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This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult and pediatric (but not neonatal) patients. With the functions of real-time recording and displaying parameters, such as ECG, heart rate(HR), non-invasive blood pressure (NIBP), functional oxygen saturation (SpO2), respiration rate (RESP), body temperature (TEMP), end-tidal CO2 concentration (EtCO2), it allows comprehensive analysis of patient's physiological conditions.

This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.

This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult and pediatric (not neonatal) patients. With the functions of real-time recording and displaying parameters, such as ECG, pulse rate (PR), noninvasive blood pressure (NIBP), functional oxygen saturation (SpOz), respiration rate (RESP), body temperature (TEMP), end-tidal CO2 concentration (EtCO2), it allows comprehensive analysis of patient's physiological conditions.

This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.

There are three versions of the K serial Patient Monitor, K10, K12 and K15. The primary difference is physical dimension and display TFT size; all other specifications remain unchanged. All versions have the same indications for use.

This document, a 510(k) summary for the Shenzhen Creative Industry Co., Ltd. Patient Monitor, Models K10, K12, and K15, primarily focuses on demonstrating substantial equivalence to a predicate device (Shenzhen Creative Industry UP-7000 Patient Monitor, K123711) rather than detailing the specific acceptance criteria and study proving performance for a novel AI/software device.

Therefore, much of the requested information regarding AI device performance (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment for training) is not applicable or present in this document. This document describes a traditional medical device (patient monitor) and its components, and the "study" referred to is non-clinical and clinical testing to ensure compliance with relevant performance standards for vital sign monitoring.

However, I can extract the information that is applicable based on the provided text, particularly focusing on the performance criteria for the integrated vital sign modules.

Here's an analysis based on the provided text:

Device: Patient Monitor, Models K10, K12, K15

Indications for Use: Monitoring the vital physiological signs of adult and pediatric (but not neonatal) patients, including ECG, heart rate (HR), non-invasive blood pressure (NIBP), functional oxygen saturation (SpO2), respiration rate (RESP), body temperature (TEMP), and end-tidal CO2 concentration (EtCO2). Applicable for use in hospitals and clinical institutions, operation by qualified professionals only.

Study Type: This is a 510(k) submission seeking substantial equivalence to a predicate device. The "studies" involve non-clinical (safety and performance) and clinical (NIBP validation) testing against recognized standards rather than a comparative effectiveness study of a novel AI algorithm's diagnostic performance.

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

The document lists performance specifications for each physiological parameter module, often directly comparing them to the predicate device. The acceptance criteria are implicitly that the devices meet or are substantially equivalent to the established performance requirements of the predicate device and relevant industry standards.

Note: The document explicitly states for the NIBP and TEMP modules that "The new [module] used in subject devices complies with the same ISO [standard] and design requirement as Predicate device." This implies the acceptance criterion for these components is compliance with the cited ISO standards (e.g., ISO 80601-2-30 for NIBP, ISO 80601-2-56 for TEMP).

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

• Test Set Sample Size:
  • For NIBP (Non-invasive sphygmomanometers) clinical validation (ISO 81060-2), this standard typically requires a minimum of 85 subjects (adults and children combined) for a full validation. While the exact number isn't stated in the provided text, the reference to this specific standard implies adherence to its sample size requirements.
  • For other parameters (SpO2, CO2, ECG, RESP, TEMP), the "performance data" section refers to IEC/ISO standards (e.g., 60601-2-49, 80601-2-61, 80601-2-55, 60601-2-27, 80601-2-56). These standards define particular requirements for the performance of the devices and often involve bench testing, simulations, or phantom studies rather than large-scale human clinical trial "test sets" in the AI sense.
• Data Provenance: Not specified in the provided text (e.g., country of origin). The testing is referred to as "Non-Clinical Study" and "Clinical Study" without detail on whether retrospective or prospective data was used, except for the NIBP clinical validation which would be prospective.

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

• Not Applicable in the AI/Software Sense: This document describes a traditional patient monitor. The "ground truth" for a patient monitor's vital sign measurements is established against recognized reference measurement methods or calibrated instruments (e.g., a known SpO2 reading from a CO-oximeter, a calibrated pressure sensor for NIBP, or a physiological simulator for ECG).
• For NIBP (ISO 81060-2): This standard for clinical validation of automated sphygmomanometers typically requires measurements to be taken by trained observers (not necessarily "experts" in the diagnostic sense, but highly skilled in manual auscultatory measurements) and compared against a reference standard. The number of observers is also specified in the standard (e.g., at least 3 observers taking sequential measurements). Their "qualification" would be their training and demonstrated proficiency in the reference method.

4. Adjudication method for the test set:

• Not Applicable in the AI/Software Sense: There is no "adjudication" of expert interpretations as seen in AI studies, as the device measures physiological parameters directly.
• For NIBP (ISO 81060-2): The standard defines specific statistical methods for comparing the device's measurements to the reference measurements, often involving Bland-Altman analysis and calculating mean difference and standard deviation. There's no "adjudication" in the sense of resolving conflicting human interpretations; rather, it's a statistical comparison to a pre-defined reference.

