STREPTOLEX-STAT™ is substantially equivalent to several commercially available products utilizing similar methodology for the identification of streptococcal groups A, B, C, F and G.

AI/ML Overview

Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state pre-defined acceptance criteria (e.g., "must achieve X% sensitivity"). However, it presents the reported performance of the STREPTOLEX-STAT™ device, implying that these results are considered acceptable for demonstrating safety, efficacy, and substantial equivalence.

Strep Group/No. Tested	Reported Device Performance (Sensitivity)	Implied Acceptance Range (from "overall agreement of 97%")
Group A	111/111 (100%)	>= 97%
Group B	117/120 (98%)	>= 97%
Group C	80/83 (96%)	>= 97% (Note: This is slightly below the overall, but individual results are presented)
Group F	59/66 (89%)	>= 97% (Note: This is considerably below the overall, but individual results are presented)
Group G	90/90 (100%)	>= 97%
Total	457/470 (97%)	>= 97%

Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set:
  - Group A: 111
  - Group B: 120
  - Group C: 83
  - Group F: 66
  - Group G: 90
  - Total: 470 isolates
- Data Provenance: The study was conducted at "three test sites": one clinical laboratory in the US, one in Canada, and one in the UK. This indicates a multi-site, international study. The data appears to be prospective, generated specifically for this comparison.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not specify the number of experts used or their qualifications for establishing the ground truth. The ground truth appears to be based on the results from "commercially available, substantially equivalent grouping kits," implying these kits served as a reference standard.
Adjudication Method for the Test Set:

For discrepancies (e.g., initial negative reactions for Groups B, C, and F), the document states: "Discrepancies were related to insufficient number of colonies used. Discrepancies were resolved upon retest." This suggests a re-testing and re-evaluation approach for identified discrepancies, rather than a formal expert adjudication panel.
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 is not applicable. The device is a diagnostic kit (latex agglutination test for streptococcal grouping), not an AI-powered system that assists human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, the performance data presented is for the STREPTOLEX-STAT™ device itself, functioning as a standalone diagnostic test. Human interpretation is involved in reading the latex agglutination, but the performance metrics are for the device's ability to correctly identify the streptococcal groups.
The type of ground truth used:

The ground truth was established by comparison to the results obtained from "three commercially available, substantially equivalent grouping kits" (Streptex and Streptex - Acid Extraction Kit by Murex Diagnostics, PathoDx® Strep Grouping by Diagnostic Products Corporation, and Streptococcal Grouping Kit by Unipath Limited, Oxoid). This represents a comparator device reference standard. The document specifies that the STREPTOLEX-STAT™ performance was specifically compared to the Unipath (Oxoid) Streptococcal Grouping Kit for the reported data table.
The sample size for the training set:

The document does not mention a separate training set. The study describes a performance comparison against existing similar products, implying the presented data is from a validation or test set.
How the ground truth for the training set was established:

Not applicable, as a separate training set is not described or implied in the provided text.

Summary

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510k Submission K962296 Requested Revisions 11-24-96 STREPTOLEX-STAT™ UNIPATH LIMITED

DEC 1 6 1996

510K SUMMARY

Date: November 24, 1996

ﺳﮯ

ﺴﻴﺮ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠ

・・・・

Product Name: STREPTOLEX-STAT™

Sponsor's Name: UNIPATH LIMITED Wade Road Basingstoke Hants RG24 8PW England

Product to be distributed in the US by:

Orion Diagnostica, Inc. 71 Verconica Ave. Somerset, NJ 008873

Uninath. Oxoid Division 217 Colonade Rd. Nepean Ontario

Product:

SUBSTANTIAL EQUIVALENCE

STREPTOLEX-STAT™ is substantially equivalent to several commercially available products utilizing similar methodology for the identification of streptococcal groups A, B, C, F and G.

Manufacturer : Murex Diagnostics, Inc.

Streptex and Streptex - Acid Extraction Kit -Provide an alternative method for the extraction and identification of Streptococcal Lancefield group antigens from cultured organisms. This test offers a nitrous acid extraction procedure that is substantially equivalent to the STREPTOLEX-STAT™ procedure.

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510k Submission K962296 Requested Revisions - 11-24-96 STREPTOLEX-STAT™ UNIPATH LIMITED

Manufacturer: Diagnostic Products Corporation

Product: PathoDx® Strep Grouping - a latex agglutination test designed to identify beta-hemolytic streptococci of Lancefield groups A, B, C, F, and G. This test offers a nitrous acid extraction procedure that is substantially equivalent to the STREPTOLEX-STAT™ procedure.

Manufacturer: Unipath Limited, Oxoid

Streptococcal Grouping Kit - A latex agglutination test for the identification of Streptococcal groups, A, B, C, D, F and G. This kit does not include a nitrous acid extraction method, but performance of the Unipath STREPTOLEX-STAT™ was compared to this substantially equivalent product for the qualitative grouping of streptococcal organisms. ( K854929), and is currently being marketed by Unipath (Orion Diagnostica, Inc.)

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510k Submission K96296 Requested Revisions - 11-24-96 STREPTOLEX-STAT™ UNIPATH LIMITED

PERFORMANCE DATA

The performance of the STREPTOLEX-STAT™ was compared to three commercially available, substantially equivalent grouping kits listed above. Studies were done at three test sites. The following is a summary of the performance data.

The data compiled from one clinical laboratory in the US, one in Canada and one in the UK. The following is a summary of the test results.

Strep Group/No. Tested	Unipath (Oxoid) Acid Extraction Sensitivity
Group A	111	111/111(100%)
Group B	120	117/1201(98%)
Group C	83	80/832(96%)
Group F	66	59/663(89%)
Group G	90	90/90(100%)
Total	470	457/470(97%)

At one site, upon initial testing, 3 negative reactions were observed. Discrepancies were related to insufficient number of colonies used. Discrepancies were resolved upon retest.
At one site, upon initial testing, 3 negative reactions were observed. Discrepancies were related to insufficient number of colonies used. Discrepancies were resolved upon retest.
At one site, upon initial testing, 7 negative reactions were observed. Discrepancies were related to insufficient number of colonies used. 5 of the 7 discrepancies were resolved upon retest.

Data comparing the STREPTOLEX-STAT™ Group Reagent with other commercially available grouping kits demonstrated an overall agreement of 97%.

These data clearly demonstrate the safety and efficacy and substantial equivalence of the STREPTOLEX - STAT™.

These data will be made available to any person within 30 days of a written request.

Regulation Number and Section

§ 866.3740

Streptococcus spp. serological reagents.(a)
Identification. Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identifyStreptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusStreptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.