(120 days)
This device is used to provide cushioning, torso support and totation (by manually-controlled alternating pressure) with pressure-relieving capabilities, as well as provide an aid to a nurse or other care-giver, in the home, we read foinical setting, to assist a patient in shifting their body position, to minimize possibility of bed sores, or other problems that can result from lying or sitting in one position for excessive periods of time.
An air-flotation, alternating pressure mattress, with detachable electric pump/compressor, reuseable, with available washable/disposable mattress cover.
The provided text describes a flotation mattress called "Nurse's Aid Patient Rotation System." This is a Class II medical device (Product Code: IOQ) intended to cushion patients, provide torso support and rotation with pressure-relieving capabilities, and assist caregivers in shifting a patient's body position to minimize issues like bed sores.
The submission is a 510(k) premarket notification, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" here are actually the criteria for demonstrating substantial equivalence, and the "study" is the comparison made against the predicate devices.
Here's an analysis of the provided text based on your requested information points:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission demonstrating substantial equivalence, the "acceptance criteria" are implied to be the characteristics and performance of the predicate devices. The "reported device performance" is the claim that the new device meets or is equivalent to these.
| Acceptance Criterion (Implied from Predicate Devices) | Reported Device Performance |
|---|---|
| 01. Device Name: Similar to predicate devices (K931594 and K933091) | Flotation mattress / Nurse's Aid Patient Rotation System |
| 03. Description: Air-flotation, alternating pressure mattress, detachable electric pump/compressor, reusable, with available washable/disposable mattress cover. Similar to or better than predicate devices. | 5.1, 5.2, 5.4, 06: "No substantive change in materials, basic components, or method of manufacture between this device and the predicate." "No change in basic construction." "The function and use of this product will be no different than that of the predicate devices." "There are no substantive differences between the products..." |
| 04. Intended Use: To cushion patient; provide torso support/rotation with pressure-relieving capabilities; assist nurse/caregiver in shifting patient's body position; minimize bed sores, embolisms. | Indications For Use (Revised 01/05/98): "This device is used to provide cushioning, torso support and rotation (by manually-controlled alternating pressure) with pressure-relieving capabilities, as well as provide an aid to a nurse or other care-giver... to assist a patient in shifting their body position, to minimize possibility of bed sores..." |
| Safety: Materials/components used without patient problems in medical industry; compliant with EMC and safety standards. | 5.1: "The raw materials/components used have been used in the medical (and water-boyancy) industry on similar/identical products and for similar/identical uses since pre-amendment, with no record of any patient problems, adverse reactions." |
| 5.3: "The device and its components have been tested by an independent lab for EMC and safety..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission does not describe a formal clinical "test set" in the way one might for a novel diagnostic or therapeutic device. It is a substantial equivalence claim based on comparison to predicate devices, material safety, and independent lab testing for EMC and safety. Therefore, concepts like "sample size for the test set" or "data provenance" related to patient outcomes are not applicable in this type of submission. The "test set" is the device itself and its components, evaluated against known standards and predicate device characteristics.
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. The "ground truth" here is established by the characteristics and safety of the predicate devices and general medical practice regarding flotation mattresses. There is no mention of external experts used to establish a "ground truth" for a specific test set of this device. The FDA's review process itself involves expert evaluation by the Division of General and Restorative Devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no human-involved "test set" requiring adjudication or consensus for this type of substantial equivalence claim.
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 device is a physical medical mattress, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical mattress, not an algorithm. However, the device itself does function "standalone" in its ability to alternate pressure, cushion, and provide support, performing its intended function without continuous human intervention once set up. The "aid to a nurse or other care-giver" is about facilitating their tasks, not replacing judgment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's substantial equivalence claim relies on:
- Predicate Device Characteristics: The established design, function, and safety profile of the legally marketed predicate devices (K931594 and K933091).
- Material Safety Data: Historical use of materials/components in the medical industry without adverse events.
- Engineering and Safety Standards: Compliance with independent laboratory testing for EMC and safety (implied to be against recognized standards, though specific standards aren't listed).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI or machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this physical device.
§ 890.5170 Powered flotation therapy bed.
(a)
Identification. A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.