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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 includes disposable blood pressure cuff. All the disposable blood pressure cuff has same structure, which contains Cuff and single tube. The disposable blood pressure cuff is single use device, and which is made of non-woven fabrics (Cuff) and PVC (Air tube), thereinto, the non-woven fabrics (Cuff) is the material used to contacting with the patient. The disposable blood pressure cuff has 6 models with different population with different circumference size.

I am sorry, but the provided text does not contain the detailed information needed to fully answer your request regarding the acceptance criteria, study details, and sample sizes for the medical device described. The document is a 510(k) summary for a Disposable NIBP Cuff, which primarily focuses on establishing substantial equivalence to a predicate device.

Here's a breakdown of what is and is not in the text, relative to your request:

What is present in the document:

• Acceptance Criteria (Indirectly): The document states that "Non-clinical tests were conducted to verify that the subject device met all design specifications" and that it complies with "ISO 81060-1, Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type, First Edition 2007." This standard would implicitly define the performance acceptance criteria for blood pressure cuffs. However, the specific numerical acceptance criteria (e.g., maximum allowable error in mmHg) are not explicitly listed in the provided text. The "Max. Leakage" of "< 4mm Hg/ min." is mentioned as a comparison point to the predicate, implying it's an acceptance criterion.
• Study Proving Acceptance Criteria (Indirectly): The document mentions that "Non-clinical tests were conducted" and specifically references "Performance testing accordance with ISO 81060-1 has been conducted and provided with this submission." This indicates that a study was performed to demonstrate compliance with the standard.
• Biocompatibility Testing: It explicitly states that "Biocompatibility testing accordance with ISO 10993-1 has been conducted" and lists the types of tests: Cytotoxicity, Sensitization, and Irritation. These are acceptance criteria for biocompatibility.
• Device Performance (Indirectly): The document states that "The test results demonstrated that the subject device complies with the following standards," suggesting that the device met the performance requirements of ISO 81060-1 and the biocompatibility tests.

What is not present in the document, and therefore cannot be provided in the requested table/description:

• A table of acceptance criteria and reported device performance with specific values. While ISO 81060-1 is referenced, the specific numerical acceptance criteria from that standard are not detailed in this summary, nor are the reported results of the specific device (e.g., "Device A achieved X mmHg accuracy").
• Sample size used for the test set. The text mentions "non-clinical tests" and "performance testing" but does not specify the number of devices or measurements included in these tests.
• Data provenance (e.g., country of origin of the data, retrospective or prospective).
• Number of experts used to establish the ground truth for the test set and their qualifications. This type of detail is usually for studies involving human interpretation (e.g., imaging devices) and is not applicable here as this is a physical blood pressure cuff.
• Adjudication method. (Not applicable for this type of device testing).
• Multi-reader multi-case (MRMC) comparative effectiveness study. (Not applicable for this type of device testing).
• Standalone (algorithm only) performance. (Not applicable, as this is a physical device, not an algorithm).
• Type of ground truth used. For a blood pressure cuff, the "ground truth" would be established by validated reference measurement devices or methods within the ISO 81060-1 standard, but this is not explicitly detailed.
• Sample size for the training set. (Not applicable, as this is not an AI/ML device that requires a training set).
• How the ground truth for the training set was established. (Not applicable).

Based on the available information, here is what can be inferred and presented:

The provided text describes the acceptance criteria and related studies for the Disposable NIBP Cuff (K193629).

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 specified in the document.
• Data Provenance: The studies are "non-clinical tests" and "performance testing" conducted for the submission for an FDA 510(k) by Shenzhen Changke Connect Electronics Co., Ltd. and Chonconn Medical Device Consulting Co., Ltd. (both based in China). The specific country where the physical testing took place is not explicitly stated, but it's likely associated with the manufacturer's location. The studies are prospective in nature, designed to demonstrate compliance.

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 for the type of device (blood pressure cuff). The ground truth for such devices is established through validated measurement methods and reference instruments as per standards like ISO 81060-1, rather than expert human interpretation.

4. Adjudication method for the test set

• Not applicable for this type of device testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, an MRMC study was not done. This type of study is typically for diagnostic imaging devices where human readers interpret medical images, which is not relevant for a blood pressure cuff.

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

• This is not an algorithm-only device. The reference to "non-clinical data" and "performance testing" implies a standalone device performance evaluation against established standards.

7. The type of ground truth used

• For functional performance (ISO 81060-1): The ground truth would be established through a comparison to a validated reference method or device as per the requirements of the ISO 81060-1 standard. This standard specifies test methods for accuracy and other performance aspects of sphygmomanometers.
• For biocompatibility (ISO 10993-1): The ground truth is established by standardized biological assays and tests (cytotoxicity, sensitization, irritation) using defined cell lines, animal models, or human volunteers (for irritation patch tests) according to the ISO 10993-1 standard.

8. The sample size for the training set

• Not applicable as this is a physical medical device and not an artificial intelligence/machine learning algorithm requiring a training set.

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

• Not applicable as there is no training set for this type of device.

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