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Charmcare Tabletop Pulse Oximeter is portable device indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients via finger in hospitals, medical facilities, and subacute environments. Pediatric population in this 510(K) application is defined as 'infant' and 'child' which are ages from 1 month to 12 years according to the guidance 'Premarket Assessment of Pediatric Medical Devices' section IV. Charmcare Tabletop Pulse Oximeter is intended for spot-checking and / or continuous monitoring of patients, the sensor of device is reusable or disposable.

The device works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 940 nm, which is ultra red light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole into an oxygen saturation measurement. This measurement is referred to as SpO2. This applicant device of Accuro is the desktop pulse oximeter monitor, which mainly function are measurement, display, alarm, data storage.

Here's a breakdown of the acceptance criteria and study details for the Charmcare Tabletop Pulse Oximeter, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Study Details that Prove the Device Meets Acceptance Criteria

1. Sample Size Used for the Test Set and Data Provenance:

   • Non-clinical tests (SpO2 and Pulse Rate): The testing involved using a Fluke Index2 SpO2 simulator with varying SpO2 and Pulse Rate settings. This is a controlled, simulated environment, not human data.
   • Clinical Data: 10 subjects (7 women, 3 men).
   • Data Provenance: The study was conducted by Charmcare Co., Ltd. for their 510(k) submission, suggesting it was likely conducted in South Korea where the company is located. The nature of the study being for regulatory submission indicates it was a prospective study designed specifically to evaluate the device.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

   • Non-clinical tests: For simulator-based tests, the "ground truth" is the known, highly accurate output of the Fluke Index2 SpO2 simulator. No human experts are involved in establishing this ground truth.
   • Clinical Data: The text states, "The rms error between SaO2 and SpO2 was calculated for each sensor." SaO2 (arterial oxygen saturation) measurements taken from blood samples are generally considered the gold standard for ground truth in this context. While not explicitly stated, these measurements would typically be performed by trained lab personnel, and potentially overseen by medical professionals, but not necessarily "experts" in the sense of a consensus panel. The document does not specify the number of experts or their qualifications for establishing the SaO2 ground truth.

3. Adjudication Method for the Test Set:

   • Non-clinical tests: Not applicable, as the comparison is directly between the device's reading and the simulator's known output.
   • Clinical Data: Not applicable. The ground truth (SaO2) is an objective measurement from blood samples, not subject to individual interpretation or adjudication by multiple human readers.

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

   • No. The studies described are focused on the device's accuracy against a simulator or against objective clinical measurements (SaO2), not on how human readers perform with or without AI assistance.

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

   • Yes, implicitly. The entire evaluation (both non-clinical and clinical) assesses the performance of the Charmcare Tabletop Pulse Oximeter device itself, which includes its internal algorithms for SpO2 and pulse rate calculation. There is no mention of a human operator making interpretations or decisions based on the device's output that would then be compared to a "human-in-the-loop" scenario. The "clinical data" section directly compares the device's SpO2 output (algorithm-derived) to SaO2 (ground truth).

6. The Type of Ground Truth Used:

   • Non-clinical tests: Simulator output (Fluke Index2 SpO2 simulator).
   • Clinical Data: SaO2 measurements (arterial oxygen saturation) from blood samples. This is considered an objective physiological measurement or outcomes data (in the sense of direct measurement of the physiological parameter).

7. The Sample Size for the Training Set:

   • The document does not specify a separate training set or its size. This is typical for medical devices that utilize established physiological algorithms rather than complex machine learning models that require distinct training sets. The algorithms for pulse oximetry are based on known spectrophotometric principles, not typically "trained" on large datasets in the modern AI sense.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as a distinct training set (in the context of machine learning) is not described or implied for this device's type of technology. The device's algorithms are based on fundamental principles of light absorption and oxygen saturation, which are well-established.

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