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Duteck (micHealth) Digital Clinical Thermometer, DT2306 series (product code FLL) is used to measure human body temperature with the following features:

The device display body temperature in digital format at LCD
The device make intended contact with patient in 2 ways
(1) Surface contact: armpit.
(2) Invasive contact: oral.
The device is used and installed by patients, Nurses, doctors and people with the exception of handicapped people and children.
The device is used in ENVIRONMENT of room temperature and normal environment condition.

Duteck (micHealth) Digital Clinical Thermometer, DT2306 series is hand-held, reusable, battery operated device that can measure human body temperature via the human oral and armpit.

The provided document does not contain a study or data to establish acceptance criteria for the Duteck (micHealth) Digital Clinical Thermometer, DT2306 series. Instead, it presents a 510(k) summary claiming substantial equivalence to a predicate device (Duteck Digital Clinical Thermometer K992327).

The document focuses on comparing the technical characteristics and intended use of the new device with its predicate device. It states that the new device "had been tested to the appropriate electrical tested standard and biocompatibility standards and have been found safe for intended use." However, it does not provide any specifics about these tests, the acceptance criteria used, or the results obtained.

Therefore, I cannot fulfill your request for the tables and study details based on the provided text.

Here is an analysis of what can be extracted or inferred from the document regarding the acceptance criteria and performance, and why the other points cannot be addressed:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the document. The document only provides technical specifications for both the new device and the predicate device. It does not list specific performance metrics with associated acceptance criteria and the actual performance achieved against those criteria in a study.

Note: The "Acceptance Criteria" column above is based on the reported characteristics of the new device and the comparison to the predicate, as explicit acceptance criteria are not provided. The document states that the device "had been tested to the appropriate electrical tested standard and biocompatibility standards and have been found safe for intended use," but does not detail the results of these tests or the specific pass/fail criteria.

Study Details (Not Available in the Document)

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than presenting detailed study results for establishing performance against novel acceptance criteria. It refers to "performance and safety. testing" but provides no specifics.

Therefore, the following information cannot be provided from the given text:

2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
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 digital clinical thermometer, not an AI-powered diagnostic tool engaging with human readers.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This is a non-AI device. While its performance is standalone, no separate analysis is provided given the information.
7. The type of ground truth used: Not mentioned. For a thermometer, the "ground truth" would likely involve comparison to a highly accurate reference thermometer, but this is not detailed.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set in the typical sense.
9. How the ground truth for the training set was established: Not applicable.

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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.

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.

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The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal.

The provided document is a 510(k) clearance letter for an infrared ear thermometer (Michealth ET 1100/ET 1200). It primarily focuses on the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, sample sizes, ground truth establishment, or specific performance metrics.

The letter confirms the device's classification, indications for use, and regulatory compliance. It does not include information from the technical submission (which would detail the design, testing, and performance studies).

Therefore, based solely on the provided text, I cannot describe:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned, and generally not applicable for a standalone thermometer.
6. If a standalone performance (algorithm only without human-in-the-loop) was done: While the thermometer is a "standalone" device, the performance study details are not here.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not applicable as it's not an AI/ML algorithm requiring a training set in the modern sense. Performance is typically evaluated against calibrated reference thermometers.
9. How the ground truth for the training set was established: Not applicable.

To answer your questions thoroughly, you would need to consult the actual 510(k) submission (e.g., the "traditional 510(k)" or "special 510(k)" documentation) that contains the detailed performance studies, clinical equivalency data, and engineering specifications. This letter is merely the FDA's decision based on reviewing that submission.

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