(54 days)
The GripMate™ autoinjector is intended for use with Sun Pharma's glatiramer acetate 20 mg/mL and 40 mg/mL prefilled syringes (a 1 mL BD Hypak Biotech glass syringe, containing a ½'' fixed needle of 29G, and drug product solutions with a viscosity between 1.7 and 2.3 mPas). The GripMate™ autoinjector is a reusable injection device for patients with multiple sclerosis age 18 and older for the subcutaneous injection of Sun Pharma's glatiramer acetate 20 mg/mL and 40 mg/mL prefilled syringes.
The GripMate™ is a non-sterile, reusable, spring-loaded injection device. The device consists of two subassemblies into which the syringe is loaded and connected together to form the delivery system for self-injection. The device does not have any fluid path and does not have any contained within the syringe. The user has the option to adjust the needle extension using the device Needle Hider Feature. Injection occurs upon the activation of a trigger button which drives the syringe in a three-step sequence which includes needle penetration, injection and needle cover. Once the injection is completed the device provides visual indication to confirm that the full drug dose has been delivered.
The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the GripMate™ autoinjector.
Here's an analysis of the requested information:
1. Table of acceptance criteria and the reported device performance:
The document discusses various functional and mechanical tests. While it lists some quantitative specifications for the "Candidate Device GripMate™", it doesn't explicitly present acceptance criteria alongside the measured performance results in a formal table format. However, we can infer some criteria from the "Comparison" column and the descriptions of the tests.
| Acceptance Criteria (Inferred) | Reported Device Performance (GripMate™ Values) |
|---|---|
| Overall device length (mm) | 224.0 |
| Overall device width - at widest point (mm) | 34.0 |
| Needle extension penetration (mm) | Variable, 6-8 mm |
| Injection time as indicated in labeling | 80 |
| Syringe loading force (N) | ≤ 27.1 |
| Needle shield remover force (N) | ≤ 35 |
| Biocompatibility | Conforms to ISO 10993 |
| Environmental Conditions | Performance and reliability not affected by specified environmental conditions |
| Shelf Life and In-Use Life | Established as per accelerated stability studies and use life testing (Real-time protocol for ongoing stability) |
| Functional Testing (Dose Accuracy, Injection Time, Needle Extension, Safety Features, Indicators) | Demonstrated to meet design specifications and perform as intended |
| Human Factors | Use-related risks adequately mitigated by design and labeling |
2. Sample size used for the test set and the data provenance:
The document broadly states "Design verification and performance testing have been conducted to verify GripMate™ meets design specifications and performs as intended" and lists various functional and mechanical tests. It does not provide specific sample sizes for any of the test sets.
Regarding data provenance:
- Country of origin of data: Not explicitly stated, but the applicant "Synthon Hispania S.L." is in Spain, and the correspondent "Lachman Consultant Services, Inc." is in the United States. Functional and biocompatibility testing was performed by "certified testing laboratories," implying external entities, but their location is not specified.
- Retrospective or prospective: The description of the studies ("Design verification and performance testing have been conducted") suggests these were prospective tests specifically performed to demonstrate the device's performance for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document describes "Human Factors Testing" which involved a "simulated use Human Factors study." While this implies user interaction and potentially expert evaluation, the number of experts and their specific qualifications are not provided. It's also not clear if "ground truth" in the traditional sense was established by experts for performance metrics (e.g., whether an injection was "successful"), or if it relied on objective measurements.
4. Adjudication method for the test set:
Not applicable or not explicitly stated for the described tests. The performance data seems to be based on direct measurements and observations from functional and mechanical tests rather than subjective human assessment requiring adjudication. For human factors testing, the adjudication method (if any) is not detailed.
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:
This is not applicable. The GripMate™ is an autoinjector, a physical medical device, not an AI-powered diagnostic or decision support system. Therefore, MRMC studies and "human readers improving with AI assistance" are not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. As mentioned above, this is a physical medical device, not an algorithm. Performance tests were conducted on the device itself.
7. The type of ground truth used:
For the functional and mechanical tests, the "ground truth" would be the objective physical measurements and observations of the device's operation against its design specifications and relevant ISO standards (e.g., measured injection time, force, needle extension, visual/audible indicators working as designed). For biocompatibility, it's conformance to ISO 10993. For human factors, it's the assessment of whether use-related risks are adequately mitigated. There is no mention of pathology or outcomes data as ground truth, as it is a device for drug delivery, not a diagnostic tool.
8. The sample size for the training set:
This is not applicable. The GripMate™ is a physical medical device for drug injection, not an AI/ML model that requires a "training set."
9. How the ground truth for the training set was established:
This is not applicable, as there is no training set for this device.
§ 880.6920 Syringe needle introducer.
(a)
Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.(b)
Classification. Class II (performance standards).