The XPOD/XMAP is a nerve stimulation device intended to be used by an anesthetist during regional anesthesia procedures wherever peripheral anesthesia is normally applied. The XMAP is intended for percutaneous nerve mapping using the non-invasive Nerve Mapping Probe (supplied). The XPOD is intended for nerve localization using invasive electrodes/neEdles (not supplied).

Device Description

The XPod/XMap devices are battery powered peripheral nerve stimulators that can be used for

nerve mapping using the non-invasive Nerve Mapping Probe (supplied)
nerve locating using invasive electrodes/needles (not supplied)
The stimulus is generated by a constant current source. The waveform is a square wave with 2 options for pulse width. These are: 0.1 and 0.3 milliseconds.
The units will continuously check for a closed circuit at 2Hz. Once a closed circuit is detected, the twitches will repeat at 2Hz, until an open circuit is detected.
Visual feedback of the current amplitude as well as pulse-width is given by means of an LCD screen.
The unit is permanently attached to the anode. The anode comprises a modified ECG type pad. The cathode comprises a permanently attached nerve mapping probe, in the XMap model, and a separate nerve locating needle in the XPod model.

AI/ML Overview

The provided document is a 510(k) summary for the XAVANT Technology XPOD/XMAP Nerve Stimulator. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding performance metrics, sample sizes, ground truth establishment, or expert involvement as requested.

Therefore, I cannot provide the requested table and information based on the input text. The document focuses on regulatory submission and affirmation of substantial equivalence rather than performance study results.

Here's what I can extract from the provided text for relevant sections, noting the absence of the requested performance study details:

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

Cannot be provided. The document does not describe acceptance criteria or report performance data from a study. It outlines technological characteristics (e.g., current ranges, pulse width, voltage) but does not present these as performance metrics against acceptance criteria.

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

Cannot be provided. The document does not mention any clinical or performance studies, and therefore, no sample size for a test set or data provenance is detailed.

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)

Cannot be provided. No test set or ground truth establishment process is described.

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

Cannot be provided. No test set or adjudication method 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

Cannot be provided. This device is a nerve stimulator, not an AI-assisted diagnostic tool. An MRMC study is not relevant here, and no such study is mentioned.

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

Cannot be provided. This device is a hardware nerve stimulator, not an algorithm. Standalone performance as typically understood for AI or software is not applicable or detailed.

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

Cannot be provided. No ground truth establishment is described.

8. The sample size for the training set

Cannot be provided. No training set is mentioned as this is a hardware device, not a machine learning model.

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

Cannot be provided. No training set or ground truth establishment is described.

Summary of what the document does provide:

Device Description: The XPOD/XMAP devices are battery-powered peripheral nerve stimulators used for nerve mapping (XMAP) and nerve localization (XPOD).
Technological Characteristics:
- Stimulus Modes: Square wave, repeating at 2Hz.
- Current Ranges:
  - XMAP: 0 - 20mA (adjustable in 1mA increments)
  - XPOD: 0.0 - 1.6mA (adjustable in 0.1mA increments); 1.6 - 5.0mA (adjustable in 0.2mA increments)
- Pulse Width: 0.1ms, 0.3ms
- Stimulation Voltages: Max 100V p-p for both XMAP and XPOD.
- Waveform: Constant Current Monophasic Squarewave.
Intended Use: Used by an anesthetist during regional anesthesia procedures wherever peripheral anesthesia is normally applied.
Predicate Devices: HDC CORP, Neuro-Trace III (K023342) and Stockert GmbH, Stimuplex HNS12 (K052313).
Conclusion: The device is found substantially equivalent to predicate devices based on design, function, materials, operational principles, and intended use. This implies that the device is expected to perform adequately for its intended purpose, similar to existing devices on the market, but does not include explicit performance study data or acceptance criteria against which it was tested.

Summary

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SECTION 4

K072092

ION 4 -- 510(k) SUMMARY SECT

NOV 1 5 2007

[As required by 21CFR807.92]

Image /page/0/Picture/5 description: The image shows the logo for Xavant Technologies. The logo features a large, bold "X" followed by the word "AVANT" in a similar bold font. Below "AVANT" is the word "TECHNOLOGIES" in a smaller, less bold font.

