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The device is intended to be used with ECG. The lead wire is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional.

The device is used to transmit ECG signals from electrodes which are affixed to the patient's body for both diagnostic and monitoring purposes. Each lead wire is attached to ECG patient electrodes. The lead wire connector plugs into one end of the trunk cable which are plug into an ECG monitor. The proposed devices are available in disposable and reusable two types.

The provided text is a 510(k) summary for Patient Cables and Leadwires, Disposable ECG Leadwires. It focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and does not include a study proving that the device meets specific performance acceptance criteria in the context of a clinical or standalone effectiveness study.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not applicable based on the provided document.

Here's a breakdown of what can be extracted and what cannot:

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

The document does not present explicit performance acceptance criteria in the format typically used for studies evaluating a device's diagnostic or monitoring accuracy against a specific metric. Instead, it refers to compliance with safety and performance standards for non-clinical aspects.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. The document describes non-clinical tests (biocompatibility, electrical safety, functional performance) on the device itself or its materials, not studies with a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. There is no test set or ground truth established by medical experts for evaluating clinical performance.

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

Not applicable. No test set requiring expert adjudication is mentioned.

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 an ECG leadwire, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.

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

Not applicable. This device is an ECG leadwire, which facilitates signal transmission, not an algorithm.

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

Not applicable. For the non-clinical tests, the "ground truth" is defined by the requirements of the standards (e.g., cytotoxicity assays, electrical safety measurements, material property tests).

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device requiring a training set.

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

Not applicable. This is not an AI/algorithm-based device requiring a training set.

Summary of the Study (as described in the document):

The "study" described in this 510(k) summary consists of non-clinical tests performed to verify that the proposed device (Patient Cables and Leadwires, Disposable ECG Leadwires) meets design specifications and is substantially equivalent to a predicate device (K120010).

• Type of Study: Non-clinical bench testing.
• Purpose: To demonstrate compliance with recognized industry standards for biocompatibility (ISO 10993 series), electrical safety (IEC 60601-1), and functional performance of ECG leadwires (ANSI/AAMI EC53).
• Conclusion: "The test results demonstrated that the proposed device complies with the following standards." and "No clinical study is included in this submission."
• General conclusion: Based on these non-clinical tests, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.

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Orantech Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Philips Model MP30 and Nihon Kohden Model BSM-6301A. These devices are indicated for used by qualified medical personnel only.

Reusable temperature probes are used during patient temperature measurement for multi-patient use. These probes consist of a phone plug connector on the monitor end and a thermistor on the patient end. Temperature probes measure temperature by a resistor that is sensitive to temperature changes. These probes are connected to the patient monitor either directly by using a phono plug or by an interconnect cable. These probes have a skin or core contact with a patient.

These temperature probes are typically used with legacy Philips monitor model MP30 and Nihon Kohden monitor model BSM-6301A.

The medical device in question is the Orantech Inc. Temperature Probe, models TS-Y400-AG30, TS-Y400-AS30, TS-PH-AG30, and TS-PH-AS30.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Accuracy: The 'Product Specification' table explicitly states an accuracy of "± 0.1°C" for all models within the 25-45°C range. The "Laboratory accuracy" test result states "Not greater than 0.3°C", which is a broader allowance than the stated ± 0.1°C. Assuming the ± 0.1°C is the target, 'Not greater than 0.3°C' still indicates compliance.

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

The provided document does not specify the sample size used for the test set for any of the performance studies (biocompatibility, safety, accuracy, time response, use life, cleaning/disinfection).

The document does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective). The testing was conducted by or for Orantech Inc., which is based in China.

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

This information is not provided in the document. The type of device (temperature probe) and the nature of the tests (laboratory accuracy, electrical safety, biocompatibility) typically do not involve establishing ground truth through human experts in the same way, for example, an AI diagnostic imaging device would. The "ground truth" for these tests would be derived from calibrated equipment and established scientific methods, rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies in ground truth establishment. For the types of tests conducted for a temperature probe, such methods are not relevant.

