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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.

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.

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."

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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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, Carbon Dioxide, Amylase, Cholesterol(includes HDL), Triglycerides, Total Bilirubin, Direct Bilirubin, Uric Acid, Lactate Dehydrogenase L, Lactate Dehydrogenase P, Alanine Aminotransferase. Aspartate Aminotransferase; Gamma Glutamyl Transferase, Lipase, 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 and Medical Analysis Systems Reagents. It is used to monitor various physiological diseases or conditions. Precision Systems Inc will distribute, recommend and sales MAS Reagents without any modification of MAS packaging using PSI Applications sheets.

An in vitro diagnostic automated clinical chemistry analyzer for the analysis of analytes in solution.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ANALETTE™ clinical chemistry analyzer and Medical Analysis Systems Reagents:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a submission for substantial equivalence (510(k)) for the ANALETTE™ clinical chemistry analyzer using Medical Analysis Systems (MAS) Reagents, comparing it to the same ANALETTE™ analyzer using Synermeds® 072 reagents (the predicate device). The core of the acceptance criteria here is the demonstration of "substantial equivalence" of the new reagent system to the predicate. Specific quantitative acceptance criteria are not explicitly detailed in the provided text in the form of numerical thresholds for accuracy, precision, or comparison studies. Instead, the performance section broadly states:

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

The document states that "comparative studies" were conducted. However, it does not provide any details regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature).

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. For a clinical chemistry analyzer, the ground truth is typically established by reference methods or highly accurate laboratory instruments rather than expert adjudication in the way it would be for image-based diagnostics.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable in the context of a clinical chemistry analyzer's performance evaluation as described. Ground truth is established through analytical measurements, not through human adjudication of diagnostic findings. Therefore, no adjudication method like 2+1 or 3+1 would be used.

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

No, an MRMC comparative effectiveness study was not done for this device. MRMC studies are typically used for diagnostic imaging devices where human interpretation is a critical component, often comparing human readers with and without AI assistance. This device is a clinical chemistry analyzer, which provides quantitative measurements directly.

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

The performance described for the ANALETTE™ clinical chemistry analyzer with MAS reagents is inherently a standalone performance in the context of the instrument measuring analyte concentrations. There is no "human-in-the-loop" performance component in the direct measurement by the analyzer. The comparison is between two reagent systems on the same analyzer, assessing the analytical performance.

7. The Type of Ground Truth Used

The ground truth for this type of device (a clinical chemistry analyzer) would typically be established by:

• Reference standard methods: Highly accurate and precise laboratory methods, often more complex or expensive than routine clinical tests.
• Certified reference materials: Samples with known, validated concentrations of the analytes.
• Comparison to the predicate device: For a 510(k) submission seeking substantial equivalence, the performance of the new device (or reagent system) is directly compared to the legally marketed predicate device using patient samples and/or quality control materials. The predicate device's results serve as the pragmatic "ground truth" for demonstrating equivalence in a clinical setting.

The document implies the latter, stating "Substantially equivalence was established in comparative studies," meaning performance was compared against the predicate system.

8. The Sample Size for the Training Set

This information is not provided in the document. Clinical chemistry analyzers and their associated reagents are developed through analytical validation, which involves extensive testing, but the term "training set" is more commonly associated with machine learning algorithms. If there were any computational models or algorithms within the analyzer's software that required training (which is not explicitly indicated as relevant here beyond basic instrument calibration), the details of such a training set are absent.

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

Since no "training set" in the machine learning sense is explicitly mentioned or detailed, and the focus is on analytical performance comparison (substantial equivalence), the method for establishing ground truth for a training set is not applicable or provided. The development of a clinical chemistry reagent kit involves rigorous analytical validation, where performance characteristics like accuracy, precision, linearity, and interference are established using known standards and patient samples, rather than a "ground truth for training" in the way an AI model would be trained.

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The Precision Systems ANALETTE Chemistry Analyzer is intended for the quantitative determination of analytes in solutions, 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 Synermed's Reagents for Albumin, ALT, AST, ALP, Amylase, Calcium, CO2, Cholesterol, Creatinine, CK, Glucose, GGT, LDH, Maqnesium, Phosphorus, Total Protein, Triglycerides, Urea Nitrogen, Total Bilirubin, Direct Bilirubin, HDL Cholesterol, UBIC, Iron, Chloride, and Uric Acid as shown in 510(k) K971491 using the ANALETTE under Synermed's name IR 200

An in vitro diagnostic automated clinical chemistry analyzer for the analysis of analytes in solution.

The provided text is a 510(k) premarket notification summary and the FDA's response letter for the PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER. It establishes "substantial equivalence" to a predicate device, the Synermed IR® 200.

However, the document does not contain specific acceptance criteria, detailed study designs, or reported device performance metrics in the format requested. The "Performance" section within the Summary of Safety and Effectiveness only states: "Substantially equivalence was established in comparative studies. It was concluded from these results that this product is safe and effective." This is a general statement, not a detailed report of performance against quantitative criteria.

The information requested in the prompt (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, etc.) is typically found in the full 510(k) submission, not in this public summary document. The summary only attests that such studies were performed and deemed sufficient to show substantial equivalence.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

2. Sample sizes used for the test set and the data provenance

• Test Set Sample Size: Not specified in the provided document.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not specified in the provided document. It refers generally to "comparative studies" but provides no details on their design or origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not specified. This device is an automated clinical chemistry analyzer. The "ground truth" for chemical measurements would typically be established through reference methods or certified standards, not expert reader consensus. The document does not mention experts establishing a ground truth for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are relevant for subjective interpretations (e.g., image reading), not for automated chemical analyzers where results are quantitative.

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. The device is a standalone automated clinical chemistry analyzer, not an AI-assisted diagnostic tool for human readers. Such a study would not be relevant for this type of device.

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

• Yes, implicitly. The ANALETTE™ is described as an "automated clinical chemistry analyzer for the analysis of analytes in solution." Its performance is inherently standalone for quantitative measurements. The "comparative studies" mentioned would have evaluated its direct measurements against a predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Implied Reference Methods/Standards: For an automated clinical chemistry analyzer, the ground truth would typically be established by validated reference methods, certified reference materials, or comparison to results from highly accurate lab instruments. The document does not explicitly state the method, but this is the standard for such devices.

8. The sample size for the training set

• Not applicable/Not specified. This device is a traditional automated chemistry analyzer, not an AI/ML device that requires a "training set" in the machine learning sense. Its operation is based on established chemical principles and pre-programmed algorithms for measurement and calculation.

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

• Not applicable. As noted above, this is not an AI/ML device that uses a "training set."

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