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The 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 infant, pediatric and adult sizes. The 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 proposed device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, pediatric and adult sizes. The proposed device includes disposable blood pressure cuff and reusable blood pressure, both disposable and reusable blood pressure cuff has same structure, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube. The disposable blood pressure cuff is single use device, and which is made of non-woven fabrics &PVC (Cuff) and PVC (Air Hose), thereinto, the non-woven fabrics & PVC (Cuff) is the material used to contacting with the patient. The disposable blood pressure cuff has 26 models with different size for different population with different arm size, and the 13 models of 26 are use single tube of air hose and other 13 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system. The reusable blood pressure cuff is reusable device, and which is made of 210D Nylon TPU (Cuff) and PVC (Air Hose), thereinto, the 210D Nylon TPU (Cuff) is the material used to contacting with the patient. The reusable blood pressure cuff has 16 models with different size for different population with different arm size, and the 8 models of 16 are use single tube of air hose and other 8 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.

This is a 510(k) premarket notification for Reusable Blood Pressure Cuffs and Disposable Blood Pressure Cuffs. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by compliance with specific international standards. The performance is reported as meeting these standards.

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

The document does not explicitly state the sample sizes used for the non-clinical tests (biocompatibility and physical performance). The testing was conducted to verify compliance with ISO standards (e.g., ISO 10993-5, ISO 10993-10, ISO 81060-1). The provenance of the data is not specified in terms of country of origin or whether it was retrospective/prospective, but it would have been generated during product development and testing phases.

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

This information is not applicable as the acceptance criteria are based on compliance with international standards (e.g., ISO 10993, ISO 81060-1) rather than expert-established ground truth in a diagnostic context. The ground truth for such tests is derived from the established testing methodologies and pass/fail criteria defined within those standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic devices where human interpretation and consensus are needed to establish ground truth. For the non-clinical tests described (biocompatibility, physical performance), outcomes are determined by adherence to standardized testing protocols and objective measurement against defined thresholds in the ISO standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable. The device is a blood pressure cuff, a measurement accessory, not an AI-powered diagnostic device. Therefore, an MRMC study and analysis of AI assistance is irrelevant to this submission.

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

This is not applicable. The device is a physical medical accessory (blood pressure cuff), not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for demonstrating compliance is based on objective measurements and pass/fail criteria defined within recognized international standards (e.g., ISO 10993 for biocompatibility, ISO 81060-1 for non-invasive sphygmomanometers). These standards provide the established benchmarks for device performance and safety.

8. The Sample Size for the Training Set

This is not applicable. As the device is a physical accessory and not an AI/ML algorithm requiring a training set, this information is irrelevant.

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

This is not applicable for the same reason as point 8.

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