The document doesn't explicitly state "acceptance criteria" with numerical thresholds. Instead, it justifies substantial equivalence based on the comparison to a predicate device. I've inferred the performance metrics used for this justification.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (with Borderline as Positive)
Relative Sensitivity	High (demonstrate equivalence to predicate)	100.0%
Relative Specificity	High (demonstrate equivalence to predicate)	99.3%
Overall Agreement	High (demonstrate equivalence to predicate)	90.4%

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

Sample Size:
- Positive Cases (from predicate): 21 + 2 + 0 = 23 (assuming "borderline" on the predicate is not explicitly categorized but contributes to comparison)
- Borderline Cases (from predicate): 1 + 4 + 0 = 5
- Negative Cases (from predicate): 0 + 1 + 140 = 141
- Total Sample Size Analyzed: 23 (positive by predicate) + 5 (borderline by predicate) + 141 (negative by predicate) = 169 samples (implied from the sum of the table cells).
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

Not applicable. The ground truth was established by a predicate device (Immuno Concepts RELISA® Screening Assay K935129), not by human experts for this specific comparative study.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by a predicate device, not by human adjudication of individual results.

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 applicable. This is a comparison between two immunoassays, an "algorithm" as described in your prompt for AI is not involved.

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

Yes, in a sense. The "device" being evaluated is essentially an automated immunoassay test system (RELISA® Jo-1 Antibody Test System). Its performance is measured directly against a predicate immunoassay system (RELISA® ENA Antibody Screening Tests System) without human interpretation as part of the core measurement. The output of both devices is quantitative/qualitative (positive, borderline, negative).

7. The type of ground truth used

The ground truth used for this study was the results from a legally marketed predicate device: the Immuno Concepts RELISA® Screening Assay (K935129).

8. The sample size for the training set

Not applicable. This is not a machine learning model, but a traditional immunoassay. Therefore, there is no "training set" in the context of AI.

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

Not applicable, as there is no training set for a machine learning model.

Summary

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K955605

Image /page/0/Picture/1 description: The image shows the logo for Immuno Concepts. The logo consists of two horizontal lines on the left, followed by a stylized "IC" symbol. To the right of the "IC" symbol is the word "immuno" stacked on top of the word "concepts". The logo is black and white.

APR 1 9 1996

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Date Prepared: December 4, 1995 Contact Person: Eric S. Hoy, Ph.D. Name of Device:

· Trade Name RELISA® Jo-1 Antibody Test System
· Common Name Jo-1 Antibody Test System
· Classification Name Extractable Antinuclear Antibody (21 CFR 866.5100)

Legally marketed device with which this device has been shown to be equivalent: RELISA® ENA Antibody Screening Tests System, K935129

Description:

This is an enzyme immunoassay for the detection of antibodies to nuclear antigen Jo-1 in human serum.

Intended Use:

This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigen Jo-1 in human serum.

Summary of Technological Characteristics Compared to the Predicate Device:

This device is identical to the predicate device with the following exceptions :

The predicate device has six different autoantigens coated on individual a) microwells; the present device has only Jo-1 autoantigen coated on the microwells.

b) The predicate device includes a procedure control well on each strip of microwells, the present device includes a calibrator serum in the kit.

Description of Laboratory Data That Indicate Substantial Equivalence:

For direct determination of relative sensitivity and specificty, we used the Immuno Concepts RELISA® Screening Assay (K935129) as a reference method. The data obtained in this comparison are shown in the following Table.

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K955605

		Immuno Concepts RELISA® Screening Assay
		Positive	Borderline	Negative
Immuno ConceptsRELISA® Jo-1	Positive	21	1	0
	Borderline	2	4	1
	Negative	0	0	140

Table 1. Detection of antibodies to the Jo-1 autoantigen.

If we assume that "borderline" results are actually positive, these data yield the following statistics: relative sensitivity, 100.0%; relative specificity, 99.3%; and overall agreement 90.4%

In accordance with 21 CFR 807.92(b)(3), we conclude from these data that the present device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 866.5100 Antinuclear antibody immunological test system.

(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).