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The Biolis 12i is a discrete photometric chemistry analyzer with ion-selective electrode (ISE), with direct quantitative measurement of sodium, potassium, chloride, and glucose in serum. It is a device intended for the in-vitro, spectrophotometric determination of general chemistry assays for clinical use. The Biolis 12i includes an optional lon Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum. The Biolis 12i is not for Point-Of-Care testing. It is for vitro diagnostic use only.

Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance.

Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.

The Biolis 12i analyzer with glucose hexokinase assay is intended to measure glucose quantitatively in human serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic glycemia, and of the pancreatic islet cell carcinoma.

Using photometry, the Biolis 12i instrument measures the glucose concentration in serum by monitoring the change in absorbance at 340 nm. Additionally, the Biolis 12i with lon-Selective Elective module additionally measures the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry.

The provided 510(k) summary describes the Biolis 12i, a clinical chemistry analyzer with an optional Ion-Selective Electrode (ISE) module, and its performance for measuring glucose, sodium, potassium, and chloride in serum. The study focuses on demonstrating substantial equivalence to predicate devices (Sirrus for Glucose and Prestige 24i for ISE).

Here's an analysis of the acceptance criteria and study as requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical "acceptance criteria" in the format of a predefined pass/fail threshold. Instead, it presents performance characteristics (correlation, linearity, precision, and interference) and asserts "substantial equivalence" to the predicate devices. The implicit acceptance criterion is that the performance of the Biolis 12i must be comparable or equivalent to the predicate devices.

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

• Test Set Sample Size: The document does not explicitly state the total number of patient samples (serum) used for the correlation, linearity, and interference studies.
  • For precision studies:
    • ISE (Sodium, Potassium, Chloride): N=20 for Within Run (repeated measurements of 3 samples), N=15 for Day-by-Day (measurements of 3 samples over 15 days).
    • Glucose: N=20 for Within-run (repeated measurements of 3 samples), N=20 for Between-run (measurements of 3 samples over 20 runs, likely implying 20 days if one run/day).
• Data Provenance: The document does not specify the country of origin of the data or explicitly state whether the study was retrospective or prospective. Given that the manufacturer is in Japan, it's possible the studies took place there, but this is not confirmed in the text.

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

• Experts: Not applicable. For this type of in vitro diagnostic device, "ground truth" is established by reference methods or predicate devices, not human expert consensus on interpretations. The ground truth for the correlation studies was the measurements obtained from the predicate devices (Prestige 24i for ISE and Sirrus for glucose) and for linearity studies, it would be prepared known concentrations. For calibrator verification, the ground truth for glucose was NIST SRM 965b.
• Qualifications: Not applicable in the context of expert interpretation for ground truth.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. This is an IVD device measuring analytes, not making diagnostic interpretations that require human adjudication. The performance is assessed by direct comparison to established methods or known concentrations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• This is not applicable. The Biolis 12i is an automated clinical chemistry analyzer, not an AI-assisted diagnostic tool that involves human readers interpreting images or data outputs and making diagnoses. Therefore, an MRMC study and effects on human reader improvement are not relevant to this device.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Yes, this study essentially represents standalone performance. The Biolis 12i is an automated analyzer. The performance characteristics (correlation, linearity, precision, interference) are measured for the device itself using predefined protocols, without a "human-in-the-loop" interaction for interpretation that would alter its output. The results are quantitative measurements directly from the algorithm/instrument.

7. The Type of Ground Truth Used:

• For Correlation Studies: The ground truth was the measurements obtained from the predicate devices (Sirrus for Glucose, Prestige 24i for Na, K, Cl).
• For Linearity Studies: The ground truth was based on a range of known concentrations (likely serially diluted or prepared samples).
• For Calibrator Verification (Glucose): The ground truth was NIST SRM 965b, Glucose in Frozen Serum, which is a certified reference material.

8. The Sample Size for the Training Set:

• Not applicable / Not disclosed. Automated clinical chemistry analyzers typically do not have a "training set" in the machine learning sense. Their operational parameters are often determined by engineering design, chemical principles, and calibration curves established with known standards. The document clarifies how calibrators were verified but does not mention a distinct "training set" for an algorithm.

