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EndoTool SubQ is a software application for use by trained healthcare professionals to calculate and recommend an individual patient's next dose of insulin to be administered subcutaneously to manage blood glucose levels in patients with Diabetes Mellitus in both adult and pediatric patients (age 2 years and above and 12 kg or more). The software is designed to recommend the insulin dose(s) (and when indicated a carbohydrate dose) based on the prescribing healthcare provider's nutritional regimen, insulin regimen, target glucose range, and patient specific characteristics.

The EndoTool SubQ is not a substitute for clinical reasoning, but is an aid for trained healthcare professionals to manage patients. The System is based on obtained glucose readings and clinical data entered by the medical staff. Final dose decisions for a patient must be made only after consideration of the full clinical status of the patient. No medical decision should be made based solely on the recommendations provided by this software program.

Monarch Medical Technology's EndoTool SubQ Glucose Management System is a glucose management software solution for healthcare institutions. This system uses proprietary control technology to provide patient-specific glycemic control across a broad population of adult and pediatric patients using basal/bolus insulin therapy. This system is designed to correctly dose subcutaneous insulin (and amount of carbohydrates if and when indicated to treat hypoglycemia) to achieve patient-specific, sustained control with different nutritional and insulin regimens, selected by the patient's physician responsible for glycemic control.

EndoTool SubQ Glucose Management System is designed to be used following a physician order with physician set optional diet, insulin regimen, basal/bolus distribution, initial total daily dose of insulin, and glucose target range. The primary user of the EndoTool SubQ Glucose Management System is the bedside caregiver (e.g. nurse) who will use the system to enter clinical data (e.g. food intake and scheduled blood glucose readings). With confirmation of previous data entered, the system makes the next dose calculation of subcutaneous insulin and the next time for a scheduled glucose determination.

The provided text is a 510(k) summary for the EndoTool SubQ™ device, a software application designed to recommend insulin doses for managing blood glucose levels in diabetic patients. However, the document does not contain explicit acceptance criteria and a detailed study report that proves the device meets specific performance metrics. It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and general functionality.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I detail specific study parameters such as sample size, data provenance, expert qualifications, adjudication methods, or effects of AI assistance. The document refers to "Requirements-based testing for all functionality" and "Automated algorithm test case execution" but does not provide the results or details of these tests.

Specifically, the document states:

• Test Summary: "Testing included the following: 1) Requirements-based testing for all functionality. 2) Requirements-based testing for all risk-related requirements. 3) Integration testing to ensure that data flows correctly into and out of the database. 4) Automated algorithm test case execution. 5) Off The Shelf (OTS) software embedded in the application was included in the technical verification protocols. Each OTS component was tested to ensure that it functioned as intended."
• Test Summary Conclusion: "The performance of the EndoTool SubQ Glucose Management System is substantially equivalent to that of the Glytec Glucommander G+ Enterprise System (K113853) and EndoTool IV Glucose Management System (K132547) and raises no new safety or effectiveness issues and performs as well as the predicate."

This indicates that testing was performed, but the results, acceptance criteria, and detailed methodology are not included in this summary.

Therefore, most of the requested information cannot be extracted from this document.

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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

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.

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The space chamber obtains maximum benefit from your M.D.I. It improves delivery to lungs and reduces the amount of drug deposited in the throat.

Not Found

Based on the provided text, a detailed description of acceptance criteria and a study proving device performance cannot be generated. The document is a 510(k) clearance letter from the FDA for a device called "Space Chamber™." This type of letter generally indicates that the device has been found substantially equivalent to a predicate device already on the market, but it does not contain details about specific acceptance criteria or the results of a study demonstrating performance against such criteria.

The document only states the intended use of the device: "The space chamber obtains maximum benefit from your M.D.I. It improves delivery to lungs and reduces the amount of drug deposited in the throat."

To answer your request, information about a performance study, acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and adjudication methods would need to be in a separate, more detailed technical document (e.g., a summary of safety and effectiveness, clinical trial report, or engineering validation report) that typically accompanies or underpins the 510(k) submission. This letter only confirms clearance based on substantial equivalence.

Therefore, I cannot populate the table or answer the specific questions about the study details.

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