(88 days)
The CLEEN-ABLE™ blood pressure cuff is used in conjunction with non-invasive blood pressure monitoring systems by personnel properly trained in the use of manual and automatic sphygmomanometers. The device is non-sterile and is intended as a multi- patient rewable device and is available in infant through adult sizes.
The device is comprised of one er two tubes attached to a soft fabric with an integral inflatable bladder that is wrapped around a patient's limb and secured by a hook and loop closure. The tubing connects to a non-invasive blood pressure measurement system. The blood pressure cuffs contain no latex. Sizes will include infant through adult. Each unit is packaged in a polyfilm bag. Connectors, adapters and pump bulb /valve assemblies are available for use with a variety of manual and automatic sphygmomanometers.
Here's an analysis of the provided information regarding the CLEEN-ABLE™ Blood Pressure Cuff, structured to address your specific points:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Requirement (Acceptance Criteria) | Test Methodology | Reported Device Performance |
|---|---|---|
| Cuff Closure/Construction | ANSI/AAMI SP-9, 1994 Standard for Cuffs with Integral bladder | Bench testing conducted and met requirements (implied by conclusion) |
| Pressure Capacity | ANSI/AAMI SP-9, 1994 Standard for Cuffs with Integral bladder | Bench testing conducted and met requirements (implied by conclusion) |
| Repeated Inflation Testing | ANSI/AAMI SP-9, 1994 Standard for Cuffs with Integral bladder | Bench testing conducted and met requirements (implied by conclusion) |
| Systems Leak Testing | ANSI/AAMI SP-9, 1994 Standard for Cuffs with Integral bladder | Bench testing conducted and met requirements (implied by conclusion) |
| General Safety and Effectiveness | Compliance with relevant standards and predicate device comparison | Device determined to be safe, effective, and substantially equivalent to predicate device (DURA-CUF®) |
Note: The document states that bench testing was "conducted to demonstrate performance (safety and effectiveness)" and that the device "meets the appropriate requirements of ANSI/AAMI SP-9." While specific numerical performance values are not provided, the conclusion implies successful adherence to the standard's criteria for these performance aspects.
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes bench testing for performance. This type of testing typically involves physical samples of the device and does not involve human subjects or clinical data in the traditional sense of a "test set" for AI/algorithmic evaluation. Therefore, information about human data provenance (country of origin, retrospective/prospective) and sample size in that context is not applicable. The sample size for the bench tests themselves (e.g., how many cuffs were tested for repeated inflation) is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a physical blood pressure cuff, and its performance was evaluated through bench testing against established engineering standards (ANSI/AAMI SP-9). There was no need for human expert consensus to establish "ground truth" for the performance criteria listed (cuff construction, pressure capacity, inflation cycles, leak testing).
4. Adjudication Method for the Test Set
Not applicable, as the evaluation involved objective engineering tests against a standard, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a blood pressure cuff, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant to its evaluation.
6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance was established by the ANSI/AAMI SP-9, 1994 Standard for Cuffs with Integral bladder. This standard outlines predefined, objective criteria and test methodologies for evaluating the physical and functional characteristics of blood pressure cuffs.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is not an AI algorithm.
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).