Siemens INFINITY EEG Pod is indicated for use in the adult, pediatric and neonatal populations, in an Stement where patient care is provided by healthcare professionals, i.e. Physicians, Nurses, Technicians, when the professional determines that the device is required to monitor the state of the brain by data acquisition of EEG signals.

Device Description

The INFINITY EEG pod is an addition to Siemens SC9000/SC8000/SC7000/SC9000XL INFINITY patient monitoring series. When connected to an INFINITY EEG pod, an INFINITY Modular Bedside Monitor is capable of measuring up to four channels of EEG waveforms. Each waveform has its own parameter box, and each parameter box displays up to three parameters that can be trended, printed, and displayed on a central station.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device called the Siemens INFINITY EEG Pod. The goal is to show substantial equivalence to a previously cleared device, the Aspect Medical Systems, Inc. Model A-1000 EEG Monitor (K963644).

However, the provided text does not contain the detailed acceptance criteria or the study that proves the device meets them in the way you've requested (e.g., specific performance metrics, sample sizes, ground truth establishment, MRMC studies, etc.). Instead, it focuses on the device description, intended use, comparison tables for features with a predicate device, and general statements about assessment of non-clinical and clinical performance data for equivalence.

The document lists "Exhibit U" for "Assessment of non-clinical performance data for equivalence" and "Exhibit V" for "Assessment of clinical performance data for equivalence." These exhibits would likely contain the detailed information you're looking for, but they are not included in the provided text. The FDA letter confirms substantial equivalence based on the submitted materials, but the specific study details are omitted from this summary.

Given the information provided, I can only fill out very limited parts of your requested table and study description based on what's explicitly stated.

Summary of Available Information Regarding Acceptance Criteria and Study:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in the provided text. The submission hinges on demonstrating "substantial equivalence" to the predicate device, meaning its performance should be comparable.
Reported Device Performance: Not explicitly stated in the provided text in terms of quantitative metrics. The document states that "Exhibit U" contains non-clinical performance data and "Exhibit V" contains clinical performance data for equivalence, but these exhibits are not provided. The comparison table (Section 5) only highlights computed parameters, indicating that the Siemens INFINITY EEG Pod computes similar parameters (Total Power, Delta, Theta, Alpha, Beta Power, Spectral Edge Frequency, Median Frequency, Burst Suppression ratio) to the predicate device, but lacks some (Power of user-defined Bands, Asymmetry, Bispectral Index, EMG Power Bands). This suggests an implicit acceptance criterion of performing adequately on the shared parameters.

Acceptance Criterion (Implicit based on Predicate Comparison)	Reported Device Performance (Implicit/Not detailed)
Ability to measure up to four channels of EEG waveforms	Device design states it measures up to four channels of EEG waveforms
Computation of Total Power	Same as predicate
Computation of Delta, Theta, Alpha, Beta Power	Same as predicate
Computation of Spectral Edge Frequency	Same as predicate
Computation of Median Frequency	Same as predicate
Computation of Burst Suppression ratio	Same as predicate
(Absence of certain parameters like Bispectral Index)	Device does not support these parameters (stated as a difference)

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the provided text. The "Exhibit V: Assessment of clinical performance data for equivalence" would likely contain this information.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This would typically be found in the detailed clinical study report.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified in the provided text.

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

Not specified in the provided text.

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:

Not specified and highly unlikely for this type of device (EEG signal acquisition and parameter computation) from 1999. The device is for "data acquisition of EEG signals" and parameter calculation, not for image interpretation by human readers. It is not an AI-assisted diagnostic tool.

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

This device functions as a standalone acquisition and computation unit in its core function (measuring EEG and deriving parameters). The performance assessment mentioned in "Exhibit U" (non-clinical) and "Exhibit V" (clinical) would have evaluated its ability to accurately acquire signals and compute parameters, which is essentially its "standalone" performance. However, no specific details of such a study are included here.

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

Not specified in the provided text. For an EEG device primarily measuring and processing signals, ground truth would likely involve:
- For signal acquisition: Comparison against a gold-standard EEG amplifier/recorder using known electrical signals or phantom tests, and in clinical settings, potentially expert review of raw waveforms for signal quality.
- For computed parameters: Validation of algorithms against known mathematical derivations and possibly against another validated device or manual calculations from raw EEG data by experts.

