition or faults occurring. | PASS |
| Heating Performance (Full IV solution load - upper and lower wire baskets) | • Temperature reading of each thermocouple must not vary from set-point temperature by more than ±3°F for temperature settings between 90-110°F.• Controls temperature display must reach set-point within 12 hours.• Normal system operation is maintained without over-temperature condition or faults occurring. | PASS |
| Heating Performance (Full irrigation solution load - upper and lower wire baskets) | • Temperature reading of each thermocouple must not vary from set-point temperature by more than ±3°F for temperature settings between 90-110°F and ±5°F for temperature settings between 110-160°F• Controls temperature display must reach set-point within 12 hours.• Normal system operation is maintained without over-temperature condition or faults occurring. | PASS |
| Heating Performance (Full irrigation solution load - upper wire basket) (Full blanket load - bottom shelf) | • Temperature reading of each thermocouple must not vary from set-point temperature by more than ±3°F for temperature settings between 90-110°F and ±5°F for temperature settings between 110-160°F• Controls temperature display must reach set-point within 12 hours.• Normal system operation is maintained without over-temperature condition or faults occurring. | PASS |
| Drop Test | • Pass dielectric strength test per UL 61010-1, section 6, clause 6.8• No damage that allows access to electrical live parts• No damage to the enclosure that could cause a safety hazard• No damage that could cause spread of fire• No damage to insulation of internal wiring | PASS |
| Stability Test | • No overbalance during test | PASS |
| Wire Basket Load and Force Test | • No catastrophic failure at 125 pounds.• No catastrophic failure at 105 pounds with the sliding of wire basket in a back and forward horizontal motion for at least 100 cycles. | PASS |
| ETL/cETL Code Compliance | • Meet UL 61010-1 Standard for Safety Electrical Equipment for Measurement, Control, and Laboratory Use.• Meet CAN/CSA C22.2 61010-1 Standard for Safety Electrical Equipment for Measurement, Control and Laboratory Use. | PASS |
2. Sample sized 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 the specific number of units used for each test. However, it details "verification and validation activities" conducted on the "Mid-size Single Compartment Warming Cabinet". The nature of these tests (electrical, system functions, heating performance, mechanical tests) suggests that the testing was performed on the device itself (product prototypes or final units) rather than on a dataset of external data. This would be considered prospective testing of the device hardware and software. The country of origin of the data is not specified, but the manufacturer (STERIS Corporation) is based in Mentor, OH, USA, implying the testing was likely conducted in the US or by a contracted lab.
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 is a medical device (warming cabinet) validation, not an AI or diagnostic imaging study. Ground truth in this context is established by engineering specifications, safety standards (UL, CAN/CSA), and performance requirements for heating and mechanical integrity. There are no "experts" in the clinical sense establishing ground truth; rather, the device's performance is measured against predefined objective physical and electrical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As described above, the acceptance criteria are objective physical and electrical measurements against established standards. There is no subjective interpretation or "adjudication" required in the typical sense of a clinical study or AI model evaluation.
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 or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI or algorithm-based device in the context of diagnostic or interpretive functions. The "software" mentioned is for control and data recording within the device's operational functions, not for independent diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device's performance is based on:
- Engineering Specifications: Specific temperature ranges, electrical parameters, power draw.
- Safety Standards: Compliance with UL 61010-1 and CAN/CSA C22.2 61010-1 for electrical safety.
- Performance Requirements: Functional operation of fans, alarms, door locks, and heating profiles under various load conditions.
- Mechanical Integrity Standards: Resistance to physical stress (drop test, load test).
These are objective, measurable criteria, not subjective expert consensus or clinical outcomes data.
8. The sample size for the training set
Not applicable. This is not an AI or machine learning device that requires a training set. The device operates based on predefined engineering and control logic.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth for such a set.
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