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510(k) Data Aggregation
(231 days)
GRAFTSITE
Assistance in the delivery of local anaesthetic after hamstring ligament reconstruction procedures
GRAFTSITE is 28.25 cm in length with an inner diameter of 2.6 mm and an outer diameter of 4.0 mm, sized to fit down the hamstring harvest site. It is rounded and blocked at the patient end and has a 6% female luer at the user end. There are lateral eyes over a length at the patient end of the catheter. A buttoned stylet consisting of a rigid stainless steel rod of diameter slightly less than the bore of the catheter, functions to stiffen the device. GRAFTSITE can be used to directly administer a bolus of the users chosen local anesthetic, via injection down the lumen of the catheter, into the terminus of the gutter at the site of comorbidity.
The provided text describes the GRAFTSITE Local Anesthetic Delivery Assistance Device. It details the device's characteristics and the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.
1. Table of acceptance criteria and the reported device performance
Since this is a non-clinical submission, the "acceptance criteria" are the ability to perform equally well as the predicate device in specific non-clinical tests. The "reported device performance" refers to the successful completion of these tests.
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Pressure testing of the catheter/hub for resistance to liquid leakage (EN 1618 and ISO 594-2) | GRAFTSITE performed equally well to the predicate. |
| Tensile bond performance of the catheter/hub and stylet/button (BS 6196 and EN 1618) | GRAFTSITE performed equally well to the predicate. |
| Corrosion resistance of the stylet (EN 1618) | GRAFTSITE performed equally well to the predicate. |
| Flow rate of the catheter (EN 1618) | GRAFTSITE performed equally well to the predicate. |
| Radio-opacity of the catheter (ASTM F640-12) | GRAFTSITE performed equally well to the predicate. |
| Human factors/usability validation | GRAFTSITE was proven to be usable in a cadaveric usability investigation and did not raise different questions of safety and effectiveness when compared to the predicate. |
| Biocompatibility (ISO 10993-1 and FDA guidance) | Biocompatibility testing on the fully finished device demonstrated that GRAFTSITE is biocompatible in relation to its intended use. This included cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, particulate analysis, hemolysis, and endotoxin testing. |
| Gamma irradiation validation (ISO 11137-1 and ISO 11137-2) | Validation using the VDmax25 method was successful in eliciting no growth for a routine processing dose of 25-40kGy and giving a SAL of 10-6 (in accordance with EN 556). |
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 provide specific numerical sample sizes for each test set (e.g., number of devices tested for flow rate). However, it states that "GRAFTSITE was directly compared to the predicate in comparative performance tests" and that "comparative in vitro testing was performed, with the results for GRAFTSITE compared to the predicate."
The data provenance is not explicitly stated in terms of country of origin but is implicitly from the manufacturer, Summit Medical Ltd. in the United Kingdom. The tests performed are non-clinical (in vitro and cadaveric usability), not human clinical studies, so the terms "retrospective" or "prospective" are not applicable in the same way they would be for patient data.
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 tests performed are physical and mechanical performance evaluations against established standards, and a cadaveric usability study. While the cadaveric study would involve experts (e.g., surgeons/clinicians), the document does not specify their number or qualifications as ground truth experts for a diagnostic algorithm.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable as the studies described are non-clinical, mechanical, and biocompatibility tests, and a cadaveric usability study. There's no "ground truth" to be adjudicated in the sense of medical image interpretation or diagnosis.
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 MRMC comparative effectiveness study was done. This device is a local anesthetic delivery assistance device, not an AI-powered diagnostic or interpretive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests were established engineering and medical device performance standards (e.g., EN 1618, ISO 594-2, BS 6196, ASTM F640-12, ISO 10993-1, ISO 11137-1, ISO 11137-2). For the usability study, the ground truth was the ability to perform the intended function in a cadaveric model.
8. The sample size for the training set
This is not applicable since the device does not employ machine learning or AI models, and therefore does not have a "training set."
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this device.
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