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Disposable blood Pressure Cuff is intended to be wrapped on the upper arm and used with a non-invasive blood pressure device to determine blood parameters on neonate, pediatric and adult patients.

The proposed devices, Disposable blood Pressure Cuff, are claimed to be Substantially Equivalent (SE) to the predicate devices, Disposable Blood Pressure Cuff.

The provided text describes the acceptance criteria and the study for a Disposable Blood Pressure Cuff.

Here's the information extracted and organized:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific sample size for a "test set" in the context of an algorithm or AI. Instead, it refers to standards for evaluating biocompatibility and performance of a physical device.

• Test Set Sample Size: Not explicitly stated for specific human subjects or data points, but implies adherence to the sample size requirements of ISO 10993 and AAMI SP10 for device testing.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The manufacturer is Wuxi Medical Instruments Factory in China.

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

Not applicable. This is not an AI or algorithm-based device that would require expert-established ground truth for a test set. The "ground truth" for this device relates to its physical performance and biocompatibility according to established medical device standards.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI or algorithm-based device that would require an adjudication method for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a physical medical device (blood pressure cuff), not an AI system. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is a physical medical device (blood pressure cuff). The concept of "standalone performance" for an algorithm is not applicable. The device's performance is tested according to AAMI SP10, which evaluates the physical function of the cuff.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by adherence to recognized international standards:

• Biocompatibility: ISO 10993 series standards.
• Performance: AAMI SP10:2002+A1:2003+A2:2006.
• Substantial Equivalence: Comparison to legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment.

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The Disposable Blood Pressure cuff is intended to be used with a non-invasive blood pressure measurement system to determine blood pressure parameters on neonate, pediatric and adult patients.

The device comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device is connected to a non- invasive blood pressure measurement system. The device is available in the following configurations:
· 15 sizes (five neonate, ten pediatric/adult)
· Single and dual cuff tubing with connectors available for use with a wide variety of manual and automated sphygmomanometers

This submission describes a disposable blood pressure cuff. The relevant information related to acceptance criteria and performance studies is as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The device was tested against two recognized standards and an internal marketing specification. The submission states, "These tests have indicated passing results." However, specific numerical acceptance criteria and the detailed performance results for each criterion are not provided in this document.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective). It simply states that "The Disposable Blood Pressure Cuff has been tested to... standards and requirements."

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 to the type of device and testing described. The device is a physical medical device (blood pressure cuff), and its performance is assessed against technical standards for accuracy and safety, rather than requiring expert interpretation for ground truth.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are typically used in studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For a physical device like a blood pressure cuff, performance is measured objectively against technical 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

An MRMC comparative effectiveness study is not applicable as this device is a disposable blood pressure cuff, not an AI-powered diagnostic tool that assists human readers.

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

The "ground truth" for this device's performance is established by the specified industry standards (AAMI SP10: 2002 and IEC 60601-2-30:1999) and an internal marketing specification. These standards define the acceptable range of accuracy for blood pressure measurements and other physical and safety features of the cuff. The device's performance is measured against these objective criteria.

8. The sample size for the training set

This information is not applicable. The development and testing of a physical blood pressure cuff do not involve a "training set" in the context of machine learning or AI. The design and manufacturing process would involve engineering specifications, prototyping, and validation testing.

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

This information is not applicable, as there is no "training set" in the context of this device. The "ground truth" for general design and safety parameters would be established by relevant engineering principles, material science, and regulatory requirements that predate the specific device being developed.

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