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TS-F-D
The Finger Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range > 20 kg (> 44 pounds)

TS-E-D
The Ear Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. The headband is single-patient use. Patient weight range > 10 kg (> 22 pounds)

TS-W-D
The Wrap Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. The tape and foam wrap are single-patient use. Patient weight range > 3 kg (> 6.6 pounds)

TS-SE-3
The Sensitive Skin Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. The tape and foam wrap are singlepatient use. Patient weight range All patients

TS-AF-10 and TS-AF-25
The AllFit Sensor is a single-patient use adhesive sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range All patients

Trusignal SpO2 Interconnect cables
The Interconnect Cable is a reusable cable intended for use for all patients for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring when used with a compatible SpO2 sensor.

Pulse oximeter sensors and interconnect cables connecting to patient monitors

Here's a breakdown of the acceptance criteria and the study details for the TruSignal® SpO2 Sensors and Interconnect Cables, based on the provided 510(k) summary:

1. Acceptance Criteria and Device Performance

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Intended use & Indication for use for tympanic probes (REF M1024233 and M1024237):

The Tympanic Temperature Probe is intended for atraumatic placement in proximity of the tympanic membrane.

The temperature probes are designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. Please consult your monitoring system manual for information specific to the temperature probe usage.

The device is indicated for use by qualified medical personnel only

Disposable tympanic temperature probes are used during patient temperature measurement from the outer auditory canal. These probes are assu auring patient temperature from the adapter cable end and a thermistor on the patient end. These probes are to be used with 400-series compatible temperature measurement systems only. The temperature probe measures temparature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor by a using an interconnect cable. These strobes have skin contact with a patient. Probes are shipped in non-sterile condition and there is a shelf life declared for each manufacturing batch. These temperature probes can be used with legacy GE Medical System monitors like Dash 300/4000 (K033304), Solar (K012467), TRAM (K900540) and also with the new GE Healthcare S/3 modules like M-PRESTN (K041772) and also with legacy Datex-Ohmeda patient monitors and modules like Cardiocap 5 (K992323), Light (K981378) or M-ESTPR (K953175). Products are packed inside a cardboard box having 25 pcs of individually packed probes (inside a plantics are pouch) in non-sterile condition. The package label describes product REF codes, manufacturing date, shelf life, CE-mark, legal entity information and a caution "Rx Only (USA), U.S. Federal law restricts this device to sale by or on the order of a physician.". There is one instruction for use insert in the sales package of 25 probes.

The provided text is a 510(k) Premarket Notification for a Tympanic Temperature Probe. It details the device's description, intended use, and comparison to a predicate device. However, it does not include information about specific acceptance criteria or an analytical or comparative study proving the device meets those criteria.

The submission focuses on proving substantial equivalence to a predicate device (DeRoyal temperature probes K925792) based on similarities in:

• Intended use and shelf life
• Mechanical design (colors, dimensions, materials, manufacturing processes)
• Thermistor and functional performance
• Sterilization process

The document states: "Tympanic Temperature Probe with foam (M1024233) and Tympanic Temperature Probe w/o foam (M1024237) have been assessed against the standards below. The devices have been thoroughly tested through validation and verification of specifications."

However, it only lists the standards against which it was assessed (e.g., IEC 60601-1, IEC 60601-2-49, 21 CFR Part 898, ISO 15223, EN 980+A1+A2, ISO 10993-x, ISO 14971:2000) rather than providing the performance data or specific acceptance criteria and results from the "validation and verification of specifications."

Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based solely on the provided text.

Based on the provided text, the following information is available (or not available):

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

• Not provided. The document states testing was done against standards and specifications were validated/verified, but no specific performance metrics or acceptance criteria are listed.

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

• Not provided. The document does not detail any specific test sets or sample sizes used for performance validation.

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

• Not applicable / Not provided. No ground truth establishment is described for a test set in the context of performance metrics.

4. Adjudication method for the test set:

• Not applicable / Not provided. No details on test set adjudication are present.

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 temperature probe, not an AI diagnostic tool. No MRMC study or AI assistance is mentioned.