4.1 Date Prepared [21CFR807.92(a)(1)]

July 26, 2007

4.2 Submitter's Information [21CFR807.92(a)(1)]

Company Name:	XAVANT Technology (Pty) LTD
Street Address:	181 Soutpansberg Road, Rietondale
City:	Pretoria
State/Province:	Gauteng
Country:	South Africa
Telephone:	+27(0) 12 329 1188
Facsimile:	+27(0) 86 671 8334
Contact Person:	Roché van Rensburg
Contact Title:	Director
Contact Email:	roche@xavant.com

4.3 Trade Name, Common Name, Classification [21CFR807.92(a)(2)]

Trade Name:	The XPOD/XMAP Nerve Stimulator
Common Name:	Battery Powered Peripheral Nerve Stimulator
Classification Name:	Battery Powered Nerve Stimulatorper 21 CFR § 868.2775
Device Class:	Class II
Product Code:	BXN

XAVANT Technology Nerve Stimulator

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SECTION 4

4.4 Identification of Predicate Device(s) [21CFR807,92(a)(3)]

PREDICATE DEVICES
HDC CORP, Neuro-Trace III
(K023342)
Stockert GmbH, Stimuplex HNS12
(K052313)

There are no significant differences between the XPOD/XMAP Nerve Stimulator and the predicate devices which would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use.

4.5 Description of the Device [21CFR807.92(a)(4)]

The XPod/XMap devices are battery powered peripheral nerve stimulators that can be used for

nerve mapping using the non-invasive Nerve Mapping Probe (supplied) ﻬ
nerve locating using invasive electrodes/needles (not supplied) ◆ ◆

The stimulus is generated by a constant current source. The waveform is a square wave with 2 options for pulse width. These are: 0.1 and 0.3 milliseconds.

The units will continuously check for a closed circuit at 2Hz. Once a closed circuit is detected, the twitches will repeat at 2Hz, until an open circuit is detected.

Visual feedback of the current amplitude as well as pulse-width is given by means of an LCD screen.

The unit is permanently attached to the anode. The anode comprises a modified ECG type pad. The cathode comprises a permanently attached nerve mapping probe, in the XMap model, and a separate nerve locating needle in the XPod model.

4.6 Intended Use [21CFR807.92(a)(5)]

XAVANT Technology Nerve Stimulator

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SECTION 4 4.7 Technological Characteristics [21CFR807.92(a)(6)]

Stimulus Modes

Square wave, repeating at 2Hz

Current Ranges

Xmap:	0 - 20mA adjustable in 1mA increments
Pulse Width:	0.1ms, 0.3ms
Xpod:	0.0 - 1.6mA adjustable in 0.1mA increments
	1.6 - 5.0mA adjustable in 0.2mA increments
Pulse Width:	0.1ms, 0.3ms

Stimulation Voltages

XMap:	Max 100V p-p
XPod:	Max 100V p-p

Waveform

Constant Current Monophasic Squarewave

Nerve Mapping Probe

Ergonomically designed cutaneous Nerve Mapping Probe

Technical Specifications

Power Supply	2x 1.5V AAAA Alkaline Batteries
Weight	60g
Dimensions	80mm x 80mm x 22mm

XAVANT Technology Nerve Stimulator

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and four horizontal bars above it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 5 2007

Mr. Roche Van Rensburg Director Xavant Technology Party, Limited 181 Soutpansberg Road, Rietondale Pretoria, Gauteng 0084 South Africa

Re: K072092

Trade/Device Name: XPOD/XMAP Nerve Stimulator Regulation Number: 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: II Product Code: BXN Dated: October 5, 2007 Received: October 29, 2007

Dear Mr. Rensburg:

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.

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Page 2 - Mr. Rensburg

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 (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.

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) 276-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Liu, Ph.D.

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

Device Name:
--------------

The XPOD/XMAP Nerve Stimulator

Indications for Use:

Prescription Use × (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)

Mrij Thlhl

Comment sion of Anesthesion)
Non of Anesthesiology, General Hornital,
Continuesthesional Device: Device al Chirol, Dental Device

Regulation Number and Section

§ 868.2775 Electrical peripheral nerve stimulator.

(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).