(247 days)
By evaluating current and cumulative blood glucose levels, the EndoTool Glucose Management Sysstem (EGMS) - a glycemic management software support program is designed for use by healthcare professionals in all patient care settings to recommend intravenous and subcutaneous transition dosing, as well as dextrose, to adjust and maintain the blood glucose level within a configurable clinician- determined target range.
The EndoTool Drug Delivery Calculator is indicated for use in adult and pediatric patients ages 2 years and above and who weigh 12 kgs. or more.
The EGMS logic is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software program.
The EGMS includes: security features, software upgrades, data backup capabilities, and technical support. Each user has an individual User ldentification (ID) and Password in order to access portions of the application. Software upgrades are accessible through the EndoTool Portal website and the technical support is made easier by the use of Microsoft .Net technologies. EndoTool is designed to safeguard the confidentiality, integrity, and availability of electronic protected health information of patients according to the Health Insurance Portability and Accountability Act (HIPAA) privacy rules. EndoTool is packaged in a user friendly, stand-alone program using Microsoft .Net technologies. The application requires Windows XP or Windows 7. The application was developed for use on Personal Computers (PCs), network servers, and terminal server environments.
The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets them beyond a general statement that "Clinical user validation studies demonstrated that the EGMS performs safely and effectively, as intended." Therefore, I cannot fully complete the requested table or answer all questions.
Here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific performance metrics (e.g., accuracy, safety thresholds) are not provided in the document. | "Clinical user validation studies demonstrated that the EGMS performs safely and effectively, as intended." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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
- A MRMC comparative effectiveness study is not explicitly mentioned. The document states "Clinical user validation studies demonstrated that the EGMS performs safely and effectively, as intended," but does not detail the study design to determine if it was an MRMC study or if it measured improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies human-in-the-loop performance as it states, "The EGMS logic is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software program." This suggests it is not a standalone algorithm without human intervention, but the specifics of a standalone performance study are not detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified.
8. The sample size for the training set
- Not specified.
9. How the ground truth for the training set was established
- Not specified.
Summary of available information:
The provided 510(k) summary for the EndoTool Glucose Management System (K132547) presents a high-level overview. It mentions "Clinical user validation studies" that "demonstrated that the EGMS performs safely and effectively, as intended." However, it does not provide any specific details regarding:
- Quantitative acceptance criteria (e.g., specific accuracy, precision, or safety metrics).
- The methodology or results of these studies.
- Sample sizes for training or testing sets.
- The provenance or characteristics of the data used.
- How ground truth was established.
- Details about expert involvement or adjudication.
- Whether MRMC or standalone performance studies were conducted.
The document primarily focuses on regulatory compliance (IEC 62304, ISO 14971) and substantial equivalence to predicate devices, rather than detailed performance study results.
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).