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

The subject device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes. The subject device contains Cuff with bladder and Air Hose. Air hose has single tube and double tube. Wrapped the cuff 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. The device 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 22 models with different size for different population with different arm size, and the 11 models of 22 are use single tube of air hose and other 11 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 "Disposable Blood Pressure Cuff" by Wenzhou Xikang Medical Instruments Co., Ltd. This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed acceptance criteria and study results for performance efficacy in the way a clinical trial or algorithm validation study would.

Instead, the "acceptance criteria" for this device are regulatory and technical standards, and the "study" demonstrating it meets these criteria are non-clinical tests to verify design specifications and compliance with recognized standards.

Here's an breakdown based on the information provided, recognizing that it's a regulatory submission rather than a performance study report:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The "Disposable Blood Pressure Cuff" is seeking 510(k) clearance, which is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the "acceptance criteria" are compliance with relevant regulatory standards and the predicate device's characteristics, and the "study" involves non-clinical testing to verify this compliance.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated as a number of patients or cuffs in a typical clinical study. The testing appears to consist of laboratory measurements and evaluations against standards. For biocompatibility, standard test methods typically involve specific numbers of samples for in vitro (cytotoxicity, irritation) and in vivo (sensitization) tests, but these numbers are not detailed in this summary.
• Data Provenance: The testing was "non-clinical tests... conducted to verify that the proposed device met all design specifications." This indicates testing was likely performed by the manufacturer or a contract lab. The country of origin of the data is implicitly China, as the manufacturer is Wenzhou Xikang Medical Instruments Co., Ltd. (Wenzhou, Zhejiang, China). The data is retrospective, generated to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable as this is not a study involving expert-derived ground truth (e.g., medical image interpretation). The "ground truth" here is compliance with established engineering and biocompatibility standards (e.g., ISO 81060-1, ISO 10993).

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

• This is not applicable as there are no expert interpretations or subjective assessments requiring adjudication. The evaluations are based on objective measurements against defined 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:

• No, an MRMC comparative effectiveness study was not done. This device is a blood pressure cuff and does not involve AI or human interpretation in the way a diagnostic imaging device would.

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

• No, a standalone performance study was not done in the context of an algorithm. The device itself is a standalone physical accessory. Its performance is evaluated through compliance with physical and biological standards.

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

• The "ground truth" is defined by international and recognized consensus standards for medical device safety and performance, specifically:
  • ISO 81060-1: For non-invasive sphygmomanometer performance.
  • ISO 10993-1, -5, -10: For biocompatibility.
• The "ground truth" for showing equivalence also includes the technical specifications and materials of the legally marketed predicate device.

8. The sample size for the training set:

• This is not applicable. This device is a physical medical accessory, not an AI/machine learning algorithm that requires a training set.

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

• This is not applicable. As there is no training set for an AI algorithm.

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WX non-Automated Blood Pressure Meter is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on children or adults. The device is intended to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. There are a variety of stethoscopes can be an optioned accessory, depending on the model. The device is applicable to all patients at least 2 years of age.

WX non-Automated Blood Pressure Meter is a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories of MODEL WX02, WX0201, WX0202, WX0203 also includes one selected cuff, one inflation bulb, instruction manual and a vinyl bag. Model WX0201, WX0202, WX0203 include additional stethoscope (Single head, Dual head, and Sprague Rappaport). It is conjunction with Stethoscope when use.

The provided text describes WX non-Automated Blood Pressure Meters. Here's an analysis of the acceptance criteria and supporting studies based on the document:

1. Table of acceptance criteria and the reported device performance:

| Criteria | Device Performance (New Device) Total Result |
| :--------------------- | :---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | :----------- |
| Accuracy (Pressure) | +/- 3 mmHg of reading | SAME |
| Biocompatibility | Biocompatible as requirement of ISO 10993-1, ISO 10993-5, ISO 10993-10 | SAME |
| Performance | Compatible as requirement of ISO 81060-1 | SAME |
| Display | Aneroid Manometer | SAME |
| Monitor Scale | From 0 to 300 mmHg with a minimum interval of 2 mmHg | SAME |
| Compatibility with environment | It can be used from 50°F to 104°F (10°C to 40°C) and 15%~85%RH humidity. | SAME |

The document states that the new device meets these criteria by being "compatible as requirement of ISO 81060-1" for performance and "biocompatible as requirement of ISO 10993-1, ISO 10993-5, ISO 10993-10" for biocompatibility. The accuracy is explicitly stated as "+/- 3 mmHg of reading". For all these criteria, the "Result of Comparison" field in the table is marked as "SAME" when compared to the predicate device.

2. Sample sized used for the test set and the data provenance:

The document mentions "Non-clinical testing included biocompatibility and bench testing." It does not specify the sample size used for these tests. There's no information about data provenance (e.g., country of origin, retrospective or prospective) for the non-clinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The document refers to "bench testing" and compliance with standards (ISO10993 and ISO81060-1), which implies objective measurements rather than expert-established ground truth in the context of clinical interpretation.

4. Adjudication method for the test set:

Not applicable, as no external expert review or adjudication process for a test set is mentioned. The testing mentioned is non-clinical bench 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. The device is a "non-Automated Blood Pressure Meter" and does not involve AI or human-in-the-loop performance.

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

Not applicable. The device is a physical, non-automated blood pressure meter. It does not involve an algorithm.

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

For the accuracy and performance criteria, the "ground truth" would be established by reference measurement instruments or standardized methods as defined by the ISO 81060-1 standard for non-invasive sphygmomanometers. For biocompatibility, the ground truth is established by adherence to the testing protocols outlined in the ISO 10993 series. These are objective standards, not subject to expert consensus in the diagnostic sense.

8. The sample size for the training set:

Not applicable. This device does not use machine learning or AI, and therefore does not have a training set.

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

Not applicable, for the same reason as point 8.

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