(155 days)
The Acuity ST Analysis option is being incorporated into the Acuity central station (licensed with Arrhythmia and Full Disclosure) as part of a network system within the hospital environment or clinical setting. The ST Analysis option is intended to be used to provide real-time monitoring and alarms for ST segment deviations (from a reference beat) for patients with suspected heart disease or anomalies.
Acuity Central Station, Cardiac ECG ST Analysis Central Station Monitor
This 510(k) summary (K972121) for the Acuity Central Station with ST Analysis option provides very limited information regarding specific acceptance criteria and study details. Based on the provided text, a comprehensive answer to your request is not possible. However, I can extract and infer what is present:
Missing Information:
The provided document, being a 510(k)-summary, does not contain the detailed technical data and study reports that would typically outline the acceptance criteria and the comprehensive study conducted to demonstrate the device's performance. The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, and often, extensive new clinical studies with detailed acceptance criteria are not required if equivalence can be shown through other means (e.g., bench testing, comparison to predicate performance).
Therefore, many of the specific points you requested (sample sizes, expert qualifications, adjudication methods, MRMC studies, training set details, types of ground truth) are not present in this summary.
Here's what can be extracted and inferred from the provided text, along with a clear indication of what is not available:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated - Inferred Basis of 510(k)) | Reported Device Performance (Not Explicitly Stated - Inferred Basis of 510(k)) |
|---|---|
| The device performs ST segment analysis comparable to the predicate device (PCI Model 2041-PC/ST, 510(k) K925411/A). | The device's ST Segment Analysis functionality is deemed substantially equivalent to the predicate device. |
| Provides real-time monitoring and alarms for ST segment deviations. | The device is cleared for real-time monitoring and alarming for ST segment deviations. |
| Suitable for adult and pediatric patients one year or older. | The device is recommended for use with Adult and Pediatric patients one year or older; ST Analysis is automatically disabled in Neonatal patient mode. |
| Intended for use by trained healthcare practitioners. | Device use is contingent on healthcare practitioners being trained and acquiring/interpreting vital signs. |
| Cannot replace skilled care and proper surveillance by a clinician. | A clinician should review all data obtained from Acuity before implementing therapy. |
Study Details (Based on available information)
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1. A table of acceptance criteria and the reported device performance:
- As noted above, explicit numerical acceptance criteria are not provided in this 510(k) summary. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device (PCI Model 2041-PC/ST).
- No specific reported device performance metrics (e.g., sensitivity, specificity, accuracy for ST segment deviation detection) are detailed in this summary. The summary focuses on the intended use and equivalence.
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2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. This 510(k) summary does not mention details about a specific test set, its size, or data provenance. Substantial equivalence might have been demonstrated through other means (e.g., comparison of technical specifications, bench testing, or a limited clinical comparison not detailed here).
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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 specified. Given the lack of information on a formal test set with ground truth establishment, this detail is absent.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. This information is not present.
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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. This is highly unlikely given the device's nature and the era of the 510(k) (1997). The Acuity Central Station is for monitoring and alarm generation, not for direct AI-assisted diagnostic interpretation by human readers in the way an imaging AI might be. Therefore, an MRMC comparative effectiveness study in the context of "human readers improve with AI vs without AI assistance" is not relevant or described. The guidance clearly states the clinician is responsible for determining clinical significance and reviewing all data.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Implied, but no details provided. The device is an algorithm (ST Analysis option) performing its function ("real-time monitoring and alarms for ST segment deviations"). However, the summary does not provide specific performance metrics of this standalone algorithm. The "human-in-the-loop" is explicitly mentioned as necessary for clinical interpretation.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not specified. Without details on a specific study or test set, the type of ground truth used is unknown. For ST segment analysis, ground truth would typically come from clinical diagnosis confirmed by other cardiac assessments or expert ECG interpretation.
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8. The sample size for the training set:
- Not specified. This information is absent from the 510(k) summary.
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9. How the ground truth for the training set was established:
- Not specified. This information is absent from the 510(k) summary.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.