(154 days)
Blood Pressure Cuffs, include reusable and disposable, are intended to be wrapped on the upper arm and used with a non-invasive blood pressure monitor system to determine blood parameters on neonate, pediatric and adult patients.
The proposed device, Blood Pressure Cuff, is a rectangle soft inelastic sleeve. Some types are disposable without a bladder; some are reusable with a bladder or without a bladder. There is a single-tube or twin-tube connected to the bladder and the NIBP measurement device for inflating and deflating. It is available in various sizes for different arm range. It is provided non-sterile and each cuff. It is used in conjunction with NIBP Monitor System.
The provided text describes a 510(k) submission for a blood pressure cuff and references some testing, but does not contain the detailed study information typically required to directly answer all parts of your request.
Specifically, it lacks:
- Explicit "acceptance criteria" for performance that are separate from the testing standards.
- "Reported device performance" in terms of specific metrics like accuracy, bias, or precision of blood pressure measurement.
- Details about a "test set" in the context of AI/algorithm performance (which is not applicable here as this is a physical device).
- Information on "experts" or "ground truth" establishment, as this is a physical measurement device, not an image analysis or diagnostic algorithm.
- Any mention of "multi reader multi case (MRMC) comparative effectiveness study" or "standalone (algorithm only)" performance, as these are related to AI/software.
- Sample sizes for training sets (again, not applicable to this type of device).
The document focuses on substantial equivalence to predicate devices and adherence to recognized standards for physical devices.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with specific performance metrics (e.g., mean difference in mmHg). Instead, it states that the device was tested per AAMI SP10:2002+A1:2003+A2:2006. For blood pressure cuffs, AAMI SP10 is the recognized standard for performance requirements and testing. Compliance with this standard implies that the device meets the performance specifications outlined within it (e.g., accuracy, pressure stability, deflation rates, etc.).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with AAMI SP10:2002+A1:2003+A2:2006 | Device was tested per AAMI SP10:2002+A1:2003+A2:2006, implying compliance. |
| Compliance with ISO 10993 series standards (Biocompatibility) | Device was tested per ISO 10993 series standards, implying compliance. |
2. Sample size used for the test set and the data provenance
Not applicable in the context of an AI/algorithm test set. For a physical blood pressure cuff, testing typically involves a number of samples of the cuff itself and a number of human subjects for clinical validation studies if required, but these details are not provided in this summary. The summary only states "The device was tested per... AAMI SP10." The data provenance is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical device intended for measurement, not an AI/algorithm requiring expert-established ground truth for diagnostic accuracy.
4. Adjudication method for the test set
Not applicable to this type of device or study described.
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
Not applicable. This is a physical device, not an AI system assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical blood pressure cuff, not an algorithm.
7. The type of ground truth used
For a blood pressure cuff, "ground truth" for blood pressure accuracy is typically established by comparing the device's readings against a reference standard method (e.g., intra-arterial measurement, auscultatory method by trained observers with mercury sphygmomanometer) as specified by standards like AAMI SP10. The document does not specify the exact method used for establishing the ground truth beyond stating compliance with AAMI SP10.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model requiring a training set.
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).