The provided text describes the Coag-A-Mate MTX, a multipurpose system for in vitro coagulation studies. Here's a breakdown of the acceptance criteria and study details based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in a quantitative format before presenting the results. Instead, it presents performance metrics and compares them to typical system performance and NCCLS recommendations, implying these form the basis of acceptance.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Correlation with Predicate Device	High correlation (e.g., r > 0.95)	Clot-based screening assays: r = 0.954 - 0.994
		Clot-based quantitative assays: r = 0.988 - 0.995
		Chromogenic assays: r = 0.954
Total Imprecision (CV)	Well within NCCLS recommendations	Clot-based screening assays: < 5%
		Clot-based quantitative assays: < 8%
		Colorimetric (chromogenic) assays: < 7%
Normal Range	Established and consistent with clinical expectations	Determined (detail of range not provided)
Bias	Acceptable bias compared to predicate	Determined (detail of bias not provided)
Interfering Substances	Performance unaffected or effects well-documented	Well documented as per NCCLS standards and ISTH recommendations

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document mentions "patient specimens over the normal, diagnostic and therapeutic range." It does not provide a specific number of patient samples used for the comparison study.
Data Provenance: The document does not explicitly state the country of origin. It refers to "patient specimens," implying real-world data. It is a prospective study in the sense that the study was conducted for this device clearance, but the patient samples themselves could have been collected prospectively or retrospectively. The document doesn't clarify this detail.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The documentation describes performance using "patient specimens" and control plasma. For coagulation assays, the ground truth is typically assessed through established reference methods and/or comparison against a predicate device. There is no mention of "experts" establishing ground truth in the context of interpreting results or consensus. The ground truth for such devices is usually the result of a validated reference method or the performance of a legally marketed predicate device.

4. Adjudication Method for the Test Set

Not applicable. This type of device (in vitro diagnostic for coagulation studies) does not typically involve human adjudication of results in the way image analysis or clinical endpoint studies might. The results are quantitative measurements compared against established ranges or predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging or subjective clinical assessments where multiple human readers interpret cases. The Coag-A-Mate MTX is an automated system providing quantitative measurements.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

Yes, the performance data presented is for the device in a standalone capacity. The device is an automated system, and its performance (correlation, precision, etc.) is measured directly on patient samples and controls, not as a human-assisted tool.

7. The Type of Ground Truth Used

The ground truth used was based on:
- Comparison to a Legally Marketed Predicate Device: The study's primary goal was to demonstrate substantial equivalence to the Organon Teknika MDA-180 and Organon Teknika Coag-A-Mate X2.
- Established Clinical Ranges and Controls: Performance was evaluated across normal, diagnostic, and therapeutic ranges, likely utilizing results from established reference methods or assays for these ranges.
- Commercially Available Normal and Abnormal Control Plasma: Used for precision studies.

8. The Sample Size for the Training Set

Not applicable as this is an in-vitro diagnostic device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The device's operational parameters and algorithms are designed and validated, not trained from data in the same way an AI model would be.

9. How the Ground Truth for the Training Set was Established

Not applicable for the reasons stated in point 8.

Summary

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K962857

5.0 510(k) Summary

JAN 22 1997

Coag-A-Mate MTX

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and the final rule under 21 CFR 807.92 published December 14, 1994.

(A)(1) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared:

Submitter's Name: Organon Teknika Corporation

Submitter's Address: 100 Akzo Avenue, Durham, NC, 27712

Submitter's Telephone: (919) 620-2634

Submitter's Contact: Ann M. Quinn

Date 510(k) Summary Prepared: July 19, 1996

(a)(2) The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known.

Trade or Proprietary Name: Coag-A-Mate MTX

Common or Usual Name: Multipurpose System for In Vitro Coagulation Studies

Classification Name: Multipurpose System for In Vitro Coagulation Studies

(2)(3) An identification of the legally marketed device to which the submitter claims substantial equivalence.
Device Equivalent to: Organon Teknika MDA-180 (K924453) Organon Teknika Coag-A-Mate X2 (K813564)

(2)(4) A description of the device

Device description: Automated system for in vitro coagulation studies, clot based and chromogenic.

(೩)(೭) A statement of the intended use of the device

Device Intended Use: The Coag-A-Mate MTX is a multipurpose system for use in performing in-vitro coagulation studies, clot based and chromogenic.

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A summary of the technological characteristics of the new device in comparison to those of (a)(6) the predicate device.

The CAM MTX, MDA-180 and CAM-X2 are multipurpose systems capable of performing invitro coagulation studies, all three perform clot based assays. The MDA-180 and CAM MTX are also capable of performing chromogenic assays.

Similar to the MDA-180, the Coag-A-Mate MTX is a fully automated system that has features which increase its ease of use. Table 1.1 below outlines similarities/differences between the MDA-180 and the CAM MTX.

Table 1.1
Similarities and Differences Between the MDA-180 and the CAM-MTX

	MDA-180	CAM-MTX
Spectrophotometric Detection	405 - 710 nm	405 nm
Random Access	yes	-
Stat Mode Capability	yes	yes
LIS Interface	yes	yes
Assay Capability	Clot BasedChromogenicImmunoassay	Clot BasedChromogenic
Ancillary Components	Imidazole BufferReagent WaterWash SolutionProbe CleanerVeriCal CalibratorsTest Cuvettes	Probe CleanerCleaning SolutionTest Cuvettes
User Definable AssayParameters	yes	yes

(b)(1) A brief discussion of the nonclinical tests submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalency.

Testing was performed to determine normal range, correlation and bias, precision and interfering substances. Interfering substances, and specimen collection and preparation are well documented for these types assays and are in accordance with NCCLS standards and recommendations of the International Society of Thrombosis and Hemostasis.

(b)(2) A brief discussion of the clinical tests submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalency.

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A comparison study was conducted using patient specimens over the normal, diagnostic and therapeutic range. R values ranged from (0,954 - 0.994) for clot based screening assays. (0.988 -0.995 for clot based quantitative assays and (r = 0.954) for chromogenic assays. Total imprecision for each analyte was well within NCCLS recommendations.

(b)(3) The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3).

The performance characteristics of the new device are comparable to those of the predicate device and typical of these systems in general. The data presented in the premarket notification demonstrate that the new device performs substantially equivalent to the predicate device. Comparison studies were performed to demonstrate the CAM MTX is equivalent to the MDA-180 and CAM-X2 for the performance of in vitro congulation studies (clotting, chromogenic).

Equivalence was demonstrated using currently commercially available reagents along with patient specimens covering the normal, therapeutic and diagnostic range. Correlation coefficients ranged from r = 0.954 to 0.995 for clot based assays. A correlation coefficient of r = 0.954 was obtained for assays requiring spectrophotometric measurement at a specified wavelength such as chromogenic assays.

Precision studies were performed following NCCLS EPS-T2 "Evaluation of Precision Performance of Clinical Chemistry Devices." Total precision c.v.'s were less than 5% for clot based screening assays, less than 8% for clot based quantitative assays and less than 7% for colorimetric assays. Data was generated on the CAM MTX using commercially available normal and abnormal control plasma.

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.