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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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