(27 days)
The WarmAir® 135 patient warming system is intended to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. The thermal regulating system is used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-airheated blanket. The single-patient use blankets transfer the thermal energy to adult, pediatric or neonate patients to obtain/maintain normal body temperature. It is intended for use by appropriately trained healthcare professionals in clinical environments.
The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to a blanket that is placed over or under adult, pediatric or neonatal patients in order to warm them. The heated air is blown through connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air.
The provided text describes a Special 510(k) submission for a device modification, not a study evaluating a device's performance against acceptance criteria in the way a diagnostic or AI-driven device would be.
The document pertains to the WarmAir® Model 135 Hyperthermia System, specifically a modification to add a new non-sterile blanket with modified geometry. This is a Class II medical device (Thermal Regulating System), and the submission focuses on demonstrating substantial equivalence to existing predicate devices (cleared WarmAir® Model 135 Hyperthermia System including blankets K101148 and K121669).
Therefore, many of the requested categories for a study proving a device meets acceptance criteria (like sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission because it's not a clinical performance study in the traditional sense for a diagnostic device.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
For this device modification, the "acceptance criteria" are related to safety and performance specifications for a warming blanket, as established by a recognized standard. The "reported device performance" is a statement that the modified blanket meets these specifications.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Criteria for Blanket Safety (Maximum Contact Surface Temperature): Meeting requirements identified in ASTM F-2196. This standard likely specifies limits on how hot the blanket surface can get to prevent burns or discomfort to the patient. | Modified blanket meets the specification for maximum contact surface temperature to be within the requirements identified in ASTM F-2196. (Stated as a positive outcome of testing) |
| Substantial Equivalence: The modified device has the same intended use as the predicates and similar technological characteristics that do not raise different types of questions of safety and effectiveness. | Testing shows the modified blanket to perform similarly to the predicate blankets. (Supports the claim of substantial equivalence for regulatory approval.) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document states "Testing of the blanket under a simulated patient," implying controlled laboratory testing of the blanket unit itself, rather than a clinical trial with a patient population. It would likely involve a small number of physical blanket prototypes.
- Data Provenance: The testing was conducted internally by Cincinnati Sub-Zero Products, Inc. in Cincinnati, Ohio, as part of their design control activities. It is not clinical data from patients or a specific country of origin. It's retrospective in the sense that it's performed on a prototype before market release, but not involving pre-existing patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the context of diagnostic performance (e.g., expert consensus on an image) is not relevant here. The ground truth for this engineering-based acceptance criteria would be the objective measurements obtained during simulated testing against the ASTM standard.
4. Adjudication method for the test set
Not applicable. There is no subjective assessment requiring adjudication in this type of engineering test. The "adjudication" is essentially the direct measurement against the ASTM F-2196 standard.
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 a special 510(k) for a physical medical device (a warming blanket modification), 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 algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation is the objective measurement of the blanket's maximum contact surface temperature against the predefined limits specified in the ASTM F-2196 standard.
8. The sample size for the training set
Not applicable. This is not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. (See #8)
§ 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).