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The Tenso TS-101S and TS-101D 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 infant, pediatric and adult sizes. They are used in hospital settings.

"Tenso TS-101S and TS-101D Disposable Blood Pressure Cuffs" are an accessory used in conjunction with noninvasive blood pressure measurement systems. They incorporate an inflatable nondistensible bladder, sized to encircle a patient's limb. This allows air to flow in and out of the cuff for inflation and deflation, for the purpose of occlusion of an artery. "Tenso TS-101S and TS-101D Disposable Blood Pressure Cuffs" have a structure which contains Cuff with bladder and Air Hose. Air hose has either single tube or double tubes." The device is secured by hook and loop closure onto the patient limb. It has two variations: TS-101S" is the variant that has single tube structure, while "TS-101D" is the variant that has double-tube structure. The cuff is made from non-woven fabrics, the air hose and tubes are made from polyvinyl chloride. Therefore, the non-woven fabric (cuff) is the material used to contacting with the patient. "Tenso TS-101S and TS-101D Disposable Blood Pressure Cuffs" are single use device and are provided as non-sterile. They are available in infant, pediatric and adult sizes. "Tenso TS-101S Disposable Blood Pressure Cuffs" (single tube model) have 6 models with different size for different population with different arm size. "TS-101D Disposable Blood Pressure Cuffs" (double tube model) also have 6 models with different size for different population with different arm size.

Acceptance Criteria and Study for Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff

This document describes the acceptance criteria and the study performed to demonstrate that the Tenso TS-101S and TS-101D Disposable Blood Pressure Cuffs meet these criteria.

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 specific sample sizes for the mechanical and biocompatibility testing. It indicates that "Non clinical tests were conducted to verify that the proposed device met all design specifications" and that "Performance testing was performed on the subject device." The testing was conducted internally and following recognized standards.

The data provenance is from non-clinical testing performed by the manufacturer, Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd., in China. The study is retrospective in the sense that the testing was performed on manufactured devices to demonstrate compliance for regulatory submission.

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

N/A. For mechanical and biocompatibility testing of a blood pressure cuff, the "ground truth" is established by adherence to predefined technical specifications and international standards (ISO 81060-1, ISO 10993-5, ISO 10993-10) rather than expert consensus on interpretation. The results are objective measurements.

4. Adjudication Method for the Test Set

N/A. The nature of the tests (mechanical performance and biocompatibility) involves objective measurements against established criteria defined in international standards, not subjective interpretations requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images, and the AI's impact on their performance is evaluated. The Tenso TS-101S and TS-101D are disposable blood pressure cuffs, which are mechanical accessories to a measurement system, not interpretive devices.

6. Standalone Performance Study

Yes, a standalone performance study was done in the sense that the device was subjected to a series of non-clinical tests (mechanical strength, fatigue strength, leakage rate, cytotoxicity, irritation, sensitization) to evaluate its performance independently against predefined specifications and international standards. The results (reported as "Meet" or stating the absence of adverse effects) indicate the device's ability to perform its intended function and be biologically safe on its own.

7. Type of Ground Truth Used

The ground truth used for these tests is based on objective measurements against established technical specifications and international consensus standards.

• For mechanical tests (strength, fatigue, leakage), the ground truth is the numerical threshold specified in the standard (e.g., 300 mm Hg for strength, 300 cycles for fatigue, < 4 mm Hg/Minute for leakage).
• For biocompatibility tests (cytotoxicity, irritation, sensitization), the ground truth is defined by the absence of specific biological reactions as outlined in the ISO 10993 series of standards.

8. Sample Size for the Training Set

N/A. This device is a mechanical accessory, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of AI development. The device's design and manufacturing rely on engineering principles and materials science, not on learning from data.

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

N/A. As explained above, there is no training set for this type of device.

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