CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999 by NIEN MADE ELECTRNICS CORP.

For intermittent measurement of body temperature in patients of all ages in the home environment by measurement of infrared radiation emitted, solely, from the tympanic membrane.

Device Description

The Cecilia® Thermometer consists of an IR sensor, an electronic signal processing detector, a digital LCD display, and disposable probe covers.

AI/ML Overview

The provided text is a 510(k) summary for the Cecilia® Penguin Multi-Use Thermometer. It details the device's substantial equivalence to a predicate device and mentions general testing, but does not contain the specific information required to complete the table and answer all questions related to acceptance criteria, detailed study design, ground truth establishment, or sample sizes for specific tests.

The document states: "The Cecilia® Thermometer was subjected to safety and performance tests for compliance against applicable recognized standards. Additional testing activities were conducted to establish the performance and reliability characteristics of the device, including testing to establish laboratory and clinical accuracy." However, the results of these tests and the methodologies are not described in this summary.

Therefore, I cannot provide a complete answer with the requested details from the given text.

Here's what I can extract or infer based on the provided text, and what is missing:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Specific metrics and thresholds are missing from the text)	Reported Device Performance (Specific results are missing from the text)
Accuracy: (Likely defined by a specific deviation from a reference temperature within a clinical range)	The document states "testing to establish laboratory and clinical accuracy" was performed, but does not provide the specific performance values (e.g., mean bias, standard deviation of differences, clinical acceptance based on limits of agreement).
Safety: (Likely compliance with electrical safety, biocompatibility, etc.)	The document states "safety...tests for compliance against applicable recognized standards" were performed, but does not detail the specific safety criteria or the device's performance against them.
Reliability/Durability: (Likely stability of measurements over time, resistance to environmental factors)	The document states "testing activities were conducted to establish the performance and reliability characteristics," but specific criteria and results are absent.
Functionality: (e.g., proper display, ease of use)	Implied by "performance characteristics," but specific criteria and results are absent.

Missing Information Details:

2. Sample sizes used for the test set and the data provenance: Not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text. For a thermometer, "ground truth" would typically refer to a highly accurate reference thermometer.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/specified. For a thermometer, ground truth is usually established by a calibrated reference device, not human expert consensus.
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: Not applicable. This device is a thermometer, not an AI diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone measurement tool. Its performance would be evaluated in a standalone manner against a reference, but "algorithm only" implies a more complex AI system which this is not.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a thermometer, the ground truth would typically be established using a calibrated reference thermometer in a controlled environment (laboratory testing) and potentially a clinical reference method (e.g., rectal thermometry for core body temperature, or another established tympanic thermometer as a clinical reference) for clinical accuracy. The document mentions "laboratory and clinical accuracy" testing.
8. The sample size for the training set: Not applicable. This device is not an AI/machine learning model that typically requires a "training set." It's a medical device with an IR sensor and electronic signal processing.
9. How the ground truth for the training set was established: Not applicable, as there is no "training set" in the context of this device.

Summary of what is present:

Device Name: Cecilia® Penguin Multi-Use Thermometer
Intended Use: Intermittent measurement of body temperature in individuals of all ages in the home environment by measurement of infrared radiation emitted, solely, from the tympanic membrane.
Predicate Device: Braun Thermoscan® IRT 3020/3520 (K983295)
Technology: IR measurement technology, electronic signal processing, digital LCD display.
Testing conducted: Safety and performance tests against recognized standards, including laboratory and clinical accuracy.

Summary of what is NOT present in the provided text:

Specific acceptance criteria (numerical thresholds for accuracy, reliability, etc.).
Detailed performance results against those criteria.
Sample sizes for clinical or laboratory accuracy studies.
Details about the "ground truth" methods (e.g., type of reference thermometer used, environmental controls).
Any information related to AI/ML specific concepts like training sets, test sets, expert adjudication methods, or MRMC studies, as the device is not an AI diagnostic system in the sense implied by these questions.

Summary

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K993950

510(k) Summary As Required By 21 C.F.R. 8807.92

1. The submitter of this premarket notification is: James Delaney EXPERTech Associates, Inc. 100 Main Street, Suite 120 Concord. MA 01742 Tel: 978.371.0066, Fax: 978.371.1676
  This summary was prepared on July 5, 2000
1. The name of this device is the Cecilia® Penguin Multi-Use Thermometer. The classification name is as follows:

Regulation Number &ProCode	ClassificationName
880.2910, 80 FLL	Clinical electronic thermometer

1. The Cecilia® Thermometer is substantially equivalent to the Braun Thermoscan® IRT 3020/3520 (K983295).
1. The Cecilia® Thermometer consists of an IR sensor, an electronic signal processing detector, a digital LCD display, and disposable probe covers.
1. The Cecilia® Thermometer has the same intended use as the legally marketed predicate device. The Cecilia® Thermometer is intended for intermittent measurement of body temperature in individuals of all ages in the home environment by measurement of infrared radiation emitted, solely, from the tympanic membrane.
1. The Cecilia® Thermometer and the predicate Braun Thermoscan® IRT 3020/3520 device both operate using the same IR measurement technology. The measurement technology, including the processing, transmission, and display of signals, are similar, and therefore the technological characteristics of the Cecilia® Thermometer are essentially the same as those of the legally marketed predicate device.
7 . The Cecilia® Thermometer was subjected to safety and performance tests for compliance against applicable recognized standards. Additional testing activities were conducted to establish the performance and reliability characteristics of the device, including testing to establish laboratory and clinical accuracy.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, representing the department's focus on people and health.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 2000

Nien Made Electrnics Corporation C/O Mr. James M. Delaney Expertech Associates, Incorporated 100 Main Street Suite 120 Concord, Massachusetts 01742

Re : K993950 Cecilia Penquin Multi-Use Thermometer, Trade Name: Model HP-ET09999 Requlatory Class: II Product Code: FLL Dated: July 10, 2000 Received: July 13, 2000

Dear Mr. Delaney:

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 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). You may, therefore, market the device, subject to the qeneral 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 TI (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 Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 Druq 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 - Mr. Delaney

This letter will allow you to begin marketing your device as Inis recter will arrow your emarket notification. The FDA described in your 510(x) promazioe of your device to a legally Illuling of subscancial equire results in a classification for your marketed predicate device robated as to proceed to the market.

If you desire specific advice for your device on our labeling II you debire bpoortary and additionally 809.10 for in regulacion (21 crk rares), please contact the Office of Villo diagnoscic acvices) / productionally, for questions on Compilance at (501) 332 issing 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 807.97). Other general premation on your responsibilities under the Act may be Information on your respon of Small Manufacturers Assistance obeathed from the Division (800) 638-2041 or (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

14993950

510 (k) Number (if known)

Device Name

Nien Made Electronics Corporation Cecilia® Penguin Multi-Use Thermometer

Indications for Use

For intermittent measurement of Indications: body temperature in patients of all ages in the home environment by measurement of infrared radiation emitted, solely, from the tympanic membrane.

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) OR

Over-The-Counter Use

Patricia Currenite

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number .

Regulation Number and Section

§ 880.2910 Clinical electronic thermometer.

(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.