Search Results

The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on 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 device comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure . The device tubing is connected to a non-invasive sphygmomanometer.

The acceptance criteria for the SUZHOU JJ METER CO., LTD's Sphygmomanometer (models JHT-1110, JHT-1500, JHT-1611) are based on conformance to the international standard ISO 81060-1:2007 "Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type". Additionally, the device was tested for biocompatibility according to ISO 10993-5 and ISO 10993-10.

However, the provided text does not contain a table of specific acceptance criteria values with corresponding reported device performance, nor does it detail a standalone study with quantitative results against specific thresholds. Instead, it broadly states that the device "have been tested conform to" these standards. The conclusion is that the device is "safe and effective, and substantially equivalent to the predicate device" based on this conformance.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the device conforms to ISO 81060-1:2007. This standard outlines requirements for accuracy of blood pressure measurements. Typically, for non-automated sphygmomanometers, key aspects include:

• Accuracy of Pressure Indication: The error of the pressure indicator should be within specified limits (e.g., ±3 mmHg).
• Measurement Accuracy: The device's measurement performance when compared to a reference standard (e.g., intra-arterial measurement) should meet defined criteria (e.g., mean difference and standard deviation of differences).

The document states: "The JJ METER's Sphygmomanometer(model: JHT-1110, JHT-1500, JHT-1611) have been tested conform to the ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type, and ISO 10993-5 and ISO 10993-10."

Without the full test report or detailed results from the submission, specific numerical acceptance criteria and reported performance cannot be extracted into a table. The statement of conformance implies that the device met all the required specifications within this standard, but the exact values are not provided in this summary.

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

The document does not specify the sample size for the test set (number of subjects/measurements) or the data provenance (e.g., country of origin, retrospective/prospective) for the testing against ISO 81060-1:2007.

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

This information is not provided in the document. For blood pressure measurement device testing per ISO 81060-1, ground truth is typically established by trained observers taking reference measurements (e.g., using auscultation by multiple observers or intra-arterial pressure monitoring). The specifics of who performed this, their number, or qualifications are not detailed.

4. Adjudication method for the test set

This information is not provided in the document. For blood pressure studies using multiple observers, adjudication methods (e.g., averaging readings, using a consensus) are common but not mentioned here.

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

This is not applicable as the device is a manual sphygmomanometer, not an AI-assisted diagnostic tool for interpretation by human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not explicitly described as a distinct "standalone" study in the context of an algorithm. The testing against ISO 81060-1:2007 is essentially a standalone performance evaluation of the device itself, as it assesses the device's ability to accurately measure blood pressure. However, it's a hardware device, not an algorithm. Therefore, the "standalone" phrasing typically used for AI/software is not directly applicable.

7. The type of ground truth used

For the ISO 81060-1:2007 testing, the ground truth would typically be established by:

• Reference standard measurements: This often involves highly accurate invasive (intra-arterial) blood pressure measurements or auscultatory measurements by trained observers using a calibrated mercury sphygmomanometer (or other validated reference method), against which the device under test is compared.

The document does not explicitly state which method was used, only that the device conformed to the standard.

8. The sample size for the training set

This is not applicable. The device is a hardware medical device (manual sphygmomanometer) and does not involve AI/machine learning models that require a training set.

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

This is not applicable, as there is no training set for this device type.

Ask a specific question about this device