ACUITY CENTRAL STATION by PROTOCOL SYSTEMS, INC.

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.

Device Description

Acuity Central Station, Cardiac ECG ST Analysis Central Station Monitor

AI/ML Overview

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)

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.
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).
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.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. This information is not present.
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.
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.
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.
8. The sample size for the training set:
- Not specified. This information is absent from the 510(k) summary.
9. How the ground truth for the training set was established:
- Not specified. This information is absent from the 510(k) summary.

Summary

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KAN2121

510(k) Summary

NOV - 7 Joer

In compliance with section 21 CFR 807.92, this document comprises a 510(k) Summary for K972121.

Submitter: Protocol Systems, Inc. 8500 SW Creekside Place Beaverton, OR 97008-7107 Phone: (503) 526-8500

Contact Persons: James P. Welch, Vice President, Quality Systems (Primary)

Jim Sandberg, Director, Regulatory Affairs, (Secondary)

Date Prepared: June 4, 1997

Predicate Device: "Cardiac Central Station Monitor with ST Segment Analysis" (PCI Model 2041-PC/ST, Pacific Communications, Inc. (PCI, now VitalCom), 510(k) Number K925411/A)

Device Name: Acuity Central Station

Classification Name: System, ECG Analysis (ST), Class III under section 513 of the Federal Food, Drug and Cosmetic (FD&C) Act, Panel 74 Cardiovascular, Product Code 74LOS,

Federal Regulation Number 870.2340

Trade/Proprietary Name: Acuity Central Station

Common/Usual Name: Cardiac ECG ST Analysis Central Station Monitor

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

. . . . . .

NOV - 7 1997

Mr. James P. Welch Protocol Systems, Inc. 8500 S.W. Creekside Place Beaverton, Oregon 97008-7107

Re: к972121 Acuity Central Station Monitor Regulatory Class: III (three) Product Code: 74 MLD Dated: September 5, 1997 Received: September 8, 1997

.Dear Mr. Welch:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. James P. Welch

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

sincerely yours
Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K972121

Device Name: Acuity Central Station, Cardiac ECG ST Analysis Central Station Monitor

Indications For Use:

It is recommended for use with Adult and Pediatric patients one year or older. ST Analysis is automatically disabled when the corresponding Propaq Encore is in the Neonatal patient mode.

It is intended for use by healthcare practitioners who know to acquire and interpret patients' vital signs and are trained in the use of the Acuity System and its components. The clinician is responsible for determining the clinical significance of each alarm generated by Acuity. As with all computerized ST Analysis systems, Acuity cannot replace skilled care and proper surveillance by a clinician. A clinician should review all data obtained from Acuity before implementing therapy based on this data.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Christy Fouman for AAC
	Division Sign-Off)
	Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	K972121

Prescription Use	OR	Over-The-Counter Use
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.