The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The system provides results for both direct hemostasis measurements and calculated parameters.

Device Description

Major software/test parameter modifications to the factor assays include:

The calibration levels are now prepared by aspirating the calibrator directly from the calibrator vial (direct dilution instead of serial dilution).
The number of calibration points is being increased from 5 to either 7 or 8, dependent on the individual factor.
New mathematical tools are being implemented for generating the calibration curve, e.g. polynomial curve fitting capability as well as the capability for using segmented calibration curve (two different calibration curves for the lower and upper ends).
The robustness of the assays is increased by optimizing incubation time, transport air gap and probe rinse parameter modifications.

AI/ML Overview

The provided 510(k) summary (K063679) describes modifications to the ACL TOP device, focusing on optimizing the performance of intrinsic and extrinsic factor assay applications. However, it does not contain a detailed study report with specific acceptance criteria and performance data in the format requested. The document primarily focuses on explaining what changes were made to the software and test parameters and noting that the performance of the optimized factor assay is substantially equivalent to the predicate device.

Specifically, the document lacks the following information required to fully answer the request:

A table of acceptance criteria and reported device performance: The document states that the performance is "substantially equivalent" to the predicate, but it doesn't provide specific numerical acceptance criteria (e.g., precision limits, accuracy targets) or the measured performance values for the optimized assays.
Sample sizes used for the test set and data provenance: No information is given regarding the number of samples used in any validation or verification testing, nor their origin (country, retrospective/prospective).
Number of experts used to establish ground truth and their qualifications: This information is not provided as there is no mention of an expert panel or adjudication process for establishing ground truth for a test set. This type of device (coagulation analyzer) typically uses reference methods or calibrated controls for ground truth rather than expert interpretation of results in the way image-based diagnostics might.
Adjudication method: Not applicable/not provided.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a benchtop analyzer, not an AI-assisted diagnostic tool for Human-in-the-Loop performance with human readers.
Standalone performance study: The document doesn't provide a detailed standalone performance study report with specific metrics. It states the performance is equivalent but doesn't quantify it.
Type of ground truth used: While implicitly using calibrated controls or reference methods for coagulation factor assays, the document does not explicitly state how ground truth was established for performance validation.
Sample size for the training set: Not applicable and not provided, as this is not an AI/machine learning device that typically involves a separate training set. The "optimization" refers to mathematical tools for curve fitting, not a machine learning model trained on a dataset.
How ground truth for the training set was established: Not applicable and not provided.

Based on the provided text, the most relevant information regarding "acceptance criteria" and "proving the device meets the acceptance criteria" is in the context of demonstrating substantial equivalence to a predicate device, rather than a detailed performance study against specific, quantified acceptance targets.

Here's a summary of what can be extracted or inferred, and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion Type	Acceptance Criteria (from document)	Reported Device Performance (from document)
Overall Performance	Substantial Equivalence to Predicate Device (K033414)	"The performance of the optimized factor assay applications on the ACL TOP (K033414) is substantially equivalent to the performance of the current legally marketed factor assay applications on the ACL TOP (K033414)."
Calibration (indirectly inferred)	Improved calibration curve generation	"The calibration levels are now prepared by aspirating the calibrator directly from the calibrator vial (direct dilution instead of serial dilution).""The number of calibration points is being increased from 5 to either 7 or 8, dependent on the individual factor.""New mathematical tools are being implemented for generating the calibration curve, e.g. polynomial curve fitting capability as well as the capability for using segmented calibration curve."
Assay Robustness (indirectly inferred)	Increased robustness	"The robustness of the assays is increased by optimizing incubation time, transport air gap and probe rinse parameter modifications."
Intended Use/Indications	No change from predicate	"There are no changes to the intended use/indications for use or labeled performance claims of either the ACL TOP or the factor assays with this submission."

Missing from the document: Specific numerical acceptance thresholds for performance metrics (e.g., %CV for precision, % bias for accuracy), or specific numerical results for these metrics before and after optimization.

