(75 days)
The GEM Premier 3000 is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood pH, pCO2, pO2, Na+, K+, Ca++, Glucose, Lactate and Hct. These parameters along with derived parameters aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.
The GEM Premier 3000 is designed as a portable system for use by health care professionals to rapidly analyze whole blood samples, in central laboratory or point-of-care clinical settings. The instrument provides both measured and calculated results for blood gases, hematocrit, electrolytes, glucose, and lactate.
Here's an analysis of the provided text regarding the acceptance criteria and study for the GEM Premier 3000 device, formatted to answer your questions.
It's important to note that this document is a 510(k) summary for a special FDA submission, specifically for an operating system update. Therefore, the details about original device validation and comprehensive performance studies might be summarized or assumed to be met from the predicate device.
Acceptance Criteria and Study for GEM Premier 3000 (Software V6.3.0 Update)
This submission describes an update to the GEM Premier 3000 device's software (V6.3.0) and operating system (Linux Fedora Core 21) due to component obsolescence. The primary focus of the provided text is to demonstrate that these changes do not alter the previously established performance and safety of the device.
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states: "No change to labeled performance claims." This indicates that the performance criteria for the updated device are identical to those of the predicate device (GEM Premier 3000, K052121), which was already cleared by the FDA. The submission's goal is to prove that the software/OS update maintains these pre-existing performance claims.
Therefore, the acceptance criteria are not new performance metrics but rather the demonstration that the updated device performs equivalently to the predicate device across all its established parameters. The "reported device performance" in this context refers to the verification and validation activities showing that the device continues to meet those original, unlabeled performance claims.
| Parameter/Test | Acceptance Criteria (Implicit from Predicate) | Reported Device Performance (for v6.3.0) |
|---|---|---|
| Measurement Performance | All labeled performance claims for pH, pCO2, pO2, Na+, K+, Ca++, Glucose, Lactate, Hct as established for the predicate device (K052121). | "Testing verified that the SW V6.3.0 change meets requirements and that no new hazards have been introduced." (Implies equivalent measurement performance) |
| Functional Equivalence | Device operates as intended with the new software and OS, without new hazards. | Demonstrated through software verification and validation activities. |
| User Interface | Same menu-driven touch screen functionality as predicate. | "Same" (stated in comparison table) |
| Controls Compatibility | Compatible with existing GEM CVP 1-4 controls. | "Same" (stated in comparison table) |
2. Sample Size Used for the Test Set and the Data Provenance
The document details software verification and validation activities. However, it does not specify a particular sample size for a "test set" in terms of patient samples or clinical data from a specific geographic region. The testing appears to be focused on software functionality and its impact on performance rather than a new clinical study with patient samples.
- Sample Size: Not explicitly stated for testing of the updated software/OS in a clinical or laboratory setting with a defined number of cases. The testing appears to be centered on software function verification and validation.
- Data Provenance: Not specified. Given it's a software/OS update, the "data" would primarily be software test results rather than patient data. The original predicate device presumably had data provenance established during its clearance.
- Retrospective/Prospective: Not applicable to the software/OS update described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The nature of this submission (a Special 510(k) for an OS update) means that new ground truth establishment by external experts for device performance is likely not required, as the performance claims are carried over from the predicate device. The verification and validation would be internal engineering and quality assurance activities.
4. Adjudication Method for the Test Set
This information is not provided and is unlikely to be relevant for a software/OS update focused on maintaining equivalence to a predicate device's performance. Adjudication methods are typically used in clinical studies where multiple human readers interpret data that requires consensus for ground truth.
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 comparative effectiveness study was not done. This device is an analyzer for blood samples, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, the concept of "human readers improve with AI" does not apply here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device itself, the GEM Premier 3000, is a standalone instrument that provides quantitative measurements. The update discussed here is for its internal operating system and software. The "standalone" performance for the measurements is inherent to the device's function, and the submission's purpose is to confirm this performance is maintained after the software/OS update. It is not an AI algorithm in the typical sense.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the original predicate device's performance, the ground truth for parameters like pH, pCO2, pO2, Na+, K+, Ca++, Glucose, Lactate, and Hct would typically be established through reference methods (e.g., highly accurate laboratory methods, calibrated standards). The current submission relies on the established performance of the predicate device, implying that the ground truth for its performance was originally established via these reference methods and that the updated device continues to align with those.
The "ground truth" for the software update itself is that the software performs its functions correctly and reliably, and that no regression or new hazards are introduced. This is verified through software testing against design specifications.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The GEM Premier 3000 is a measurement device, not a machine learning or AI algorithm that requires a "training set" in the context of developing a diagnostic model. The software update is for an operating system and application software, not for an AI model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of this device and its software update.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.