(130 days)
The HumaPen Luxura HD is a reusable pen injector designed for the self-injection of a desired dose of insulin. The pen injector uses 3.0 mL cartridges of Lilly insulin and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.
HumaPen Luxura HD is a reusable mechanical pen-injector designed for use for the self-injection of insulin. The pen-injector is intended for use with Eli Lilly and Company 3.0 mL insulin cartridges and single-use, detachable and disposable pen needles (supplied separately).
The provided document is a 510(k) summary for the HumaPen Luxura HD, a pen-injector for insulin. It describes the device's characteristics and its equivalence to a predicate device but does not contain the detailed information requested regarding the study design, sample sizes, expert involvement, or specific performance metrics in table format, as typically found in clinical trial reports or detailed scientific studies.
However, I can extract the available information and highlight what is missing based on your request.
Acceptance Criteria and Device Performance (Based on available information)
| Metric | Acceptance Criteria (Standard Reference) | Reported Device Performance (HumaPen Luxura HD) |
|---|---|---|
| Dose Accuracy | ISO 11608-1.2000 requirements | Met ISO 11608-1.2000 requirements |
| Tighter tolerance for 0.5 unit dialing | Met tighter dose accuracy tolerance | |
| Functionality | Not explicitly defined, but implied | Met functionality standards |
| Biocompatibility | ISO 10993-1 | Materials shown to be safe for patient contact |
| Pen Operation and Function | Unchanged from predicate device | Unchanged from currently cleared HumaPen Luxura HD |
Study Information Pertaining to Device Performance
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Sample size used for the test set and the data provenance:
- Not provided. The document states "HumaPen Luxura HD was tested per ISO 11608-1 for dose accuracy and functionality" and "HumaPen Luxura HD components were evaluated for biocompatibility per ISO 10993-1." However, it does not specify the number of devices or components tested, the number of dose deliveries, or the origin of any data used.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. For a mechanical device like an insulin pen, "ground truth" and expert consensus as typically seen in image analysis or diagnostic AI studies are not relevant in the same way. Performance is measured against engineering standards (like ISO 11608-1) and physical properties (like dose delivery).
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Adjudication method for the test set:
- Not applicable/Not provided. Adjudication is not typically used for testing mechanical device performance against engineering standards. The device's output (e.g., delivered dose) is directly measured.
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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:
- Not applicable. This device is a pen-injector, a mechanical medical device, not an AI-assisted diagnostic tool or an imaging system that involves human readers interpreting results. Therefore, an MRMC study is not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical pen-injector. The concept of an "algorithm only" or "human-in-the-loop" performance does not apply to this type of device. Its performance is measured based on its mechanical function of drug delivery.
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The type of ground truth used:
- For dose accuracy: Instrumental measurements against an established international standard (ISO 11608-1.2000). The "ground truth" is the physically measured dose delivered by the device compared to the dialed dose, assessed according to the specified tolerances in the standard.
- For biocompatibility: Laboratory testing against established international standard (ISO 10993-1). The "ground truth" here is determined by the results of biocompatibility tests on the device materials.
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The sample size for the training set:
- Not applicable/Not provided. This is a mechanical device, not an AI model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As this is not an AI/ML device, there is no training set or corresponding ground truth establishment process in that context.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).