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510(k) Data Aggregation
(99 days)
Single use device that is indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.
The proposed device, NovaGuard SA Safety System, is a non-sterile, single use anti needlestick accessory for pre-filled ISO standard glass syringes that are 1ml long with a max needle length of 5/8" The NovaGuard SA Safety System consist of two components, a subassembly (syringe holder, sleeve and spring) and a clip. The proposed device will be assembled along with the pre filled syringe by the pharmaceutical company. Upon completion of the needle is then covered by the sleeve protecting the user from potential sharps needle stick injury. There is a visual, tactile and audible recognition that the device safety feature has activated.
The provided text describes the NovaGuard SA Safety System, an accessory for pre-filled syringes designed to prevent needlestick injuries. However, the document is a 510(k) summary for FDA clearance and does not contain detailed information about specific acceptance criteria or a comprehensive study report in the format requested.
Therefore, I cannot populate all the fields in the table or answer all the questions directly from the provided text. The information is primarily focused on demonstrating substantial equivalence to predicate devices and fulfilling FDA guidance requirements.
Here's what can be extracted and inferred, along with limitations:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly listed in a detailed quantitative manner as "acceptance criteria X and reported performance Y." Instead, the document mentions compliance with general principles and performance requirements for sharps injury prevention devices.
| Acceptance Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|
| Device functions as intended. | "It was confirmed that the device functioned as intended." (Bench testing) |
| Biocompatibility requirements met. | "Biocompatibility testing performed demonstrates that the NovaGuard SA Safety System, met the requirements of ISO 10993- 1 Biological evaluation of medical devices- Part 1: Evaluation and testing. Per this standard, The NovaGuard Safety System is categorized as skin contact with a duration of category A- limited (< 24 h)." |
| No premature activation. | "did not activate prematurely under expected conditions of use" (Simulated use study) |
| Provides protection against unintended sharps injury until disposal. | "provided protection against unintended sharps injury until disposal." (Simulated use study) |
| Does not impede or adversely affect the intended clinical performance. | "did not impede or adversely affect the intended clinical performance of the device" (Simulated use study) |
| Failure rate for activation (implied acceptable low rate). | "528 devices were tested with zero failures for activation for a '97.5% confident that the true failure rate was no higher than 0.7% and 99.5% confidence that it is no higher than 1 %' as per the FDA Guidance." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: 528 devices (for the simulated use study).
- Data Provenance: The document does not explicitly state the country of origin or if the study was retrospective or prospective. It describes "simulated use studies," which are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The study described is a performance validation of the mechanical safety feature, not one requiring expert interpretation of results in the traditional sense of diagnostic AI. The "ground truth" here would be objective observations of device function (e.g., did the safety feature activate correctly).
4. Adjudication method for the test set
This information is not provided. Given the nature of a mechanical safety device, it's unlikely a multi-expert adjudication method was used in the same way it would be for image interpretation. The "failures" would likely be objectively observable or measurable during the simulated use.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI or diagnostic imaging devices where human interpretation is a key component. The NovaGuard SA Safety System is a physical medical device designed to prevent sharps injuries.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a physical, mechanical system. There is no "algorithm only" or "AI" component to assess in a standalone manner. The performance described is inherent to the device itself.
7. The type of ground truth used
The ground truth used for the simulated use study appears to be objective observation of device activation and function (e.g., "zero failures for activation," "did not activate prematurely," "provided protection"). This is based on mechanical performance rather than clinical outcomes or expert consensus in a diagnostic sense.
8. The sample size for the training set
This information is not applicable as the device does not employ machine learning or AI that would require a "training set."
9. How the ground truth for the training set was established
This information is not applicable as the device does not employ machine learning or AI.
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