(108 days)
The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. This product can measure the blood pressure of people aged 3 years and above.
Aneroid sphygmomanometer Model QL-20, QL-201/ Aneroid sphygmomanometer with stethoscope, Model QL-50 are a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories include cuff, inflation bulb, instruction manual and carrying case. Model OL-50 also includes a stethoscope. It is conjunction with stethoscope when use.
The provided text describes a 510(k) premarket notification for an aneroid sphygmomanometer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness or algorithm performance.
Therefore, the requested information (acceptance criteria for an AI/device algorithm, MRMC study, standalone performance, training/test set details, expert ground truth establishment, etc.) is largely not applicable to this specific document as it pertains to a traditional medical device (manual blood pressure cuff) and not an AI/ML-driven diagnostic or assistive device.
However, I can extract and present the performance criteria that are relevant to this device type based on the provided document:
Acceptance Criteria and Device Performance (for an Aneroid Sphygmomanometer)
Since this is a traditional medical device (aneroid sphygmomanometer) and not an AI/ML-driven device, the acceptance criteria and performance evaluation focus on its physical and functional accuracy for blood pressure measurement, as well as biocompatibility, rather than AI performance metrics like sensitivity, specificity, or AUC.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria (Standard Reference) | Reported Device Performance (Subject Device) |
|---|---|---|
| Accuracy (Pressure) | ± 3 mmHg of reading (ISO 81060-1) | ± 3 mmHg of reading |
| Biocompatibility | Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10 | Biocompatible as required by ISO 10993-1, ISO 10993-5, ISO 10993-10 |
| Environmental Compatibility | 50°F to 104°F (10°C to 40°C) and 15%~85% RH humidity | Can be used from 50°F to 104°F (10°C to 40°C) and 15%~85% RH humidity |
| Monitor Scale | From 0 to 300mmHg with a minimum interval of 2mmHg | From 0 to 300mmHg with a minimum interval of 2mmHg |
| Inflation Method | Manual by inflation bulb | Manual by inflation bulb |
| Deflation Method | Manual deflation via valve | Manual deflation via valve |
| Display Type | Aneroid Manometer | Aneroid Manometer |
2. Sample size used for the test set and the data provenance:
- The document does not specify a patient sample size for testing the aneroid sphygmomanometer itself. The testing performed was "Non-clinical testing" conducted to verify compliance with standards like ISO 81060-1. This standard typically involves technical accuracy testing, often on a test bench or with simulated pressures, and potentially with a limited number of human subjects for specific validation aspects depending on the exact test protocol followed.
- The data provenance is not explicitly stated as it would be for a clinical study. The device is manufactured by Zhejiang LuDe Technology Development Co., Ltd. in China. The testing would have been conducted by the manufacturer or a designated testing facility to meet regulatory requirements.
- The testing was described as "Non-clinical testing," implying it was not a large-scale prospective clinical trial with a defined patient population.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the device is a manual blood pressure monitor. "Ground truth" for blood pressure measurement (the actual pressure) is established through standardized calibration and reference measurement methods, not through expert consensus on images or interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in studies where human readers interpret data (e.g., medical images) and their interpretations need to be reconciled to form a ground truth. For a physical measurement device like a sphygmomanometer, accuracy is determined by comparison to a calibrated reference standard.
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, an MRMC study was not done. This type of study is specifically designed for AI-assisted diagnostic tools and involves human readers interpreting cases with and without AI assistance. This document is for a traditional, manual blood pressure monitor without AI capabilities.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not have a standalone algorithm in the sense of an AI interpreting medical data. Its "performance" refers to its physical accuracy in measuring blood pressure.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the "Accuracy" criterion would be calibrated reference pressures, produced by a precisely controlled pressure source. This is standard for testing blood pressure measuring devices against the ISO 81060-1 standard.
8. The sample size for the training set:
- Not applicable. This device is a hardware product, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI/ML model is involved.
§ 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).