(16 days)
The Disetronic Penfine® Injection Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an injector pen.
The 6 mm Disetronic Penfine® Injection Pen Needles are the same sterile, non-pyrogenic, single use needles designed to be used with commercially available Injection Pens as the 8, 10 and 12 mm Disetronic Penfine® Injection Pen Needles. The only difference is in the length of the cannula.
The provided text describes a 510(k) submission for the Disetronic Penfine® Injection Pen Needle. This is a medical device clearance, not an AI/ML device, and therefore the requested information regarding acceptance criteria, study details, and AI/ML specific metrics (sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance) does not directly apply in the way it would for an AI/ML device.
However, I can extract and present the information available in a format that aligns as closely as possible with your request, interpreting "acceptance criteria" as the basis for substantial equivalence for this type of medical device.
Key takeaway: This is a 510(k) for a physical medical device (pen needle), not an AI/ML device. Therefore, many of the requested AI/ML specific details are not applicable or provided.
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission for a physical device, the "acceptance criteria" is typically demonstrating substantial equivalence to a predicate device. The "performance" is shown through engineering equivalence and safety/functional testing rather than diagnostic accuracy metrics.
| Acceptance Criteria (Basis for Substantial Equivalence) | Reported Device Performance (Evidence Provided) |
|---|---|
| Design Equivalency to Predicate Device | The 6 mm Disetronic Penfine® Injection Pen Needles are the same sterile, non-pyrogenic, single-use needles designed to be used with commercially available injection pens as the 8, 10, and 12 mm Disetronic Penfine® Injection Pen Needles (K982399). The only difference is in the length of the cannula. |
| Technological Characteristics Equivalency | "The technological characteristics are the same as the predicate devices." |
| Functional and Safety Testing | "Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices." |
| Indications for Use Equivalency | Intended for "hypodermic injection of fluids into the body when attached to an injector pen," which is implicitly equivalent to the predicate. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of an AI/ML test set. The submission refers to "performance data generated in compliance with existing international standards and protocols." This refers to engineering and quality control tests on the physical device, not an AI algorithm's performance on a dataset. Specific sample sizes for these standard tests are not provided in this summary.
- Data Provenance: Not applicable in the context of an AI/ML dataset (e.g., country of origin, retrospective/prospective). The "data" refers to physical device testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not an AI/ML device requiring expert ground truth for image or data interpretation. The "ground truth" for a physical medical device involves meeting predefined engineering specifications and safety standards through physical testing.
4. Adjudication method for the test set
- Not applicable. This is not an AI/ML device and does not involve adjudication of expert interpretations for a test set.
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
- Not applicable. This is a physical medical device (injection pen needle), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study on human reader improvement with AI assistance was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For physical medical devices, "ground truth" typically refers to established engineering specifications, material properties, sterility standards, functional performance metrics (e.g., fluid flow rate, needle sharpness, cannula integrity), and safety margins as defined by international standards and regulatory guidance. The summary states, "Performance data has been generated in compliance with existing international standards and protocols."
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).