(210 days)
Prevention and treatment of decubitus ulcers, treatment of burns, flaps and grafts and to aid circulation.
This product provides the therapeutic surface features and leg elevation bed features of the Flexicair® Low Airloss Therapy Unit while eliminating the hospital bed frame. The intent of the design of the SILKAIR™ Low Airloss Therapy is to provide a zoned low airloss surface with the capabilities of head and leg elevation for non articulating bed frames or mattress box springs. SILKAIR attaches the low airloss surface to a positioning base which provides the head and leg articulation features. This positioning base can be attached to any flat surface such as a box spring, converting a regular bed into a hospital bed. The SILKAIR™ Low Airloss Therapy System is a zoned low airloss surface. The system distributes different pressures in different zones relative to the main air manifold pressure. This system uses basic, simple mechanical and electrical components. Head and leg articulation required by many patients in the home is achieved through the use of a positioning base. This positioning base consists of plastic support plates and accordion bladders to raise and lower the head and leg sections of the surface.
The provided 510(k) summary for the SILKAIR™ Low Airloss Therapy device does not contain information about specific acceptance criteria or a study proving that the device meets those criteria.
This document is a premarket notification for a medical device (510(k)), which primarily focuses on demonstrating substantial equivalence to a predicate device already on the market. It outlines the device's general description, indications for use, and a comparison to the predicate, but it does not typically include detailed performance studies with acceptance criteria in the same way a clinical trial or a performance data summary might.
Therefore, many of the requested details cannot be extracted from this document, as they are not present in a typical 510(k) submission of this nature (particularly for devices prior to more rigorous performance mandates).
Here's an analysis based on the information provided, and where information is missing or not applicable:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The 510(k) process for this type of device (a low airloss therapy unit) in 1997 focused on demonstrating substantial equivalence to a predicate, not on meeting specific, quantified performance criteria through a dedicated study presented in the summary. | The document states: "The safety characteristics of this product compare to those of the predicate devices. No significant changes have been made which impact the safety and efficacy of the SILKAR™ Low Airloss Therapy System as compared to the predicate device." This is a qualitative statement of equivalence, not a quantitative performance result against defined criteria. |
Missing Information: Specific numerical or qualitative acceptance criteria (e.g., pressure reduction thresholds, comfort metrics, durability standards, etc.) are not provided. The summary relies on the assertion of equivalence to a legally marketed predicate device (Flexicair® Low Airloss Therapy Unit K863047) rather than presenting new performance data against specific benchmarks.
Study Details
Given the nature of this 510(k) summary, specific performance studies with detailed methodologies (sample size, ground truth, expert adjudication, etc.) are not included. The "study" here is essentially the comparison and justification for substantial equivalence.
2. Sample size used for the test set and the data provenance:
- Sample size: Not applicable/Not provided. There is no mention of a dedicated "test set" in the context of a performance study.
- Data provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No "ground truth" or expert adjudication for a test set is mentioned.
4. Adjudication method for the test set:
- Not applicable/Not provided.
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 therapy bed system, not an AI diagnostic or assistance tool. Therefore, an MRMC study related to human reader performance with AI is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical therapy bed system, not an algorithm.
7. The type of ground truth used:
- Not applicable/Not provided. The "ground truth" in a 510(k) for such a device is implicitly the established safety and efficacy of the predicate device.
8. The sample size for the training set:
- Not applicable/Not provided. There is no mention of a "training set" in the context of this device.
9. How the ground truth for the training set was established:
- Not applicable/Not provided.
Summary of Missing Information and Context
The provided document is a 510(k) premarket notification for a physical medical device (a low airloss therapy bed). For such devices, especially from 1997, the primary regulatory pathway is to demonstrate "substantial equivalence" to a predicate device already on the market. This often means showing that the new device has similar technological characteristics and indications for use, and does not raise new questions of safety or effectiveness, without necessarily conducting entirely new, extensive performance studies with detailed acceptance criteria as one might see for a novel diagnostic or treatment technology today.
The key statements in the document regarding performance are:
- "The safety characteristics of this product compare to those of the predicate devices."
- "No significant changes have been made which impact the safety and efficacy of the SILKAR™ Low Airloss Therapy System as compared to the predicate device."
- "There are no performance standards established for this classification." (This is a crucial point regarding the absence of specific, pre-defined acceptance criteria for this device type at the time.)
Therefore, the "proof" the device meets acceptance criteria is primarily the FDA's concurrence that it is substantially equivalent to the predicate device (Flexicair® Low Airloss Therapy Unit, K863047), implying that if the predicate was safe and effective, this device is as well. No specific performance study data is presented in this summary to quantify device performance against defined criteria.
§ 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.