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The Disetronic H-TRON V 100 Plus Insulin Infusion Pump is intended for the controlled delivery of insulin as prescribed by a physician. It is indicated for patients with insulin dependent diabetes Mellitus who do not have optimum blood glucose control on conventional insulin injection therapy. Patients for insulin pump therapy must be highly motivated to perform self glucose monitoring on a frequent and regular basis, as well as adhere to a proper diet and exercise regiment. Patients must be capable of operating the pump. They must also have access to the educational training, support, and follow-up of health care professional experienced in insulin pump therapy.

The physical dimensions and specifications, pumping method, safety systems, accuracy and basic design and operation of the device have not been changed by the modifications.

The provided text describes a 510(k) submission for the Disetronic H-TRON Plus V 100 Insulin Infusion Pump, asserting its substantial equivalence to a predicate device (Disetronic H-TRON V 100 Insulin Infusion Pump, K905693). This type of submission focuses on demonstrating equivalence rather than conducting a full clinical study with acceptance criteria in the typical sense of a novel device.

Therefore, the information you've requested regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable or explicitly stated in this 510(k) summary.

Here's why and what information can be extracted:

• 510(k) Submissions Focus: 510(k)s are premarket submissions made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device). They typically rely on demonstrating technological characteristics, performance data, and intended use are substantially equivalent, rather than proving performance against specific clinical acceptance criteria in a de novo study.

• Performance Data Mentioned: The summary mentions "Performance Data" (Section 9.8) but describes it in terms of compliance with standards (IEC 601-2-24, IEC 601-1, IEC 801-2, 801-3) and internal testing to ensure specifications and functional requirements are met. This is about engineering and safety compliance, not clinical performance against specific patient outcomes.

Let's address each point based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as clinical performance metrics. The stated "acceptance criteria" are adherence to international standards and internal system specifications/functional requirements. These are engineering and safety standards, not clinical performance metrics like accuracy of glucose control or specific adverse event rates in a clinical population.
• Reported Device Performance:
  • Compliance with IEC 601-2-24 (infusion pump safety): Met.
  • Compliance with IEC 601-1 (general safety, including EMI/ESD): Met.
  • System specifications and functional requirements: Met.
  • Physical dimensions, specifications, pumping method, safety systems, accuracy, basic design, and operation: Unchanged by modifications, implying they perform equivalently to the predicate device.

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 Test Set: Not applicable/not specified. The testing described is likely bench testing for engineering and safety compliance, not a clinical test set with human subjects.
• Data Provenance: Not applicable/not specified. The testing is internal to the manufacturer for design validation and compliance.

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)

• Number of Experts & Qualifications: Not applicable/not specified. Ground truth as typically defined for medical AI/imaging studies (e.g., expert consensus on diagnoses) is not relevant to this type of device submission. The "ground truth" here would be objective measurements against engineering specifications and safety standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable/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

• MRMC Study: No. This device is an insulin infusion pump, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable/not specified. The device operates as intended by delivering insulin based on programming, but there's no "algorithm only" performance reported in the context of clinical decision-making or diagnostic tasks. The device itself is "standalone" in its operation once programmed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: For engineering and safety, the "ground truth" would be objective measurements and adherence to established industry standards (e.g., flow rate accuracy measured by calibrated equipment, electrical safety parameters measured against limits). No clinical ground truth (like pathology or outcomes data) is mentioned for a specific clinical study for this 510(k).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/not specified. This is not an AI/ML device that requires a training set in the typical sense.

9. How the ground truth for the training set was established

• How Ground Truth for Training Set was Established: Not applicable/not specified.

In summary, this 510(k) submission demonstrates substantial equivalence through:

• Asserting that physical dimensions, pumping method, and safety systems are unchanged from the predicate device.
• Indicating that the intended use has not changed.
• Stating that technological characteristics have not been affected.
• Confirming compliance with international standards for infusion pump safety (IEC 601-2-24, IEC 601-1 incorporating IEC 801-2 and 801-3 for EMI/ESD).
• Stating adherence to software development and Good Quality Assurance procedures, with test results demonstrating system specifications and functional requirements were met.

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