(177 days)
The GL Cartridge is intended for professional use with the IRMA® Blood Analysis System for the direct measurement of sodium, potassium, glucose, and chloride in human whole blood. The GL Cartridge and the IRMA® Blood Analysis System are for in vitro diagnostic use.
The electrolyte measurements (Nat, K*, Cl ) are used to assess hydrational status, aid in the diagnosis of respiratory and metabolic acid-balance, and prevention of cardiac arrhythmia. Common disease states, which use these measurements for diagnosis, are acid-base disturbances, dehydration, diarrhea, ketoacidosis, alcoholism and other toxicities.
The measurement of glucose aids in the diagnosis and treatment of diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia.
The IRMA® SL Blood Analysis System GL Cartridge is for use with the IRMA Blood Analysis System. The GL cartidge is a single use, disposable carridge, for the in vitro measurement of any of the may on the may GL cartidge comprises the analytes sodium, potassium (K945240), chloride (K981270) and glucose. Oiz currently markets cartridges with sodium, potassium, (K945240) and chloride.
Samples are introduced via syringe or capillary injections with the IRMA® Capillary Collection Device. The glucose sensor uses an amperometric electrode along with a reference electrode that measures the glucose oxidase reaction. The IRMA® sensors are calibrated prior to each test using a calibrant packaged with the sensors. Calibration of the cartridge is completed when information a canorally partil the factory for each lot of cartridges is combined with measurements taken during the calibration process. Factory derived calibration parameters are input into the analyzer by calibration code entry.
Throughout the calibration and analysis process, signals from the sensors are analyzed. If any abnormal conditions are detected, an error message is generated and the test will be terminated. If abliotinal continuent a conditions, then the sample results (measured and calculated) are displayed after successful calibration and analysis. In addition, the user has the option to print a hard copy of the results.
The provided text describes the acceptance criteria and performance of the IRMA® SL Blood Analysis System GL Cartridge, specifically focusing on its glucose measurement capabilities.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for accuracy, precision, or linearity with numerical targets. Instead, it presents the performance data of the IRMA® device and claims substantial equivalence to the predicate device, the YSI Model 2300 Stat Plus. The implied acceptance is that the performance is comparable or within an acceptable range for clinical use, particularly when compared to a legally marketed predicate device.
Based on the "Summary of Performance Data" section:
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (IRMA® GL Cartridge) |
|---|---|---|
| Accuracy (Glucose) | N/A (Substantial Equivalence to YSI 2300 Stat Plus) | Slope: 0.97 |
| Intercept: 5.47 | ||
| r: 0.992 | ||
| Sy.x: 11.08 | ||
| Precision (Glucose) | N/A (Substantial Equivalence to YSI 2300 Stat Plus) | Level 1 (47.7 mg/dL): 5.9 %CV |
| Level 2 (103.0 mg/dL): 4.5 %CV | ||
| Level 3 (198.5 mg/dL): 4.0 %CV | ||
| Level 4 (351.3 mg/dL): 4.8 %CV | ||
| Linearity (Glucose) | N/A (Substantial Equivalence to YSI 2300 Stat Plus) | Linear over 20-500 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance
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Accuracy (Glucose):
- Sample Size: n = 37
- Data Provenance: Not explicitly stated (e.g., country of origin, prospective/retrospective). However, it's generally understood that such studies for medical devices are conducted on human samples, likely from clinical settings, and are typically prospective for regulatory submissions.
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Precision (Glucose):
- Level 1: n = 59
- Level 2: n = 58
- Level 3: n = 60
- Level 4: n = 59
- Data Provenance: Not explicitly stated (e.g., country of origin, prospective/retrospective). These types of studies often use control materials or pooled patient samples to evaluate reproducibility.
-
Linearity (Glucose):
- Sample Size: n = 20
- Data Provenance: Not explicitly stated. Linearity studies typically involve prepared samples with known, varying concentrations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number of experts, qualifications) is not relevant for in vitro diagnostic devices like the IRMA® SL Blood Analysis System GL Cartridge. The "ground truth" for glucose measurement is established by reference methods or a predicate device, which are assumed to be accurate based on established analytical principles and prior validation. The study compares the IRMA® device's measurements to another measurement device (likely the predicate or a laboratory reference method), not to expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. As explained above, this is for an in vitro diagnostic device measuring an analyte, not for subjective interpretation by experts. Ground truth is established by quantitative measurement, not expert consensus.
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. This device is an automated blood analysis system, not an AI-assisted diagnostic tool that involves human readers interpreting images or data. Therefore, an MRMC study and AI assistance effect size are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance data presented (accuracy, precision, linearity) reflects the standalone performance of the IRMA® SL Blood Analysis System GL Cartridge for glucose measurement. It is an automated system designed for direct measurement.
7. The Type of Ground Truth Used
The ground truth for the glucose measurements in the performance study would have been established by a reference method or a legally marketed predicate device (YSI Model 2300 Stat Plus, mentioned as the predicate in the substantial equivalence claim). This means the measurements from the IRMA® device were compared against measurements from a highly accurate and validated method or device.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" for the glucose measurement. In the context of this type of in vitro diagnostic device, the "training" for the device's internal algorithms and calibration parameters happens internally at the factory and during the initial calibration process described (using factory-derived parameters combined with measurements during daily calibration). There isn't typically a large external "training set" of patient data in the same way an AI/ML algorithm might have for image classification.
9. How the Ground Truth for the Training Set Was Established
Given the explanation in point 8, the concept of "ground truth for the training set" as it applies to AI/ML is not directly applicable here. However, the accuracy of the device's measurements (and thus its "training" or calibration parameters) relies on the use of calibrants and control materials with known, highly accurate concentrations, which themselves are verified against reference methods. The device states: "The IRMA® sensors are calibrated prior to each test using a calibrant packaged with the sensors. Calibration of the cartridge is completed when information a canorally partil the factory for each lot of cartridges is combined with measurements taken during the calibration process. Factory derived calibration parameters are input into the analyzer by calibration code entry." This suggests the "ground truth" for its internal calibration is established through a combination of factory-set parameters and on-board calibration using precise, standardized solutions.
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.