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

There was no MRMC comparative effectiveness study done. This type of study is relevant for AI-powered diagnostic devices that assist human readers (e.g., radiologists interpreting images). The Orantech Temperature Probe is a physical medical device for direct measurement, not an AI software.

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

This concept is not applicable to the Orantech Temperature Probe. It is a physical device, not an algorithm. The performance tests (laboratory accuracy, time response, etc.) represent its "standalone" performance in a controlled environment, but it's not an algorithm whose performance can be evaluated independently of human interaction in the clinical use context that AI devices are.

7. The Type of Ground Truth Used

The ground truth for the various tests was established through:

• Biocompatibility: Adherence to established international standards (ISO 10993 series) using laboratory testing for cytotoxicity, sensitization, and irritation. The "ground truth" is the scientific determination of biological response to the materials.
• Safety: Compliance with electrical safety standard (IEC 60601-1) through testing. The "ground truth" is the objective measurement of electrical parameters against the standard's limits.
• Performance (Laboratory Accuracy, Time Response, Use Life): Measurement against calibrated reference instruments and established performance criteria defined by medical device standards or internal specifications. For accuracy, the "ground truth" is the actual temperature measured by a highly accurate reference thermometer.
• Cleaning and Disinfection: Validation against AAMI TIR documents and FDA guidance, likely involving microbiological testing to confirm the reduction/elimination of pathogens. The "ground truth" is the demonstrably effective reduction of microbial load.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical temperature probe and not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the same reason as above (not an AI/ML algorithm).

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The Disposable and Reusable SPO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40 kg at hospital facilities.

The proposed device, Disposable and Reusable SpO2 Sensors are accessories to the oximeters, which are intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive with U.S. legally marketed oximeters or patient monitors. The SSD-001-W09AN sensors is disposable while the SS-010-AF10 and SS-018-AF10 sensors are reusable. They are only intended for adult.

The sensor shall be connected with its corresponding monitor. Oxygenation of blood is measured by detecting the infrared and red light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin, which consists of a probe attached to the patient's finger. The sensor is connected to a data acquisition system which is used to calculate and display oxygen saturation levels and heart rate conditions.

Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. Red and infrared light lit alternately according to certain sequence, when the fingertips of capillary repeatedly with the heart pumps blood congestion, light emitting diode after blood vessels and projected onto a photodiode, photodiode can be induced to change with pulse light intensity, the electrical signals in the form of change. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. By measuring the wave crest of the pulse wave and the absorbance of the trough, SpO2 is calculated to obtain the correct oxygen saturation value. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).

Here's an analysis of the provided information regarding the acceptance criteria and study for the Disposable SpO2 Sensors and Reusable SpO2 Sensors:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states the acceptance criteria for SpO2 and Pulse Rate (PR) accuracy, and it reports that the device meets these requirements.

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

• Sample Size: 12 human adult volunteers were used for each clinical study (there were two studies). This means a total of 24 human adult volunteers were used for the two studies combined.
• Data Provenance: The studies were described as "Clinical hypoxia test results obtained in human adult volunteers." The document doesn't specify the country of origin, but it implies a prospective clinical study using induced hypoxia.

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

The document does not specify the number of experts or their qualifications for establishing the ground truth. It only states that the ground truth for arterial oxygen saturation (SaO2) was "determined by co-oximetry."

4. Adjudication Method for the Test Set

The document does not provide details on any adjudication method used for the test set.

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 device is a sensor, and the clinical study focuses on its accuracy against a gold standard (co-oximetry) rather than a comparison of human reader performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the accuracy tests described are effectively a standalone performance evaluation of the device. The device itself (sensor and its internal algorithms for calculating SpO2 and PR) is directly compared against the ground truth (co-oximetry) measurements. There's no human 'reading' or interpretation of the sensor's output being evaluated in this context, other than potentially reading the numerical display that the device provides.

