Search Results

The 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 a patient and manually inflated along with a manual method for detecting Korotkoff sounds.

The product is 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 of MODEL Ks-1222,Ks-1621,Ks-3201,Ks-2203 also includes one selected cuff, one inflation bulb, instruction manual and a vinyl bag. It is conjunction with Stethoscope when use.

The provided document is a 510(k) summary for an Aneroid Sphygmomanometer. It details the device's characteristics and its comparison to a predicate device to establish substantial equivalence. However, this document does not describe a study involving an AI-powered device or a multi-reader multi-case (MRMC) comparative effectiveness study.

The device in question, an "Aneroid Sphygmomanometer," is a manual, non-automated blood pressure meter. The performance testing cited is against ISO 81060-1:2007 "Non-invasive sphygmomanometersPart 1: Requirements and test methods for non-automated measurement type." This standard governs the accuracy of manual blood pressure devices, not AI performance.

Therefore, many of the requested details, such as acceptance criteria for AI performance, sample sizes for test/training sets for AI, ground truth establishment for AI, expert involvement for AI, MRMC studies, and standalone AI performance, are not applicable to this submission.

The document focuses on demonstrating that the new manual device performs similarly to a legally marketed predicate manual device and meets relevant performance and biocompatibility standards for non-automated devices.

However, I can extract the general "acceptance criteria" for the accuracy of the blood pressure measurement as stated in the comparison table and the performance test standard:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size for performance testing: The document states "full performance testing representing the current devices currently marketed" and mentions compliance with ISO 81060-1. While the specific number of subjects/measurements is not detailed in this summary, ISO 81060-1 typically requires clinical validation with a certain number of subjects (e.g., at least 85 subjects for blood pressure accuracy evaluation). The document does not specify data provenance (country, retrospective/prospective).
• Data Provenance: Not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable for AI-driven performance. For a manual blood pressure device assessed against ISO 81060-1, the "ground truth" for blood pressure typically comes from a reference measurement method (e.g., intra-arterial measurement or a highly accurate clinical standard measurement performed by trained personnel). The document does not specify the number or qualifications of these individuals involved in the ground truth establishment for clinical validation, as it's a standard process dictated by the ISO standard.

4. Adjudication method for the test set:

• Not applicable for AI-driven performance. For a manual blood pressure device, adjudication would not be in the typical sense of expert review of AI outputs.

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 is a manual, non-AI device.

6. 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. The performance testing is for the physical device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For blood pressure measurement accuracy (referenced by ISO 81060-1), the ground truth is typically established by simultaneous measurements using a highly accurate reference method (e.g., intra-arterial pressure or a validated mercury sphygmomanometer measurement by trained observers). This is a technical ground truth related to physical measurement.

8. The sample size for the training set:

• Not applicable. This is a non-AI device; there is no "training set."

9. How the ground truth for the training set was established:

• Not applicable. This is a non-AI device.

In summary, the provided FDA 510(k) summary is for a traditional, non-automated medical device (Aneroid Sphygmomanometer). Therefore, it does not contain information related to AI-specific study designs, acceptance criteria, or performance metrics. The "study" proving the device meets acceptance criteria refers to non-clinical performance testing against established international standards for manual blood pressure devices and biocompatibility.

Ask a specific question about this device