(207 days)
The device is intended to be used by medical professionals or in 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.
Aneroid sphygmomanometer Model HS-20A,HS-20D,HS-201W, HS-201Y,HS-201C1, HS-201Q3/ Aneroid sphygmomanometer with stethoscope, Model HS-50C,HS-50B, HS-50D 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 HS-50C,HS-50D,HS-50B also include a stethoscope. It is conjunction with stethoscope when use.
The provided document is a 510(k) premarket notification for an Aneroid Sphygmomanometer. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed study results of the device meeting specific acceptance criteria in the same way, for example, a novel AI algorithm might. Therefore, some of the requested information, particularly around clinical studies, ground truth establishment, and expert consensus, is not directly applicable or available in this document.
However, I can extract information related to the device's technical specifications and the standards it aims to meet for substantial equivalence.
Here's an analysis based on the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device, the "acceptance criteria" are primarily defined by the performance requirements of the ISO 81060-1 standard for non-invasive sphygmomanometers, and the "reported device performance" indicates compliance with these standards.
| Feature | Acceptance Criteria (from ISO 81060-1, implicitly) | Reported Device Performance (as stated) |
|---|---|---|
| Pressure Accuracy | ±3mmHg of reading | ±3mmHg of reading |
| Monitor Scale | 0 to 300mmHg with a minimum interval of 2mmHg | 0 to 300mmHg with a minimum interval of 2mmHg |
| Operating Environment | 10°C to 40°C (50°F to 104°F) and 15%-85% RH humidity | 10°C to 40°C (50°F to 104°F) and 15%-85% RH humidity |
| Biocompatibility | Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10 | Biocompatible as requirement of ISO 10993-1, ISO 10993-5, ISO 10993-10 |
| Performance Standard | Compatible with ISO 81060-1 | Compatible as requirement of ISO 81060-1 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "sample size" for a test set in the context of a clinical study or a dataset for an algorithm. This submission references "Non-clinical testing included biocompatibility and bench testing." It does not provide details on the number of units tested or the specific methodology for these bench tests, beyond stating that they were included in the ISO 10993 and ISO 81060-1 standards.
The data provenance is from non-clinical testing conducted to demonstrate compliance with standards like ISO 10993 and ISO 81060-1. The document does not specify country of origin for this testing data, but the manufacturer is HONSUN (NANTONG) Co., Ltd in China. The testing would be considered bench testing rather than retrospective or prospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. For this type of device (a mechanical aneroid sphygmomanometer), ground truth for performance claims is established through a calibrated reference standard (e.g., a manometer calibrated to a known pressure standard) during bench testing, as specified by standards like ISO 81060-1. There would be no "experts" establishing a ground truth in the context of subjective interpretation like with medical imaging.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in studies involving human interpretation of data, often in clinical trials or studies for AI algorithms. For a mechanical device's performance testing (like pressure accuracy), the measurement is objective against a standard, not subject to adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improving with AI vs. Without AI Assistance
No. This device is an aneroid sphygmomanometer, which is a manual non-invasive blood pressure measurement device. It does not incorporate artificial intelligence, nor does it involve "readers" in the context of image interpretation or diagnostic decision-making. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not relevant or applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a mechanical instrument and does not contain an algorithm. "Standalone performance" in this context would refer to the device's accuracy and performance specifications as outlined in the table above, which are assessed through bench testing against established standards.
7. The Type of Ground Truth Used
For this device, the "ground truth" for pressure accuracy is a calibrated pressure standard as mandated by the ISO 81060-1 standard for non-invasive sphygmomanometers. This standard defines the methods for verifying the accuracy of the device against a known, precise pressure.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical medical instrument. It does not utilize an algorithm, machine learning, or artificial intelligence; therefore, there is no "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this mechanical 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).