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510(k) Data Aggregation
(69 days)
CRITICAL PATIENT CARE, INC.
'Critical Care Assessment' is intended for noninvasive measurements of pulse waveforms by photoelectric plethysmography and heart rate electrocardiograph. The system is intended for use of patients in medical clinics, healthcare practices and in out-patient department of hospitals.
Critical Care Assessment device is a microprocessor based, monitor biomedical acquisition system - it identifies, classifies, and collects ECG and Plethysmograph signals from the human body. The analog signals are converted to digital data and transferred to the personal computer via isolated USB connection. This isolation separates the human body from the main power system to ensure maximum patient safety. The patient data collected from the unit is used to perform Heart Rath Variability Analysis and obtain several detailed assessment of the Autonomic Function (Autonomic Nervous System Balance), Blood flow, Stress, Fitness and the overall health risk analysis.
Here's an analysis of the provided text regarding the device's acceptance criteria and study information:
Device Acceptance Criteria and Study Information:
Based on the provided 510(k) summary, the device, "Critical Care Assessment," is claiming substantial equivalence to a predicate device, "ANSHA-QHRV1" (K083735). The document indicates that the acceptance criteria and performance are identical to the predicate device because the submission is primarily for "re-labeling device under new trade name."
Therefore, the "acceptance criteria" for the "Critical Care Assessment" device are the same as those met by the predicate device "ANSHA-QHRV1." The "study" proving this device meets its acceptance criteria is a comparison to the predicate device, asserting that it has undergone the "same identical performance testing."
1. Table of Acceptance Criteria and Reported Device Performance
Given that the submission states the current device "met the requirements" previously established for the predicate, the reported device performance for "Critical Care Assessment" is presumed to meet the same standards.
| Acceptance Criteria (Met by Predicate Device ANSHA-QHRV1) | Reported Device Performance ("Critical Care Assessment") |
|---|---|
| QRS Detection and Heart Rate Variability & Algorithm Verification (ANSI-AAMI EC57-98) | Met: The document explicitly states, "Critical Care Assessment™ has met the requirements for QRS Detection and Heart Rate Variability & Algorithm Verification (ANSI-AAMI EC57-98)." |
| General Requirements for Safety and Collateral Standard Safety Requirements for Medical Electrical Systems (IEC 60601-1 (1998) with Am. 1 (1991), Am. 2 (1995)) | Met: The document states, "Met the General Requirements for Safety and Collateral Standard Safety Requirements for Medical Electrical Systems (IEC 60601-1 (1998) with Am. 1 (1991), Am. 2 (1995))." |
| Electromagnetic Compatibility Test (UL 601-1 (2003)) | Met: The document states, "Also, complies with Electromagnetic Compatibility Test (UL 601-1 (2003))." |
| Functions are substantially equivalent to the predicate. | Substantially Equivalent: The document repeatedly asserts: "The functions are substantially equivalent to the predicate." and "All materials used have gone through the same identical performance testing as the legally marketed predicate device 'ANSHA-QHRVI' ... Both devices are identical in all areas of design, materials used, software, function and application to the predicate device and have undergone through the same performance testing." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document does not disclose any specific sample size for a test set or data provenance (country of origin, retrospective/prospective study design) for the "Critical Care Assessment" device. It relies entirely on the prior testing conducted for the predicate device, stating, "This performance testing is identical to the predicate device."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The provided document does not disclose any information about the number or qualifications of experts used to establish ground truth for any test set. The submission focuses on the device's technical specifications and substantial equivalence to a predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The provided document does not disclose any information about adjudication methods used for a test set. This type of detail is typically not included in a 510(k) summary focused on substantial equivalence.
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 MRMC comparative effectiveness study was done as described. The device "Critical Care Assessment" is presented as a diagnostic tool for noninvasive measurements of pulse waveforms and heart rate, not an AI-assisted diagnostic aid for human readers. Its primary function pertains to signal acquisition and analysis, not interpretation enhancement for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device, "Critical Care Assessment," is described as a "microprocessor based, monitor biomedical acquisition system" that "identifies, classifies, and collects ECG and Plethysmograph signals." It performs "Heart Rate Variability Analysis and obtain several detailed assessment of the Autonomic Function, Blood flow, Stress, Fitness and the overall health risk analysis." This indicates an algorithm-only (standalone) performance in terms of its signal processing and analysis capabilities. However, no specific "standalone study" with detailed metrics is provided in this summary, other than the general statement that it met the required standards (ANSI-AAMI EC57-98, IEC 60601-1, UL 601-1).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for the validation of the algorithms in the predicate device. However, given the nature of the tests mentioned (QRS Detection and Heart Rate Variability & Algorithm Verification (ANSI-AAMI EC57-98)), the ground truth would typically be established through reference physiological measurements or expert annotation of physiological signals. It's likely that established medical standards and validated methods for heart rate and plethysmography served as the "ground truth."
8. The sample size for the training set
The provided document does not disclose any information about the sample size for a training set. As this is a 510(k) submission for a device claiming substantial equivalence, the focus is on meeting established performance standards rather than detailing the machine learning model's training specifics.
9. How the ground truth for the training set was established
The provided document does not disclose how ground truth for any training set was established. Similar to point 8, this level of detail is not part of this 510(k) summary, which is based on demonstrating equivalence to a previously cleared device.
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