(219 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 NT-20, NT-201/ Aneroid sphygmomanometer stethoscope, Model NT-50 are a manual non-invasive aneroid with 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 NT-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 performance against specific acceptance criteria for a new AI/software-as-a-medical-device (SaMD) feature.
Therefore, the document does not contain the detailed information typically found in a study demonstrating how a device meets acceptance criteria, especially for AI or SaMD. Specifically:
-
A table of acceptance criteria and the reported device performance: Not provided. The submission states that performance was "compatible as requirement of ISO 81060-1" and that "All performance specification was verified to comply with the ISO 81060-1 standard" and "Pressure : ±3mmHg of reading," but a detailed table of acceptance criteria and results is absent.
-
Sample size used for the test set and the data provenance: Not provided. The document states "No clinical study is included in this submission," further indicating that a test set against ground truth as would be used for AI/SaMD performance evaluation was not conducted.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical study or test set with expert-established ground truth was conducted.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical study or test set was conducted.
-
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, not an AI or imaging device that would involve human readers.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a manual device; there is no algorithm in the sense of AI/SaMD.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly defined in the context of a "test set" for performance evaluation, as the submission focuses on meeting ISO standards. The accuracy is stated as "Pressure : ±3mmHg of reading", implying comparison against a reference standard.
-
The sample size for the training set: Not applicable, as this is not an AI/SaMD device requiring a training set.
-
How the ground truth for the training set was established: Not applicable, as this is not an AI/SaMD device.
Summary of available information related to acceptance criteria and performance:
The acceptance criteria are generally implied to be compliance with relevant standards, primarily ISO 81060-1 for performance and ISO 10993 series for biocompatibility.
Table of Acceptance Criteria and Reported Device Performance (based on implicit statements in the document):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy | Pressure: ±3mmHg of reading (compatible as requirement of ISO 81060-1) |
| Material Biocompatibility | Biocompatible as requirements of ISO 10993-1, ISO 10993-5, ISO 10993-10. Results of testing were acceptable. |
| Environmental Compatibility | Can be used from 50°F to 104°F (10°C to 40°C) and 15%~85% RH humidity. |
| Performance Standard | Compatible as requirement of ISO 81060-1. All performance specifications verified to comply with ISO 81060-1. |
| Mechanical Safety | (Implicitly similar to predicate and acceptable based on discussion) |
Study Description:
The document states, "No clinical study is included in this submission." Instead, the submission relies on non-clinical testing which included biocompatibility and bench testing. The tests listed in the ISO 10993 series (for biocompatibility) and ISO 81060-1 (for performance) were included. The results of these tests were deemed acceptable, demonstrating that the device meets the performance specifications outlined in the standards. The primary method for proving the device meets the acceptance criteria (which are essentially the requirements of these ISO standards) is through this non-clinical testing and comparison to a predicate 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).