The VSA 3000 - Vibratory Sensory Analyzer is a computerized device for the quantitative assessment of large nerve fiber dysfunction, designed for both clinical and advanced research applications. It measures the sensory threshold for vibration.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the VSA 3000 Vibratory Sensory Analyzer. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results to establish acceptance criteria and performance. Therefore, much of the requested information regarding acceptance criteria, specific study design, and statistical outcomes is not present in the provided document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as numerical performance targets (e.g., sensitivity, specificity, accuracy). The acceptance criteria for a 510(k) submission primarily revolve around demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed predicate device.
Reported Device Performance: The document describes the functionality and purpose of the device, but does not provide quantitative performance metrics (e.g., specific accuracy, precision, or diagnostic yield values).

What the document does state regarding performance/equivalence:

Acceptance Criteria (Implied by 510(k))	Reported Device Performance (Functionality & Equivalence)
Substantial Equivalence: Device is as safe and effective as legally marketed predicate devices.	"The VSA 3000 - Vibratory Sensory Analyzer is a computerized device for the quantitative assessment of large nerve fiber dysfunction..."
Similar Indications for Use: Addresses similar clinical needs as predicate devices.	"For use in the measurement of vibratory thresholds, or sensibility, in clinical situations where various neuropathies may exist."
Similar Technological Characteristics: Operates on similar principles and has comparable components.	"The various devices used in Vibration Threshold Measurement all operate by means of applying varying amounts of vibration to the skin by the use a controller which allows the operator to vary the amount of vibration delivered."
	"The VSA 3000 and Case IV both have data processing features while the Bio-Thesiometer and the Vibraton II do not." (Highlights a feature improvement over some predicates, implying at least equivalent, if not superior, functionality in this aspect).
Compliance with Standards: Meets relevant safety and performance standards.	"The VSA 3000 is designed and manufactured to meet various domestic and international standards such as: UL 544; UL 2601-1/1994; EN 60601-1-2."

2. Sample Size Used for the Test Set and Data Provenance:

Not provided. The 510(k) summary does not contain information about a specific test set or clinical study with a defined sample size for the VSA 3000 itself. The focus of the 510(k) is on comparing the device to existing predicates rather than presenting novel clinical performance data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not provided. This information would typically be part of a clinical study report, which is not included in this 510(k) summary.

4. Adjudication Method for the Test Set:

Not provided. Adjudication methods (e.g., 2+1, 3+1) are relevant to studies where multiple readers or experts independently assess cases, typically for diagnostic accuracy. This information is not present.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No indication of an MRMC study. The document does not mention any study comparing human readers with and without AI assistance, nor does it quantify an effect size for such a comparison. The VSA 3000 is described as a device for "measurement of vibratory thresholds," which implies a direct measurement tool rather than an AI-assisted diagnostic aid for human readers.

6. Standalone Performance Study (Algorithm Only):

No indication of a standalone performance study in the context of an algorithm's diagnostic accuracy. While the device itself performs measurements, the document does not present data from a "standalone" study in the sense of an algorithm's diagnostic performance without human-in-the-loop, as would be typical for AI/ML devices. The device is a standalone vibrating sensory analyzer, but its performance is described in terms of its function and equivalence, not as an algorithm's diagnostic output.

7. Type of Ground Truth Used:

Not provided. For a device that measures vibratory thresholds, the 'ground truth' would implicitly be the actual vibratory sensation perceived by the patient, often correlated with clinical diagnoses of neuropathy. However, the exact methodology for establishing this in a formal study is not detailed.

8. Sample Size for the Training Set:

Not applicable / Not provided. The VSA 3000 is a measurement device, not an AI/ML system that would typically have a "training set" in the context of machine learning model development.

9. How Ground Truth for the Training Set Was Established:

Not applicable / Not provided. As above, the concept of a "training set" ground truth as applied to AI/ML is not relevant here.

In summary: The provided document is a 510(k) substantial equivalence letter and summary. It focuses on demonstrating that the VSA 3000 is similar in indications for use, technology, and safety/effectiveness to predicate devices (Bio-thesiometer, Vibraton II, Case IV) that were already legally marketed. It does not contain the detailed clinical study data, acceptance criteria, or performance metrics typically found in documents for devices requiring de novo clearance or a PMA, especially those involving AI/ML. The "study" here is the assertion and argument for substantial equivalence, rather than a clinical trial proving specific performance against predefined statistical targets.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

MAY 1 1 2017

Mr. Emanuel A. Rosen, M.S., R.Ph. EARE Consulting Service P.O. Box 13009 88112 Eilat ISRAEL

Re: K970180

Trade/Device Name: VSA 3000 Vibratory Sensory Analyzer Regulation Number: 21 CFR 882.1200 Regulation Name: Two-point discriminator Regulatory Class: Class I Product Code: LLN Dated: January 8, 1997 Received: January 17, 1997

Dear Mr. Rosen:

This letter corrects our substantially equivalent letter of April 25, 1997.

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. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

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Page 2 - Mr. Emanuel A. Rosen

as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Michael J. Hoffmann -S

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K970180

Device Name:

VSA-3000 Vibratory Sensory Analyzer

Indications For Use:

For use in the measurement of vibratory thresholds, or sensibility, in clinical situations where various neuropathies may exist.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thomas J. Callahon

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number _ K970/80

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

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K970180

APR 25 1997

510(K) SUMMARY [as per 21 CFR 807.92]

8 January, 1997

Product: VSA 3000 - Vibratory Sensory Analyzer

Submitted by:

Emanuel A. Rosen - official correspondent for MEDOC LTD., Ramat Yishai, Israel P.O. Box 1309

Eilat, ISRAEL

Tel: International + 972 7 637-9645 Fax: International + 972 7 633-1069

Other commercially available devices:

Bio-thesiometer - Bio-Medical Instruments Co. - available for over 50 years. Vibraton II, Vibration Sensitivity Tester - Sensortek - K863607 approved 1986 Case IV - WR Medical Electronics Co. - K910624 approved in 1993

Metabolic neuropathies Neurological disease associated with the workplace Neuropathies due to drug toxicity Pain assessment Lesions of the central nervous system

Vibratory testing is also a useful tool in tracking the progression of disease or response to treatment.

Page 1 of 2

0004

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510(K) SUMMARY [as per 21 CFR 807.92]

Page 2 of 2 8 January, 1997

The VSA 3000 can also be used in the early detection and clinical evaluation of peripheral nerve dysfunction as well as being a useful tool in tracking the progression of disease or response to treatment.

The various devices used in Vibration Threshold Measurement all operate by means of applying varying amounts of vibration to the skin by the use a controller which allows the operator to vary the amount of vibration delivered.

The patient then indicates awareness of the vibrations either verbally or, in the VSA 3000, by pressing a patient response button. There are various protocols available for testing sensitivity such as Forced choice. Limits, Levels and Staircase, from which the tester may choose.

The VSA 3000 and Case IV both have data processing features while the Bio-Thesiometer and the Vibraton II do not.

All the devices are similar in their energy source and design as well as meeting the various standards for clinical safety.

The VSA 3000 is designed and manufactured to meet various domestic and international standards such as:

UL 544; UL 2601-1/1994; EN 60601-1-2.

0005

Regulation Number and Section

§ 882.1200 Two-point discriminator.

(a)
Identification. A two-point discriminator is a device with points used for testing a patient's touch discrimination.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.