DOCUMENT Ammonia, Ethanol, Lactate Calibrator is intended for in vitro diagnostic use for the quantitative calibration of automated, semi-automated, or manual clinical chemistry systems used for the measurement of ammonia. ethanol, and lactate. DOCUMENT Ammonia. Ethanol, Lactate Calibrator is intended to provide for the quantitative calibration of automated, semi-automated, and manual clinical chemistry systems. Each lot of DOCUMENT Ammonia, Ethanol, Lactate Calibrator has lot specific calibration set point values included for the various analytical systems on which it was assayed.

Device Description

DOCUMENT Ammonia, Ethanol, Lactate Calibrators consist of one level of an aqueous matrix containing ammonia, ethanol. and lactate. The formulation design provides a liquid calibrator intended for use on automated. semi-automated, and manual clinical chemistry systems for the quantitative determination of ammonia (AMM), ethanol (ALC) and lactate (LAC).

AI/ML Overview

The provided text describes a 510(k) summary for the DOCUMENI® Ammonia, Ethanol, Lactate Calibrator. The primary purpose of this document is to establish substantial equivalence to predicate devices, not to present a comprehensive study proving the device meets specific acceptance criteria in the context of a typical AI/medical device study.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, MRMC study, ground truth for training set) are not applicable to the information provided because this is a submission for a calibrator, not a diagnostic or AI-driven medical device.

However, I can extract the relevant information from the document that aligns with your request as much as possible for a calibrator device:

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

The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., target accuracy, precision thresholds). Instead, the performance is demonstrated by comparing the new calibrator's behavior to that of predicate calibrators through an established protocol. The implicit acceptance criterion is "comparable behavior" or "similar manner" to the predicate devices when used in an analytical system.

Characteristic / Performance Aspect	Acceptance Criteria (Implicit)	Reported Device Performance (Summary of results)
Ammonia Calibration	Comparable to NERL 100µmol/L Ammonia Standard using BMC Ammonia reagents on a Hitachi 717	"behaves in a similar manner" compared to the predicate
Ethanol Calibration	Comparable to Beckman Alcohol Kit Calibrator with Beckman Reagents on a Beckman Synchron CX5	"behaves in a similar manner" compared to the predicate
Lactate Calibration	Comparable to Beckman CX Multi Calibrator using Beckman Lactate reagent on a Beckman Synchron CX5	"behaves in a similar manner" compared to the predicate
Suitability	Suitable for use as a calibrator	"is suitable for use as a calibrator for the listed analytes on those systems tested."

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

Sample Size: The document mentions "patient samples" were used in the equivalence study. It states the study followed "NCCLS EP9 Protocol: Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline." The NCCLS EP9 guideline typically recommends a minimum of 40 patient samples for method comparison and bias estimation. However, the exact number used in this specific study is not explicitly stated in the provided text.
Data Provenance: The data provenance is from "patient samples." The country of origin is not specified, and it is a prospective comparison study between the new calibrator and existing predicate calibrators using real patient samples.

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

This is not applicable as the document describes a calibrator device, not a diagnostic device requiring expert interpretation or ground truth establishment in the traditional sense. The "ground truth" for a calibrator is its assigned value, verified through analytical methods.

4. Adjudication method for the test set

This is not applicable for a calibrator device. Adjudication methods are typically used in studies involving human interpretation or subjective assessments.

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

No, an MRMC study was not performed. This type of study is relevant for AI-powered diagnostic devices involving human readers, which is not the case for a chemical calibrator.

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

This is not applicable. The device is a calibrator, not an algorithm. The "standalone performance" in this context would be the calibrator's assigned values and its stability, which are implied by the comparison to predicate devices and the stability information provided in the table. The study compared the entire analytical system's performance when using the new calibrator versus the predicate calibrators.

7. The type of ground truth used

For a calibrator, the "ground truth" is established by its traceability (for ammonia and ethanol) or assigned value (for lactate), often derived through validated reference methods or comparison to established reference materials. The comparison study itself uses the predicate calibrators as the reference for "ground truth behavior" within the analytical systems.

8. The sample size for the training set

This is not applicable. The device is a chemical calibrator, not an AI model requiring a training set.

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

This is not applicable.

Summary

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SEP 13 1996

Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers 9, 6, 2, 6, 2, and 9. The numbers are written in a bold, slightly irregular style, giving them a hand-drawn appearance. The black ink contrasts sharply with the white background, making the characters stand out.

