Search Results

The TL-101T, TL-120T and TL-121T SpO2 Probes are intended for use with Nihon Kohlen patient monitoring devices to measure the blood oxygen saturation of a patient based upon the amount of reflected or scattered light.

The TL-101T is a finger probe intended for use on adult patients heavier than 20 kg. The TL-120T is a multi-site probe intended for use on adults and infants heavier than 3 kg. The TL-121T is a foot probe intended for use on infants and neonates lighter than 3 kg.

The TL-101T. TL-120T and TL-121T SpO2 Probes are accessories for use with Nihon Kohden patient monitoring devices and are not individually classified. Common names for the devices include SpO2 probe, SpO2 sensor, pulse oximeter probe, pulse oximeter sensor, probe and sensor.

Nihon Kohden's TL-101T, TL-120T and TL-121T SpO2 Probes are used with Nihon Kohden patient monitoning devices to measure the blood oxygen saturation of a patient based upon the amount of reflected or scattered light.

The provided text describes SpO2 Probes and indicates that safety and performance testing procedures were conducted, which "verified that the device performed within specifications." However, the document does not explicitly define specific acceptance criteria (numerical thresholds for performance metrics) or provide detailed results from a study proving the device meets these criteria. It states that no performance standards or special controls were established at the time.

Therefore, much of the requested information cannot be extracted from the given text.

Here's a breakdown of what can and cannot be provided based on the input:

Acceptance Criteria and Study for Nihon Kohden TL-101T, TL-120T, and TL-121T SpO2 Probes

The provided 510(k) notification summary and FDA letter mention general safety and performance testing but do not detail specific acceptance criteria or the quantitative results of these tests relating to SpO2 measurement accuracy. The document states explicitly: "To date, no performance standards or special controls are known or established for this device as required by Section 514 of the Food, Drug and Cosmetic Act and implemented by 21 CFR Part 861."

Therefore, the following table and subsequent sections are largely based on the absence of detailed information in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only refers to successful biocompatibility testing with quantitative results for irritation, sensitization, and cytotoxicity, but these are not performance criteria for SpO2 measurement accuracy.

2. Sample Size and Data Provenance for Test Set

• Sample Size for Test Set: Not specified for the SpO2 performance testing.
• Data Provenance: Not specified. The document only mentions "safety and performance testing procedures." It does not indicate if this involved human subjects, animal models, or bench testing, nor does it provide country of origin or whether it was retrospective or prospective.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

• Not applicable as the nature of the "performance testing" for SpO2 measurement is not detailed, and no ground truth establishment by experts for such a test is mentioned.

4. Adjudication Method for Test Set

• Not applicable as the nature of the "performance testing" for SpO2 measurement is not detailed, and no adjudication method is mentioned.

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

• No MRMC comparative effectiveness study was mentioned or performed. This type of study (comparing human readers with and without AI assistance) is not relevant to a medical device like an SpO2 probe, which provides a direct physiological measurement rather than aiding human interpretation of diagnostic images.

6. Standalone Performance Study

• A standalone performance evaluation was implicitly done in the sense that the "safety and performance testing procedures" would assess the device's function directly. However, the document does not provide the specific metrics or results of this standalone performance. The wording "verified that the device performed within specifications" suggests such a study occurred, but without detailed findings.

7. Type of Ground Truth Used

• The document does not specify the type of ground truth used for the SpO2 performance testing. For SpO2 probes, ground truth is typically established through co-oximetry (blood gas analysis) under controlled desaturation studies. However, this is not detailed in the provided text.

8. Sample Size for Training Set

• Not applicable. SpO2 probes are typically developed through engineering and calibration processes based on physiological models and optical principles, not through machine learning models requiring a "training set" in the conventional sense.

9. How Ground Truth for Training Set Was Established

• Not applicable, as there is no mention of a training set for a machine learning model.

Ask a specific question about this device