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The Reusable Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and reusable. It is available in adult size.

The proposed device is an accessory used in conjunction with non-invasive blood pressure measurement systems, and wrap around the patient's limb. The cuff is non-sterile and reusable. The model difference of the proposed device includes bladder type, tube, color, joint model and size.

The provided text is a 510(k) summary for a Reusable Blood Pressure Cuff. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device's performance against specific acceptance criteria for an AI/ML medical device.

Therefore, the document does not contain the information required to describe the acceptance criteria and the study that proves an AI/ML device meets those criteria.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance: The document lists standards the device complies with (IEC 80601-2-30, ISO 81060-1, ISO 10993-5, ISO 10993-10), but these are general safety and performance standards for a mechanical device, not AI/ML acceptance criteria like sensitivity, specificity, or AUC. No specific performance metrics are reported against quantitative acceptance criteria.
• Sample size and data provenance for a test set: No mention of a test set, data provenance, or sample size for evaluating AI/ML algorithm performance.
• Number and qualification of experts for ground truth: Not applicable, as this is not an AI/ML device requiring expert-established ground truth.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How ground truth for the training set was established: Not applicable.

The document states:

• "6. Non-Clinical Test Conclusion" and "6.1 Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: IEC 80601-2-30: 2018..., ISO 81060-1:2007..., ISO 10993-5: 2009..., ISO 10993-10: 2010..."
• "6.2 Human Factors / Usability Testing Usability testing is not required per the risk profile of this product."
• "7. Clinical Test Conclusion No clinical study is included in this submission."

This unambiguously indicates that the submission is for a physical medical device (a blood pressure cuff), assessed through non-clinical bench testing for compliance with manufacturing and biocompatibility standards, and not an AI/ML driven diagnostic or assistive device that would require the specified performance evaluations.

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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 neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

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 neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

The proposed device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes.

The proposed device includes disposable blood pressure cuff and reusable blood pressure cuff, 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), the non-woven fabrics & PVC (Cuff) is the material used to contacting with the patient.

The disposable blood pressure cuff has 24 models with different population with different arm size, and the 12 models of 24 are use single tube of air hose and other 12 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 PU & PVC (Cuff) and PVC (Air Hose), thereinto, the PU & PVC (Cuff) is the material used to contacting with the patient.

The reusable blood pressure cuff has 16 models with 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 provided document is a 510(k) summary for the Caremed Reusable Blood Pressure Cuff and Caremed Disposable Blood Pressure Cuff. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study for a new medical AI or advanced diagnostic device. Therefore, much of the requested information (e.g., sample size for test sets and training sets, number of experts, adjudication methods, MRMC studies, ground truth types) is not directly applicable or available in this type of submission for a blood pressure cuff.

However, I can extract information related to the performance data provided within the context of a 510(k) submission for this device.

1. Table of Acceptance Criteria and Reported Device Performance

For a blood pressure cuff, the "acceptance criteria" and "reported device performance" are primarily related to safety, material biocompatibility, and functional performance (e.g., pressure range, leakage, and compliance with recognized standards).

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

This information is typically not provided in a 510(k) summary for a blood pressure cuff. The "test set" here refers to samples of the device materials tested for biocompatibility and the device itself for functional performance.

• Sample Size for Test Set: Not specified in the document. Standard practice would involve testing a representative number of samples to demonstrate compliance with standards for biocompatibility and functional performance.
• Data Provenance: Not explicitly stated as country of origin but likely conducted by testing laboratories in China, given the manufacturer's location. The studies are "non-clinical" and likely retrospective in that they characterize the manufactured product.

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

Not applicable in this context. The "ground truth" for a blood pressure cuff's performance is typically established by objective physical and chemical testing against established international standards (e.g., ISO for biocompatibility and sphygmomanometers), not by expert consensus or readings.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for evaluating human reader performance in diagnostic studies, which is not relevant for a blood pressure cuff's mechanical and material performance testing.

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 is a blood pressure cuff, not an AI-powered diagnostic device. No human-in-the-loop performance or MRMC study was conducted or is relevant.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims of these blood pressure cuffs is based on objective measurement against established international standards (e.g., ISO 81060-1 for non-invasive sphygmomanometers, ISO 10993 for biocompatibility) and direct physical/chemical testing.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable.

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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 reusable in infant, pediatric but not neonatal, and adult sizes.

The proposed device is an accessory used in conjunction with noninvasive blood pressure measurement systems, and wrap around the patient's limb. The cuff is non-sterile and reusable. The model difference of the proposed device includes bladder type, tube, color, joint model and size.

The given text is a 510(k) Summary for a Reusable Blood Pressure Cuff, which is a submission to the FDA to demonstrate substantial equivalence to previously marketed devices. This document focuses on proving that the new device is as safe and effective as existing products, primarily through non-clinical testing and comparison to predicate devices, rather than an extensive study proving new performance criteria for a novel device or an AI algorithm.

Therefore, many of the requested details, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "sample size for training set," are not applicable to this type of regulatory submission and product. The device is a physical medical accessory, not an AI algorithm.

I will extract the available and relevant information.

Acceptance Criteria and Device Performance for Reusable Blood Pressure Cuff (K171889)

The acceptance criteria for the Reusable Blood Pressure Cuff (K171889) are established by demonstrating compliance with recognized international standards and substantial equivalence to predicate devices. The study conducted was primarily non-clinical testing to verify design specifications and biological compatibility.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for the non-clinical tests (e.g., how many cuffs were tested for biocompatibility or performance). The data provenance is not detailed beyond the manufacturer being Suzhou Minhua Medical Apparatus Supplies Co., LTD in China, implying testing was likely conducted in China. The study refers to "non-clinical tests" and "test results" and "laboratory tests," which are inherently prospective for the specific devices being tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The device is a physical medical accessory, and the "ground truth" for its performance is established by compliance with international engineering and biocompatibility standards, not by expert consensus on diagnostic interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are typically used in clinical studies involving interpretation (e.g., imaging reads) where there can be differing opinions among experts. This product's evaluation is based on objective measurements against engineering and biological standards.

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. MRMC studies are relevant for diagnostic devices, particularly those involving human interpretation of data/images, often with AI assistance. This device is a blood pressure cuff and does not involve "readers" or "AI assistance" in that context.

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

This information is not applicable. The device is a physical blood pressure cuff, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the Reusable Blood Pressure Cuff is compliance with:

• Engineering Standards: IEC 80601-2-30: 2013 (Medical Electrical Equipment - Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers).
• Biocompatibility Standards: ISO 10993-5: 2009 (Tests For In Vitro Cytotoxicity) and ISO 10993-10: 2010 (Tests For Irritation And Skin Sensitization).
• Substantial Equivalence: Comparison to legally marketed predicate devices (K133117 and K152468) regarding intended use, principles of operation, materials, and performance specifications.

8. The sample size for the training set

This information is not applicable. "Training set" refers to data used to train algorithms, primarily in machine learning or AI. This device is a physical medical accessory.

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

This information is not applicable as there is no "training set" for this physical device.

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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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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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