(203 days)
The CUFF-ABLE PLUS™ 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 single patient use disposable device and is available in child and adult sizes.
The device comprises a soft fabric with an integral bladder that is wrapped around a patient's limb and secured by a hook and loop closure. One or two tubes extend from the bladder and are connected to a non-invasive blood pressurement system. The blood pressure cuffs contain no latex. Sizes will include child through adult. The device is treated with and antimicrobial agent that helps prevent bacterial growth, mildew and odors. Each unit is packaged in a polyfilm bag.
The provided text describes a 510(k) premarket notification for the CUFF-ABLE PLUS™ blood pressure cuff. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical trials with specific acceptance criteria and performance metrics for an AI-powered diagnostic device.
Therefore, many of the requested elements are not applicable or cannot be extracted from the given information. The information primarily concerns physical and functional equivalence of a medical device (blood pressure cuff).
Below is an analysis based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Attributes based on ANSI/AAMI SP-9, 1994 Standard) | Reported Device Performance (CUFF-ABLE PLUS™ vs. CUFF-ABLE®) |
|---|---|
| Cuff Closure Performance | Equivalent performance |
| Pressure Capacity Performance | Equivalent performance |
| Repeated Inflations Performance | Equivalent performance |
| Hook Seal Strengths | Equivalent performance |
| Fabric Seal Strengths | Equivalent performance |
| Flange Seal Strengths | Equivalent performance |
| Seal Burst | Equivalent performance |
Study Details:
The study conducted was a comparative functional and environmental testing of the CUFF-ABLE PLUS™ against its predicate device, the CUFF-ABLE®, single-use blood pressure cuff.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size used for the functional and environmental testing. It only states that "The CUFF-ABLE PLUS™ blood pressure cuff was compared to the CUFF-ABLE®, single use blood pressure cuff."
- Data Provenance: Not applicable. The testing appears to be laboratory-based functional and physical performance testing of the device itself, not involving patient data or clinical retrospective/prospective studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This is not applicable to the type of testing described (functional and physical performance of a blood pressure cuff). Ground truth in this context would likely be established by engineering specifications and objective measurements against standards, not expert adjudication of diagnostic outcomes.
4. Adjudication Method for the Test Set
- Not applicable. The testing was objective measurement against an industry standard (ANSI/AAMI SP-9, 1994) and comparison to a predicate device, not subjective interpretation 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. The device is a traditional blood pressure cuff, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. The device is a traditional blood pressure cuff, not an algorithm.
7. The Type of Ground Truth Used
- The ground truth for the functional and environmental testing was based on objective physical and functional measurements against the ANSI/AAMI SP-9, 1994 Standard and direct comparison to the performance characteristics of the predicate device (CUFF-ABLE® blood pressure cuff).
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that would require a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for this type of device.
§ 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).