MODEL 1210, MEDIUM E-NET by PHYSIOMETRIX, INC.

The e-Net serves two functions as a part of the Hydro Dot NeuroMonitoring System. First, it locates the EEG electrodes according the 10-20 International System. Secondly, it conducts the electrical signal sensed by the electrodes from the skin to the EEG equipment.

Device Description

The Medium e-Net is designed to fit patients with a head size in the range of 48 - 54 cm in circumference. It is constructed using the same materials and manufacturing processes as the larger sized net (54 - 62 cm) which is described in K930080. The e-Net serves two functions as a part of the Hydro Dot NeuroMonitoring System. First, it locates the EEG electrodes according the 10-20 International System. Secondly, it conducts the electrical signal sensed by the electrodes from the skin to the EEG equipment. The Medium e-Net is fabricated from the same materials as the larger version. Only the size of the components was reduced to achieve the proportional fit on the intended head sizes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Physiometrix, Inc. HydroSpot System, Model 1500 & 1501, and specifically the Medium e-Net Model 1210. However, the document does not contain information about acceptance criteria or a study that proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, etc. The document is primarily a regulatory approval letter based on substantial equivalence to a predicate device (K930080, HydroDot NeuroMonitoring System).

Here's a breakdown of why I cannot fulfill your request for performance data, and what information is available in the provided text:

Missing Information:

Acceptance Criteria & Reported Device Performance: This document does not specify any quantitative performance metrics (like accuracy, sensitivity, specificity, etc.) nor their acceptance criteria. It primarily asserts that the device is "substantially equivalent" to a predicate device.
Sample Size for Test Set & Data Provenance: No information on a test set, its size, or the provenance of the data is provided.
Number of Experts & Qualifications for Ground Truth: No mention of experts or ground truth establishment for a test set.
Adjudication Method: Not applicable as no test set evaluation is described.
MRMC Comparative Effectiveness Study: There is no mention of a multi-reader multi-case comparative effectiveness study or any effect size related to human reader improvement with or without AI assistance. The device in question is a physical electrode net, not an AI algorithm.
Standalone Performance Study: No standalone algorithmic performance study is mentioned.
Type of Ground Truth Used: Not applicable, as no performance study is described.
Sample Size for Training Set: No information on a training set is provided.
How Ground Truth for Training Set was Established: Not applicable.

Information Available related to Substantial Equivalence:

The document states that the new device (Medium e-Net, Model 1210) is substantially equivalent to a predicate device (HydroDot NeuroMonitoring System, K930080). This determination is based on the following:

Intended Use: "The e-Net serves two functions as a part of the Hydro Dot NeuroMonitoring System. First, it locates the EEG electrodes according the 10-20 International System. Secondly, it conducts the electrical signal sensed by the electrodes from the skin to the EEG equipment." This is consistent with its role as a "Cutaneous Electrode" for "EEG Monitoring."
Design/Materials: "The Medium e-Net is fabricated from the same materials as the larger version [predicate device]. Only the size of the components was reduced to achieve the proportional fit on the intended head sizes."

Regarding "Acceptance Criteria" and "Study" and "Reported Device Performance":

In the context of this 510(k) submission, the "acceptance criteria" for the device to be cleared were based on demonstrating substantial equivalence to a previously cleared predicate device. The "study" that proves this is primarily a comparison of the new device's technological characteristics, materials, and intended use to the predicate device.

Since this device is a physical cutaneous electrode and not an AI/software device, the concepts of sensitivity, specificity, training sets, test sets, expert ground truth adjudication, and MRMC studies as typically applied to diagnostic AI are not relevant here. The substantial equivalence argument relies on the device being made of similar materials, having similar design principles (just scaled for different head sizes), and serving the same intended purpose as the predicate device. The 510(k) summary (K960873) explicitly compares the new device (Model 1210 Medium e-Net) to the predicate (K930080 HydroDot NeuroMonitoring System) based on physical attributes and intended function.

Therefore, I cannot populate the table or answer most of your questions as the provided text does not contain the type of performance study data you are asking for. It's a regulatory clearance document based on substantial equivalence, not a performance study report for a diagnostic algorithm.

Summary

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K960873

Physiometrix, Inc. 510(k), Premarket Notification HydroSpot System, Model 1500 & 1501

SUMMARY OF SAFETY AND EFFECTIVENESS

Date:	March 1, 1996
Company:	Physiometrix, Inc.Five Billerica Park101 Billerica AvenueN. Billerica, MA 01862
Contact:	Dawn E. FrazerDirector, Regulatory Affairs & Quality Assurance(508) 670-2422(800) 474-9746
Subject Device:	Model 1210 , Medium e-Net (48 - 54 cm)
Predicate Device:	K930080, HydroDot NeuroMonitoring System
Classification:	Class II, CFR 21 Part 882.1320, Cutaneous Electrodes
Description:	The Medium e-Net is designed to fit patients with a head size in therange of 48 - 54 cm in circumference. It is constructed using the samematerials and manufacturing processes as the larger sized net 54 - 62cm) which is described in K930080.
Intended Use:	The e-Net serves two functions as a part of the Hydro DotNeuroMonitoring System. First, it locates the EEG electrodes accordingthe 10-20 International System. Secondly, it conducts the electricalsignal sensed by the electrodes from the skin to the EEG equipment.
Design/Materials:	The Medium e-Net is fabricated from the same materials as the largerversion. Only the size of the components was reduced to achieve theproportional fit on the intended head sizes.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged around the upper half of the circle.

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

Ms. Dawn E. Frazer Director, Regulatory Affairs & Quality Assurance Physiometrix, Inc. Five.Billerica Park 101 Billerica Avenue N. Billerica, Massachusetts 01862

Re: K960873

Trade/Device Name: Medium e-Net Model 1210 Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated (Date on orig SE ltr): March 1, 1996 Received (Date on orig SE ltr): March 4, 1996

APR - 9 2012

Dear Ms. Frazer:

This letter corrects our substantially equivalent letter of April 26, 1996.

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.

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Page 2 - Ms. Dawn E. Frazer

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); medical device reporting (reporting of 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 Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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10(k) Number (if known): K960873

evice Name: Model 1210, Medium e-Net

dications For Use:

eadpiece (48-54 cm) for EEG Monitoring

K96073 K960873

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Per 21 CFR 801.109

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).