(10 days)
The Devon AccuBP Cuff is intended to be used in conjunction with non-invasive blood pressure monitoring systems for determination of a person's blood pressure. The device is non-sterile and disposable. It is available in neonatal, through adult sizes.
Per CFR 870.1120, a Blood Pressure Cuff is a device that has an inflatable bladder within, or integral to, an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with an appropriate measuring device to determine a subject's blood pressure. The Devon AccuBP Cuffs are Latex Free.
The Devon AccuBP Cuff comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to an appropriate non-invasive blood pressure measurement system. The blood pressure cuffs contain no latex. Sizes include neonatal through large adult. Each cuff is packed in a sealed polyethylene (non-sterile) bag and each cuff is marked with the effective size range of limbs on which it may be used.
Attached to the end of each PVC tube are a variety of connectors for use with most monitoring systems.
The AccuBP Cuffs are available in the following configurations:
Five sizes for Neonatal (Neonatal #1-#5) and eight sizes for (Infant, Child, Small Adult, Adult, Adult Long, Large Adult, Large Adult Long, and Thigh)
Both Single Tube and Double Tube configuration are available for all size.
The provided 510(k) summary for the Devon AccuBP Cuff describes performance testing, but it is not a study that fits the typical criteria for evaluating algorithmic performance as requested in the prompt. This submission is for a medical device (blood pressure cuff) that performs a physical function, not an algorithm that interprets data.
Therefore, many of the requested fields are not applicable (N/A) in this context, as they pertain to the evaluation of machine learning models or diagnostic algorithms.
Here's an analysis based on the available information:
Acceptance Criteria and Device Performance for Devon AccuBP Cuff (K090664)
The Devon AccuBP Cuff is a non-invasive blood pressure cuff. The performance evaluation presented is for the physical device itself, ensuring it meets established standards for blood pressure cuffs.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI/AAMI SP-10 (Compression) | Meets standard |
| ANSI/AAMI SP-10 (Pressure Control) | Meets standard |
| ANSI/AAMI SP-10 (Leakage) | Meets standard |
| ANSI/AAMI SP-10 (Safety Parameters) | Meets standard |
| ANSI/AAMI SP-10 (Operational Parameters when connected to inflation and measurement equipment) | Meets standard |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): Not specified. The document indicates "Bench and laboratory testing," which would imply a number of cuffs were tested, but the exact quantity is not provided.
- Data Provenance: N/A as it's physical product testing, not data-driven. The testing would have been conducted in a laboratory setting by the manufacturer or a contracted lab.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
- Number of Experts: N/A. Ground truth for physical device testing is established by direct measurement against a known standard or validated equipment by qualified technicians, not through expert human interpretation.
- Qualifications of Experts: N/A. Testing would be performed by engineers or technicians skilled in medical device testing and quality control according to the ANSI/AAMI SP-10 standard.
4. Adjudication Method for the Test Set:
- Adjudication Method: N/A. Performance is determined by objective physical measurements compared against the quantitative limits set by the ANSI/AAMI SP-10 standard. There is no subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done: No. This type of study is relevant for diagnostic imaging or algorithmic interpretation where human readers' performance is being compared or improved with AI assistance. The Devon AccuBP Cuff is a physical medical device, not an AI for interpretation.
- Effect Size of Human Readers Improvement with AI vs. without AI Assistance: N/A.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Done:
- Standalone Performance Done: No. This pertains to algorithmic performance. The cuff itself is a standalone device in that it functions independently (when connected to a monitoring system), but it does not have an "algorithm" in the sense of a machine learning model.
7. Type of Ground Truth Used:
- Type of Ground Truth: Established metrics and thresholds defined within the ANSI/AAMI SP-10 standard for blood pressure cuffs. This includes quantitative measurements for compression, pressure control, and leakage, as well as adherence to safety and operational parameters.
8. Sample Size for the Training Set:
- Sample Size (Training Set): N/A. This concept applies to machine learning models that are "trained" on data. The manufacturing of a physical device like a blood pressure cuff does not involve a training set in this context. Design and manufacturing might involve iterative testing, but that's different from a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth Established: N/A (as no training set in the algorithmic sense). The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and the requirements of the ANSI/AAMI SP-10 standard.
§ 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).