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Ohmnsiscan NG is a non prescription device and is used on healthy subjects with no known disease or condition, and is identified as used for generally healthy adults (18-65). It is used to estimate the following:

• Impedance(Z in ohms) .
• Total body water (TBW in L and in %) .
• Lean Mass(LM in KG) .
• Fat Mass (FM in KG and %) .
• Basal Metabolism(Kcal) .
• Daily energy needs(Kcal) ●
• B.M.I. (Body Mass Index). .

Ohmniscan NG is a high performance portable bioimpedance measuring device that enables evaluation of daily energy needs, fat mass (in % of total weight and in kg), lean mass (in kg) hydric condition (in % of total weight and in kg), body mass index, using a painless micro current technique.
It is used for the initial assessment and for treatment monitoring. Regular check allows fat loss to be monitored and the results are used as a highly motivational tool.
Ohmniscan NG releases a very low intensity alternating current at a 50 KHz frequency, by applying the four polar methods to measure the body resistance. This measurement determines the client's impedance.
Ohmniscan NG enables the creation of 100 customer cards with upto 8 measurements of the customer, their records, the interpretations, and the comparison between 2 measurements of the same client. It enables the creation of a customer file with surname, first name, sex, race, age, height, weight, activity, date of measurement, interpretation, and comparisons. Its fast measuring function allows calculations to be made in a minimum amount of time and they can be interpreted later. The unit comes complete with pen, connection wires and electrodes. The device is delivered with printer for ticket results.

The provided text is a 510(k) summary for the Ohmniscan NG device, which is a bioimpedance measuring device intended for body composition analysis. The core of this submission is to demonstrate substantial equivalence to a predicate device, not to present a de novo study with detailed acceptance criteria and performance data for the Ohmniscan NG itself.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this document. The document primarily focuses on comparing the new device to the predicate device to assert substantial equivalence.

Here's an breakdown based on the provided text, indicating where information is present and where it is not:

Acceptance Criteria and Device Performance Study

The K073334 510(k) summary does not describe specific acceptance criteria or an independent study conducted to prove the Ohmniscan NG device meets those criteria with performance metrics like sensitivity, specificity, or accuracy. Instead, the submission's goal is to establish "substantial equivalence" to a legally marketed predicate device (Bodystat K002835).

The manufacturer asserts that "besides the point that Ohmniscan NG comes with the printer for ticket results, there are no differences between the Multiwell Machine, Ohmniscan NG and the predicate device specifications, and therefore no new issues are raised regarding safety and effectiveness. There are no differences in the technological characteristics or in the intended use of these devices."

This means the "acceptance criteria" here are met by demonstrating the new device is functionally and technologically identical to the predicate device, excluding a minor accessory (the printer).

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

No explicit table of acceptance criteria or reported device performance metrics (e.g., accuracy, precision) for the Ohmniscan NG is provided in this 510(k) summary. The "performance" is implicitly tied to being substantially equivalent to the predicate device.

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

Not applicable. The document does not describe a clinical study or a test set of data used to evaluate the Ohmniscan NG device's performance independently. The claims are based on similarity to a predicate device.

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)

Not applicable. No test set requiring expert ground truth establishment is described.

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

Not applicable. No test set requiring adjudication is 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

Not applicable. The Ohmniscan NG is a standalone bioimpedance analyzer, not an AI-assisted diagnostic tool that would involve human readers.

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

The device itself is a standalone bioimpedance measuring device. However, a standalone performance study with specific metrics (e.g., accuracy against a gold standard) is not described in this 510(k) summary. The submission relies on the device's functional equivalence to its predicate.

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

Not applicable. No ground truth reference is mentioned as part of a performance study for the Ohmniscan NG in this document.

8. The sample size for the training set

Not applicable. This device does not appear to involve machine learning models that would require a "training set" in the conventional sense.

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

Not applicable, as there is no mention of a training set for machine learning.

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