7. The Type of Ground Truth Used

The ground truth used was arterial oxygen saturation (SaO2) as determined by co-oximetry. This is a recognized gold standard for measuring oxygen saturation in blood.

8. The Sample Size for the Training Set

The document does not mention the sample size for any training set. Given that this is a sensor (hardware with embedded algorithms) rather than a software-as-a-medical-device (SaMD) based on AI/Machine Learning that typically requires extensive re-training, it's possible that a distinct "training set" as understood in deep learning contexts was not highly relevant or explicitly documented. The development process likely involved calibration and verification, which might use internal datasets not explicitly labeled as "training."

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

Since a "training set" is not explicitly mentioned, the method for establishing its ground truth is also not provided.

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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 device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped 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 reusable NIBP cuff has 9 models with different size for different population with different arm size.

This document is a 510(k) summary for a Reusable NIBP Cuff, not an AI/ML medical device submission. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and study details for an AI-powered device.

The document discusses the substantial equivalence of the Reusable NIBP Cuff to an existing predicate device based on:

• Intended use and Indications for Use: An accessory for non-invasive blood pressure measurement systems, non-sterile, reusable, available in various sizes.
• Technical specifications: Material, tube number, limb circumference range, repeated inflation limits, pressure limits, sterility, biocompatibility.
• Performance Data: Non-clinical tests according to ISO 81060-1 (Non-Invasive Sphygmomanometers), ISO 10993-5 (In Vitro cytotoxicity), and ISO 10993-10 (irritation and skin sensitization).
• Clinical test: Explicitly stated as "not required" for this device.

None of the requested information regarding AI/ML device performance, acceptance criteria, sample sizes for AI model testing, expert consensus, MRMC studies, or ground truth establishment for AI is present in this regulatory submission for a physical medical device.

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The intended use of the ETCO2 sensor is to provide carbon dioxide monitoring to a host monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.

The ETCO2 Sensor is comprised of three main components, a sensor with photo detector and light emitter, cable and connector, The CO2 Sensor incorporates an infrared light source, of specified wavelength, and an infrared detector. The photo detector and light emitter end of the CO2 sensor is connected to an airway adapter. The airway adapter is connected between the patient airway and the respirator. As the patient completes an expiratory breath the sensor measures the CO2 levels in the expiratory breath and sends that data to the compatible CO2 monitor. The monitor then reads the data and converts the data so it can be displayed on screen.

This document is a 510(k) premarket notification for an ETCO2 Sensor (Model CTM-RP01), not a study report detailing specific acceptance criteria and performance of an AI/ML device. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) is not present in this document.

The document focuses on demonstrating substantial equivalence to a predicate device (Capnostat 5 CO2 sensor, K042601) based on similar technological characteristics and performance specifications for a carbon dioxide gas analyzer.

Here's what can be extracted and what is not available based on the provided text:

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

The document provides the performance specifications of the subject device (ETCO2 Sensor, Model CTM-RP01) and compares them to the predicate device. These specifications serve as de facto "acceptance criteria" through the lens of substantial equivalence.

The following information is NOT available in the provided text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document states "Non-clinical test data" were used, including compliance with industry standards. It does not specify a "test set" in the context of data for an AI/ML device, nor does it provide sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable, as this is a medical device (sensor) and not an AI/ML diagnostic or predictive algorithm based on expert-labeled data. The performance criteria are met through physical measurements and engineering validation.

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

• Not applicable for this type of device and 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

• No, an MRMC study was not done. This device is a sensor performing direct measurements, not an AI assisting human readers.

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

• The device's performance is inherently standalone in its measurement function, but it's a sensor, not an "algorithm only" device in the AI sense. Its output is displayed by a compatible monitor.

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

• The "ground truth" for this device would be established by reference gas standards and engineering measurement techniques for CO2 concentration, flow rates, and timing. The document references compliance with ISO 80601-2-55 (Respiratory gas monitors) which would outline such testing methods.

8. The sample size for the training set

• Not applicable. This is a hardware sensor, not an AI/ML model that requires a training set.

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

• Not applicable.

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