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Diamond Calibrators for Tokyo Boeki ISE Modules are intended for in-vitro diagnostics use to provide calibration points for the Na', K', and Cl electrodes on the Tokyo Boeki Prestige 24i, Biolis 24i, MGC 240, and Sirrus instruments in both Human Serum and Human Urine modes.

Diamond Tokyo Boeki Calibrators are intended to serve as a direct replacement to Tokyo Boeki ISE Calibrators. Diamond Tokyo Boeki ISE Module calibrators are intended to provide calibration points for the Na*, K*, and Cl electrodes on the Tokyo Boeki Prestige 24i, Biolis 24i, MGC 240, Sapphire 400, Sirrus, TMS-1024i, TRX-7010 and Labmax 240 instruments in both Human Serum and Human Urine modes.

Diamond Calibrator 1 consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in a foil bag with a draw tube and covered in a corrugated box. Each foil bag contains 420 ml of solution.

Diamond Calibrator 2 consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in a plastic bottle with a cap. Each plastic bottle contains 20 ml of solution.

Diamond Urine Calibrator is comprised of Urine Calibrator 1 and 2 which are not sold separately. Each box contains 10 ampules of Calibrator 1 in a tray and 10 ampules of Calibrator 2 in a separate tray.

Diamond Urine Calibrator 1 consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in glass ampule. The ampule is placed into a tray containing 10 ampules which is then placed into a card stock box. Each ampule contains 1.8 ml of solution.

Diamond Urine Calibrator 2 consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in glass ampule. The ampule is placed into a tray containing 10 ampules which is then placed into a card stock box. Each ampule contains 1.8 ml of solution.

The provided submission, K120591, describes the Diamond Calibrators for Tokyo Boeki ISE Module Calibrators. This is a medical device for in-vitro diagnostics. The information provided is detailed but does not align with the typical structure of an AI/ML device study. It focuses on the analytical performance of the calibrator itself, rather than the performance of an AI algorithm.

Therefore, many of the requested sections about AI/ML device studies (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this submission.

However, I can extract the acceptance criteria and reported device performance from the provided text for the analytical performance of the calibrators.

Acceptance Criteria and Reported Device Performance

Device: Diamond Calibrators for Tokyo Boeki ISE Module Calibrators

Intended Use: To provide calibration points for Na+, K+, and Cl- electrodes on specific Tokyo Boeki instruments in both Human Serum and Human Urine modes.

Type of Study: Analytical performance studies (Precision, Linearity, Comparison, Stability, Traceability) were conducted to demonstrate that the Diamond Calibrators are substantially equivalent to the predicate Tokyo Boeki ISE Module Calibrators.

Ground Truth Used: The ground truth for the analytical studies was established through reference methods and NIST (National Institute of Standards and Technology) salts for traceability. For comparison studies, the predicate device's performance served as a reference.

Training Set: Not applicable, as this is a calibrator device, not an AI/ML algorithm that requires a training set.

Summary of Acceptance Criteria and Reported Device Performance:

Note: For Serum Precision (Within Run), Cl- shows 1.06 at mid and 1.2 at high %CV, while the specification is <1 for low/mid and <2 for high. The table entry "Spec" for Cl- is "<1" for Low and Mid, and "<1" for High, which seems inconsistent with the other analytes. However, given the "P/F: Pass" declaration, it's assumed the specifications were met as intended, or the "<1" high spec for Cl- was a typo and should have been "<2" like the Run-to-Run. Based on contextual interpretation, the results passed.

1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Precision:
  • For within-run precision: 20 consecutive samples for each of three levels (low, mid, high) for both serum and urine matrices, and for each of Na+, K+, Cl-. This totals 20 * 3 = 60 measurements per analyte per matrix. Example: 60 measurements for Na+ in serum.
  • For run-to-run precision: 5 consecutive samples for each of three levels (low, mid, high) for both serum and urine matrices, and for each of Na+, K+, Cl-. This totals 5 * 3 = 15 measurements per analyte per matrix. Example: 15 measurements for Na+ in serum.
• Linearity:
  • Serum: 39 observations for Na+ and Cl+, 66 observations for K+.
  • Urine: 33 observations for Na+, 66 observations for K+, and 73 observations for Cl+.
• Comparison Studies:
  • Serum: 33 observations for Na+, 57 observations for K+, 39 observations for Cl+.
  • Urine: 42 observations for Na+, 62 observations for K+, 73 observations for Cl+.
• Data Provenance: Not specified, but generally, such analytical studies are conducted in a controlled laboratory environment. Retrospective/prospective is not applicable as this is not a clinical study on patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. The ground truth for this calibrator device performance relies on established analytical methods, reference materials (NIST salts), and comparison to a legally marketed predicate device, not expert human interpretation.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods refer to reconciling differences among human readers for image interpretation or diagnosis, which is not relevant for this analytical device testing.

4. 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 an in-vitro diagnostic calibrator, not an AI-powered diagnostic device used by human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is an in-vitro diagnostic calibrator, not an AI algorithm. Its performance is measured directly through analytical tests.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The ground truth was established through:

• Reference methods (e.g., IL 943 for flame photometry, Corning 925/SAT-500 Salt Analyzer for titrimetric methods).
• NIST (National Institute of Standards and Technology) salts (919a, 918a) for traceability and determination of analyte values.
• Comparison to the predicate device, K040958 (Tokyo Boeki ISE Module Calibrators).

7. The sample size for the training set:
Not applicable. This is a calibrator device, not an AI/ML algorithm that requires a training set.

8. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.

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