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Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable or for single patient use and designed for use with Mindray monitor Model PM-8000 and other monitors compatible with YSI 400 series temperature probes.
These devices are used by qualified medical professional only.

The subject devices are used for patient temperature measurement. The probes are reusable or disposable depending on models. 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 increases with temperature decrease, and the linear changes to the characteristics of the temperature measurement. The subject devices are designed to be used in healthcare facilities like hospital and compatible with a monitor of Mindray Model PM-8000 and other monitors compatible with YSI 400 series temperature probes.

The six models have two types of structure designs corresponding to reusable and disposable use which consists of different materials. The NTC of the six models are identical. Reusable models T1306, T2306, T3306, T4306 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials. Disposable models T5106 and T6106 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials.

Model: T1306, Description: Skin contact Temperature Probe, adult, reusable
Model: T2306, Description: Body cavity Temperature Probe, Esophageal/Rectal, adult, reusable
Model: T3306, Description: Skin contact Temperature Probe, pediatric, reusable
Model: T4306, Description: Body cavity Temperature Probe, Esophageal/Rectal, pediatric, reusable
Model: T5106, Description: Skin contact Temperature Probe, adult/ pediatric, disposable
Model: T6106, Description: Body cavity Temperature Probe, Esophageal/Rectal, adult/ pediatric, disposable

The provided FDA 510(k) clearance letter describes a medical device, the Reusable and Disposable Temperature Probes, but does not include information about AI/ML performance. Therefore, I will respond to the prompt by extracting the acceptance criteria and study information pertinent to this medical device, which focuses on traditional medical device performance rather than AI/ML.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document presents "Accuracy" and "Measurement Range" as inherent characteristics of the device and states that bench testing was conducted to verify that design specifications were met, which implies these values are the acceptance criteria.

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

The document does not explicitly state the sample sizes used for the test sets (e.g., number of units tested, number of temperature measurements, or specific test configurations) for the bench testing or biocompatibility testing.

The document also does not provide information about the provenance of data in terms of country of origin or whether studies were retrospective or prospective. The testing described appears to be laboratory-based verification and validation.

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

This information is not applicable and not provided in the document. The device is a clinical electronic thermometer, and its performance is assessed against technical specifications and international standards, not against human expert interpretation of medical images or data. Ground truth for temperature measurement is typically established by reference standards or calibrated equipment.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective assessment (e.g., image interpretation by multiple readers), which is not relevant for the objective performance testing of a temperature probe.

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

No. An MRMC comparative effectiveness study was not conducted as this is a medical device for objective temperature measurement, not an AI-assisted diagnostic tool requiring human-in-the-loop performance evaluation. The document does not mention any AI assistance.

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

No. This device is an electronic temperature probe, not an algorithm or software. Its performance is inherent to its physical and electrical properties, evaluated through bench testing against established standards.

7. Type of Ground Truth Used

The ground truth for the performance evaluations (accuracy, measurement range, electrical safety, etc.) would be established by:

• Reference Standards/Calibrated Equipment: For accuracy and measurement range, the device's readings would be compared against highly accurate and calibrated reference thermometers in controlled temperature environments.
• International Standards: Compliance with electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and thermometer-specific performance (ISO 80601-2-56) serves as the ground truth for safety and performance.
• Laboratory Analysis: For biocompatibility, laboratory tests (cytotoxicity, sensitization, irritation) are conducted to assess the biological response to the device materials according to ISO 10993 standards.

8. Sample Size for the Training Set

This information is not applicable and not provided. This device is a hardware medical device with no mention of machine learning or algorithms that would require a "training set."

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

This information is not applicable. As there is no training set for an AI/ML algorithm involved, no ground truth was established for a training set.

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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 size. The cuff is not designed, sold, or intended for use except as indicated.

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. It is available in neonatal, infant, child and adult sizes. The subject device includes disposable blood pressure cuff and reusable blood pressure cuff and contains Cuff with/without bladder and single/dual tubes Air Hose.

The provided document is a 510(k) summary for a blood pressure cuff and does not contain detailed information about acceptance criteria, reported device performance for specific metrics, or any study proving such performance. The document explicitly states:

"No clinical study is included in this submission"

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because such information is not present in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device primarily through non-clinical data and compliance with voluntary standards for design specifications.

However, I can extract the information that is present:

8. Non-clinical data

• Performance testing: Non-clinical tests were conducted to verify that the proposed devices met all design specifications.
• Compliance with standards: The test results demonstrated that the proposed device complies with ISO 81060-1, Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type, First Edition 2007.

