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IT Dr. Gambert's reusable medical SpO2 sensors, the FS and PS "silc touch" Series and FC, FP and Y Series, are intended to non-invasively measure the pulse frequency and functional oxygen saturation of arterial hemoglobin (SpO2) when used in conjunction with the BCI Advisor, Datex Ohmeda TuffSat, HP Philips M3, Nellcor NPB-40 and Novametrix 512 pulse oximeters. The sensors are to be used in accordance with the recommendations and specifications of the oximeter manufacturer.

IT Dr. Gambert's reusable SpO2 sensors are produced in several configurations as after market replacements for use with a wide variety of commercially available pulse oximeters. They are substantially equivalent (identical) to the listed predicate devices and all other SpO2 sensors currently cleared for marketing in the United States.

Acceptance Criteria and Device Performance Study for SpO2 Sensors (K062149)

The SpO2 Sensors (FS, PS "silc-touch" Series, and FC, FP, Y Series) from IT Dr. Gambert GmbH are intended to non-invasively measure pulse frequency and functional oxygen saturation of arterial hemoglobin (SpO2). The device's performance was established via substantial equivalence to a predicate device, Beta Biomed Services, Inc. K011518.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the performance specifications of the predicate device, which the IT Dr. Gambert sensors are claimed to be "substantially equivalent" to (identical).

Note: The application explicitly states that the IT Dr. Gambert SpO2 sensors are "substantially equivalent (identical)" to the listed predicate devices and other cleared SpO2 sensors, and that "Sensor types differ only in body shape and connection. They are otherwise identical and are treated the same for technical comparison." This implies that the reported performance for the IT Dr. Gambert devices is identical to the established performance of the predicate device.

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

The provided 510(k) summary does not describe a specific clinical test set for the IT Dr. Gambert SpO2 sensors. The device's performance claims are based on substantial equivalence to a predicate device (Beta Biomed Services, Inc. K011518). The summary states, "IT Dr. Gambert's re-usable SpO2 sensors are substantially equivalent to the listed predicate devices in terms of materials, performance, construction and operating principles. They have been tested, and according to EC-Council Directive 93/42/EEC, have been found to be safe and effective when used in conjunction with manufacturer's recommendations."

This suggests that the "testing" refers to meeting general safety and effectiveness standards under the EC-Council Directive, rather than a specific clinical study for this 510(k) application. Therefore, there is no disclosed data provenance or sample size for a test set in the context of this submission.

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

Not applicable, as no described clinical test set for the IT Dr. Gambert device is provided in this 510(k) summary. The ground truth for the device's performance is implicitly established by the performance characteristics of the predicate device, which is already a legally marketed device.

4. Adjudication Method for the Test Set

Not applicable, as no described clinical test set for the IT Dr. Gambert device is provided in this 510(k) summary.

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

No, an MRMC comparative effectiveness study was not performed or described in this 510(k) summary. The submission relies on substantial equivalence.

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

The device is a hardware sensor. The concept of an "algorithm only" or "standalone" performance study as typically applied to AI software would not be relevant in this context. The performance is intrinsically linked to the physical sensor and its interaction with a pulse oximeter.

7. The Type of Ground Truth Used

For the purpose of this 510(k), the ground truth is established by the performance specifications of the legally marketed predicate device (Beta Biomed Services, Inc. K011518). The SpO2 sensors themselves measure physiological data (oxygen saturation and pulse rate), where the "ground truth" for the measurement is the true physiological state, which is then compared against the device's output. However, the submission does not detail experimental protocols that establish this ground truth for the particular sensors. Instead, it relies on their "identical" technical comparison to the predicate device.

8. The Sample Size for the Training Set

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

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

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

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