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The Precision Systems™ ANALETTE™ Chemistry Analyzer is intended for the quantitative determination of Calcium, Creatinine, Phosphorus, Albumin, Total Protein, Glucose, Urea Nitrogen, Magnesium, Creatine Kinase, Alkaline Phosphatase, Cholesterol(includes HDL), Triglycerides, Total Bilirubin, Direct Bilirubin, Uric Acid, Lactate Dehydrogenase L, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Chloride, and etc. analytes in solution such as serum, plasma, or urine. It is an "open" System, which can use a variety of commercially manufactured reagents such as but not limited to Synermeds® Reagents, Medical Analysis Systems Reagents and STANBIO Laboratory Reagents. It is used to monitor various physiological diseases or conditions. Precision Systems Inc will distribute, recommend and sales STANBIO Reagents without any modification of STANBIO packaging using PSI Applications sheets.

Device Description

The ANALETTE™ Chemistry Analyzer is an in vitro diagnostic automated clinical chemistry analyzer for the analysis of analytes in solution. It is an "open" System, which can use a variety of commercially manufactured reagents.

AI/ML Overview

The document describes the acceptance criteria and the study conducted to demonstrate the substantial equivalence of the Precision Systems™ ANALETTE™ Chemistry Analyzer using STANBIO Laboratory Reagents to its predicate devices (ANALETTE™ using Synermed® Reagents and ANALETTE™ using Medical Analysis Systems Inc® Reagents).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "Performance specifications: None established under Section 514." Instead, it refers to "Acceptance Criteria" (Exhibit E and F) but does not detail the specific numerical acceptance criteria within the provided text.

However, the "Results" section (G.) provides the reported performance relative to "acceptable/equivalent results" or "Manufacturers' claim."

Performance Metric	Acceptance Criteria (Implied/Referenced)	Reported Device Performance
Imprecision	Acceptable/equivalent results (Implied)	Serum controls give acceptable/equivalent results using the described procedure for within run and total imprecision with each of the representative test methods (Synermed, Medical Analysis Systems, and STANBIO Laboratory Reagents, as shown in Table 1 and Table 2 vs insert values).
Correlation	Acceptable results (Implied)	Slopes, Intercepts and Correlation Coefficients show acceptable results. The regression (slope and intercept) and correlation coefficients are shown in Table 3 and Graphs 1-21. Acceptable results are shown between both methods (STANBIO Laboratory Reagents vs. Synermeds® or Medical Analysis Systems Reagents).
Linearity	Not exceeding Manufacturers' claim	Linearity did not exceed the Manufacturers' claim (shown in Table 4 vs insert values). A comparison is made between STANBIO Laboratory Reagents and the Least Square line to establish linearity.
Recovery	Acceptable results for assigned ranges	Acceptable results are shown between both methods (using assigned control serums ranges, shown in Table 5).
Normal Range	Remains as recommended by manufacture	Parameters were not tested, assumed to remain as recommended by manufacture as no modifications to STANBIO Laboratory Reagents or packaging.
Sensitivity	Remains as recommended by manufacture	Parameters were not tested, assumed to remain as recommended by manufacture as no modifications to STANBIO Laboratory Reagents or packaging.
Stability	Remains as recommended by manufacture	Parameters were not tested, assumed to remain as recommended by manufacture as no modifications to STANBIO Laboratory Reagents or packaging.

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

Imprecision: Two control serums were used for both within-run and total precision.
- Within-run: Up to 20 repeats.
- Total precision: Duplicates for up to 20 days.
Correlation: "about 100 serums" were used.
Linearity: "Commercially available linearity material" was assayed.
Recovery: "Commercial available Controls with assigned values" were used.

Data Provenance: The document does not specify the country of origin for the data or explicitly state if it was retrospective or prospective. However, the nature of the tests (using control serums, commercial linearity material, and patient serums for correlation by assaying them) suggests it was a prospective study conducted for the purpose of this 510(k) submission.

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

This information is not provided in the document. The "ground truth" for the test set appears to be established by comparing the performance of the STANBIO Laboratory Reagents on the ANALETTE™ to the performance of predicate reagents (Synermed® and Medical Analysis Systems Inc® Reagents) on the same ANALETTE™ or to manufacturer's claims for linearity and recovery. This is a comparison study, not a ground truthing exercise with independent experts reviewing clinical cases.

4. Adjudication Method for the Test Set:

This information is not applicable as the study described is a laboratory performance study comparing reagent efficacy, not a human reader or image-based diagnostic study requiring adjudication. The performance is assessed against established laboratory methods or manufacturer claims for the predicate reagents.

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 is not applicable as the device is a chemistry analyzer and reagents, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted.

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

This is an algorithm-only (standalone) performance study in the sense that it evaluates the analytical performance of the ANALETTE™ Chemistry Analyzer with STANBIO reagents. The purpose is to demonstrate that the device produces accurate measurement results independently. Human intervention is limited to operating the analyzer and interpreting the numerical output.

7. The Type of Ground Truth Used:

The "ground truth" in this context is established by:

Comparison to Predicate Devices/Reagents: For imprecision and correlation, the performance of the STANBIO reagents is compared to the performance of legally marketed Synermed® and Medical Analysis Systems Inc® reagents on the ANALETTE™ device (which effectively act as the reference standard).
Manufacturer's Claims/Expected Values: For linearity and recovery, the results are compared against the manufacturer's claims for the reagents or assigned values for commercial controls.

This is therefore a form of comparative analytical performance against established and accepted methods/claims, rather than clinical outcomes or pathology reports.

8. The Sample Size for the Training Set:

This information is not applicable as the ANALETTE™ is a chemistry analyzer, not a machine learning or AI-based device that requires a "training set" in the conventional sense. The "training" for such a system would involve instrument calibration and quality control procedures, which are standard for laboratory devices.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the reasons stated above (not an AI/ML device requiring a training set with established ground truth).

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