TRACCELL 2000 SLIDE MAPPING SYSTEM by ACCUMED INTL., INC.

The new TracCell™ 2000 Slide Mapping System is intended as a computeraided Slide Mapping System integrated to an automated optical microscope workstation (AccuMed International's AcCell™ Workstation). The TracCell™ 2000 Slide Mapping System is used to map adequately stained. well-preserved. cervical cytology preparations that have been prepared using a Papanicolaou or Pap-like stained protocol. In addition to the present intended use as cleared by FDA, the new TracCell™ 2000 Slide Mapping System can be used for the purposes of mapping Cytyc ThinPrep® specimens. The mapping of the slide into ìpresentedî and iexcludedî fields of view is performed by segmenting the light-absorbing objects from background material based upon standard image processing techniques for efficient presentation to a cytotechnologist or cytopathologist for diagnostic interpretation.

1. All cellular material within the expanded cell deposition area, comprising the standard cellular deposition area, and a narrow bleed zone immediately surrounding it, will be presented for human screening, using the minimum number of fields-of-view.
1. All adequately stained, well preserved cells located in the annular ring, the area lying between the expanded cellular deposition area, and the imprinted boundary area and the imprinted boundaries of the slide, will be included in additional fields-of-view presented for human screening.

The mapping of a Cytyc Thin Prep™ specimen is carried out in precisely the same manner as the predicate TracCell 2000 Slide Mapping System. The mapping of the slide in presented and excluded fields-of view, is performed by segmenting the light absorbing objects from background material based upon standard image processing techniques for efficient presentation to a cytotechnologist or cytopathologist for diagnostic interpretation. These techniques are identical to the predicate TracCell 2000™.

Device Description

Not Found

AI/ML Overview

The provided text describes a 510(k) submission for the TracCell™ 2000 Slide Mapping System. However, it does not contain the detailed information necessary to answer all sections of your request. Specifically, it lacks data regarding acceptance criteria, reported device performance, sample sizes used, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established.

Therefore, based only on the provided text, I can only address what is explicitly stated or can be reasonably inferred about the device's function.

Here's an analysis of the provided text in relation to your request, highlighting what is missing:

Acceptance Criteria and Study for TracCell™ 2000 Slide Mapping System

The provided 510(k) letter and "Indications For Use" document do not contain a table of explicit acceptance criteria or reported device performance data from a study conducted for this specific submission. The focus of the 510(k) is on demonstrating substantial equivalence to a predicate device, not on presenting novel performance data against pre-defined acceptance criteria.

The "Indications For Use" outlines how the device performs its mapping function, which can be interpreted as the functional requirements it aims to fulfill.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Indications For Use)	Reported Device Performance (Not stated in document)
1. Present all cellular material within the expanded cell deposition area (standard area + narrow bleed zone) for human screening using the minimum number of fields-of-view.	Not reported in this document. The document states this is the intended function of the device.
2. Include all adequately stained, well-preserved cells in the annular ring (between expanded cellular deposition area and imprinted boundary) in additional fields-of-view for human screening.	Not reported in this document. The document states this is the intended function of the device.
3. Map Cytyc ThinPrep® specimens in the same manner as the predicate TracCell 2000™.	Not reported in this document. The document states this is the intended function of the device and that the techniques are identical to the predicate.
4. Segment light-absorbing objects from background material using standard image processing techniques for efficient presentation.	Not reported in this document.

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

Sample Size (Test Set): Not specified in the provided documents.
Data Provenance: Not specified in the provided documents. The document refers to the device mapping "adequately stained, well-preserved, cervical cytology preparations." It does not mention country of origin or whether data was retrospective or prospective.

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

Number of Experts: Not specified in the provided documents.
Qualifications of Experts: Not specified in the provided documents. The system aims to present fields-of-view to a "cytotechnologist or cytopathologist for diagnostic interpretation," implying these are the end-users whose diagnostic interpretations would ultimately be the clinical ground truth.

4. Adjudication method for the test set

Adjudication Method: Not specified in the provided documents.

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

MRMC Study: Not specified or indicated in the provided documents. The 510(k) process often relies on substantial equivalence to a predicate device, and the provided text does not describe a comparative effectiveness study with human readers. The device serves to "map" and provide "efficient presentation" for human screening, rather than replacing or directly augmenting diagnostic performance in a quantifiable way described here.

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

Standalone Performance: Not explicitly stated as being evaluated. The device is described as a "computer-aided Slide Mapping System" for "efficient presentation to a cytotechnologist or cytopathologist for diagnostic interpretation." This strongly implies a human-in-the-loop system, where the algorithm 'pre-processes' the slide for human review, rather than making a standalone diagnostic call.

7. The type of ground truth used

Type of Ground Truth: The document implies that the human interpretation by a "cytotechnologist or cytopathologist" is the ultimate diagnostic ground truth for cervical cytology. The device's role is to ensure all relevant areas are presented for this human interpretation. The ground truth for the mapping function itself would likely be related to whether all cellular material (as defined) is indeed presented.

8. The sample size for the training set

Sample Size (Training Set): Not specified in the provided documents.

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

Ground Truth (Training Set): Not specified in the provided documents. The device uses "standard image processing techniques" for segmentation, which would typically rely on established principles for identifying cellular material.

Summary

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is a stylized image of three human profiles facing to the right.

OCT 16 19

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. John R. Miers Director of Regulatory Affairs AccuMed International, Inc. 900 N. Franklin, Suite 401 Chicago, Illinois 60610

Re: K982786 TracCell™ 2000 Slide Mapping System Trade Name: Regulatory Class: II JOY Product Code: Dated: August 7, 1998 Received: August 10, 1998

Dear Mr. Miers:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

{1}------------------------------------------------

Page 2

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

{2}------------------------------------------------

5100k) Number (if known): 4984698 K 982780

Predicate Device Name:

Indications For Use:

1. All cellular material within the expanded cell deposition area, comprising the standard cellular deposition area, and a narrow bleed zone immediately surrounding it, will be presented for human screening, using the minimum number of fields-of-view.
1. All adequately stained, well preserved cells located in the annular ring, the area lying between the expanded cellular deposition area, and the imprinted boundary area and the imprinted boundaries of the slide, will be included in additional fields-of-view presented for human screening.

(PLEASE DO NOT WRITE BELOW THIS TEXT - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Deborah Moore
for Dr. Peter Maslyn

Regulation Number and Section

§ 864.5260 Automated cell-locating device.

(a)
Identification. An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)(b)
Classification. Class II (performance standards).