(127 days)
The TheraSense Inc. FreeStyle™ Connect Data Management System is intended for use in home and clinical settings to aid people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results to support an effective diabetes management program.
The FreeStyle™ Connect Data Management System is an optional data management software accessory for use with the FreeStyle™ Blood Glucose Monitoring System. The FreeStyle™ Connect Data Management System permits the transfer of data from the FreeStyle™ Blood Glucose Meter to a personal computer for enhanced data management capability.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the TheraSense FreeStyle™ Connect Data Management System:
Summary of Acceptance Criteria and Study Information for TheraSense FreeStyle™ Connect Data Management System
The provided document is a 510(k) summary for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical trial results with acceptance criteria in the manner one might find for a novel diagnostic algorithm.
The core of the "study" described here is software verification and validation testing, confirming that the data management system functions as intended and meets specified performance requirements.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device (data management software) and the document (510(k) summary), the "acceptance criteria" are related to software functionality and safety rather than a diagnostic performance metric like sensitivity or specificity. The reported performance is adherence to these software development and testing standards.
| Acceptance Criteria (Inferred from Text) | Reported Device Performance |
|---|---|
| Developed in accordance with TheraSense Inc. Software Development Procedures | Software developed in accordance with procedures. |
| Developed in accordance with FDA's Guide on Review of 510(k)s for Computer Controlled Medical Devices (1991) | Software developed in accordance with this guide. |
| Developed in accordance with Guidance for Content of Premarket Submission for Medical Devices Containing Software (May 29, 1998) | Software developed in accordance with this guidance. |
| Developed in accordance with General Principles of Software Validation (draft, 1997), where applicable and appropriate | Software developed in accordance with this draft guidance. |
| Software Verification Testing demonstrates meeting performance requirements for intended use | Software verification testing demonstrates meeting performance requirements. |
| Software Verification and Validation testing completed and results conform to functional requirements | Will be completed, and results will conform (commitment). |
| Safe and effective for its intended use (as demonstrated by verification testing) | Software verification testing demonstrates safety and effectiveness. |
| Substantially Equivalent to predicate device (MediSense Precision Link Data Management System K952279) | FDA determination of Substantial Equivalence (K994433). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of patient data or clinical accuracy. The testing described is software verification and validation. Therefore:
- Sample Size for Test Set: Not applicable in the traditional sense of a clinical test set. The validation would involve various software testing scenarios, test cases, and simulated data, but not a specific "sample size" of patient data for accuracy measurement.
- Data Provenance: Not applicable. The validation focuses on the software's functionality, data transfer, storage, display, and analysis capabilities rather than the origin of clinical data used for accuracy assessment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For software verification and validation, the "ground truth" is defined by the software specifications, functional requirements, and relevant regulatory guidance. Software engineers, quality assurance personnel, and potentially medical device experts (to interpret regulatory requirements) would be involved in the design and review of these tests.
- Qualifications of Experts: Not explicitly stated, but typically involves software developers, quality assurance engineers, and regulatory affairs specialists.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Software verification and validation results are typically determined by comparing the software's output/behavior against predefined expected outcomes based on the software specifications. There is no mention of a human adjudication process for test results in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not performed or described. This type of study is typically done for diagnostic imaging devices where human readers interpret results with or without AI assistance. The FreeStyle™ Connect Data Management System is data management software, not a diagnostic imaging AI.
- Effect Size of Human Readers Improve with AI vs. Without AI: Not applicable, as no such study was conducted. The software aims to "aid people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results," implying an improvement in data management and insight, but not through an AI diagnostic assistance paradigm.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: Yes, in essence, the software verification and validation described is a "standalone" evaluation of the algorithm's (software's) functionality. It demonstrates that the software itself performs its intended data management tasks (transfer, storage, display, analysis) correctly according to its specifications, independent of a specific human-in-the-loop diagnostic interpretation. However, its intended use is to "aid" human users, so its ultimate value is realized with human interaction. The validation focuses on the technical correctness of the software's operations.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth used for software verification and validation is primarily software specifications, functional requirements, and regulatory guidance. The software's output and behavior are compared against these documented requirements to confirm correct operation. For data-handling aspects, the ground truth would be the original data from the FreeStyle™ Blood Glucose Meter.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The FreeStyle™ Connect Data Management System is a rule-based software that processes and displays data. It is not an AI/ML model that requires a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of software.
§ 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.