(217 days)
The Fingertip Pulse Oximeter JPD-500F is non-invasive device intended for spotchecking of functional oxygen saturation of arterial hemoglobin (Spo2) and pulse rate. The portable fingertip device is indicated for adult and pediatric patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).
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This FDA 510(k) clearance letter for the Fingertip Pulse Oximeter (Model JPD-500F) does not contain detailed information about the acceptance criteria or the specific study details for proving the device meets those criteria.
FDA 510(k) clearance letters primarily state that the device is "substantially equivalent" to a legally marketed predicate device. They typically do not include the raw data, study designs, or detailed performance metrics that would be found in a full submission. The letter confirms the device type, its classification, and intended use.
Therefore, I cannot provide the requested information based solely on the provided text. To answer your questions, one would need to access the full 510(k) submission document or a summary thereof, which often includes details of the performance testing and acceptance criteria.
However, I can infer some general information about what would typically be required for a pulse oximeter's acceptance criteria and how a study would prove it, even if the specifics are not in this document:
Inferred Information (Based on typical regulatory requirements for pulse oximeters, not directly from this document):
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Table of Acceptance Criteria and Reported Device Performance: This would typically involve accuracy and precision metrics for SpO2 and pulse rate.
- Acceptance Criteria (Example):
- SpO2 Accuracy: Aroot mean square (ARMS) difference between the device reading and reference measurement ≤ 3.0% saturation for SpO2 values between 70% and 100%. Clinical bias (mean difference) might also be specified.
- Pulse Rate Accuracy: Mean absolute difference (MAD) or ARMS difference between device reading and reference measurement ≤ 5 bpm for pulse rates between X and Y bpm.
- Reported Device Performance: This would be the actual ARMS, bias, or MAD values achieved in the clinical study.
- Acceptance Criteria (Example):
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Sample Size used for the test set and the data provenance:
- Sample Size: For SpO2 accuracy, typically involves at least 10-15 healthy adult volunteers for induced hypoxia studies (SpO2 levels typically varied down to ~70%). The number of measurements taken for each subject at various saturation levels would be substantial. Pediatric studies would involve a separate cohort.
- Data Provenance: Prospective, controlled clinical study; likely performed in a clinical setting (e.g., hospital, specialized lab) where reference SpO2 can be accurately measured (e.g., using arterial blood gas analysis with a co-oximeter). Country of origin is often the manufacturing country or a location with appropriate facilities for such studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for SpO2 and Pulse Rate accuracy. The "ground truth" for pulse oximetry is typically established through direct physiological measurements, not expert consensus.
- For SpO2, the gold standard (ground truth) is typically arterial blood gas analysis using a co-oximeter. This is a direct laboratory measurement, not an expert visual assessment.
- For Pulse Rate, the ground truth can be simultaneously recorded ECG or a direct arterial line measurement.
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Adjudication method for the test set:
- Not applicable for SpO2 and Pulse Rate accuracy. Adjudication is used when human interpretation is part of the ground truth establishment (e.g., reading medical images). Here, direct instrumental measurements provide the ground truth.
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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:
- Not applicable. This device is a standalone measurement device, not an AI-assisted diagnostic tool that interprets complex data for human readers. Therefore, an MRMC study is irrelevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this is a standalone performance study. Pulse oximeters are designed to provide direct measurements, so their performance is inherently evaluated in a standalone manner. The device outputs SpO2 and pulse rate, and these outputs are compared against a reference standard.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For SpO2: Co-oximetry of arterial blood samples.
- For Pulse Rate: Electrocardiogram (ECG) or arterial line measurement.
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The sample size for the training set:
- This information would not be relevant for a traditional pulse oximeter like this (JPD-500F). Pulse oximeters rely on optical principles and signal processing algorithms that are typically developed based on physiological models and empirical calibration, not machine learning algorithms that require large "training sets" in the sense understood in AI/ML contexts. The "calibration" would be performed during device design and manufacturing using established standards.
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How the ground truth for the training set was established:
- As above, not applicable in the AI/ML sense. Calibration procedures involve ensuring the device's optical sensors and algorithms accurately convert light absorption measurements into SpO2 and pulse rate, typically checked against known physical standards and reference instruments during development and manufacturing.
To summarize, while the provided document confirms the FDA clearance for the device, it lacks the detailed performance study information. The questions regarding expert consensus, adjudication, MRMC studies, and AI-like "training sets" are generally not applicable to the analytical performance evaluation of a pulse oximeter, which relies on comparing device output against direct physiological reference measurements.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).