(359 days)
The device provides non-invasive measurement of pulse waveform and heart rate by photoelectric plethysmography. For Professional Use only. Not for use in individuals under the age of 18 years.
The ASI Device is intended to be used to measure pulse waveform in the finger. The measurement oximeter is an optoelectronic sensor consisted of a light- emitting diode (infrared LED) and a photodiode placed on opposite side as a light receiver. The ASI System incorporates an FDA approved pulse oximeter fingertip probe. The light from the LED is transmitted through the tissue at the sensor site and a photodiode in the sensor measures the transmitted light and calculating how much light is absorbed. This device converts the changes of transmitted light from a photodiode into a waveform and displays a graphic display of the pulse waveform on computer screen. As well as the optoelectronic sensor, the system utilizes a Texas Instrument designed circuit board which in turn transfers the signal to the computer contains the downloaded ASI proprietary algorithm which analysis the generated plethysmograph. The ASI System measures and analyzes the generated pulse waveforms to produce heart rate and plethysmograph of the patient's blood circulation.
The provided document is a 510(k) Premarket Notification for the ASI Plethysmograph Analyzer Model 3.01. It details the device's indications for use, description, comparison to predicate devices, and a summary of safety and effectiveness, including references to clinical and non-clinical tests.
However, the document does not contain specific acceptance criteria (e.g., target accuracy, precision, or sensitivity/specificity metrics) or a detailed breakdown of the study that proves the device meets these criteria. The safety and effectiveness section broadly states "The results of both bench testing and clinical trial data indicates that the new device is as safe and effective as the predicate devices," but it does not quantify this.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth establishment cannot be extracted directly from this document.
Here's an attempt to answer what can be inferred from the provided text, and where information is missing:
Device: ASI Plethysmograph Analyzer Model 3.01
Indications for Use: The device provides non-invasive measurement of pulse waveform and heart rate by photoelectric plethysmography. For Professional Use only. Not for use in individuals under the age of 18 years.
1. Table of Acceptance Criteria and Reported Device Performance
Information Not Fully Provided in Document.
The document claims the device is "as safe and effective as the predicate devices" based on bench testing and clinical trial data. However, it does not provide a specific table of quantitative acceptance criteria (e.g., specific accuracy ranges for heart rate, or waveform fidelity metrics) or the measured performance results against such criteria.
The similarity table (Section 6) instead focuses on features and intended use rather than detailed performance specifications.
| Metric/Criterion | Acceptance Criteria (Target) | Reported Device Performance (Result) |
|---|---|---|
| Accuracy of Heart Rate Measurement | Not explicitly stated in document. | |
| (Implied: Comparable to predicate devices, within clinically acceptable limits for the intended use.) | Not explicitly stated as a quantitative result in document. | |
| (Implied: Deemed "as safe and effective" as predicate.) | ||
| Accuracy of Pulse Waveform Measurement | Not explicitly stated in document. | |
| (Implied: Comparable to predicate devices.) | Not explicitly stated as a quantitative result in document. | |
| (Implied: Deemed "as safe and effective" as predicate.) | ||
| Other Performance Metrics (e.g., precision, bias) | Not explicitly stated in document. | Not explicitly stated as quantitative result in document. |
2. Sample Sizes Used for the Test Set and Data Provenance
Information Partially Provided.
- Test Set Sample Size: The document mentions "clinical trial data" and "Clinical studies were conducted," but it does not specify the sample size (number of participants/patients) used in these clinical trials.
- Data Provenance: The clinical studies were conducted by "independent CRO Prism Research at 1000 Westgate Drive, Saint Paul, Minnesota 55114." This suggests the data is likely prospective given the mention of a clinical study, and the location implies the data is from the USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Information Not Provided.
The document does not detail how ground truth was established for the clinical trial data, or the number and qualifications of any experts involved in this process.
4. Adjudication Method for the Test Set
Information Not Provided.
There is no mention of any adjudication method (e.g., 2+1, 3+1 consensus) used for the test set data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Information Not Applicable/Provided.
- The ASI Plethysmograph Analyzer Model 3.01 is a device that provides measurements (pulse waveform, heart rate) directly, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. Therefore, a MRMC study comparing human readers with and without AI assistance is not relevant for this type of device.
- No information about human readers or AI assistance in interpretation is mentioned. The device directly presents the measurements.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Information Partially Inferred.
The device operates by acquiring a signal and then an "ASI proprietary algorithm which analysis the generated plethysmograph." The clinical trial data would inherently represent the "standalone" performance of the device and its algorithm in producing heart rate and pulse waveform measurements. The document states "Clinical and non-clinical tests were performed to support the determination of substantial equivalence." While this implies standalone performance was evaluated, specific metrics of this standalone performance are not provided.
7. Type of Ground Truth Used
Information Not Provided.
The document states "Clinical studies were conducted," but it does not specify the method by which "ground truth" for heart rate and pulse waveform was established in these studies (e.g., comparison to a "gold standard" device, expert consensus on a different measurement, etc.).
8. Sample Size for the Training Set
Information Not Applicable/Provided.
The document describes the device as performing measurement and analysis of a signal using a proprietary algorithm. It does not explicitly state that this algorithm involves machine learning or what would be considered a "training set" in that context. If the algorithm is rule-based or derived from physiological models, a "training set" for an AI model might not exist in the traditional sense.
9. How the Ground Truth for the Training Set Was Established
Information Not Applicable/Provided.
As a "training set" is not explicitly mentioned or implied for an AI model, the method for establishing its ground truth is also not provided.
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).