The PAM-RL is a small, limb-worn activity monitor, typically placed on the leg or wrist, designed for documenting physical movements associated with applications in physiological monitoring. The device is intended to monitor limb activity associated with movement during sleep. The unit can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable.

Device Description

The PAM-RL is a compact, limb-worn, battery-operated activity monitor. The monitor consists of the activity monitor itself and a velcro band. The PAM-RL is intended for the measurement, storage, and analysis of limb activity. The PAM-RL can be attached to the subject's limb and through the use of an accelerometer, motion of that limb is measured, the activity is stored within the activity monitor. A computer program is used to set up the PAM-RL to collect data. This program runs on an IBM-compatible personal computer (PC). The major functions of the application software are to program the device to collect data, retrieve the data from the activity monitor, display the data, and to store the data for future reference and comparison. The PAM-RL uses a smart download cable to provide a communiations link between the PAM-RL and the PC. To download data from the PAM-RL to the PC, one end of the PAM-RL's smart cable is inserted into the PAM-RL's port via a miniature 2.5 mm phone plug and the other end connected to the serial communications port of the PC via a standard 9-pin RS-232 COM port. The PAM-RL utilizes a motion sensor known as an accelerometer to monitor the occurrence and degree of motion. This type of sensor provides an analog signal where the amplitude and speed of motion produces a signal whose magnitude and duration depend on the amount of motion. The activity signals are amplified and digitized by the on-board circuit. This information is stored in memory on board the device as activity counts. Activity can alternatively be stored in units of milli-g.

AI/ML Overview

This 510(k) premarket notification for the PAM-RL device does notContain a detailed study section with specific acceptance criteria or a comprehensive study design that quantifies device performance against those criteria. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed statistical analysis.

Therefore, many of the requested details cannot be extracted from this document. However, based on the information provided, here's what can be gathered:

1. A table of acceptance criteria and the reported device performance:

This information is not explicitly provided in the 510(k) summary. Acceptance criteria for device performance were not presented, nor were specific quantified performance metrics for the PAM-RL device in a comparative study against such criteria. The submission aims to establish substantial equivalence to a predicate device, ACTITRAC (K992410), implying that its performance is considered acceptable if analogous to the predicate.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not provided in the 510(k) summary. The document does not describe any specific clinical or performance test set, its sample size, or data provenance.

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):

This information is not provided. Since no specific test set or performance study is detailed, there's no mention of experts establishing ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided.

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:

This information is not provided. The device is an activity monitor, not an AI-assisted diagnostic tool, and the summary does not describe any MRMC studies or human-in-the-loop performance evaluations.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The 510(k) summary describes the device's functionality and its basic scientific concepts. It states that the PAM-RL "utilizes a motion sensor known as an accelerometer to monitor the occurrence and degree of motion" and that "activity is stored within the activity monitor." A "computer program is used to set up the PAM-RL to collect data," "retrieve the data from the activity monitor, display the data, and to store the data for future reference and comparison."

This implies that the device functions to collect and record data automatically (standalone). However, the document does not contain a specific "standalone performance study" section with metrics and results. Its design suggests it operates independently to collect motion data without real-time human intervention in the data acquisition phase.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not provided. Without a described performance study, the type of ground truth used is not mentioned.

8. The sample size for the training set:

This information is not provided. As this is not an AI/machine learning device in the contemporary sense, there's no "training set" mentioned for an algorithm. The device measures physical motion via an accelerometer.

9. How the ground truth for the training set was established:

This information is not provided.

Summary of available information regarding performance:

The document focuses on the description and function of the PAM-RL, emphasizing its ability to measure, store, and analyze limb activity via an accelerometer. The primary "proof" of its acceptability for market clearance appears to be its substantial equivalence to a legally marketed predicate device, "ACTITRAC" (K992410). The implication is that if the new device functions similarly to an already approved device for the same intended use, its performance is considered acceptable for market. No specific performance metrics or studies are detailed in this 510(k) summary.

Summary

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Individual Monitoring Systems, Inc. "PAM-RL" 510(K) Premarket Notification April 2, 2001

OCT 1 5 2001 K010997 510(k) SUMMARY:

"This summary of 510(k) safety and effectivness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."

Submitter's Name and Address:

David T. Krausman, Ph.D.

Individual Monitoring Systems, Inc. (DBA IM Systems)

1055 Taylor Ave., Suite 300

Baltimore, MD 21286

Fax: 410-321-0643 Phone: 410-296-7723,

Contact person: David T. Krausman, Ph.D.

April 2, 2001 Date summary was prepared:

Name of Device:

Trade Name:

PAM-RL

Common Name:

Activity Recording Device

Classification Name:

Electroencephalograph

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ldentification of predicate device:

Number K992410 - "ACTITRAC" - Individual Monitoring Systems, INC. Product Code - GWQ

Statement of intended use:

The PAM-RL is a small, limb-worn activity monitor designed for documenting physical movements associated with applications in physiological monitoring. The device is intended to be used to analyze limb activity associated with movement during sleep. The unit can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable.

Device Description

Functions of the device:

The PAM-RL is a compact, limb-worn, battery-operated activity monitor. The monitor consists of the activity monitor itself and a velcro band.

The PAM-RL is intended for the measurement, storage, and analysis of limb activity. The PAM-RL can be attached to the subject's limb and through the use of an accelerometer, motion of that limb is measured, the activity is stored within the activity monitor.

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A computer program is used to set up the PAM-RL to collect data. This program runs on an IBM-compatible personal computer (PC). The major functions of the application software are to program the device to collect data, retrieve the data from the activity monitor, display the data, and to store the data for future reference and comparison.

The PAM-RL uses a smart download cable to provide a communiations link between the PAM-RL and the PC. To download data from the PAM-RL to the PC, one end of the PAM-RL's smart cable is inserted into the PAM-RL's port via a miniature 2.5 mm phone plug and the other end connected to the serial communications port of the PC via a standard 9-pin RS-232 COM port.

Basic scientific concepts:

The PAM-RL utilizes a motion sensor known as an accelerometer to monitor the occurrence and degree of motion. This type of sensor provides an analog signal where the amplitude and speed of motion produces a signal whose magnitude and duration depend on the amount of motion. The activity signals are amplified and digitized by the on-board circuit. This information is stored in memory on board the device as activity counts. Activity can alternatively be stored in units of milli-g.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Individual Monitoring Systems, Inc. David T. Krausman 1055 Taylor Avenue Suite 300 Baltimore, MD 21286

Re: K010997 Trade/Device Name: PAM-RL Regulation Number: 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWO Dated: August 20, 2001 Received: August 20, 2001

Dear Mr. Krausman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice reguirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

OCT 1 5 2001

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Page 2 - David T. Krausman, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Walker, us

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) NUMBER (IF KNOWN):	K010997
DEVICE NAME:	PAM-RL

INDICATIONS FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓
(Per 21 CFR 801.109)

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Over - The - Counter - Use (Optional Format 1

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number__

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).