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

Sample Size: Not specified in the provided text.
Data Provenance: Not specified in the provided text.

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

Number of Experts: Not applicable/Not specified. This type of device relies on analytical performance against controls and reference methods, not expert consensus for ground truth.
Qualifications of Experts: Not applicable/Not specified.

4. Adjudication method for the test set

Adjudication Method: Not applicable/Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

MRMC Study: No, this is not applicable for this device type. The ACL TOP is an automated analyzer, not an imaging device or AI-assisted diagnostic requiring human reader input or comparison.

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

Standalone Performance: The submission implies that the device itself (the "algorithm"/software modifications) was tested to confirm its performance is substantially equivalent. However, a detailed report of this standalone performance, with specific metrics and data, is not included in the provided 510(k) summary. The summary simply states that the performance is "substantially equivalent."

7. The type of ground truth used

Type of Ground Truth: Not explicitly stated but inferred to be based on calibrated controls, reference materials, or recognized standard methods for coagulation factor assays, which are standard for laboratory instruments of this type.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. The "new mathematical tools" for calibration curve generation are described as established methods (polynomial curve fitting, segmented calibration) rather than a machine learning algorithm requiring a separate training set.

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

Ground Truth for Training Set: Not applicable.

Summary

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510(k) Summary

K063679

JAN 1 2 2007

Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421

Contact Person:

Carol Marble, Regulatory Affairs Director Phone No .: 781-861-4467 781-861-4207 Fax No .:

Prepared:

December 8, 2006

Device Name:

ACL TOP

Regulatory Information:

81GKP	Instrument, Coagulation, Automated
864.5400	Coagulation Instrument	Class II

Predicate Device:

K033414 ACL TOP

Device Description:

Reason for Submission:

The ACL TOP system software and test parameters are being modified to optimize the performance of the intrinsic and extrinsic factor assay applications on the instrument.

Major software/test parameter modifications to the factor assays include:

1. The calibration levels are now prepared by aspirating the calibrator directly from the calibrator vial (direct dilution instead of serial dilution).
1. The number of calibration points is being increased from 5 to either 7 or 8, dependent on the individual factor.
1. New mathematical tools are being implemented for generating the calibration curve, e.g. polynomial curve fitting capability as well as the capability for using segmented calibration curve (two different calibration curves for the lower and upper ends).
1. The robustness of the assays is increased by optimizing incubation time, transport air gap and probe rinse parameter modifications.

Statement of Technological Characteristics of the Device Compared to Predicate Device:

The performance of the optimized factor assay applications on the ACL TOP (K033414) is substantially equivalent to the performance of the current legally marketed factor assay applications on the ACL TOP (K033414).

There are no changes to the formulation of the factor assays, and no changes to the NOTE: intended use/indications for use or labeled performance claims of either the ACL TOP or the factor assays with this submission.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 its wings spread, symbolizing protection and care. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" in a sans-serif font. The overall design is simple and professional, reflecting the department's role in public health and welfare.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Co. 113 Hartwell Avenue Lexington, MA 02421

K063679 Re: Trade/Device Name: ACL TOP Regulation Number: 21 CFR § 864.5400 Regulation Name: Coagulation Instrument Regulatory Class: II Product Code: GKP Dated: January 4, 2007 Received: January 5, 2007

JAN 1 2 2007

Dear Ms. Marble:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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.

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Page 2 –

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. 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,

Robert L. Becker Jr.

Robert L. Becker, Jr., MD, PH.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K063679

Device Name: ACL TOP

Indications for Use:

The system provides results for both direct hemostasis measurements and calculated parameters.

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 In Vitro Diagnostic Devices (OIVD)

Josephine Bautista

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Section 2

Special 510(k): ACL TOP Factor Assay Optimization

Page 1 of 1

Regulation Number and Section

§ 864.5400 Coagulation instrument.

(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.