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

• Not applicable. This device does not involve an algorithm separate from human input in the way a diagnostic AI would.

7. The type of ground truth used:

• Not applicable / Not provided in the context of performance. The "ground truth" for a temperature probe's performance would typically be established against reference temperature standards, but these details are not discussed.

8. The sample size for the training set:

• Not applicable. This device is a hardware component (a probe), not a machine learning algorithm that requires a training set.

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

• Not applicable. (See point 8).

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Foley catheters with temperature probe (REF M1024239, M1024242 and M1024244):

The Foley Catheter with Temperature Probe is intended for continuous temperature monitoring of patients who are catheterized because of fluid management problems, evaluation of urinary output, urine clearance following surgery or trauma involving pelvic organs, or obstruction or paralysis. Maximum indwelling: 29 days.

The temperature probes are designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. Please consult your monitoring system manual for information specific to temperature probes usage. The device is indicated for use by qualified medical personnel only.

Disposable Foley catheters with temperature probe are used for drainage of the urinary bladder and simultaneous patient temperature measurement. These Foley catheters with temperature probe consist of the "Molex" plug connector on the adapter cable end, urine output flow path with a balloon and a thermistor inside the catheter. These probes are to be used with 400-series compatible temperature measurement systems only. The temperature probe measures temperature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor by using an interconnect cable. These catheters have a skin and core contact with a patient. Catheters are shipped in sterile condition and there is a shelf life declared for each manufacturing batch. These Foley catheters with temperature probe can be used with legacy GE Medical System monitors like Dash 3000/4000 (K033304), Solar (K012467), TRAM (K900540) and also with the new GE Healthcare S/5 modules like M-PRESTN (K041772) and also with legacy Datex-Ohmeda patient monitors and modules like Cardiocap 5 (K992323), Light (K981378) or M-ESTPR (K953175). Products are packed inside a cardboard box having 25 pcs of individually packed products (inside a plastic/ paper pouch) in sterile condition. The package label describes product REF codes, manufacturing date, shelf life, CE-mark, legal entity information and a caution "Rx Only (USA). U.S. Federal law restricts this device to sale by or on the order of a physician." There is one instruction for use insert in the sales package of 25 probes.

The provided document is a 510(k) Premarket Notification for Foley catheters with temperature probes. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or accuracy for a diagnostic AI device.

Therefore, many of the requested sections (Table of acceptance criteria, Sample size for test set, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, ground truth type, training set sample size, how training ground truth was established) are not applicable or not provided in this type of submission.

This submission is for a physical medical device (catheter with a temperature sensor), not an AI/ML-driven diagnostic or prognostic device that would typically involve the detailed performance studies you're asking about. The "study" mentioned here refers to verification and validation activities against recognized standards to ensure the device performs as intended and is safe.

Here's what can be extracted and inferred from the document based on the context of a 510(k) submission for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific performance acceptance criteria (like diagnostic accuracy, sensitivity, specificity) with reported device performance for an AI/ML system. Instead, for this device, "acceptance criteria" are related to compliance with recognized standards and demonstrating substantial equivalence.

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

This document does not describe a "test set" in the context of an AI/ML model for diagnostic performance. The "testing" refers to verification and validation activities conducted on the physical device to ensure compliance with standards and specifications. Therefore, sample sizes and data provenance (country, retrospective/prospective) are not applicable in the AI/ML sense but would refer to engineering test samples and bench testing.

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

Not applicable. This pertains to an AI/ML diagnostic device, not a physical temperature-sensing Foley catheter. The "ground truth" here would be established by reference temperature measurement standards and calibrated equipment during engineering verification.

4. Adjudication method for the test set

Not applicable. As above, this is for AI/ML diagnostic performance 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

Not applicable. This device is a physical catheter with a temperature sensor, not an AI/ML system that directly assists human readers/diagnosticians.

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

Not applicable. This device is a physical catheter, not an algorithm. Its "standalone" performance would be measured as part of its physical and electrical testing (e.g., temperature accuracy, material integrity).

