(102 days)
Aneroid Sphygmomanometer is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on children or adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.
The proposed device is composed of manometer, cuff bladder, inflation bulb and optioned stethoscopes. It is available in four models, MC-20A, MC-30 and MC-50, which are different in cuff material, cuff bladder material and stethoscope option. The aneroid sphygmomanometer should be used in conjunction with a stethoscope. For model MC-50, there are three types of stethoscope for option: Single Head, Dual Head and Sprague Rappaport stethoscope, while the other models of the proposed device do not have stethoscope in configuration. There are also six sizes of cuff for each model device in order to fit varies arm circumference of user. The proposed device is Over-The-Counter use, non-sterile, reusable device.
This document is a 510(k) Summary for an Aneroid Sphygmomanometer (blood pressure cuff). It primarily demonstrates substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance data in the typical sense for an AI/CADe device.
However, I can extract and structure the information related to performance criteria that would be relevant for a medical device like this, based on the non-clinical tests conducted.
Here's the breakdown of the acceptance criteria and the "study" that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy (Pressure Measurement) | +/- 3 mmHg of reading (meets ISO 81060-1 standard) |
| Biocompatibility (Cytotoxicity) | Complies with ISO 10993-5:2009 |
| Biocompatibility (Irritation & Sensitization) | Complies with ISO 10993-10:2010 |
| Performance (General Standard Compliance) | Compatible as requirement of ISO 81060-1, 2007 Edition |
| Operating Environment | 50°F to 104°F (10°C to 40°C) and 15% ~ 85%RH humidity |
| Monitor Scale Range | 0 to 300 mmHg with a minimum interval of 2 mmHg |
2. Sample size used for the test set and the data provenance
The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no information provided regarding a sample size for a test set based on human subjects or its provenance. The testing appears to be primarily laboratory-based to ensure compliance with specific ISO standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Given that no clinical study was conducted, there were no human subjects or experts required to establish a clinical ground truth for the device's performance in measuring blood pressure on patients. The ground truth for the technical specifications (e.g., pressure accuracy) would be established by the calibration standards and measurement techniques outlined in the ISO standards.
4. Adjudication method for the test set
Not applicable, as no clinical study involving human judgment on a test set (like image interpretation) was performed.
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 device is a manual aneroid sphygmomanometer and does not involve AI or human "readers" in the context of comparative effectiveness studies against AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical medical instrument, not an algorithm. Its standalone performance is assessed against technical standards like ISO 81060-1.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance relies on:
- Standardized Calibration: For pressure accuracy (+/- 3 mmHg), the device's readings are compared against a precisely calibrated reference pressure source as per ISO 81060-1.
- Laboratory Testing: For biocompatibility, in-vitro (cytotoxicity) and in-vivo (irritation and sensitization) tests are conducted according to ISO 10993 series to assess the material's interaction with biological systems.
- Technical Specifications: The operating environment, monitor scale range, and physical design aspects are verified against design specifications and relevant parts of ISO 81060-1.
8. The sample size for the training set
Not applicable. This is a mechanical device, not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this 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).