(22 days)
The Blanketrol II Model 222S Hyper-Hypothermia Temperature Management System is used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer. The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
The Blanketrol II Model 222S is a water (liquid) recirculating device providing either hypothermia, hyperthermia or normothermia treatment as determined by the health care provider. Water is either heated or cooled depending on the need of the patient. The heated or cooled water is pumped through connecting flexible tubing to a disposable or reusable pad or blanket to provide patient therapy for a site specific external surface area or for whole body surface temperature therapy by the means of conductive heat transfer.
The provided text is a 510(k) Premarket Notification for a device modification and does not contain detailed information about a study proving the device meets acceptance criteria in the format typically used for AI/ML device evaluations. The document focuses on demonstrating substantial equivalence to a predicate device based on design changes and standard adherence.
However, I can extract the information that is present and indicate where certain requested information is not available in the given text, reinterpreting "acceptance criteria" and "device performance" in the context of this 510(k) submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from 510(k)) | Reported Device Performance (Summary from 510(k)) |
|---|---|
| Functional Equivalence: Device functionality, after modifications, should operate as intended and be substantially equivalent to the predicate. | - Function of membrane control panel including button functionality verified. |
| - Device operation with modified membrane panel, including verification of water temperature and safety limits, confirmed. | |
| Safety Standards Adherence: Continued compliance with relevant medical device safety standards. | - Continues to meet IEC 60601-1 (Medical Electrical Equipment - General Requirements for Safety). |
| - Continues to meet IEC 60601-1-2 (Medical Electrical Equipment - Electromagnetic Compatibility). | |
| Intended Use: Maintain the same intended use as the predicate device. | - The Blanketrol II Model 222S has the same intended use as the Blanketrol III Model 233 predicate device. |
| Technological Characteristics: Changes do not raise new questions of safety and effectiveness. | - Modified features (membrane control, removed modes/USB, updated labeling) are considered minor and do not alter fundamental operating principles. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The document refers to "Testing was performed on the proposed Blanketrol II Model 222S" for functional and safety verification. This implies testing on the actual device hardware, not a clinical data set.
- Data Provenance: Not applicable in the context of this device modification. The testing relates to the device's operational characteristics and adherence to standards, not patient data. It is device-centric testing rather than data-centric.
- Retrospective or Prospective: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided because the "ground truth" here is the proper functioning of the device according to its design specifications and standard requirements, not the interpretation of clinical data. The verification testing would have been conducted by engineers or technicians within the company, according to established test protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for clinical data, which is not the subject of this 510(k) submission.
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
- No. This is not an AI/ML device. It is a physical medical device (temperature management system) with minor modifications. Therefore, an MRMC study and AI-related effect sizes are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device modification is its successful operation according to engineering and safety specifications. This would involve successful execution of predefined test cases (e.g., verifying buttons work, water temperature control is accurate, safety limits are met) against a baseline of expected performance (predicate device's performance, design specifications, and relevant IEC standards).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that requires a training set or ground truth for algorithmic development.
§ 870.5900 Thermal regulating system.
(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).