(89 days)
DUTECK (MicHealth) Body Composition Analyzer, BSA series are stand-on, non-invasive, reusable analyzer, measure body weight and impedance and estimates body non-invasive, of body fat, body water and skeletal muscle mass by using BIA method (bioelectrical impedance analysis). They are intended to use by healthy people age 10 to 80, (offective lifestyles for body composition assessment in the home environment.
DUTECK (MicHealth) Body Composition Analyzer, BSA series are stand-on, non-invasive, reusable analyzer, measure body weight and impedance and estimates body non-invasive, of body fat, body water and skeletal muscle mass by using BIA method (bioelectrical impedance analysis).
Given the provided document, the acceptance criteria and the study that proves the device meets the acceptance criteria are not explicitly detailed in the format requested. The document is a 510(k) clearance letter from the FDA, which confirms substantial equivalence to a predicate device, but does not typically include the full details of performance studies or acceptance criteria.
However, based on the information that can be extracted, here's what can be inferred and directly stated:
Device Name: DUTECK (MicHealth) Body Composition Analyzer, Model BSA Series (BSA-1505, -1506, -1508, -1605, -1606, -1608, -1705, -1706, -1708)
Regulation Name: Impedance plethysmograph
Product Code: MNW
Indications for Use: DUTECK (MicHealth) Body Composition Analyzer, BSA series are stand-on, non-invasive, reusable analyzers. They measure body weight and impedance and estimate body composition (body fat, body water, and skeletal muscle mass) by using the BIA method (bioelectrical impedance analysis). They are intended for use by healthy people aged 10 to 80, for effective lifestyle body composition assessment in the home environment.
Here's an attempt to answer the questions based on the limited information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or provide a table of performance data.
The FDA letter indicates that the device has been found "substantially equivalent" to legally marketed predicate devices. This means that the device's performance, as demonstrated in the 510(k) submission, was deemed comparable to that of a previously cleared device. However, the specific metrics and thresholds for that equivalence are not provided in this letter.
| Acceptance Criteria (Inferred from general BIA device standards) | Reported Device Performance (Not stated in document) |
|---|---|
| Accuracy of Body Fat Percentage measurement | Not provided in the document |
| Accuracy of Body Water measurement | Not provided in the document |
| Accuracy of Skeletal Muscle Mass measurement | Not provided in the document |
| Precision/Reproducibility of measurements | Not provided in the document |
| Safety (non-invasive, reusable) | Implied by "substantial equivalence" and general controls |
| Additional Information: The device uses Bioelectrical Impedance Analysis (BIA) and measures body weight and impedance to estimate body composition. |
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 available in the provided 510(k) clearance letter. Market clearance via a 510(k) relies on demonstrating substantial equivalence to a predicate device, which typically involves comparing device specifications and potentially limited performance data, but the detailed study protocols (sample size, data provenance) are not usually included in the public-facing clearance letter.
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 available in the provided document. The 510(k) letter does not detail the specifics of ground truth establishment for any performance studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided document. Adjudication methods are typically part of detailed clinical study protocols, which are not included in this clearance letter.
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 type of study is not applicable to this device. The DUTECK Body Composition Analyzer is a measurement device that estimates body composition using BIA, not an AI-assisted diagnostic tool that requires human readers for interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Given the nature of the device as a "stand-on, non-invasive, reusable analyzer" that "estimates body composition... by using BIA method," it operates as a standalone algorithm/device without human-in-the-loop performance for its core function of estimation. The user interacts with the device by standing on it, and the device then provides the estimations. The FDA letter confirms the device's ability to perform these estimations for "body fat, body water and skeletal muscle mass."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of ground truth used for any performance studies. For body composition analyzers, common ground truth methods in scientific studies include DEXA (Dual-energy X-ray absorptiometry), hydrostatic weighing, or direct chemical analysis (though the latter is usually for cadaver studies). The 510(k) letter does not reveal which, if any, of these methods were used for comparison.
8. The sample size for the training set
This information is not available in the provided document. Details about training sets are typically part of a detailed technical submission, not the public clearance letter.
9. How the ground truth for the training set was established
This information is not available in the provided document. Similar to the test set, the methods for establishing ground truth for any potential training set are not disclosed in this letter.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird with three wing-like shapes.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN - 7 2006
Mr. Joseph Chen President Duteck Industrial Co., Ltd. 3F-2, No. 26, Lane 513 Jui-Kuang Road Taipei, Taiwan 114 R.O.C.
Re: K060642
Trade/Device Name: DUTECK (MicHealth) Body Composition Analyzer, Model BSA Series (BSA-1505, -1506, -1508, -1605, -1606, -1608, -1705, -1706, -1708) Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: February 24, 2006 Received: March 10, 2006
Dear Mr. Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rottoned your Docurer of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass suned in the enactment date of the Medical Device Amendments, or to devices that provision 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 therefore, mainter and 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 Apploval), It they of be baciFederal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/0/Picture/10 description: The image shows a logo with the text "1906-2006 FDA Centennial" in a circular design. Below the logo, the text "Protecting and Promoting Public Health" is written in a decorative font. The logo appears to be a commemorative emblem for the FDA's centennial anniversary. The text emphasizes the organization's mission to safeguard and improve the well-being of the public.
{1}------------------------------------------------
Page 2 -
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 requirements 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.
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled; "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy Chogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Duteck Body Composition Analyzer 510(k) submission
000642 Page _ 1_of 510(k) Number: DUTECK (MicHealth) Body Composition Analyzer, Model BSA series Device Name: ( BSA-1505, BSA-1506, BSA-1508, BSA-1605, BSA-1606, BSA-1608, BSA-1705, BSA-1706, BSA-1708. )
Indications For Use:
DUTECK (MicHealth) Body Composition Analyzer, BSA series are stand-on, non-invasive, reusable analyzer, measure body weight and impedance and estimates body non-invasive, of body fat, body water and skeletal muscle mass by using BIA method (bioelectrical impedance analysis). They are intended to use by healthy people age 10 to 80, (offective lifestyles for body composition assessment in the home environment.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use_X (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
4-1
Nancy C. Brogdon
Renroductive. Abdomi and Radiological 510(k) Number
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.