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Med-link Reusable Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

The proposed device, Med-link Reusable Blood Pressure Cuffs is rectangle soft inelastic sleeve with bladder, to which a single-tube or twin-tube is connected. It is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. It is available in various sizes for different limb range. It is provided non-sterile.

The Med-link Reusable Blood Pressure Cuff underwent non-clinical testing to assess its safety and essential performance. The acceptance criteria and reported device performance are based on compliance with specific ISO and IEC standards.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for each specific non-clinical test (ISO 81060-1, IEC 80601-2-30, biocompatibility tests). It indicates that "A series of safety, essential performance and biocompatibility tests were performed."
The provenance of the data is not specified in terms of country of origin or whether the tests were retrospective or prospective. It states the tests were "conducted in accordance with" the listed standards, implying a controlled testing environment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The non-clinical testing primarily focuses on objective measurements against international standards rather than expert-derived ground truth as might be seen in diagnostic imaging studies.

4. Adjudication Method for the Test Set:

This information is not applicable and is not provided. The testing involves standardized laboratory and performance tests, not a judgmental adjudication process.

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 information is not applicable and is not provided. The device is a blood pressure cuff, not an AI-assisted diagnostic tool for which MRMC studies would typically be conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:

This information is not applicable and is not provided. The device is not an algorithm, so standalone algorithm performance is not relevant. The performance of the cuff is evaluated as a physical accessory for blood pressure measurement systems.

7. The Type of Ground Truth Used:

The ground truth for the performance claims relies on:

• International Standards: Compliance with ISO 81060-1, IEC 80601-2-30, ISO 10993-5, and ISO 10993-10. These standards establish the acceptable technical performance and safety criteria for such devices.
• Biocompatibility Testing: Objective laboratory tests (cytotoxicity, skin irritation, skin sensitization) directly measure the device's interaction with biological systems against established thresholds.
• Predicate Device Comparison: The inherent assumption is that if the device performs equivalently to legally marketed predicate devices that have already met regulatory requirements, then it is safe and effective.

8. The Sample Size for the Training Set:

This information is not applicable to this type of medical device. Blood pressure cuffs are mechanical devices, and their performance is established through physical and biological testing, not machine learning models that require training sets.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the reasons stated in item 8.

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Med-link Disposable Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

The proposed device, Med-link Disposable Blood Pressure Cuff is rectangle soft inelastic sleeve. There is a single-tube or twin-tube connected to a sealed gas chamber. It is wrapped around the patient's limb/thigh and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. It is available in various sizes for different limb range. It is provided non-sterile.

This document is a 510(k) premarket notification for the Med-link Disposable Blood Pressure Cuff. It aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on the FDA recognized consensus standard ISO 81060-1:2007/ AAMI/ANSI/ISO81060-1:2007/(R)2013 Non-Invasive Sphygmomanometers -Part 1: Requirements And Test Methods For Non-Automated Measurement Type, and ISO 10993 (Biological evaluation of medical devices) series for biocompatibility.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the performance testing. It mentions "Performance testing was performed on the subject device," but does not specify the number of devices or measurements.

The data provenance is not specified regarding country of origin or specific study design (retrospective or prospective). The tests are described as "non-clinical testing," which suggests laboratory-based evaluations rather than human subject trials for the core performance and biocompatibility aspects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This document describes the testing of a basic medical accessory (blood pressure cuff). The "ground truth" for its performance is established by objective measurements against a recognized standard (ISO 81060-1). There is no mention of experts establishing a "ground truth" in the way one might for diagnostic imaging or a subjective clinical assessment. The ground truth for biocompatibility is established through standardized laboratory tests.

4. Adjudication Method for the Test Set

Not applicable. The performance and biocompatibility tests are objective measurements against established standards, not subjective assessments requiring adjudication by multiple experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a 510(k) submission for a blood pressure cuff, which is a physical accessory, not an AI or imaging-based diagnostic device. Therefore, an MRMC comparative effectiveness study, which typically evaluates human readers' performance with and without AI assistance, is not relevant or applicable here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a passive accessory and does not involve an algorithm. Its function is to interface with a blood pressure measurement system.

7. Type of Ground Truth Used

The ground truth used for performance testing (accuracy and reliability of pressure transmission, cuff inflation/deflation, etc.) is the adherence to the ISO 81060-1 standard's objective requirements and test methods.

For biocompatibility testing, the ground truth is established by the results of standardized laboratory tests (Cytotoxicity, Skin Irritation, Skin Sensitization) as defined by the ISO 10993 series.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning algorithm and therefore does not have a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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