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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 have the same structure, which contains Cuff with bladder and single-tube Air Hose.

This document is a 510(k) Premarket Notification from the FDA regarding a non-invasive blood pressure (NIBP) cuff. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report of the device's accuracy or efficacy as one might find for a more complex AI-driven medical device.

Therefore, the requested information, particularly concerning "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-driven device (like an effect size of human readers improving with AI, or standalone algorithm performance), is largely not applicable to this document. This document primarily describes the physical characteristics, intended use, and manufacturing standards of a blood pressure cuff.

However, I can extract the relevant information where available, focusing on performance data related to blood pressure cuffs.

Here's an analysis based on the provided text:

Key Takeaway: This 510(k) submission primarily relies on physical and material testing and comparison to a predicate device to demonstrate substantial equivalence, not a clinical study proving its performance against specific physiological accuracy criteria in humans, nor an AI-driven system's performance.

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

The document doesn't present a table of acceptance criteria and corresponding reported device performance in the same way one would for an AI model's diagnostic accuracy. Instead, it refers to compliance with established standards for blood pressure cuffs.

• Acceptance Criteria (as implied by standards compliance):

  • Max. Leakage: < 4mm Hg/min (for both reusable and disposable cuffs, identical to predicate)
  • Biocompatibility: Compliance with ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization) for patient-contacting materials.
  • Non-Invasive Sphygmomanometers Performance: Compliance with ISO 81060-1 (Requirements and Test Methods for Non-Automated Measurement Type).

• Reported Device Performance:

  • Max. Leakage: Met the < 4mm Hg/min criteria (implied by "The test results demonstrated that the proposed device complies with the following standards").
  • Biocompatibility: Cytotoxicity, Sensitization, and Irritation tests were conducted and the device "Comply with ISO 10993-5; Comply with ISO 10993-10."
  • ISO 81060-1 Compliance: The device met "all design specifications as was Substantially Equivalent (SE) to the predicate device" and complied with ISO 81060-1. This standard outlines accuracy requirements for NIBP devices (e.g., mean difference and standard deviation of blood pressure measurements compared to a reference). While the specific numerical results (mean difference, standard deviation) are not provided in this summary, compliance with this standard indicates these performance metrics were met.

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

• Sample Size: The document does not specify human clinical trial sample sizes. The testing mentioned is primarily non-clinical (materials, leakage, mechanical). For ISO 81060-1, compliant NIBP devices typically undergo clinical validation with a certain number of subjects (e.g., ANSI/AAMI/ISO 81060-2 specifies requirements, often involving over 85 subjects for accuracy validation). However, this 510(k) summary likely relies on the predicate device's clinical validation and the subject device's adherence to relevant parts of the standard (ISO 81060-1, which focuses on non-automated devices and test methods, rather than the clinical validation part 2). The document notes "Non-clinical tests were conducted to verify that the proposed devices met all design specifications as was Substantially Equivalent".
• Data Provenance: Not specified. Based on the manufacturer and consultant location (Shenzhen, China), it's likely the non-clinical tests were conducted in China. The "retrospective or prospective" nature is not applicable here as no clinical trial data is presented.

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

• Not Applicable. This is not an AI/algorithm-driven device requiring expert adjudication for ground truth (e.g., radiologists reviewing images). The acceptance criteria relate to physical properties and compliance with medical device standards for blood pressure cuffs.

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

• Not Applicable. See point 3.

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 hardware medical device (blood pressure cuff), not an AI-driven diagnostic or assistive tool.

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

• Not Applicable. This is a hardware medical device.

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

• The "ground truth" for this device's performance is established by compliance with engineering and biocompatibility standards (e.g., ISO 81060-1 for performance, ISO 10993 for biocompatibility). For accuracy, the "ground truth" is typically a reference blood pressure measurement device.

8. The sample size for the training set

• Not Applicable. This device is not an AI/machine learning model and therefore does not have a "training set."

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

• Not Applicable. See point 8.

In summary, this 510(k) notification focuses on the manufacturing, physical characteristics, and material safety (biocompatibility) of blood pressure cuffs, demonstrating their substantial equivalence to a legally marketed predicate device by complying with relevant international standards. The criteria and studies are for a traditional medical device, not an AI-powered system that would involve clinical performance metrics and ground truth establishment involving human interpretation or large datasets.

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Reusable Temperature Probes:

Reusable Temperature Probes are intended to be used for monitoring temperature for multi- patient use. The temperature probes are reusable and designed for use with monitor of GE-Marquette Model DASH3000. These devices are used by qualified medical professionals only.

Disposable Temperature Probes:

Disposable Temperature Probes are intended to be used for monitoring temperature for single patient use. The temperature probes are non-sterile and designed for use with monitors of GE- Marquette Model DASH3000. These devices are used by qualified medical professionals only.

The proposed devices are used for patient temperature measurement. The probes are reusable or disposable depending on the model. These probes consist of a connector on the monitor end and a thermistor on the patient end. The working principle is resistance based on the metal conductor increasing with temperature decrease, and the linear changes to the characteristics of the temperature measurement. The proposed devices are designed to be used in a healthcare facility and compatible with a monitor, GE-Marquette Model DASH3000.

The six models have two types of structure designs corresponding to reusable and disposable use which consists of different materials. The Negative Temperature Coefficient (NTC) of the six models are identical. Reusable models ST1304, ST2304, ST3304, ST4304 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials. Disposable models ST5105A and ST6105A have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials.

The provided text describes the regulatory clearance of a medical device (Reusable and Disposable Temperature Probes) and its substantial equivalence to a predicate device, rather than a study designed to prove the device meets acceptance criteria through detailed performance metrics and a comparison to a defined ground truth.

Therefore, many of the requested details about acceptance criteria, specific study design elements (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, effect sizes, standalone performance, training set details) are not present in the provided document.

However, I can extract the following information that is available:

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

The document mentions compliance with standards which inherently include performance criteria. Specifically, the "Accuracy" is listed.

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

• Sample Size for Test Set: Not specified. The document states "Non-clinical testing has been conducted to verify that the subject devices meet all design specifications." The exact number of units or measurements in these tests is not provided.
• Data Provenance: The tests are non-clinical, conducted by the manufacturer, Shenzhen SINO-K Medical Technology Co., Ltd., which is based in Shenzhen, Guangdong, China. The testing confirms compliance with international standards (IEC, ISO, ASTM).

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

• Number of Experts: Not applicable/not specified. The testing described is non-clinical performance testing against established international standards, not expert evaluation of medical images or diagnostic outputs.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. This document describes objective performance testing against engineering standards, not a diagnostic study requiring expert adjudication.

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:

• MRMC Study: No. This device is a temperature probe, not an AI-assisted diagnostic tool.

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

• Standalone Performance: Yes, in the sense that the device's inherent performance (e.g., accuracy, measurement range) was demonstrated through non-clinical testing against standards (e.g., ISO 80601-2-56) without human interpretation of results beyond reading the device's output.

7. The type of ground truth used:

• Ground Truth Type: International standards (ISO 80601-2-56, IEC 60601-1, IEC 60601-1-2), and established biocompatibility standards (ISO 10993 series). These specify acceptable ranges and methodologies for determining performance, forming the "ground truth" for compliance.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This device is a hardware temperature probe, not a machine learning model that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

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