(184 days)
The Opt-Shield AIR Convection Warming technology is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patient to become too cold.
Proposed device: Opt-Shield™ AIR. SAFE Patient-Handling System for Surgical Patient: The proposed Opt-Shield AIR blanket consists of three layers of material: bottom layer nylon impermeable to air (non-contact), middle layer plastic with predetermined holes (non-contact), and top layer polypropylene (in contact with the patient) with microscopic holes (intrinsic to the fabric) throughout the fabric. The three layers are sewn together to create air channels to allow air distribution evenly throughout the blanket to minimize heat reduction. The warm air circulates within blanket and delivers warm air around the patient's body through perforations in the patient side layer of the blanket. The distribution of air is designed to equally deliver air at the similar temperature air at various blanket locations. It has one hose port for receiving warm air.
The provided text describes a 510(k) submission for the Opt-Shield™ AIR convective warming blanket, comparing it to a predicate device, the 3M Bair Hugger™ Temperature Management Blanket. The studies described are non-clinical bench tests comparing the performance of the proposed device to the predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device. The study aimed to demonstrate "substantially similar" performance.
| Acceptance Criteria (Implied) | Reported Device Performance (Opt-Shield™ AIR vs. 3M Bair Hugger™) |
|---|---|
| Surface Temperature performance is substantially similar | Surface temperatures are substantially similar |
| Internal Temperature performance is substantially similar | Internal temperatures are substantially similar |
| Internal Airflow performance is substantially similar | Internal Airflows are substantially similar |
| Internal Pressure performance is substantially similar | Internal pressures are substantially similar |
| Durability and Integrity for at least 8 hours at highest heat setting (43°C) | All sealed lines and fabric integrity completely intact after 8 hours of testing |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text states, "each of the Opt-Shield AIR samples were also tested." This implies multiple units were tested, but a specific number for the test set is not provided.
- Data Provenance: The study was an internal testing performed by BCG Medical, LLC. The country of origin is not explicitly stated, but BCG Medical is based in San Diego, California, USA, suggesting the data provenance is from the USA. The study is non-clinical, so the terms "retrospective" or "prospective" as typically applied to human trials are not directly applicable. These are bench test data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the described study is a non-clinical bench test evaluating physical performance parameters (temperature, airflow, pressure, durability) against a predicate device. It does not involve human interpretation or expert opinion to establish a "ground truth" in the way, for example, a diagnostic imaging device would and is not listed in the document.
4. Adjudication Method for the Test Set
This section is not applicable as the described study is a non-clinical bench test of physical performance parameters. There is no mention of adjudication, which is typically used for subjective assessments by multiple human readers.
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 section is not applicable. The device is a convective warming blanket, not an AI or diagnostic imaging device. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant or described.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical medical device (convective warming blanket), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this non-clinical study was the performance of the legally marketed predicate device (3M Bair Hugger™ Temperature Management Blanket, Full Access Underbody, model 635) under the same test conditions, using the same heat source (Bair Hugger/3M Warming Unit Model 775). The goal was to prove "substantially similar" performance.
8. The Sample Size for the Training Set
This section is not applicable. The described study is a non-clinical bench test for a physical device, not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This section is not applicable for the same reasons as #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).