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510(k) Data Aggregation
(27 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 31 gauge 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 29 and 30 gauge Disetronic PenFine® Injection Pen Needles. The only difference is in the thickness of the cannula.
The provided text describes a 510(k) submission (K982399) for a 31 gauge Disetronic PenFine® injection Pen Needle. This is a medical device, specifically a hypodermic single lumen needle, and the submission focuses on demonstrating substantial equivalence to existing predicate devices, not on proving new clinical performance. Therefore, many of the typical acceptance criteria and study details for AI/device performance are not applicable here.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
For a medical device like this, acceptance criteria typically involve demonstrating safety and effectiveness by meeting engineering specifications, biocompatibility standards, and functional requirements comparable to predicate devices. The document doesn't provide a table of specific numerical acceptance criteria from the submission. Instead, the "performance" demonstrated is substantial equivalence to legally marketed predicate devices based on design and functional testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Design Equivalency: Same sterile, non-pyrogenic, single use needle design. | "The 31 gauge 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 29 and 30 gauge Disetronic PenFine® Injection Pen Needles." |
| Material/Technological Characteristic Equivalency: Similar materials, manufacturing processes, and technological features. | "The technological characteristics are the same as the predicate devices." |
| Functional & Safety Equivalence: Performs comparably in intended use, with no new safety concerns. | "Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices." |
| "Based on the design equivalency and the functional and safety testing, Disetronic Medical Systems has determined that the PenFine® Injection Pen Needles are substantially equivalent to the devices currently marketed in the United States." | |
| Indicated Use Equivalency: Intended for the same use as predicate devices. | "The Disetronic PenFine® Injection Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an automatic injector pen." (Matches predicate indications) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of clinical performance data involving patient samples or diagnostic accuracy. The performance data mentioned refers to engineering and functional testing. There is no information on sample size or data provenance (country of origin, retrospective/prospective) for such a "test set."
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)
This is not applicable. The submission is for a physical medical device (injection pen needle), not a diagnostic algorithm or AI system that requires expert-established ground truth on a test set of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. There is no "test set" in the context of evaluating diagnostic performance or classifying data points for ground truth.
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. MRMC studies are used for evaluating diagnostic imaging systems or AI systems that assist human readers. This submission is for an injection pen needle.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is an injection pen needle, which is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This is not applicable. For a physical device like an injection pen needle, "ground truth" would relate to its physical properties, sterility, and functional performance, verified through laboratory testing and engineering standards, not through methods like expert consensus on medical images or pathology results.
8. The sample size for the training set
This is not applicable. There is no "training set" for an injection pen needle. The device is manufactured based on design specifications and quality control.
9. How the ground truth for the training set was established
This is not applicable. As there is no training set, there is no ground truth for it to be established.
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