(259 days)
The Pintler Patient Warming System aids in the function of assisting in maintaining patient warming during perioperative experience for pediatric and adult patients and would be indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol.
The Pintler Patient Warming System a thermal regulating operating room pad, and a power control unit mounted to a standard IV pole. The operating room pad utilizes a low voltage resistant heating element , DC power and warms patients with conductive warming technology.
This document focuses on the Pintler Patient Warming System, a thermal regulating operating room pad. The provided text is a 510(k) summary, which describes the device and its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information provided in the input, specifically focusing on what is stated and what is not explicitly stated as per your request:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly list specific numerical acceptance criteria for performance metrics (e.g., target temperature range, heating rates, safety thresholds with specific values). Instead, it makes a general statement about meeting performance/effectiveness/safety parameters.
| Acceptance Criteria (Explicitly stated) | Reported Device Performance (Explicitly stated) | Notes |
|---|---|---|
| Safety parameters met | Testing conducted, demonstrated the device met the performance/effectiveness/safety parameters. | The document states "Bench testing for safety of the Pintler Patient Warming System has been completed. Testing was conducted, demonstrated the device met the performance/effectiveness/safety parameters." This is a high-level statement without specific measurable criteria or detailed performance results. |
| Effectiveness parameters met | Testing conducted, demonstrated the device met the performance/effectiveness/safety parameters. | Similar to safety, a general claim without specific metrics. The "Indication for use" defines the intended function: "aids in the function of assisting in maintaining patient warming during perioperative experience for pediatric and adult patients." The study implies it achieved this, but no numerical data is given. |
| EN60601-1-2 Compliance | Both devices are required to be compliant to EN60601-1-2. (Implied compliance for the Pintler Device) | The document states that both devices (Pintler and predicate) are required to be compliant with EN60601-1-2. While it doesn't explicitly say "Pintler is compliant," completion of "bench testing for safety" for a medical device strongly implies compliance with relevant standards like EN60601-1-2 for safety. |
| Substantial Equivalence | Found to be substantially equivalent to the predicated device. | The primary conclusion of the 510(k) process is substantial equivalence. The document states: "Testing and comparison of the Pintler Patient Warming System found the product to be substantially equivalent to the predicated device and there are no new safety or effectiveness issues introduced." |
2. Sample Size for Test Set and Data Provenance
The document explicitly states "Bench testing for safety of the Pintler Patient Warming System has been completed."
- Sample Size: Not specified.
- Data Provenance: Not specified. This "bench testing" would typically involve testing the device in a laboratory setting, not on human subjects.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. As this is bench testing of a physical medical device (patient warmer) and not for an AI/imaging device requiring expert interpretation of data like images, there's no mention of experts establishing ground truth in the way it would be for a diagnostic AI.
4. Adjudication Method for Test Set
- Not Applicable. Since no experts are involved in establishing ground truth for the type of bench testing described, there is no adjudication method mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is not mentioned as this device is a patient warmer, not an AI/imaging diagnostic tool that would typically involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No. This question is also typically relevant for AI/software devices. The Pintler Patient Warming System is a physical device, and its performance would be assessed directly, not as a standalone algorithm.
7. Type of Ground Truth Used
- Engineering/Performance Standards & Benchmarks: The ground truth for this device's performance would be established by objective measurements against engineering specifications, safety standards (like EN60601-1-2), and comparison to the predicate device's known performance characteristics. The document implies that the "performance/effectiveness/safety parameters" served as the basis for evaluation.
8. Sample Size for the Training Set
- Not Applicable. The concept of a "training set" is relevant for AI or machine learning models. This is a physical, electrically powered medical device for patient warming, not an AI model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for this type of device, this question is not relevant.
In summary, the provided text details a 510(k) submission for a patient warming system. The "study" mentioned is "bench testing," which confirmed the device met general safety, effectiveness, and performance parameters, leading to its determination as substantially equivalent to a predicate device. The detailed statistical and expert-driven information requested for AI/diagnostic devices is not relevant or present in this context.
§ 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).