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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 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 is Reusable blood pressure cuff, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube.

During the operation process, the integrated inflatable bladder will wrapped around the patient's limb and secured by hook and loop closure, and the air hose will connected to the noninvasive blood pressure measurement systems.

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.

The Reusable blood pressure cuff is provided as non-sterile.

This document pertains to the 510(k) premarket notification for a Reusable Blood Pressure Cuff (K152468).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" as a separate, quantitative table for the device's main function (blood pressure measurement accuracy). Instead, it focuses on demonstrating substantial equivalence to a predicate device (K151290) through a comparison of various features and compliance with relevant standards for safety and performance.

The "Non-Clinical Test Conclusion" section indicates that the device met design specifications and was substantially equivalent, based on compliance with specific ISO standards.

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

The document does not explicitly state the sample size used for the test set for the non-clinical tests (e.g., biocompatibility testing). It mentions compliance with ISO standards, which would imply specific sample size requirements within those standards.

• Data Provenance: Not explicitly stated regarding the origin of the test data (e.g., country of origin). The submission is from Shenzhen Vistar Medical Supplies Co., Ltd. in China, implying tests were likely conducted there or by affiliated labs. The studies were non-clinical, so the concept of retrospective or prospective data doesn't directly apply in the same way as clinical trials with human subjects.

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

This information is not provided. The non-clinical tests (biocompatibility, performance against ISO standards) typically rely on standardized laboratory procedures and equipment rather than expert human consensus for "ground truth." For example, cytotoxicity would be measured by laboratory assay, not expert opinion.

4. Adjudication Method for the Test Set

Not applicable in the context of these non-clinical tests. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or patient outcomes, not for laboratory testing of device materials or physical performance.

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

Not applicable. This device is a blood pressure cuff, a physical accessory for measurement. It does not involve AI, image interpretation, or human "readers" in the context of diagnostic decision-making. Therefore, an MRMC study is irrelevant to this submission.

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

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

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the non-clinical tests was based on the requirements and methodologies specified in the relevant ISO standards:

• Biocompatibility: In vitro cytotoxicity results (ISO 10993-5) and in vivo irritation/sensitization results (ISO 10993-10) using standardized testing protocols.
• Performance (Blood Pressure Measurement): Requirements and test methods for non-automated measurement type as defined by ISO 81060-1. This standard would set specific limits for accuracy, leakage, etc., which serve as the "ground truth" for compliance.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires 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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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 is disposable blood pressure cuff, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube.

During the operation process, the integrated inflatable bladder will wrapped around the patient's limb and secured by hook and loop closure, and the air hose will connected to the noninvasive blood pressure measurement systems.

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 disposable blood pressure cuff is provided as non-sterile.

The provided document describes the 510(k) premarket notification for a Disposable Blood Pressure Cuff (K152465) by Shenzhen Vistar Medical Supplies Co., Ltd. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K151290).

Here's an analysis of the acceptance criteria and the study that proves the device meets these criteria, based on the provided text:

Key Takeaways:

• This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness.
• The primary means of demonstrating compliance is through non-clinical testing against recognized industry standards and a comparison of specifications with the predicate device.
• No clinical study was included in this submission. Therefore, there is no information about human reader performance (MRMC studies) or standalone algorithm performance, as these are typically part of clinical trials for AI/software devices.
• The device is a physical medical device (blood pressure cuff), not a software or AI-driven diagnostic tool. Thus, concepts like "ground truth" in the AI sense, expert panels for ground truth establishment, or training sets are not directly applicable in the way they would be for an AI device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from recognized standards and comparison with the predicate device. The performance is reported as compliance with these standards or equivalence to the predicate.

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

Since this is a non-clinical device and no human clinical trials were conducted for this 510(k) submission, the concept of a "test set" in the context of patient data is not applicable. The testing was performed on the device itself (e.g., individual cuffs, materials).

• Sample Size for Test Set: Not specified in terms of number of units tested, but physical units of the device were subjected to laboratory tests.
• Data Provenance: Not applicable in the context of patient data. The tests were laboratory-based (e.g., material testing, pressure testing) conducted by the manufacturer. The company is based in China: Shenzhen Vistar Medical Supplies Co., Ltd. (Shenzhen, China). The data is retrospective in the sense that it's generated for the submission but not from a prospective clinical study.

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

This question is not directly applicable to this type of device submission.

• "Ground truth" for a physical device is established by meeting engineering specifications and performance standards. These are defined by regulatory bodies and industry standards (e.g., ISO, FDA guidance documents). The "experts" are the engineers and scientists who developed and validated the test methods to ensure compliance with these standards, not external clinicians establishing diagnostic ground truth from patient data.
• No specific number or qualifications of experts are mentioned for establishing ground truth, as it's not a diagnostic AI device requiring expert consensus on images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, especially for evaluating diagnostic performance where disagreements among readers need resolution to establish a reference standard (ground truth). This submission relies on objective laboratory tests and engineering comparisons.

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 MRMC study was done. This is a blood pressure cuff, not an AI diagnostic tool that assists human readers.

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

Not applicable. The device is a blood pressure cuff, which is a physical accessory for a non-invasive blood pressure measurement system. It does not contain an algorithm nor is it intended for standalone diagnostic performance in the way an AI software device would be.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on engineering specifications, industry standards, and the performance characteristics of the predicate device.

• Engineering Specifications: E.g., pressure range, maximum leakage, tubing dimensions.
• Biocompatibility Standards: ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation and Skin Sensitization). Compliance with these standards is considered the "ground truth" for material safety.
• Performance Standards: ISO 81060-1:2012 (Non-Invasive Sphygmomanometers - Part 1: Requirements And Test Methods For Non-Automated Measurement Type). Compliance with this standard is the "ground truth" for the cuff's functional performance.
• Predicate Device Characteristics: The characteristics of the legally marketed predicate device (K151290) serve as a de facto "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model. There is no "training set."

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

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

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