The Mini-Logger® Series 2000 (hereafter referred to as Mini-Logger) is a compact, lightweight, physiological data logger for monitoring heart rate, interbeat-interval (IBI), temperature, ambient light, and activity. The Mini-Logger® can be used in behavioral and circadian rhythm studies, sleep research, occupational health and sports medicine research, and obesity/weight loss studies. The device can be used for any assement of human heart rate or IBI, temperature, and activity that requires logging of data over time and an integrated analysis of the forementioned parameters. The Mini-Logger® may be used in any instance where quantifiable analysis of physiological data is desirable.

Device Description

The Mini-Logger® Series 2000 is a compact physiological data logger whose physical size and appearance are similar to a small TV remote control. The Mini-Logger® is powered from two replaceable, non-rechargeable lithium cells. The Mini-Logger® is generally worn in the shirt pocket or on a belt using its optional soft pouch. Direct-wired probes used to sense the physiological data are plugged into one or more of the four available data input channels. The device acquires and logs digital data and resistances whose values represent the amplitudes of physiological signals. The physiological signals are temperature, heart inter-beat-interval (IBI), counts representing gross motor activity, and resistance representing ambient light intensity.

AI/ML Overview

This 510(k) Premarket Notification document for the Mini-Logger® Series 2000 does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria. The document focuses on demonstrating substantial equivalence to a predicate device (Vitalog HMS-5000) rather than presenting a performance study with defined acceptance metrics.

Therefore, many of the requested sections regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies cannot be extracted from the provided text.

Here's an assessment based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (Implied by substantial equivalence)
Physiological Parameter Measurement:	Performance expected to be equivalent to predicate device	Acquire and log digital data and resistances for temperature, heart inter-beat-interval (IBI), gross motor activity, and ambient light intensity.
Data Logging Capabilities:	Performance expected to be equivalent to predicate device	Store data until downloaded to a PC. User-definable data collection algorithms, numbers of channels, and types of channels. Internal clock and event marker for time-stamping.
Physical Characteristics:	Defined values in Table 11	- Size: 65x120x22 mm- Weight: 125 grams- Battery type: 3.6 volt lithium cells (2 each)- Moisture susceptibility: Not water resistant- Memory: 128 Kilobyte or 1 Megabyte- Storage Temperature: -10 C to 50 C at 0-95% relative humidity- Operating Temperature: 0 C to 40 C
Compatibility:	Compatible with IBM-compatible computer for data download (Implied by substantial equivalence)	Communicates data with an IBM-compatible computer.
Sensor Interface:	Ability to interface with specified sensor technologies	Accepts direct-wired probes for physiological data into four input channels; utilizes thermistor, Polar chest band with ECG skin electrode, motion-sensitive switch, and photoconductive sensor technologies.

2. Sample Size Used for the Test Set and Data Provenance

Not provided. This document is a 510(k) submission focused on substantial equivalence, not a detailed clinical or performance study report. There is no mention of a specific "test set" in the context of device performance evaluation with a defined sample size or data provenance (e.g., country of origin, retrospective/prospective). The assessment appears to be based on a comparison of technical characteristics and intended use to the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable/Not provided. Since there's no described "test set" for performance evaluation, there's no mention of experts establishing ground truth or their qualifications.

4. Adjudication Method for the Test Set

Not applicable/Not provided. Without a defined test set requiring ground truth, there is no adjudication method described.

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. The Mini-Logger® is a physiological data logging device, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed or described.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, not in the context of an "algorithm" as typically conceived in AI/imaging. The device itself is a standalone data logger. Its performance is inherent in its ability to accurately acquire and record physiological signals according to its specifications and the principles of the sensors used. The 510(k) primarily assesses this standalone capability against a predicate.

7. The Type of Ground Truth Used

Not explicitly stated in the context of a performance study. For a device like the Mini-Logger®, "ground truth" would typically refer to the actual physiological values (e.g., a reference thermometer for temperature, a gold-standard ECG for heart rate/IBI) used to calibrate and verify the accuracy of the device's sensors and logging. However, the document does not detail such calibration or verification studies with specified ground truth methods. The ground truth for this submission is implicitly the performance and established safety/effectiveness of the predicate device for the purpose of demonstrating substantial equivalence.

8. The Sample Size for the Training Set

Not applicable/Not provided. This device is not an algorithm that uses a "training set" in the sense of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no "training set" for this device.

Summary

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510(k) Premarket Notification Mini-Logger® June 22, 1999

K991045

10.0 510(K) SUMMARY

10.1 Summary Information

Submitter's Name and Address 10.1.1

Jack E. McKenzie, Ph.D. Mini-Mitter Co., Inc. P.O. Box 3386 56885 Enterprise Dr. Sunriver, Oregon 97707

June 22, 1999 Date summary was prepared:

10.1.2 Name of Device

Mini-Logger® Series 2000 Trade Name: Physiological Data Logging Device Common Name: Classification Name: Physiological signal conditioner (Product Code GYE)

Identification of predicate device 10.1.3

Vitalog HMS-5000 510(k) Number : K914085

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10.1.4 Device Description

10.1.4.1 Functions of the device

10.1.4.2 Basic scientific concepts

The device acquires and logs digital data and resistances whose values represent the amplitudes of physiological signals. The physiological signals are temperature, heart inter-beat-interval (IBI), counts representing gross motor activity, and resistance representing ambient light intensity. The scientific concepts and technologies that are used to sense the signals are summarized in Table 10.

