(157 days)
The NavaClick Injection System is intended for injection of fluids into the body. It is specifically indicated for injection of botulinum neurotoxin, consistent with the neurotoxin's approved labeling.
The NavaClick Injector is a manually-operated, 1 mL piston syringe consisting of a calibrated, hollow barrel with a standard luer-lock connector into which is inserted a closely-fitted, ratcheted, moveable plunger. The syringe is printed with a graduated scale (1 mL volume), and has audible and tactile feedback upon delivery of each 0.02 mL fluid. The syringe has been designed to enhance the efficiency and precision of neurotoxin injections.
The syringe has been packaged with other components for convenience. The NavaClick Injection System is a kit containing the NavaClick Injectors (syringes), needles, and a vial adapter for delivery of neurotoxin per the labeled indication.
The product is sterile, single use only, non-pyrogenic and sterilized by electron beam radiation.
The provided text is a 510(k) premarket notification summary for the NavaClick Injection System, which is a medical device classified as a piston syringe.
The document does not describe acceptance criteria and a study that proves the device meets the acceptance criteria in the context of an AI/ML-driven medical device. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Merit Syringe K171362) through performance testing against recognized standards, biocompatibility testing, and sterility/shelf-life testing.
The questions in the prompt (regarding sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details, etc.) are highly relevant to the evaluation of AI/ML devices, particularly those involving image analysis or diagnostic support. However, these concepts are not applicable to the NavaClick Injection System as described in this 510(k) summary because:
- The NavaClick Injection System is a physical medical device (a syringe), not an AI/ML-driven software device. Its functionality is mechanical (injecting fluids) and does not involve AI or machine learning algorithms for diagnosis, prediction, or image interpretation.
- The "study" described is a series of engineering and biological tests, not a clinical study involving the interpretation of data by AI or humans.
- "Acceptance criteria" are presented in terms of compliance with recognized international standards (ISO, ASTM, USP), not performance metrics like accuracy, sensitivity, or specificity as would be expected for an AI/ML diagnostic tool.
Therefore, I cannot populate the requested table or answer most of the questions using the provided text, as the context of the prompt (AI/ML device evaluation) does not align with the nature of the device (a mechanical syringe) described in the input.
I can, however, extract information about the types of tests conducted and the standards they adhere to, which serve as "acceptance criteria" for this specific type of piston syringe.
Here's a summary of the compliance and testing information available in the document, framed as close as possible to the prompt's request but acknowledging the different device type:
Device Name: NavaClick Injection System
Device Type: Piston Syringe (mechanical medical device)
Regulatory Pathway: 510(k) Premarket Notification (demonstrating substantial equivalence to a predicate device)
Reason why the prompt's questions are not directly applicable: The NavaClick Injection System is a physical, mechanical device (a syringe) and not an AI/ML-driven software device. Therefore, concepts like "AI assistance," "human readers," "ground truth establishment by experts for image interpretation," "training sets," or "MRMC studies" are not relevant to its regulatory submission. The "acceptance criteria" for this device are primarily based on engineering performance standards, biocompatibility, and sterility.
1. A table of "Acceptance Criteria" (Compliance with Standards) and Reported Device Performance:
| "Acceptance Criteria" (Standard Compliance) | Reported Device Performance (Summary) |
|---|---|
| Performance Testing | |
| ISO 7886-1:2017 | Components tested and demonstrated conformance. |
| ISO 80369-7:2021 | Components tested and demonstrated conformance. |
| ISO 7864:2016 | Components tested and demonstrated conformance. |
| Biocompatibility Testing | |
| ISO 10993-1:2018 (overall guidance) | Testing conducted per various parts of ISO 10993 (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Hemolysis, Material Mediated Pyrogenicity). No deviations noted. Results support biocompatibility and safety. |
| USP (Particulate matter) | Evaluation of particulate in the fluid path conducted. Although no specific USP specifications for devices, by comparison, kit components met the specification for small volume parenteral fluids. |
| Sterility & Shelf Life | |
| ISO 11137-1:2006/Amd 2:2019 | Acceptable test results from sterilization validation demonstrated ability of electron beam process to consistently yield a Sterility Assurance Level (SAL) of 10^-6. No deviations noted. |
| ISO 11137-2:2013 | Acceptable test results from sterilization validation. No deviations noted. |
| ISO 11137-3:2017 | Acceptable test results from sterilization validation. No deviations noted. |
| AAMI TIR29:2012 (R2017) | Sterilization and endotoxin testing completed in accordance. No deviations noted. |
| USP (Bacterial Endotoxin Test) | Sterilization and endotoxin testing completed in accordance. No deviations noted. |
| ASTM F1980-21 (Accelerated Aging) | Accelerated stability testing demonstrates sterility and performance for a 1-year shelf-life. Product performance testing of each component conducted according to relevant ISO standards and functional performance testing as a kit. |
| ASTM F1886 (Visual inspection) | Package (sterile barrier) testing performed after accelerated aging & simulated environmental/distribution conditioning. No deviations noted. |
| ASTM 2096-11 (Bubble Leak Test) | Package (sterile barrier) testing performed after accelerated aging & simulated environmental/distribution conditioning. No deviations noted. |
| ASTM F88/F88M-21 (Seal Strength) | Package (sterile barrier) testing performed after accelerated aging & simulated environmental/distribution conditioning. No deviations noted. |
2. Sample size used for the test set and the data provenance:
- The document does not specify exact sample sizes for each test (e.g., number of syringes tested for flow rate, number of samples for biocompatibility).
- Data provenance is implicitly "Lineage Biomedical" (the manufacturer) and conducted by their testing partners or internal labs as part of the device development and validation. The data is for a physical device and is based on prospective testing/validation conducted specifically for this 510(k) submission. Country of origin for data is not explicitly stated but would typically be the location of the testing facilities (likely within the US or compliant international labs).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the context of expert consensus for AI/ML evaluation is not relevant here. Device performance is measured against established engineering and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept applies to human-in-the-loop or expert review processes, not the physical testing of a syringe against engineering standards.
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 not an AI/ML device, and no human reader studies (MRMC or otherwise) are relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not have an "algorithm" in the sense of AI/ML.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is adherence to defined parameters within recognized international standards (e.g., ISO, ASTM, USP) for piston syringes, biocompatibility, and sterilization. This is a technical/engineering ground truth, not a diagnostic one.
8. The sample size for the training set:
- Not applicable. No "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
- Not applicable. No "training set" or "ground truth" in the context of AI/ML.
In conclusion: The provided document is a regulatory submission for a physical medical device (syringe) and details its compliance with established engineering and biological standards to demonstrate substantial equivalence, rather than a clinical study evaluating an AI/ML-driven medical device. Therefore, most of the prompt's specific questions regarding AI/ML evaluation criteria are not applicable to this content.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).