8. The sample size for the training set:

Not applicable/Not specified. This device is an acquisition and signal processing unit, not an AI/machine learning model that typically involves a distinct "training set." Its algorithms are based on established signal processing techniques, not learned from data in the same way a deep learning model would be.

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

Not applicable/Not specified, as it's not an AI/ML device with a training set.

Conclusion:

The provided text from the 510(k) summary for the Siemens INFINITY EEG Pod (K991012) describes the device, its intended use, and its substantial equivalence to a predicate. It refers to exhibits containing non-clinical and clinical performance data (Exhibit U and Exhibit V, respectively), but the detailed acceptance criteria and the specifics of the studies proving these criteria are not included in this document. Therefore, I cannot provide most of the requested information based solely on the input text.

Summary

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K991012

510(k) SUMMARY

as required per 807.92(c)

Submitters Name, Address:

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: David Simard, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco Date submission was prepared: March 19, 1999

Trade Name, Common Name and Classification Name: 3.

A. Trade Name: Siemens INFINITY EEG Pod

Common Name, Classification Name, Class and Regulation Number: B

Common Name	ClassificationNumber	Class	Regulation Number
Electroencephalograph	OLT, ORT	II	882.1400
	OMC

Predicate Device Identification: 2. Aspect Medical Systems, Inc. Model A-1000 EEG Monitor 510(k) K963644

3. Device Description:

4. Intended Use:

To monitor the state of the brain by data acquisition of EEG signals.

COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923 USA

Tel: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD)

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	Substantial Equivalent Device	Applicant	Explanation of Difference
Manufacturer	Aspect Medical Systems, Inc.A-1000 EEG Monitor and A-1050 EEG Monitor	Siemens Medical SystemsInfinity EEG Pod
510(k) Number	K963644	To be assigned
Intended Use	To monitor the state of thebrain by data acquisition ofEEG signals	Same
IntendedPopulation	All patient populations	Same
IntendedEnvironment	The intensive care unit,operating room and clinicalresearch	An environment where patient careis provided by HealthcareProfessionals
ComputedParameters	Total Power	Same
	Delta, Theta, Alpha, BetaPower	Same
	Spectral Edge Frequency	Same
	Median Frequency	Same
	Burst Suppression ratio	Same
	Power of user defined Band 1	No	Parameter not supported
	Power of user defined Band 2	No
	Asymmetry	No
	Bispectral Index	No
	EMG Power Band 1	No
	EMG Power Band 2	No

COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923 USA

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Assessment of non-clinical performance data for equivalence: Exhibit U
Assessment of clinical performance data for equivalence: Exhibit V

1. Biocompatability: Not applicable
1. Sterilization: Not applicable

FDA Electroencephalograph Devices Guidance for 510(k) 10. Standards and Guidances: Content, Draft Document Version 1.0, November 3, 1997

IEC 601-2-26: 1994, Medical Electrical Equipment: Part 2: Particular Requirements for the Safety of Electroencephalographs

3

COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923 USA

Tel: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD)

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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 features a stylized eagle with three stripes forming its wing and leg. The eagle is positioned to the right of a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

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

Ms. Penelope H. Greco Regulatory Submissions Manager Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, Massachusetts 01923

APR - 9 2012

Re: K991012

Trade/Device Name: Siemens INFINITY EEG Pod Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLT, ORT, OMC Dated (Date on orig SE ltr): March 19, 1999 Received (Date on orig SE ltr): March 26, 1999

Dear Ms. Greco:

This letter corrects our substantially equivalent letter of June 24, 1999.

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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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

Image /page/4/Picture/8 description: The image shows the name and title of Malvina B. Eydelman, M.D. She is the Director of the Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices. The division is part of the Office of Device Evaluation. The office is part of the Center for Devices and Radiological Health.

Enclosure

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510(k) Number (if known): K 991012

Device Name: Siemens INFINITY EEG Pod

Indications for Use:

MRI Compatibility Statement: The Siemens INFINITY EEG Pod is not intended for use in a MRI magnetic field.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

coiledo

Divisio 510iki Nu

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).