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

TracCell™ 2000 System is intended as a computer-aided optical microscope system used to map adequately stained, well-preserved, cervical cytology preparations that have been prepared using a Papanicolaou or Pap-like stained protocol. The mapping of the slide into "presented" and "excluded" areas 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.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for the AccuMed International's TracCell™ 2000 Slide Mapping System, dated August 18, 1997. This type of letter generally grants market clearance based on substantial equivalence to a predicate device and does not typically include detailed studies or acceptance criteria for the device itself. Instead, it confirms that the device is substantially equivalent to a previously cleared device. Therefore, a significant portion of the requested information cannot be extracted from this document alone.

However, I can extract the available information and point out what is missing based on common practices during that era for 510(k) submissions.

Here's a breakdown of the available and unavailable information:

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

Not Available: The document does not provide specific performance metrics, acceptance criteria, or a table detailing them for the TracCell™ 2000. 510(k) clearance in 1997 focused on substantial equivalence, and detailed performance studies with acceptance criteria were often not a mandatory component of the public summary unless specifically requested by the FDA for certain device types.

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

Not Available: The document does not mention any sample sizes for test sets, data provenance, or study design (retrospective/prospective).

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)

Not Available: The document does not discuss the establishment of ground truth by experts.

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

Not Available: The document does not describe any adjudication methods.

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 Available: The document does not mention an MRMC study or any assessment of human reader improvement with or without AI assistance. The device is described as a "computer-aided optical microscope system" for "mapping" and "segmenting," suggesting it assists cytotechnologists/cytopathologists, but no comparative effectiveness data is provided.

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

Not Available: The document does not provide standalone performance data for the algorithm. Its stated use is "for efficient presentation to a cytotechnologist or cytopathologist for diagnostic interpretation," implying a human-in-the-loop system.

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

Not Available: The document does not specify the type of ground truth used.

8. The sample size for the training set

Not Available: The document does not provide information about a training set or its sample size.

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

Not Available: The document does not provide information about how ground truth was established for a training set.

Summary of Available Information from the Document:

Device Name: AccuMed International's TracCell™ 2000 Slide Mapping System
Intended Use: "as a computer-aided optical microscope system used to map adequately stained, well-preserved, cervical cytology preparations that have been prepared using a Papanicolaou or Pap-like stained protocol. The mapping of the slide into 'presented' and 'excluded' areas 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."
Regulatory Class: II
Product Code: JOY
Date of Clearance: August 18, 1997

Conclusion:

This 510(k) clearance letter primarily confirms the substantial equivalence of the TracCell™ 2000 Slide Mapping System to a predicate device. It does not contain the detailed study results, acceptance criteria, or methodologies typically found in more recent, comprehensive device evaluations or public summaries. To obtain such information, one would generally need to refer to the full 510(k) submission (which is not publicly available in detail, only the summary), internal company documents, or potentially a peer-reviewed publication if one exists for the device's validation.

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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized design that resembles an abstract caduceus, a symbol often associated with healthcare.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 8 1997

Mr. John R. Miers Director of Regulatory Affairs ACCUMED INTERNATIONAL, INC. 900 N. Franklin, Suite 401 Chicago, Illinois 60610 ..

Re : K964689/S2 AccuMed International's TracCell™ 2000 Slide Trade Name: Mapping System Regulatory Class: II Product Code: JOY Dated: May 30, 1997 Received: June 2, 1997

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 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 Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (05) for Medical Devices: General regulation (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 regulatory 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 Regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

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 requlation (21 CFR Part 801 and additionally 809.10 for in xitro 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 Also, please note the regulation entitled, (301) 594-4639. "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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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 Radiological Health

Enclosure

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Page 1_of_1

510(k) Number (if known):

Device Name: _

TracCell™ 2000 Slide Mapper System_

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carter E. Madison

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

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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).