Exhibit 21. 510(k) Summary

FEDERAL FOOD, DRUG AND COSMETIC ACT 510(k) SUMMARY

DOCUMENI® Ammonia, Ethanol, Lactate Calibrator, Levels I, III, III

1. Submitted by: CASCO Standards P.O. Box 970 Yarmouth, ME 04096
- Attention: Christine V. Beach Manager, Regulatory Affairs

(207) 878-7550 (207) 878-7578 FAX

1. Product Name:
  Proprietary Name: DOCUMENI® Ammonia, Ethanol, Lactate Calibrator

Classification Name: Control, multiple analyte, assayed.

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Predicate Device:

Analyte: Ammonia Manufacturer. Boehringer Mannheim Corp., Indianapolis, IN System: Hitachi 717 System Reagents: Boehringer Mannheim Corp., Ammonia, Kit No. 450055 Calibrator. New England Reagent Laboratories, East Providence, RI Ammonia Standards, 100umol/L, part of Kit No. NERL 1207

Analyte: Ethanol Manufacturer. Beckman Instruments, Brea, CA System: Beckman Synchron CX5 Reagents: Beckman Instruments, Alcohol, Kit No: 445900 Calibrator. Beckman Instruments, Fullerton, CA Alcohol, part of Kit No. 445900

Analyte: Lactate Manufacturer. Beckman Instruments, Brea, CA System: Beckman Synchron CX5 Reagents: Beckman Instruments, Lactate, Kit No. 445875 Calibrator. Beckman Instruments, Fullerton, CA Lactate, CX Multi Calibrator, Part No. 442600

1. Product Description: DOCUMENT Ammonia, Ethanol, Lactate Calibrators consist of one level of an aqueous matrix containing ammonia, ethanol. and lactate. The formulation design provides a liquid calibrator intended for use on automated. semi-automated, and manual clinical chemistry systems for the quantitative determination of ammonia (AMM), ethanol (ALC) and lactate (LAC).
1. Intended Use: DOCUMENT Ammonia, Ethanol, Lactate Calibrator is intended for in vitro diagnostic use for the quantitative calibration of automated, semi-automated, or manual clinical chemistry systems used for the measurement of ammonia. ethanol, and lactate. DOCUMENT Ammonia. Ethanol, Lactate Calibrator is intended to provide for the quantitative calibration of automated, semi-automated, and manual clinical chemistry systems. Each lot of DOCUMENT Ammonia, Ethanol, Lactate Calibrator has lot specific calibration set point values included for the various analytical systems on which it was assayed.

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K962629

1. Comparison to the Predicate Device:

Characteristic	DOCUMENI®Ammonia, Ethanol,Lactate Calibrator	New EnglandReagent LaboratoryAmmoniaStandards	Beckman AlcoholKit Calibrator	Beckman CX MultiCalibrator
Intended Use	Intended for thequantitativecalibration ofautomated, semi-automated, andmanual clinicalchemistry systems.	None given	Intended for thequantitativedetermination ofalcoholconcentration inserum or plasmaon SYNCHRONCX Systems	Intended for use onthe SYNCHRONCX Systems for thecalibration of ...,Lactate, ...
Number of Levels	One	Five	One	One
Type	Traceable: AmmoniaEthanolAssigned: Lactate	Assigned	Assigned	Assigned
Analytes	3	1	1	Many
Volume	4 mL	5 mL	5 mL	20 mL
Matrix	Aqueous	Aqueous	Aqueous	Human serum,Liquid
Dilution	None required	None required	None required	None required
Unopened Stability	Until Expiration Date	Until ExpirationDate	Until ExpirationDate	Until ExpirationDate
Open Stability	30 Days	None indicated	7 Days	20 Days
Container	Plastic,Dropper Tip	Plastic.Dropper Tip	Plastic,Dropper Tip	Plastic,Dropper Tip

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Test Results:

The equivalence for this product was carried out by comparing quantitative analytical recovery of patient samples using the NCCLS EP9 Protocol: Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. The DOCUMENT Ammonia, Ethanol, Lactate Calibrator was compared to the NERL 100µmol/L Ammonia Standard using BMC Ammonia reagents on a Hitachi 717 Clinical Chemistry Analyzer, the Beckman Alcohol Kit Calibrator with Beckman Reagents on a Beckman Synchron CX5 System, and the Beckman CX Multi Calibrator using Beckman Lactate reagent on a Beckman Synchron CX5 System. The results show that the DOCUMENT Ammonia, Ethanol, Lactate Calibrator behaves in a similar manner compared to the predicate devices and is suitable for use as a calibrator for the listed analytes on those systems tested.

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.