The Xilas Medical VPT Meter is designed to identify patients with sensory neuropathy. These patients have lost sensation and the "gift of pain" from their extremities or elsewhere. The instrument provides a quantitative measurement of vibration perception threshold (VPT). The digital device allows the clinician to quantify the loss of sensation, initially to establish a baseline loss of sensation and subsequently monitor the progression of established pathology.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Xilas Medical VPT Meter, which is a vibration threshold measurement device. However, the document does not contain explicit acceptance criteria, detailed study designs, or comprehensive performance data in the format requested.

The text focuses on establishing substantial equivalence to a predicate device (Vibrameter, Somedic AB) by comparing design, functionality, and intended use. While it mentions "Testing of the device (included with this submission) demonstrates the VPT Meter to be both safe and efficacious," it does not provide the specifics of these tests.

Therefore, much of the requested information cannot be extracted directly from the provided document. I can only report what is implicitly stated or where there is a lack of information.

Here's a breakdown based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:

Safety: Implicitly, the device must be safe for human use. (Specific criteria not provided)
Efficacy: Implicitly, the device must be efficacious in measuring vibration perception threshold. (Specific criteria not provided)
Substantial Equivalence: The device must demonstrate similar intended use, characteristics, and performance to the predicate device, the Vibrameter. (Specific performance metrics for equivalence not provided)

Reported Device Performance:
The document states that "Testing of the device (included with this submission) demonstrates the VPT Meter to be both safe and efficacious." However, it does not provide any quantitative or qualitative data on how this safety and efficacy were demonstrated, nor does it present specific performance metrics like sensitivity, specificity, accuracy, or agreement with a gold standard. The primary performance assertion is that it is substantially equivalent to the predicate device.

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

Test Set Sample Size: Not explicitly stated. The document mentions "Testing of the device (included with this submission)," but the sample size of subjects or data used in these tests is not provided.
Data Provenance: Not explicitly stated.

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

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

Adjudication Method: Not mentioned.

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

MRMC Study: Not mentioned. The document focuses on device-to-predicate comparison rather than human reader performance with/without AI assistance. The device itself is a measurement tool, not an AI diagnostic aid for human readers.
Effect Size: Not applicable as no MRMC study is mentioned.

6. Standalone (Algorithm Only) Performance

Standalone Performance Study: The device itself is a standalone measurement instrument. The document implies its performance was evaluated to ensure safety and efficacy, and substantial equivalence, but detailed "standalone performance" metrics (like accuracy against a true vibratory threshold) are not provided. The comparison made is against another device (the predicate), not an absolute ground truth.

7. Type of Ground Truth Used

Ground Truth Type: Not explicitly stated. For a vibration perception threshold device, ground truth would ideally be derived from a highly accurate, perhaps laboratory-grade, reference vibratory stimulus or established clinical benchmarks. The document's closest mention to a "ground truth" is the comparison to the predicate device, implying that the predicate's measurements serve as a reference for equivalence, but not necessarily a "true" physiological ground truth.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is a measurement instrument, not an AI/machine learning algorithm that requires a training set in the conventional sense.

9. How Ground Truth for the Training Set Was Established

Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

Public Health Service

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

Mr. Ruben G. Zamorano President Xilas Medical, Inc. 12665 Silicon Drive San Antonio, Texas 78249

11 2017 MAY

Re: K030829

Trade/Device Name: Vibration threshold measurement device Regulation Number: 21 CFR 882.1200 Regulation Name: Two-point discriminator Regulatory Class: Class I Product Code: LLN Dated: September 30, 2003 Received: October 2, 2003

Dear Mr. Zamorano:

This letter corrects our substantially equivalent letter of December 5, 2003.

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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

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Page 2 - Mr. Ruben G. Zamorano

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.

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/ResourcesforYou/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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Indications for Use

510(k) Number (if known): K030829

Device Name: _VPT Meter

Indications For Use:

The VPT Meter is an instrument designed to measure simply and accurately the threshold of appreciation of vibration in human subjects.

Presctiption Use XX (Part 2) CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off)
Division of General, Restorative and Neurological Devices
K(k) Number	1030829
Page	1 of 1

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September 30, 2003

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is K030829.

1. Submitter:
  Xilas Medical Inc. (formerly Salix Medical, Inc.) 12665 Silicon Drive San Antonio, Texas 78249

Name of Device: 2.

Vibration Perception Threshold (VPT) Meter

3. Predicate Device Information:

The VPT Meter is similar to the following predicate device: 1) Vibrameter, Somedic AB, Stockholm, Sweden (510(k) number K843486).

4. Device Description:

5. Intended Use:

The VPT Meter is an instrument designed to measure simply and accurately the threshold of appreciation of vibration in human subjects.

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K030829 2/2

Substantial Equivalence: 6.

The Xilas Medical VPT Meter is substantially equivalent to the Vibrameter, a product produced by Somedic AB, Stockholm, Sweden.

Both devices consist of a control box and a handheld vibration apparatus. The ● handheld apparatus on both devices is similar in size, shape and weight and both use a tip to transfer vibrations to the patients skin.
Both devices have a digital display and easy access to the control mechanism on ● the face of the box.
Both devices are free standing and independent and do not require a computer ● interface to achieve the desired output.
Both devices vibrate at a similar frequency and vibration displacement. ●
Both devices ramp up power to the handheld vibration apparatus, which changes ● the amplitude of the vibration displacement at the tip.
Both devices are dependent on patient acknowledgement of the level where ● vibration is being felt.
The Vibrameter measures in microns and the VPT Meter measures in volts, . however in the VPT Meter User's Manual a conversion graph is provided that represents the relationship between microns and volts.
Both devices are easy-to-use and non-invasive. .
Both devices are designed to be used as a clinical assessment tool by health care . professionals to evaluate peripheral sensory neuropathy on the upper and lower extremities.

7. Conclusions:

The Xilas Medical VPT Meter has the same intended use and similar characteristics to the Somedic AB Vibrameter. Testing of the device (included with this submission) demonstrates the VPT Meter to be both safe and efficacious. Therefore, the VPT Meter is substantially equivalent to the predicate product, the Vibrameter.

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.