7. The type of ground truth used

For the temperature sensing function, the "ground truth" for proving accuracy would be established using calibrated reference thermometers and temperature control baths. For the catheter's physical properties, the ground truth would be established through material specifications, mechanical testing standards, and biological compatibility testing protocols.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device.

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GP probes (REF M1024231 and M1024229): The General Purpose Temperature Probe is intended for continuous temperature monitoring. The probe is inserted into the esophagus or the rectum. It is sterile and individually packaged. It has a low-friction surface finish to make the insertion easier. The temperature probe beneath the cuff at the distal tip is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes.The device is indicated for use by qualified medical personnel only.

Skin probe (REF M1024222): The Skin Temperature Probe is intended for monitoring the skin surface temperature. It is sterile and individually packaged. There is a temperature sensor affixed to the center of the foam naterial on the adhesive cover. The disk-shaped adhesive cover has a reflective backing and a hypo-allergenic adhesive which follows closely the contour of the skin. The skin temperature probe is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Scries temperature probes. The device is indicated for use by qualified medical personnel only.

Esophageal probes (REF M1024205, M1024212, M1024215 and M1024218): The Esophageal Stethoscope with Temperature Probe is to be used for monitoring temperature, heart, and respiratory sounds on an anesthetized patient. The stethoscope tube is inserted into the esophagus. The probe is sterile, individually packaged and connes in different sizes. It has a low-friction surface finish to make the insertion easier, and a thin cuff to enhance sound transmission and fidelity. The stethoscope has a male luer fitting for attachment to a standard ear piece. The temperature probe, beneath the cuff at the distal tip, is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.

Disposable temperature probes (Table below) are used during patient temperature measurement. These probes consist of the "Molex" plug connector on the adapter cable end and a thermistor on the patient end. These probes are to be used with 400-series compatible temperature measurement systems only. Esophageal stethoscopes with temperature probes have a dual role, in addition to temperature probe they can be used also as a stethoscope. The temperature probe measures temperature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor by using an interconnect cable. These probes have skin or core contact with a patient. Probes are shipped in sterile condition and there is a shelf life declared for each manufacturing batch.

The provided text describes disposable temperature probes and does not contain information about an AI/ML powered medical device. Therefore, it is not possible to describe acceptance criteria, a study proving the device meets the criteria, or any other related information for an AI/ML device.

The document discusses the regulatory submission (510(k)) for various types of disposable temperature probes (skin, general purpose, and esophageal with stethoscopes). The core of the submission focuses on the substantial equivalence of these probes to previously marketed predicate devices.

Key points from the document regarding the physical probes:

• Acceptance Criteria for the physical device: While specific numerical acceptance criteria for performance (e.g., temperature accuracy limits) are not explicitly detailed in the provided summary, the document states that the devices have been "thoroughly tested through validation and verification of specifications" against several standards. These standards implicitly define the performance acceptance criteria.
  • Relevant standards mentioned:
    • IEC 60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995 (Part 1: General requirements for safety)
    • IEC 60601-2-49:2001 (Part 2:-49: Particular requirements for the safety of multifunction patient monitoring equipment)
    • EN 12470-4, Performance of Electrical Thermometers (This standard would contain specific performance criteria for electrical thermometers, including accuracy).
    • 21 CFR Part 898 (Likely pertains to performance standards for clinical electronic thermometers)
    • ISO 15223:2000, EN 980+A1+A2 (Labeling and symbols)
    • ISO 10993-x (Biological evaluation/biocompatibility)
    • ISO 14971:2000 (Risk management)
    • 510(k) Sterility Review Guidance K90-1 (Sterility)
• Study Proving Acceptance Criteria: The document states that "The disposable temperature probes... have been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications." This indicates that studies (validation and verification testing) were performed to confirm compliance with the aforementioned standards. However, the details of these studies (e.g., sample sizes, specific test protocols, precise results against numerical thresholds) are not provided in this summary.
• Data Provenance/Sample Size/Experts/Adjudication/MRMC/Standalone/Ground Truth/Training Set: These questions are not applicable to the provided document, as it describes a physical medical device (temperature probes) and not an AI/ML software. The document focuses on the hardware's compliance with established safety and performance standards.

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