Based on this, here's what can be stated about the available information:

1. A table of acceptance criteria and the reported device performance: Not provided. The document mentions compliance with ISO 81060-1, which would contain performance requirements for non-automated sphygmomanometers (blood pressure cuffs). However, the specific acceptance criteria used for the device and the reported device performance against those criteria are not detailed.
2. Sample sized used for the test set and the data provenance: Not provided. The document only mentions "non-clinical tests" and "performance testing" but does not give details about 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: Not applicable, as no clinical study or expert-based ground truth establishment is mentioned. The testing focused on technical specifications and standards compliance.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. The document explicitly states "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a blood pressure cuff, which is a physical accessory, not an algorithm.
7. The type of ground truth used: Not applicable for performance evaluation as no clinical data or comparative performance study is provided. For demonstrating substantial equivalence, the ground truth indirectly relies on the established performance and safety of the predicate device and the standards.
8. The sample size for the training set: Not applicable. This is a non-AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is a non-AI/ML device.

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Medke Oximetry Finger 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 40kg,

The Medke Oximetry Finger Sensors are compatible sensor for use with major types of patient monitors and oximeter devices of Original Equipment Manufacturer (OEM). The sensors are made up of connector, cable, two specific wavelength LEDs & a photo detector assembled into the sensor housing. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The Medke Oximetry Finger Sensors contain finger clip type and soft tip type. The finger clip sensor is comprised of a plastic shell with silicone pads which position the optical components, and a cable with OEM compatible connector. The soft finger sensor consists of an integrated silicone rubber tip which is installed the optical components, and a cable with OEM compatible connector. The Medke Oximetry Finger Sensors have unique labeling and specifications designed for compatibility with Nellcor patient monitor(NPB40) cleared in K963707.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document states the predicate device has a SpO2 Accuracy of "±2%(70-100%)" and Pulse Rate Accuracy of "±2(30-250bpm)". While the Medke device reports RMS values (Arms), the conclusion states they "meets the requirements of ISO80601-2-61," implying these results fall within acceptable limits based on that standard, and are presented as meeting the predicate's performance or being substantially equivalent.

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

• Sample Size for Test Set (SpO2 Accuracy): 12 healthy adults were selected as subjects. Each subject provided 25 data samples, resulting in a total of 300 data pairs (SpO2 vs. SaO2).
• Data Provenance: The study involved an "invasive 'breathe-down' test" on "healthy adult volunteers." The location or country of origin for these volunteers is not explicitly stated, but the company is based in Shenzhen, China. The study appears to be prospective as it involves active testing on human subjects.
• Sample Size for Test Set (PR Accuracy): Not explicitly stated, but tested using a "simulator."

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

• Number of Experts: Not applicable. The ground truth for SpO2 accuracy was established through direct measurement of arterial blood SaO2 using a CO-Oximeter, which is a clinical reference method, not through expert interpretation of images or other subjective data.
• Qualifications of Experts: Not applicable for establishing ground truth as it was based on objective measurements.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The SpO2 accuracy was determined by comparing the device's SpO2 readings directly with SaO2 measured by a CO-Oximeter from arterial blood samples. There was no mention of multiple reviewers or adjudication of subjective data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This study focuses on device accuracy against a reference standard in controlled conditions, not on how human readers perform with or without AI assistance. The device is an oximetry sensor, not an AI diagnostic tool that assists human readers.

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

• Standalone Performance: Yes, in essence, the accuracy studies for both SpO2 and Pulse Rate represent the standalone performance of the device. The device's output (SpO2 and PR) was directly compared against established ground truth (CO-Oximeter for SpO2, simulator for PR). There is no "human-in-the-loop" interaction described that would affect the device's measurement performance for these parameters.

7. The Type of Ground Truth Used

• SpO2 Accuracy: The ground truth was outcomes data/physiological measurement (SaO2 measured directly from arterial blood samples using a CO-Oximeter). This is an objective, gold-standard method for determining true oxygen saturation.
• PR Accuracy: The ground truth was established by using a simulator with known pulse rates (30-250 BPM). This is also an objective, controlled method.

8. The Sample Size for the Training Set

• Training Set Sample Size: The document does not provide information about a "training set" or "training data." This type of device (oximetry sensor) is based on fundamental biophysical principles and calibrated during manufacturing. It does not typically involve machine learning or AI models that require a separate training dataset for algorithm development in the way a diagnostic AI would. The studies described are for verification/validation of the finished product's performance.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set for an AI/ML model for this device. The device's underlying measurement principles are well-established for pulse oximetry.

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