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 patient monitor, not an AI diagnostic imaging tool or a system that assists human "readers" with interpretation. Therefore, no MRMC study was performed or is relevant to this submission.

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

• Not Applicable in the AI/Software Sense: The described device functions as a standalone vital sign monitor. Its "performance" is inherently "algorithm only" in that its internal processing generates the vital sign values. However, this is not an "AI algorithm" in the context of complex pattern recognition or decision support. The performance is assessed by comparing its output against reference standards, which is a form of standalone evaluation for a monitor.

7. The type of ground truth used:

The ground truth for the performance evaluations of this patient monitor would be derived from:

• Reference Measurements/Calibrated Standards:

  • Physiological Simulators: For ECG, RESP, and potentially SpO2 and NIBP, to generate known, controlled physiological signals.
  • Calibrated Instruments: For SpO2 (e.g., CO-oximeter), CO2 (calibrated gas mixtures), NIBP (auscultatory measurements by trained observers or calibrated pressure transducers), and Temperature (calibrated thermometers).
  • In-vitro/Bench Testing: As implied by adherence to IEC/ISO performance standards, which often dictate specific test setups and reference instruments.

• Clinical Data (for NIBP): As per ISO 81060-2, the ground truth for NIBP accuracy relies on trained human observers taking simultaneous or sequential auscultatory blood pressure measurements (the "reference method").

8. The sample size for the training set:

• Not Applicable: This device is a traditional patient monitor, not an AI/machine learning device that requires a "training set" in the context of deep learning models. Its algorithms are based on established physiological signal processing principles.

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

• Not Applicable: As stated above, there is no "training set" for this type of device. The ground truth for its performance verification (as opposed to AI training) is established using validated, calibrated reference standards and methods as described in point 7.

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Shenzhen Med-link Cable / lead-wire are intended to be used with ECG, EKG, SpO2 and Invasive Blood Pressure monitoring devices. The Cable / lead-wire are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by heath care professional.

Med-link Cable / Lead-wire with specific various lengths are the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) and other third party after market manufacturers for their respective monitors. These cables consist of connectors on each cable end and a shielded bulk cable. The cables are used to transfer the signals from the electrodes to the patient monitor. The Med-link cables use the same type of constructions and have the same technological characteristics as the predicate devices. They use a medical grade PVC and TPU cable jacket with medical grade PVC and ABS over molded connectors with integral relief.

Here's the analysis of the provided text regarding acceptance criteria and the supporting study for the medical device:

Device: Cable / lead-wire (ECG, EKG, SpO2 and Invasive Blood Pressure) manufactured by Shenzhen Med-link Electronics Tech Co., Ltd.

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to predicate devices through various safety and performance standards. The acceptance criteria are defined by compliance with these standards, and the reported performance confirms this compliance.

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the test set. It states that "Med-Link Cable / Lead-wire" were tested according to various standards and "Performance Bench testing was conducted on the Shenzhen Med-link cable / lead-wire according with established protocols." This implies testing of a representative number of cable/lead-wire units to ensure compliance with each standard.
• Data Provenance: The data is internally generated by the manufacturer (Shenzhen Med-link Electronics Tech Co., Ltd.) through "Performance Bench testing." No information about the country of origin of the data itself (beyond the manufacturer's location in China) or whether it's retrospective or prospective is explicitly stated. However, given it's bench testing for a premarket submission, it would be prospective data generated for the purpose of demonstrating compliance.

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

This section is not applicable to this submission. The "ground truth" here is defined by compliance with established international and national medical device standards (ISO, IEC, ANSI/AAMI, FDA regulations). The testing involves objective measurements against these predefined criteria, not subjective expert judgment that would require establishing a ground truth via consensus.

4. Adjudication Method for the Test Set

This section is not applicable. As the testing involves objective measurements against predefined standards, there is no need for an adjudication method by experts. The results are either compliant or non-compliant with the specified technical requirements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, often with and without AI assistance. This submission describes an ECG/EKG/SpO2/IBP cable and lead-wire device, which does not involve human interpretation of diagnostic images or AI assistance in that context.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This section is not applicable. The device is a passive accessory (cable/lead-wire) for monitoring devices, not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance does not apply. The tests performed (biocompatibility, electrical safety, bench testing) assess the device's inherent physical and electrical properties.

7. The Type of Ground Truth Used

The "ground truth" used for this device is compliance with established international and national medical device standards and regulations. These include:

• ISO 10993-5:1999 (Cytotoxicity)
• ISO 10993-10:2002/Amd1:2006 (Irritation & Delayed-Type Hypersensitivity)
• IEC 60601-1:1998; Am1; A2:1995 (Medical electrical equipment - General requirements for safety)
• ANSI/AAMI EC53:1995/(R) 2001 (ECG cables and leadwires)
• FDA 21CFR Part 898 Final rule
• DIN 42-802 (for specific interconnection requirements)

These standards define the objective performance and safety benchmarks that the device must meet.

8. The Sample Size for the Training Set

This section is not applicable. The device is a hardware component (cable/lead-wire), not an AI/ML algorithm that requires a "training set."

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

This section is not applicable for the same reason as point 8.

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