(100 days)
Disposable blood Pressure Cuff is intended to be wrapped on the upper arm and used with a non-invasive blood pressure device to determine blood parameters on neonate, pediatric and adult patients.
The proposed devices, Disposable blood Pressure Cuff, are claimed to be Substantially Equivalent (SE) to the predicate devices, Disposable Blood Pressure Cuff.
The provided text describes the acceptance criteria and the study for a Disposable Blood Pressure Cuff.
Here's the information extracted and organized:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Tested per ISO 10993 series standards. |
| Performance | Tested per AAMI SP10:2002+A1:2003+A2:2006. |
| Substantial Equivalence | Found to be substantially equivalent (SE) to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size for a "test set" in the context of an algorithm or AI. Instead, it refers to standards for evaluating biocompatibility and performance of a physical device.
- Test Set Sample Size: Not explicitly stated for specific human subjects or data points, but implies adherence to the sample size requirements of ISO 10993 and AAMI SP10 for device testing.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The manufacturer is Wuxi Medical Instruments Factory in China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is not an AI or algorithm-based device that would require expert-established ground truth for a test set. The "ground truth" for this device relates to its physical performance and biocompatibility according to established medical device standards.
4. Adjudication Method for the Test Set
Not applicable. This is not an AI or algorithm-based device that would require an adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a physical medical device (blood pressure cuff), not an AI system. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is a physical medical device (blood pressure cuff). The concept of "standalone performance" for an algorithm is not applicable. The device's performance is tested according to AAMI SP10, which evaluates the physical function of the cuff.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by adherence to recognized international standards:
- Biocompatibility: ISO 10993 series standards.
- Performance: AAMI SP10:2002+A1:2003+A2:2006.
- Substantial Equivalence: Comparison to legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment.
§ 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).