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

• Not applicable. As a traditional in vitro diagnostic device, it does not involve machine learning "training sets" and associated ground truth establishment in the way AI/ML devices do. Its "calibration" is performed using known concentration calibrator materials and validated against reference standards. For instance, the glucose calibrator was verified against NIST SRM 965b.

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The Biolis 24i Clinical Chemistry Analyzer is a discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose.

The Biolis 24i analyzer with glucose hexokinase assay is intended to measure glucose quantitatively in human serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic glycemia, and of the pancreatic islet cell carcinoma.

Using photometry, the Biolis 24i instrument measures the glucose concentration in serum by monitoring the change in absorbance at 340 nm. Additionally, the Biolis 24i with Ion-Selective Elective module additionally measures the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tokyo Boeki Medisys Inc. Biolis 24i Clinical Chemistry Analyzer, specifically for glucose measurement:

Acceptance Criteria and Device Performance for Biolis 24i Clinical Chemistry Analyzer (Glucose)

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state pre-defined acceptance criteria values for each performance characteristic. Instead, it presents the results of the performance studies and implicitly suggests that these results demonstrated substantial equivalence to the predicate device. For the purpose of this response, I infer the reported performance as the outcome that met the (unspecified) acceptance criteria for substantial equivalence.

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

• Method Comparison: The document does not explicitly state the total number of samples used for the method comparison (correlation analysis) with the Beckman CX-7.
• Precision (Repeatability): 60 replicates for each of 5 serum samples.
• Precision (Total Imprecision): 80 replicates for each of 4 samples (2 controls, 2 serum pools) on each of two different analyzers.
• Linearity: The sample size for the linearity study is not explicitly stated, but it covered a range of 25 - 500 mg/dL.
• Interferences: The sample sizes for the interference study are not explicitly stated, but tests were performed at two glucose concentrations (e.g., 75 mg/dL and 140 mg/dL for Ascorbic acid).
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective clinical studies. Given the manufacturer's location (Japan) and the context of typical lab instrument validation, these are likely prospective laboratory studies rather than large-scale clinical trials. The samples used (serum, controls, serum pools) suggest laboratory-generated or purchased materials.

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

This device is a clinical chemistry analyzer, which measures quantitative values of analytes. The "ground truth" for such devices is established by reference methods or validated calibrated materials, not typically by human expert consensus or adjudication on individual cases.

• For Method Comparison: The "ground truth" was essentially the measurements obtained from the predicate device, the Beckman CX-7.
• For Calibration: The calibrator (Pointe Scientific Chemistry Calibrator) was verified against NIST SRM 965b (Glucose in Frozen Serum), which serves as a highly reliable reference.
• No human experts were used to establish the ground truth for the analytical performance of the test set in this context.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth for this type of device is established by reference methods/calibrators, not by human expert adjudication of individual cases.

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

No. An MRMC study is not relevant for a standalone clinical chemistry analyzer. MRMC studies are typically used for diagnostic imaging devices where human readers interpret images or data, and the effect of AI assistance on their performance is evaluated. This device provides a quantitative measurement directly.

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

Yes, this entire submission focuses on the standalone performance of the Biolis 24i analyzer as a device for measuring glucose quantitatively. There is no human-in-the-loop component in its measurement principle; it is an automated instrument.

7. The Type of Ground Truth Used

The ground truth used was based on:

• Reference measurements from a predicate device (Beckman CX-7) for method comparison studies.
• NIST Standard Reference Material (SRM 965b, Glucose in Frozen Serum) for verifying the calibrator used to establish the measurement accuracy.
• Known concentrations in control materials and serum pools for precision studies.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of device development. Clinical chemistry analyzers are typically developed and validated using well-established analytical principles and internal testing, calibration, and verification processes rather than machine learning "training sets" in the way an AI algorithm might have one. The "training" would refer to the calibration of the instrument using known calibrators. The text states:

• The calibrator (Pointe Scientific Chemistry Calibrator) was assayed eight times over each of four analytical runs against NIST standard levels 3 and 4, each assayed in duplicate. This process helps "train" or verify the calibration curve for the device.

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

As mentioned above, the "training" in this context refers to the calibration and verification process. The ground truth for the calibrator was established by comparing it to NIST SRM 965b, Glucose in Frozen Serum, which has certified glucose values (118.5 mg/dL and 294.5 mg/dL). This comparison allowed for the verification of the 185 mg/dL glucose set point for the Pointe Calibrator.

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