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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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