PS-2100 is a device for the quantitative detection of sensory neurological impairments. The population of subjects for whom this device may be used include any individual capable of communicating their perception of cutaneous sensation. PS-2100's examination may be conducted as part of a routine neurological examination or as a screening procedure. This device may be used by healthcare professionals to evaluate or diagnose a patient for peripheral neuropathy.

Device Description

The PS-2100 is a type of Sensory Nerve Threshold Measurement System Device. The electrical stimulus is applied in gradually increasing amounts to the electrode attached to the patient. Disposable gel electrodes are attached to the patient connecting the electrode. The current value at which the patient initially senses the stimulation is referred to as the Current Perception Threshold (C.P.T.) value. Measurement may be conducted in one of two modes - Standalone mode by which the device itself is used for measurements, and System mode whereby the device is connected to a personal computer for administration of data. The patient is provided a hand switch to cease measurement at any time during the test.

AI/ML Overview

The provided text is a 510(k) summary for the PS-2100 device, which is a Sensory Nerve Threshold Measurement System. This document focuses on demonstrating substantial equivalence to a predicate device (NEUROMETER K853608) rather than presenting a detailed clinical study for acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be fully extracted from this document. The document lists the device's indications for use and general information but does not contain the specifics of a clinical validation study with performance metrics, sample sizes for test or training sets, expert qualifications, or comparative effectiveness.

Here’s what can be inferred or directly stated from the provided text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not Explicitly Stated in Document)	Reported Device Performance (Not Explicitly Stated in Document)
The document does not explicitly state quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy, or specific thresholds for CPT values relative to a gold standard).	The document does not provide quantitative reported device performance data against specific acceptance criteria. It states the PS-2100 is a "Sensory Nerve Threshold Measurement System" and measures the "Current Perception Threshold (C.P.T.) value," but no performance metrics are given.

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

Sample Size for Test Set: Not specified in the document.
Data Provenance: Not specified in the document. The document is a 510(k) summary focused on substantial equivalence, not a clinical study report.

3. Number of Experts Used to Establish Ground Truth and Qualifications

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

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

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

MRMC Study: An MRMC comparative effectiveness study is not mentioned in this document. The focus is on demonstrating substantial equivalence to a predicate device, which usually involves comparing technical characteristics and indications for use, rather than a direct comparison of human performance with and without the device.
Effect Size of Human Readers Improvement: Not applicable, as no MRMC study is detailed.

6. Standalone (Algorithm Only) Performance Study

Standalone Performance Study: Not explicitly described as a performance study in the context of clinical metrics. The document mentions a "Standalone mode by which the device itself is used for measurements," but this refers to the operational mode of the device without a connected computer, not an algorithm-only performance study in the regulatory sense. The device measures "Current Perception Threshold" (CPT), which is a direct physiological measurement, not an AI algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: Not specified in relation to a performance study. The device measures the "Current Perception Threshold (C.P.T.) value," which itself could be considered a form of "ground truth" for sensory perception at a given point in time, but the document does not describe how this would be validated against an independent, objective ground truth for clinical performance.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. The PS-2100 is described as a "Sensory Nerve Threshold Measurement System" that applies an electrical stimulus and measures the C.P.T. value. This is a direct measurement device, not an AI/ML-based algorithm that would typically require a training set.

9. How Ground Truth for the Training Set Was Established

How Ground Truth Was Established: Not applicable, as there is no mention of a training set for an AI/ML algorithm.

In summary, the provided document is a regulatory submission (510(k) summary) aiming to establish substantial equivalence for the PS-2100 device. It does not contain the detailed information typically found in a clinical study report that would describe acceptance criteria and performance data for a device, especially not for an AI/ML system.

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 & Human Services. The logo consists of the department's name arranged in a circular fashion around a stylized symbol. The symbol is a representation of a human figure embracing a bird, which is meant to symbolize the department's mission of protecting the health of all Americans and providing essential human services.

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

MAY : 1 2017

Mr. James R. Greenwood. Ph.D., M.P.H Chairman, Regulatory Advisor Osachi Co., Ltd. c/o International Medical Device Partners. Inc. 3027 E. Sunset Rd., Suite 105 Las Vegas, NV 89120

Re: K072882

Trade/Device Name: PS-2100 Regulation Number: 21 CFR 882.1200 Regulation Name: Two-point discriminator Regulatory Class: Class I Product Code: LLN Dated: October 10, 2008 Received: November 7, 2008

Dear Dr. Greenwood:

This letter corrects our substantially equivalent letter of January 8, 2009.

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. Iisting 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

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Page 2 - Dr. James R. Greenwood

medical device-related adverse events) (21 CFR 803); 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.

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.

for

Sincerely yours, Michael J

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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510(k) Notification - PS-2100

K072882

JAN - 8 2009

C. 510(K) summary

1. General Information

Submitter's Name Address Telephone Contact Person .
: OSACHI Co., Ltd. : 9-11, Osachikohagi 2-chome, Okaya-shi, Nagano, Japan : 81-266-280866 : Dr. James R. Greenwood Ph. D., M.P.H. Registration Number : 8043882

2. Device

Name	: PS-2100
Trade Name	: PS-2100
Common Name	: Sensory Nerve Threshold Measurement System
Classification Name	: device, vibration threshold measurement
Product Code	: LLN
Class	: II

3. Identification of Legally Marketed Devices

Name	: NEUROMETER
K Number	: K853608

4. Product Overview

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510(k) Notification - PS-2100

Image /page/3/Figure/1 description: This image is a graph that shows the degree of perceived sensation over time. The x-axis is labeled "Time" and the y-axis is labeled "Degree of Perceived Sensation". There is a line that represents the minimum perception current, and another line that represents the stimulating current gradually increased. The point where the two lines intersect is labeled "CPT" and the sensation experienced by stimulating current.

5. Indication for use

PS-2100 is a device for the quantitative detection of sensory neurological impairments. The population of subjects for whom this device may be used include any individual capable of communicating their perception of cutaneous sensation. PS-21.00's examination may be conducted as part of a routine neurological examination or as a screening procedure. This device may be used by healthcare professionals to evaluate or diagnose a patient for peripheral neuropathy.

6. Standard compliance list

Application Standard	ISO13485:2003	IEC60601-1-1:2000
	IEC60601-1:1988+A1+A2	IEC60601-1-2:2004
	IEC60601-2-40:1998	ISO10993-1:2003

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Image /page/4/Picture/0 description: The image shows a simple freehand drawing with a few distinct elements. A long, slightly curved line extends vertically, positioned towards the left side of the frame. To the right of this line, there's a rough sketch of a quadrilateral, resembling a rectangle or parallelogram, with dashed lines indicating some of its edges, suggesting it might be a 3D representation or an incomplete shape.

Applicant: OSACHI CO., LTD.

510(k) Number : K072882

Device Name: PS-2100

Indications for Use:

Prescription Use	✓
(Part 21 CFR 801 Subpart D)

123,533

Over-the-Counter-Use (Part 21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millican

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number

Page 1 of 1

B=1

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.