(53 days)
The iSecure Syringe Cartridge Holder is intended for use in the withdrawal and administration of sterile materials under aseptic conditions in accordance with the best judgment of the physician.
The proposed change is to combine the Carpuject® cartridge and holder into one preassembled unit thereby eliminating the need for a separate holder. The operating principle remains the same. The modified syringe holder accessory can still be used with both empty and prefilled (not the subject of this 510(k) application) Carpuject® Syringe Cartridges. The proposed name for this modification is the iSecure Syringe Cartridge Holder.
The provided text is a 510(k) summary for the iSecure Syringe Cartridge Holder. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria. As such, most of the information requested in your prompt is not available in this document.
Here's a breakdown of what can and cannot be extracted from the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify any quantitative acceptance criteria or numerical performance metrics for the iSecure Syringe Cartridge Holder. The "performance" described is largely qualitative, asserting that it functions the same as the predicate device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not available in the provided document. The 510(k) relies on a comparison to a predicate device and does not detail specific new performance testing data sets.
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 information is not available. No such expert-verified test set is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not available. No test set requiring adjudication is described.
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
An MRMC study was not done, as this device is a syringe cartridge holder, not an AI-powered diagnostic tool. The concept of "human readers improving with AI" is not applicable here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study was not done in the context of an algorithm. This device is a mechanical holder, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to performance studies (especially for AI or diagnostic devices) is not applicable here. The substantial equivalence is based on the device's design and intended use being the same as the predicate.
8. The sample size for the training set
This information is not available. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not available. As above, no training set or ground truth in that context exists for this device.
Summary of available information regarding substantial equivalence (not a performance study):
The 510(k) summary for the iSecure Syringe Cartridge Holder focuses on demonstrating substantial equivalence to a predicate device, the Empty Sterile Carpuject® Cartridge Syringe holder Accessory.
- Basis for Equivalence: The claim for substantial equivalence is based on the following technological characteristics:
- Both devices are intended to be used with either empty or prefilled Carpuject cartridges.
- The technology and operating principles are the same for both devices.
- The plunger rod for both devices is attached to the end of the syringe cartridge to actuate an injection.
- Proposed Change: The only proposed change is to combine the Carpuject® cartridge and holder into one preassembled unit, eliminating the need for a separate holder. The operating principle, however, remains the same.
Therefore, while the document confirms the device meets the regulatory requirement for substantial equivalence, it does not provide the details of a quantitative performance study with specific acceptance criteria that you have requested.
§ 890.5050 Daily activity assist device.
(a)
Identification. A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. If the device is not labeled or otherwise represented as sterile, the device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.