(78 days)
Nova Max Plus Glucose and β-Ketone Control Solutions are intended for use with the Nova Max Family of Monitors (Nova Max, Nova Max Plus, and Nova Max Link), BD Logic and Paradigm Link Monitors, Nova Max Glucose Test Strips, and Nova Max Plus Ketone Test Strips as a quality control check to verify the accuracy of blood Glucose and ß-Ketone test results. There are two levels of Nova Max Plus Glucose and ß-Ketone Control Solutions (Mid and High).
Nova Max Plus Glucose and ß-Ketone Control Solutions are for in vitro diagnostic use ONLY (for testing outside the body).
Nova Max Plus Glucose and β-Ketone Control Solutions are intended for use with the Nova Max Family of Monitors (Nova Max, Nova Max Plus, and Nova Max Link), BD Logic and Paradigm Link Morr yours, Nova Max Glucose Test Strips, and Nova Max Plus Ketone Test Strips as a quality control check to verify the accuracy of blood Glucose and fl-Ketone test results. There are two levels of Nova Max Plucose and B-Ketone Control Solutions (Mid and High).
Nova Max Plus Glucose and B-Ketone Control Solutions are for in vitro diagnostic use ONLY (for testing outside the body).
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Nova Max Plus Glucose and β-Ketone Control Solutions.
The provided document describes a 510(k) submission for Nova Max Plus Glucose and β-Ketone Control Solutions, a Class I medical device (quality control material). As such, the information typically provided for more complex Class II or Class III devices regarding clinical trials, extensive performance metrics, and human reader studies is not applicable or present in this type of submission for a control solution.
The acceptance criteria here refer to the product demonstrating substantial equivalence to predicate devices. The study conducted primarily focuses on bench testing to support this claim, rather than clinical efficacy or diagnostic accuracy in patients.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a quality control solution and a 510(k) submission for a Class I device, "acceptance criteria" here relate to demonstrating that the new control solutions perform comparably to previously cleared predicate device components and are safe and effective for their intended use. The performance is assessed through laboratory studies.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Pertains to control solutions for glucose and β-ketone: | All studies were performed, and results support the conclusion of substantial equivalence: |
| 1. Functional equivalency to predicate device components | The proposed Nova Max Plus Glucose and β-Ketone Control solutions use the same fundamental scientific technology and have the same intended use as the previously cleared predicate device components: Nova Max Plus Blood Glucose and β-Ketone Monitor System (K091547) and Nova Max Blood Glucose Monitor (K070255). |
| 2. Stability of control solutions | Stability studies were performed. (Specific results or duration not detailed in this summary). |
| 3. Reproducibility/Accuracy in relevant test systems | Averages in equivalency studies were performed. (Specific results or metrics not detailed, but imply comparison to expected values or predicate performance). The device measures Glucose and β-Ketone electrochemically, where the magnitude of current is proportional to the amount of analyte, providing a quantitative measure in control solutions. |
| 4. No new concerns for safety and effectiveness | Results of laboratory testing demonstrate that the performance of the Nova Max Plus Glucose and β-Ketone Control Solutions is "comparable to the performance of the previously cleared predicate devices." The device utilizes the same fundamental scientific technology and has the same intended use. "There are no new concerns for safety and effectiveness that have been shown through testing." This implies that testing did not reveal any unexpected adverse performance or safety issues compared to predicates. |
| 5. Adherence to general controls and regulatory requirements | The device is classified as Class I (21 CFR 862.1660 and 862.1435) with product codes JJX, JIN. The FDA's substantial equivalence determination implies compliance with necessary general controls (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the "test set." It broadly refers to "stability studies" and "averages in equivalency studies" being performed in the laboratory. For a control solution, the "test set" would refer to the batches of control solution produced and tested, as well as the number of measurements taken. This detail is not provided.
- Data Provenance: The studies were conducted "in the laboratory." Given the submitter's address (Waltham, MA, U.S.A.) and the context of a U.S. FDA 510(k) submission, the data is presumably derived from retrospective internal laboratory testing conducted by Nova Biomedical Corporation in the U.S.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts & Qualifications: This category is not applicable in the traditional sense for this device. For quality control solutions, "ground truth" is typically established by certified reference materials, analytical chemistry methods, or the manufacturing specifications and target values for the control. The document refers to the proposed solutions being for "in vitro diagnostic use ONLY." The "averages in equivalency studies" would likely compare the control solutions' measured values to these pre-defined target values or to the performance of predicate controls, as determined by laboratory experts, not clinical experts for diagnostic accuracy. No specific number or qualifications of experts for "ground truth" are mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: This concept is generally not applicable for a quality control solution. Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert interpretations (e.g., radiologists reading images). Here, "performance studies" would involve comparing quantitative measurements against established norms or predicate device performance, which is a direct measurement and comparison rather than a subjective interpretation requiring adjudication.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic imaging or interpretation devices, particularly those involving AI. The device in question is a quality control solution, not an AI-powered diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: This concept is not applicable to this device. A standalone (algorithm-only) performance is relevant for AI or automated diagnostic algorithms. The Nova Max Plus Glucose and β-Ketone Control Solutions are chemical solutions used to verify the accuracy of a monitor system; they do not have an "algorithm-only" performance in the way an AI diagnostic tool would. Their performance is inherent in their chemical composition and stability when measured by the intended monitor.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground-truth for quality control solutions is typically based on certified reference values, analytical standards, or established manufacturing targets for the glucose and β-ketone concentrations. The document implies that the device's performance, as measured by the monitor, is compared to these predetermined values or the performance of predicate controls, which represent the "ground truth" for what the control solution should measure. The text mentions "averages in equivalency studies," which would rely on such established truth.
8. The Sample Size for the Training Set
- Sample Size for Training Set: This is not applicable. This device is a quality control solution. It is manufactured, not "trained" in the context of machine learning or AI. Performance studies for control solutions involve batch testing, stability testing, and equivalency testing, but not a "training set" like an algorithm would require.
9. How the Ground Truth for the Training Set was Established
- How Ground Truth for Training Set was Established: This is not applicable as there is no "training set" for a quality control solution.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.