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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.

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The BSM-1101 and BSM-1102 Pattern Monitors are intended for medical purposes to measure the heart rate from a signal produced by an electrocardiograph. The devices sound an alarm when the heart rate falls outside preset upper and lower limits. The devices include an oximeter used to transmit radiation at a known wavelength through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. The devices include a noninvasive blood pressure measurement system that provides a signal from which systolic, diastolic, and mean pressures can be derived through the use of pressure cuffs placed on the arm, leg or finger. The devices may be used as a radio frequency physiological signal transmitter to condition physiological signals so that they can be transmitted via radio frequency from one location to another, e.g. a central monitoring station.

Common names for the BSM-1102 include Patient Monitor, Portable Monitor, Transport Monitor, Cardiac Monitor and Bedside Monitor. Nihon Kohden's BSM-1101 and BSM-1102 Patient Monitors are intended for medical purposes to measure the heart rate from a signal produced by an electrocardiograph. These devices sound an alam when the heart rate falls outside oreset upper and lower limits. The devices include an oximeter used to transmit radiation at a known wavelenath through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. These devices include a noninvasive blood pressure measurement system that provides a signal from which systolic, and mean pressures can be derived through the use of pressure cuffs placed on the arm, leg or finger. The devices may be used as a radio frequency physiological signal transmitter to condition physiological signals so that they can be transmitted via radio frequency from one location to another, e.g. a central monitoring station.

The provided text describes the Nihon Kohden BSM-1101 and BSM-1102 Patient Monitors and their clearance via a 510(k) premarket notification (K973918). However, it does not contain the detailed information necessary to answer all the questions about acceptance criteria and a specific study proving device performance.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Nihon Kohden BSM-2101A Patient Monitor, K914092), rather than providing a detailed report of a study that establishes specific performance against predefined acceptance criteria for the new devices.

Here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as numerical values or thresholds in the provided text. The submission focuses on compliance with general testing and equivalence to a predicate.
• Reported Device Performance: The document states that the devices are subjected to "electromagnetic, environmental, safety and performance testing procedures to verify the operation of the device." It also mentions "Software validation tests the operation of the software functions of acquiring, processing, displaying and recording of the device." However, no specific performance metrics (e.g., accuracy, precision for heart rate, SpO2, NIBP) or their results are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not specified. The document does not describe a clinical study or a specific test set with sample sizes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not specified. Ground truth establishment by experts is typically relevant for diagnostic imaging or interpretation tasks, which are not detailed for these patient monitors. The document describes a patient monitor measuring physiological parameters, not interpreting complex medical images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not specified. Adjudication methods are typically associated with expert review processes for ground truth establishment, which is not detailed here.

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

• No. An MRMC comparative effectiveness study is not mentioned as this device is a patient monitor, not an AI-assisted diagnostic tool for human readers.

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

• This question is more geared towards AI algorithms. While the device contains algorithms for processing physiological signals, the document does not break down performance into "algorithm only" vs. "human-in-the-loop" in the way this question implies for AI tools. The device's performance is assumed to be its standalone function as a monitor.
• The document implies standalone performance testing through "performance testing procedures" and "Software validation tests the operation of the software functions of acquiring, processing, displaying and recording of the device." However, no specific results are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not explicitly stated in detail. For heart rate, SpO2, and NIBP, the "ground truth" would typically be established by highly accurate reference measurement devices or invasive clinical standards (e.g., arterial line for NIBP, co-oximetry for SpO2, ECG for heart rate). The document states "performance testing procedures" were used, but doesn't specify how ground truth was established for these tests.

8. The sample size for the training set

• Not applicable/Not specified. This device is a patient monitor, not an AI/ML model that undergoes a training phase with a specific dataset.

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

• Not applicable/Not specified. As there is no training set mentioned, this question is not relevant.

In summary:

The provided 510(k) summary is a high-level regulatory document focused on substantial equivalence. It confirms that the devices underwent various types of testing (electromagnetic, environmental, safety, performance, software validation) to verify operation, but it does not disclose the specific methods, sample sizes, acceptance criteria, or performance results from these tests in detail. This level of detail is typically found in design verification and validation reports, which are part of the full 510(k) submission but not usually present in the public summary document.

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