(63 days)
ACCU-CHEK® FlexLink Plus is an infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps.
ACCU-CHEK® LinkAssist Plus is an insertion device, which is intended specifically for placement of compatible ACCU-CHEK® FlexLink Plus infusion sets.
The ACCU-CHEK® FlexLink Plus is a disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The unit is designed to interface with commercially available insulin infusion pumps with suitable connections. The insulin infusion pump systems are designed to control the delivery of insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus.
The ACCU-CHEK® LinkAssist Plus is an insertion aid for automatic application of ACCU-CHEK® infusion sets equipped with a compatible adapter. The ACCU-CHEK® LinkAssist device is non-invasive, non-sterile and intended for multiple uses by the same patient.
The provided text describes the 510(k) summary for the ACCU-CHEK® FlexLink Plus infusion set and the optional ACCU-CHEK® LinkAssist Plus insertion device. Based on the document, here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or specific failure rates. Instead, the acceptance criteria appear to be met through demonstrating functional equivalence to a predicate device and successful completion of functional and human factors testing, implying performance within expected parameters for such devices.
Therefore, the table below reflects the qualitative acceptance criteria and the summary of the performance as reported:
| Acceptance Criteria Category | Specific Criteria / Test | Reported Device Performance |
|---|---|---|
| Functional Equivalence (Infusion Set) | Same intended use as predicate device | Met (ACCU-CHEK® FlexLink Plus has same intended use as ACCU-CHEK® Ultraflex infusion set) |
| Same storage conditions | Met | |
| Same luer connector | Met | |
| Same operating conditions | Met | |
| Flexible catheter and needle for insertion | Met | |
| Separate extension tubing with detachable connector | Met | |
| Adhesive patch for securement | Met | |
| Requires introducer needle removal prior to infusion | Met | |
| Incorporates needle protection feature (automatic retraction) | Met | |
| Functional Equivalence (Insertion Device) | Same intended use as predicate device | Met (ACCU-CHEK® LinkAssist Plus has same intended use as ACCU-CHEK® LinkAssist insertion device) |
| Same storage conditions | Met | |
| Same operating conditions | Met | |
| Same general functionality | Met | |
| Overall dimensions (slightly wider and longer than predicate) | Acceptable (not presented as a failure) | |
| Safety catch mechanism (incorporated in device base) | Acceptable (not presented as a failure) | |
| Functional Testing (In vitro) | Functioned according to specifications | Met (Results indicated device functioned according to specifications) |
| Biocompatibility Testing | Materials used are biocompatible | Met (Materials used in devices are biocompatible) |
| Human Factors Usability Testing | Customer requirements met | Met (Evaluations determined customer requirements were met) |
| Primary operating function operated as intended | Met (Primary operating function operated as intended) | |
| No needle stick injuries reported (unintentional ejection) | Met (No needle stick injuries reported) | |
| Overall Conclusion | Considered acceptable for human use | Met (Based on study results, product is considered acceptable for human use) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the functional testing or the human factors usability testing. It mentions "individuals who participated in the evaluation included patients who routinely use an insulin pump and infusion set," but no specific number is provided.
- Data Provenance: The studies were prospective. The human factors usability testing involved individuals participating in evaluations, implying it was conducted specifically for this device submission. The in vitro functional and biocompatibility testing similarly suggests newly generated data for the device. The country of origin of the data is not explicitly stated, but the submitter is Disetronic Medical Systems AG in Switzerland, and the US contact is Roche Diagnostics in Indianapolis, Indiana. The studies would likely have been conducted according to international standards (e.g., ISO) and possibly in relevant regions (e.g., Europe, US).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable/not specified. For this type of device (infusion sets and insertion devices), the "ground truth" is typically established by engineering specifications, regulatory standards, and clinical user experience rather than expert consensus on diagnostic images or pathology. The human factors usability testing involved patients who routinely use such devices, serving as the user population for evaluating intended use.
- Qualifications of Experts: Not applicable in the traditional sense for diagnostic accuracy. The "experts" involved would be regulatory specialists, engineers, and potentially clinicians involved in setting the performance specifications, but their numbers and specific qualifications are not detailed. For the human factors testing, the "experts" were the intended users themselves (patients), providing user experience validation.
4. Adjudication Method for the Test Set
- Adjudication method: Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in studies involving subjective interpretation (e.g., image reading) where differences in expert opinions need to be resolved. For functional and usability testing of a medical device like an infusion set, the "ground truth" is determined by objective performance against specifications and direct user feedback, not by adjudicating conflicting expert interpretations.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices often involving AI algorithms, comparing human reader performance with and without AI assistance. The ACCU-CHEK® FlexLink Plus and LinkAssist Plus are mechanical devices for insulin infusion, not diagnostic imaging tools, and do not incorporate AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a mechanical infusion set and insertion device. It does not involve algorithms or AI, so there is no "standalone" algorithm performance to evaluate. The device's function is inherently "human-in-the-loop" as it requires user operation and insulin pump interface.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission was established through a combination of:
- Engineering Specifications and Design Requirements: For functional testing (e.g., luer connector compatibility, needle retraction mechanism, operating conditions).
- Biocompatibility Standards: For material testing.
- Predicate Device Performance: Demonstrating substantial equivalence to a legally marketed predicate device (ACCU-CHEK® Ultraflex infusion set and ACCU-CHEK® LinkAssist insertion device) served as a primary "ground truth" for device design and expected performance.
- User Feedback and Usability Standards: For human factors testing, the "ground truth" was whether the device met "customer requirements" and "primary operating functions" as assessed by target patients, and whether it operated safely (e.g., no needle stick injuries).
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set" in the context of data used to train an algorithm. The development of the device would have involved internal design, prototyping, and iterative testing, but not an AI training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no AI training set. The "ground truth" during the device's development would have been based on engineering principles, regulatory requirements, intended use specifications, and potentially patient and healthcare professional feedback, guiding the design and testing phases.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).