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TABLE 10. BASIC TECHNOLOGIES USED FOR PHYSIOLOGICAL SIGNAL RECORDING IN MINI-LOGGER®SENSOR PROBES.

Physiological Parameter	Sensor Used	Sensor Technology	Signal Obtained
Skin, ear canal, rectaltemperature	Thermistor probe	Thermistor resistancevaries uniquely withtemperature.	Resistance.
Heart rate	Polar chest band	Low-impedance ECG skinelectrode and high-impedance signal amplifier	Digital pulse for each heartbeat.
Heart IBI	Polar chest band	Low-impedance ECG skinelectrode and high-impedance signal amplifier	Digital pulse for each heartbeat.
Gross motor activity	Motion-sensitive switch	Hermetically-sealed andencapsulated switch	Switch closures whichprovide digital pulses.
Ambient light	Photoconductive sensor	Photoconductor whoseresistance varies withchanging light levels.	Resistance.

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10.1.4.3 Physical characteristics

Pertinent physical characteristics of the Mini-Logger® data logger are shown in Table 11.

Parameter	Value
Size	65x120x22 mm
Weight	125 grams
Battery type	3.6 volt lithium cells (2 each)
Moisture susceptibility	Not water resistant
Memory	128 Kilobyte or1 Megabyte
Storage Temperature	-10 C to 50 C at 0-95% relative humidity
Operating Temperature	0 C to 40 C

TABLE 11. PHYSICAL CHARACTERISTICS OF MINI-LOGGER®.

Statement of the intended use of the device. 10.1.5

The Mini-Logger® is an ambulatory logging device that enables out-patient data collection for clinical and research applications. The Mini-Logger® is a compact, lightweight, physiological data logger for monitoring heart rate or inter-beatinterval (IBI), temperature, ambient light, and activity. The Mini-Logger® can be used in behavioral and circadian rhythm studies, sleep research, occupational health and sports medicine research, obesity/weight loss studies, behavioral and addiction studies. The device can be used for any assement of human heart rate or inter-beat-interval, temperature, and activity that requires logging of data over time and an integrated analysis of the forementioned parameters. The Mini-Logger may be used in any instance where quantifiable analysis of physiological data is desirable.

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How the technological characteristics of the device compare to 10.1.6 those of the predicate device:

The Mini-Logger® and theVITALOG HMS-5000 Pocket Polygraph (FDA 510(k) Number: K914085) are both diagnostic test systems based upon the concept of a portable, unattended physiological monitor that logs sensor-input physiological data to the logging device. The device communicates the data with an IBM-compatible computer. These devices are both solid-state monitors with user-definable data collection algorithms, numbers of channels, types of channels, and with the ability to store data until it is down-loaded into the PC. The Mini-Logger® and theVITALOG HMS-5000 Pocket Polygraph are of similar size and weight. Both devices have an internal clock and event marker to time-stamp and mark data for later interpretation. . The Mini-Logger® has five specific types of data that can be input: temperature, gross motor activity, heart rate, heart inter-beat-interval (IBI) and ambient light. The VITALOG HMS-5000 Pocket Polygraph has the potential for twenty-three sensor inputs to include temperature, gross motor activity, heart rate, and ambient light.

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Image /page/5/Picture/1 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 image of an eagle or bird-like figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1 1999

Jack E. McKenzie, Ph.D. Vice President of Market Development Mini Mitter Co., Inc. P.O. Box 3386 Sunriver, Oregon 97707

K991045 Re: Trade Name: Mini-Logger® Series 2000 Regulatory Class: II Product Code: GWK Dated: June 22, 1999 Received: June 24, 1999

Dear Dr. McKenzie:

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 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 assumptions. Failure to comply with the GMP regulation may result in regulatory 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 - Jack E. McKenzie, Ph.D.

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) 594-4595. 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.

Sincerely yours,

Salim McWitt, Ph.D., M.D.

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

Enclosure

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Mini Mitter Co, Inc.

510(k) Premarket Notification Mini-Logger® June 22, 1999

INDICATIONS FOR USE 2.0

510(k) Number (if known):

K991045

Mini-Logger® Series 2000

Device Name:

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______________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

baséat

eral Restorative De

Regulation Number and Section

§ 882.1845 Physiological signal conditioner.

(a)
Identification. A physiological signal conditioner is a device such as an integrator or differentiator used to modify physiological signals for recording and processing.(b)
Classification. Class II (performance standards).