(128 days)
The SymCare Diabetes Management Program is intended for use in home settings to aid people with diabetes and healthcare professionals in the review, analysis and evaluation of historical blood glucose test results to support effective diabetes management. It is intended for use as an accessory to blood glucose meters with data management capabilities. This system is intended for use by people 18 years of age and older. The SymCare Diabetes Management Program is not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
The SymCare Diabetes Management Program (DMP) is an online tool that helps patients to manage their diabetes and communicate their blood glucose readings to their healthcare providers, healthcare providers manage their diabetes patient population, and insurance companies manage their diabetes patient and health care provider populations. The DMP enables a blood glucose meter to connect via a Bluetooth accessory, the Polymap Wireless Polytel® GMA Glucose Meter Accessory (GMA), to a cellular phone. Once the mobile phone has gathered the data from the meter, it transmits the data to a centralized repository database. The data is analyzed to recognize health patterns, show trends, and offer personalized health information.
The SymCare Diabetes Management Program is an online tool that helps patients manage their diabetes and communicate blood glucose readings to healthcare providers. It also assists healthcare providers and insurance companies in managing diabetes patient populations. The device connects a blood glucose meter via a Bluetooth accessory (Polytel® GMA Glucose Meter Accessory) to a cellular phone, which then transmits data to a centralized database for analysis, trend identification, and personalized health information.
1. Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not specify quantitative acceptance criteria in terms of accuracy, sensitivity, or specificity for the SymCare Diabetes Management Program. Instead, the "Nonclinical Tests" and "Clinical Tests" sections describe the device's performance in terms of software verification, validation, and usability.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with software requirements and design specifications | Extensive software verification and validation testing conducted, demonstrating compliance. |
| Comprehension by study doctors, medical team members, and participants | Demonstrated comprehension of the DMP. |
| Appropriate human factors | Demonstrated appropriate human factors related to the DMP. |
| Ease of use | Demonstrated ease of use of the DMP. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: The document does not explicitly state the sample size for the usability study (referred to as "Clinical Tests"). It mentions "study doctors, medical team members, and participants," but gives no numbers.
- Data Provenance: The document does not specify the country of origin for the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, expert consensus on imaging) is not directly applicable here. The "Clinical Tests" section focuses on usability and comprehension.
- Number of Experts: Not specified. The study involved "study doctors" and "medical team members."
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
Since the study described is a usability study and not an evaluation of diagnostic accuracy, an adjudication method for establishing a "ground truth" (e.g., 2+1, 3+1) is not relevant or described. The study assessed comprehension, human factors, and ease of use.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned in the provided information. The study described focuses on the usability of the device for a single user (patient or healthcare professional).
6. Standalone Performance Study
A standalone performance study, in the sense of an algorithm-only performance without human-in-the-loop, is not explicitly described in terms of diagnostic accuracy. The "Nonclinical Tests" section refers to "extensive software verification and validation testing" demonstrating compliance to requirements and design specifications, which would cover software functionality and integrity. However, this is distinct from quantifying the clinical performance of an AI algorithm in isolation. The SymCare DMP is described as an "online tool that helps patients to manage their diabetes and communicate their blood glucose readings to their healthcare providers," implying a human-in-the-loop design where the data analysis is presented to and used by individuals.
7. Type of Ground Truth Used
The type of ground truth used is related to usability and comprehension assessments. The "Clinical Tests" evaluated:
- Comprehension by users (doctors, medical team members, and participants) regarding the DMP.
- Appropriateness of human factors.
- Ease of use.
This is a qualitative form of "ground truth" based on user feedback and observation rather than a definitive medical outcome or diagnosis.
8. Sample Size for the Training Set
The document does not provide any information about a "training set" or sample size for it. This typically applies to machine learning models that are trained on data. While the device does "analyze data to recognize health patterns, show trends, and offer personalized health information," there is no description of an AI/ML model training process. The submission focuses on software validation and system usability.
9. How the Ground Truth for the Training Set Was Established
Since no training set is described or implies a machine learning model, information on how its ground truth was established is not applicable or provided.
§ 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.