(176 days)
The Sof-Tact Diabetes Management System is intended for in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Sof-Tact System is for home (lay user) use.
The Sof-Tact Diabetes Management System is specifically intended for the quantitative measurement of glucose in whole blood samples obtained from the finger, forearm, upper arm and the base of the thumb.
The Abbott Laboratories MediSense Sof-Tact™ Diabetes Management System for Blood Glucose Testing utilizes amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measure of glucose in whole blood and control solutions. The Sof-Tact Diabetes Management System integrates the process of blood collection from body sites including the forearm, upper arm and base of the thumb and glucose assay into a single operation by the user. A separate test port is available for blood collection glucose assay from the fingertip.
Here's a breakdown of the acceptance criteria and study information for the Sof-Tact Diabetes Management System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary for the Sof-Tact Diabetes Management System does not explicitly state quantitative acceptance criteria in terms of specific glucose difference values or accuracy percentages. Instead, the acceptance criteria are framed in terms of substantial equivalence to predicate devices and acceptable clinical performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (Precision Xtra, TheraSense FreeStyle, Amira AtLast) regarding technological characteristics and intended use. | "The Sof-Tact Diabetes Management System has equivalent technological characteristics and a similar intended used as the Precision Xtra System (K983504), TheraSense FreeStyle Meter (K992684) and the Amira AtLast Meter (K982076)." |
| Lay users can obtain blood glucose results substantially equivalent to current methods (including predicate devices). | "The studies demonstrated that lay users can obtain blood glucose that are substantially equivalent to the current methods for blood glucose measurements, which include the predicate devices listed above." |
| Clinically insignificant glucose difference between arm and finger measurements. | "Clinical evaluations indicate that under variable glycemic conditions, glucose difference between arm and finger was clinically insignificant as determined by Clarke Error Grid." |
| Trained operators and lay users obtain equivalent whole blood glucose results. | "Results of clinical performance testing demonstrate that trained operators and lay users obtain equivalent whole blood glucose results." |
| No clinically significant difference between arm glucose results at various post-prandial times (up to 3 hours) and finger glucose results. | "The Sof-Tact arm glucose results at various post-prandial times up to 3 hours show no clinically significant difference from finger glucose results." |
| Acceptable performance when used according to intended use. | "Results of laboratory and clinical testing demonstrate that the performance of the Sof-Tact Diabetes Management System, when used according to the intended use stated above, is acceptable..." |
| Comparable performance to predicate devices. | "...and comparable to the performance of the previously mentioned predicate devices for blood glucose testing." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for the test set used in the clinical studies. It mentions "studies" in the plural, suggesting multiple individuals and tests were involved.
- Data Provenance: The studies were conducted "in the laboratory and in clinical settings." No specific country of origin is mentioned, but the submission is to the U.S. FDA, so it's reasonable to assume the studies were conducted in the U.S. The studies assessed current methods and user performance, implying a prospective data collection approach for the performance of the Sof-Tact system.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with 10 years of experience). However, it refers to:
- "healthcare professionals" who participated in "clinical settings" performance studies.
- The "Clarke Error Grid" as the method for determining clinical significance, which is a standard analytical tool typically interpreted by medical professionals.
4. Adjudication Method for the Test Set
The document does not describe a specific adjudication method like 2+1 or 3+1. The use of the "Clarke Error Grid" implies a comparison to a reference method, but not necessarily a consensus-based adjudication process for individual results beyond confirming clinical significance.
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
This device is a standalone blood glucose monitoring system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the core of the evaluation is the standalone performance of the Sof-Tact Diabetes Management System itself, both in laboratory settings and when used by lay users without assistance, and also with trained operators. The device's measurement of glucose is an automated process (amperometric biosensor technology).
7. The Type of Ground Truth Used
The ground truth used for comparison appears to be:
- Current methods for blood glucose measurements: This specifically includes the predicate devices (Precision Xtra, TheraSense FreeStyle, Amira AtLast). This implies that a reference measurement from these established devices was used as the ground truth against which the Sof-Tact system's readings were compared.
- Clinically accepted standards: The use of the "Clarke Error Grid" signifies that the clinical significance of the glucose differences was evaluated against established medical criteria for blood glucose accuracy.
8. The Sample Size for the Training Set
The document does not provide information regarding a specific "training set" or its sample size. This type of device (a medical measurement instrument) typically undergoes extensive validation rather than machine learning training in the context commonly understood for AI/ML systems. Any "training" would refer to the development and calibration of the intrinsic measurement technology, not a distinct dataset for an algorithm.
9. How the Ground Truth for the Training Set Was Established
As there's no mention of a traditional "training set" in the machine learning sense, the establishment of ground truth for a training set is not applicable to this document. The development of the device's measurement principles and calibration would be based on established chemical and electrical engineering principles for biosensors, with accuracy validated against known glucose concentrations.
§ 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.