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For injection of solutions (such as lidocaine with or without 1:100,000 eninephine) into the cervix. This application includes outlines that require local anaesthetics such as loop excision (LEEP), elecro-fulguration, CO2 laser excision and vaporization, and when required, endocervical curettage and cervical biopsies.

For use with 2.2ml glass vials, such as those containing local anaesthetic agents.

CerviNeedle™ Disposable Cartridge Syringe

The provided text is a 510(k) summary for the Rocket Medical plc CerviNeedle™ Disposable Cartridge Syringe. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study data against specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, performance studies, sample sizes, and expert qualifications are not present in this document.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria or detailed performance data against them are provided in the 510(k) summary. The summary states:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not provided. The 510(k) summary does not describe a performance study with 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)

Not provided. The 510(k) summary does not describe a performance study that involved experts establishing ground truth for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No performance study 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

Not applicable. This device is a manual cartridge syringe, not an AI-powered diagnostic device. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a manual medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of a performance study for this device. The "ground truth" for the 510(k) submission is the demonstration of substantial equivalence to existing, legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This device does not use machine learning or require a training set.

9. How the ground truth for the training set was established

Not applicable. This device does not use machine learning or require a training set.

Summary of Safety and Effectiveness Information Presented (from the document):

The 510(k) submission for the CerviNeedle™ Disposable Cartridge Syringe relies on demonstrating substantial equivalence to existing predicate devices. The key elements are:

• Substantial Equivalence: The device is deemed substantially equivalent to the CooperSurgical Inc Potocky Needle™ Disposable Injection Needle (#K910252), Wallach Surgical Devices Inc, Endocervical Block Needle (#K021224), and A & A Medical Inc, Endocervical Block Needle (#K973671).
• Basis for Safety and Effectiveness: The conclusion of safety and effectiveness is drawn from "indications for use, technical characteristics and comparison to currently commercial marketed devices." This implies that because the device is technically similar and intended for the same uses as already approved devices, it is considered safe and effective.
• Ongoing Monitoring: Rocket Medical plc states they "continue to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information." This indicates a post-market surveillance commitment rather than detailed pre-market study data in the 510(k).

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