(77 days)
For use as an assayed quality control material to assist in monitoring accuracy and precision in clinical immunoassays used in cancer antigen testing.
This is a two level, multi-analyte, lyophilized quality control material prepared from human blood, with added purified chemicals, human biochemicals and preservatives.
The provided text is a 510(k) summary for a medical device called "SysCon (or other brand names) Tumor Marker Control." This document focuses on the regulatory submission for a quality control material and does not describe a study involving patient data, AI, or diagnostic algorithm performance. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truthing for such a device is not present in the provided text.
Based on the information given, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document mentions "Performance data" related to the quality control material itself, not a diagnostic device's ability to interpret patient data.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Summary Statement) |
|---|---|
| Comparison to predicate device | "Comparison of the product to the predicate device for intended use, analytes, number of levels, form, diluent, base, additives, microbial content, lot homogeneity and vial-to-vial consistency, stability and reliability of assay values supports a substantial equivalence finding." |
| Nonclinical tests | "Nonclinical tests for vial-to-vial variability, reconstituted stability and expiration dating, as well as value assignment protocols, submitted, referenced, or relied on in the premarket notification submission, support the conclusion that the device is as safe and effective, and performs as well as or better than the legally marketed devices identified in this summary." |
Note: Specific numerical acceptance criteria (e.g., CV < 5% for variability) and the exact performance values are not detailed in this summary. The summary only states that the performance "supports a substantial equivalence finding" and performs "as well as or better than" predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided as the device is a quality control material, not a diagnostic device that processes patient data. There is no "test set" in the context of patient data analysis. The "tests" mentioned are nonclinical evaluations of the control material's characteristics.
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)
This information is not applicable and not provided. There is no "ground truth" established by experts for a diagnostic output in this context. The "value assignment protocols" mentioned likely refer to laboratory procedures for determining the target values of the control material, not human interpretation of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. This refers to expert review of diagnostic outputs, which is not relevant for a quality control material.
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
This information is not applicable and not provided. The device is a quality control material, not an AI or diagnostic algorithm, so no MRMC study involving human readers and AI assistance would be conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is a quality control material, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable and not provided. The concept of "ground truth" as applied to diagnostic accuracy studies is not relevant here. The ground truth for a quality control material would be its meticulously determined analyte concentrations, established through reference methods and internal validation, rather than expert consensus on patient conditions.
8. The sample size for the training set
This information is not applicable and not provided. There is no "training set" as this device is not an AI model or a machine learning algorithm.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As there is no training set, there is no ground truth for it to be established.
In summary, the provided document describes a regulatory submission for a quality control material, which is a laboratory reagent used to monitor the performance of assays. It does not describe a diagnostic device or algorithm that interprets patient data, and therefore, the type of information requested about acceptance criteria, study sizes, expert ground truth, and AI performance is not present in this text.
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SCANTIBODIES LABORATORY, INC.
"SCANTIBODIES FOR ANTIBODIES"
KASSIA MAR 12 1996
510(k) Summary
| Submitter: | Tom CantorScantibodies Laboratory, Incorporated9336 Abraham Way, Santee, CA 92071-2862 |
|---|---|
| Date: | December 15, 1995 |
| Device Name: | SysCon (or other brand names) Tumor Marker Control |
| Predicate Device: | Dade ° Special-T" Marker, manufactured by Baxter Diagnostics Inc. |
Device Description:
This is a two level, multi-analyte, lyophilized quality control material prepared from human blood, with added purified chemicals, human biochemicals and preservatives.
Intended use:
For use as an assayed quality control material to assist in monitoring accuracy and precision in clinical immunoassays used in cancer antigen testing.
Comparison of the product to the predicate device for intended use, analytes, number of levels, form, diluent, base, additives, microbial content, lot homogeneity and vial-to-vial consistency, stability and reliability of assay values supports a substantial equivalence finding.
Performance data:
Nonclinical tests for vial-to-vial variability, reconstituted stability and expiration dating, as well as value assignment protocols, submitted, referenced, or relied on in the premarket notification submission, support the conclusion that the device is as safe and effective, and performs as well as or better than the legally marketed devices identified in this summary.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.