(164 days)
Philips Multi-Patient and Single-Patient cuffs are to be used with identified devices intended for use by, or under the supervision of, a licensed physician or other healthcare provider for the non-invasive measurement of infant, pediatric and adult human blood pressure.
The device comprises tubing attached to an inelastic sleeve with an integral inflatable bladder that is wrapped around a patient's limb. It is secured by a hook and loop fastener. Device tubing is attached to an NIBP measuring system.
The provided text describes a 510(k) summary for Philips Multi-Patient and Single-Patient Cuffs. This document primarily focuses on establishing substantial equivalence to predicate devices and adherence to recognized standards for medical device safety and performance. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and a study proving device performance in the context of AI studies.
Here's a breakdown of what can be extracted and what information is missing based on your template:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document lists several voluntary standards the cuffs were tested against (e.g., ANSI/AAMI SP10:2002 +A1:2003, EN 1060-1:1995 +A1:2002, IEC 60601-1:1988). The acceptance criteria are implicitly the requirements outlined in these standards for blood pressure cuffs.
- Reported Device Performance: The document states, "All tests passed." However, it does not provide specific performance metrics (e.g., accuracy, precision, sensitivity, specificity) against these standards. It only indicates compliance.
| Acceptance Criteria (Implicit from Standards) | Reported Device Performance |
|---|---|
| ANSI/AAMI SP10:2002 +A1:2003 | Passed |
| EN 1060-1:1995 +A1:2002 | Passed |
| EN 1060-3:1997 +A1:2005 | Passed |
| IEC 60601-1:1988 +A1:1991 +A2:1995 | Passed |
| IEC 60601-2-30:1999 | Passed |
| ISO 10993-1:2003 | Passed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified. The document only mentions "Device testing was performed according to the Validation Traceability Matrix."
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/Not specified. This document is for a blood pressure cuff, not an AI-driven diagnostic device that would typically rely on expert-established ground truth in this manner. The "ground truth" for a physical device like a blood pressure cuff is its adherence to metrological and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
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
- No MRMC study was done. This document is for a physical medical device (blood pressure cuff), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm. It's a blood pressure cuff and requires connection to an NIBP measuring system for use by a healthcare provider.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for these physical cuffs is their compliance with established medical device standards for non-invasive blood pressure measurement devices.
8. The sample size for the training set
- Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable.
§ 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).