The Balance Rehabilitation Unit (BRUTM) is a system that enables the functional assessment and training/retraining of patients with balance disorders, vertigo or instability.

Device Description

The Balance Rehabilitation Unit (BRUTM) is composed of a static force platform, virtual reality projection goggles, a head tracker for sensing head movements, a safety frame, a harness, an accessory kit for different exercises, and a computer to generate stimuli.

The system performs a sequence of posturographies while the patient is receiving different visual stimuli (images displayed on the projection goggles). By using the different stimuli to identify the patient's weakness a tailored rehabilitation program with specific perceptual cues can be designed for each patient.

The Balance Rehabilitation Unit (BRUTM) performs an assessment of the impaired postural skills of patients through a series of posturographies with different sensory stimuli. The posturographies are performed using a forcemeasuring platform, which helps the physician evaluate the patient's performance. The sensory stimuli used with the Balance Rehabilitation Unit (BRUTM) include visual stimuli, through virtual reality projection goggles, somatosensorial stimuli, and vestibular stimuli.

AI/ML Overview

The provided text does not contain acceptance criteria or a detailed study sufficient to fulfill your request comprehensively.

The document, K070085 for the WEIDMANN (Medicaa) BRUTM - Balance Rehabilitation Unit, is a 510(k) summary for premarket notification to the FDA. Its primary purpose is to demonstrate substantial equivalence to a predicate device, not to present a detailed performance study with acceptance criteria.

Here's what can be extracted based on your request, along with what is explicitly missing:

The key statement regarding testing is:

"A clinical study has confirmed the clinical efficacy of the Balance Rehabilitation Unit (BRUTM)."

This is a very high-level statement and lacks all the specific details you've asked for.

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

Acceptance Criteria	Reported Device Performance
Not provided.	Not provided.
(No specific quantitative or qualitative criteria for success were mentioned in relation to a study.)	(The exact results or measures of efficacy from the "clinical study" are not presented.)

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

Sample Size for Test Set: Not specified.
Data Provenance: The document states Medicaa is based in Montevideo, Uruguay. It doesn't explicitly state the country of origin for the clinical study data or whether it was retrospective or prospective.

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)

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

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

Adjudication Method: Not specified.

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

MRMC Study: The device is a 'Balance Rehabilitation Unit' and not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC study in the context of human readers improving with AI assistance is not applicable to this device type. The document does not mention any MRMC study.
Effect Size: Not applicable/not specified.

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

The device performs "posturographies" and "helps the physician evaluate the patient's performance." While it uses a computer to generate stimuli, it's presented as a tool for assessment and training that would involve a physician/human in the loop. The concept of "standalone algorithm performance" as typically applied to AI diagnostic tools is not directly relevant or discussed in the context of this device. No standalone performance study is mentioned.

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

The document implies the device measures "imparied postural skills" and assesses "clinical efficacy." This suggests the "ground truth" would likely be related to clinical observations or outcomes regarding balance disorders, vertigo, or instability but the specific methodology for establishing this is not detailed.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device does not inherently describe a machine learning model with a distinct "training set" in the way an AI diagnostic tool would. The "clinical study" mentioned would be for validation, not training.

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

How Ground Truth Established: Not applicable, as there's no mention of a training set for an AI model.

In summary: The provided text is a regulatory submission focused on substantial equivalence to a predicate device for marketing purposes. It briefly mentions a "clinical study" to confirm "efficacy" but lacks the detailed methodologies, acceptance criteria, sample sizes, expert qualifications, and ground truth definitions that would typically be found in a comprehensive study report or a more detailed technical overview of device performance.

Summary

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K070085

WEIDMANN

Developments for a better life

FEB 2 6 2007

510(k) Summary

(per 21 CFR 807.92)

I. Applicant Medicaa (Uruguay) S.A. Miraflores 1476 11500, Montevideo Uruguay Phone: +(598) 2 601 3998 Fax: +(598) 2 601 3839

Contact Person: Rodolfo Oppenhemier, CEO roppenheimer@medicaa.com

December 21, 2006 Date Prepared:

II. Device Name

BRUTM - Balance Rehabilitation Unit Proprietary Name: Common/ Usual Name: Apparatus, vestibular analysis Platform, force-measuring Classification Name: Unclassified / Force-measuring platform Regulation Number: Unclassified / 890.1575 Product Codes: LXV / KHX Classification: Unclassified / 1、 Ear, Nose& Throat / Physical Medicine Classification Panel:

III. Predicate Device

The Balance Rehabilitation Unit (BRU™) is substantially equivalent to the Balance Manager from Neurocom International, Inc. The Balance Manager was cleared by the FDA on August 4, 1995 under 510(k) K946229.

IV. Intended Use of the Device

Balance Evaluation and Rehabilitation

The Balance Rehabilitation Unit (BRU™) is a system that enables the functional assessment and training/retraining of patients with balance disorders, vertigo or instability.

V. Description of the Device

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REEDECK
Developments for a better life

Summary of the Technical Characteristics VI.

Testing VII.

A clinical study has confirmed the clinical efficacy of the Balance Rehabilitation Unit (BRUTM).

Safety & Effectiveness VIII.

There are no substantial differences between the Balance Rehabilitation Unit (BRUTM) and the predicate device. They have the same intended use and similar technological characteristics.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medicaa (Uruguay) S.A. C/O Ian P. Gordon Vice President Emergo Group, Inc. 1101 South Capital Texas Hwy, Suite F254 Austin, TX 78746

FEB 2 6 2007

Re: K070085

Trade/Device Name: Balance Rehabilitation Unit (BRUTM) Regulation Number: Unclassified Regulation Name: Vestibular analysis apparatus Regulatory Class: Unclassified Product Code: LXV and KHX Dated: December 26, 2006 Received: January 10, 2007

Dear Mr. Gordon:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) 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 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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.

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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 (240) 276-0115. 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/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indication for Use Statement

510(k) Number (if known):

Device Name:

Balance Rehabilitation Unit (BRUTM)

Indications for Use:

Balance Evaluation and Rehabilitation

The Balance Rehabilitation Unit (BRUTM) is a system that enables the functional assessment and training/retraining of patients with balance disorders, vertigo or instability.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millane

(Divi: n a Sign-Off) (Division of General, Restorative, and Neurological Devices

510(k) Number

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Regulation Number and Section

N/A