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510(k) Data Aggregation
(154 days)
Pressure Rated: The Q2 Low Pressure Power Injector Extension Set with needleless connector is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. This set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second. Non Pressure Rated: The Q2 Low Pressure Power Injector Extension Set with needleless connector is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration.
Sterile, single use non-pyrogenic intravenous administration extension set comprised of 7 inch tubing bonded to a male luer on one end and a female luer on the other end with a clamp in between. A swabable, needle-free port is connected to the female luer. This device is not made with the plasticizer Diethylhexylphthalate (DEHP).
The provided text describes information for the Q2® Low Pressure Power Injection Extension Set, which is a medical device, and does not contain information about an AI/ML powered device. Therefore, I cannot extract information pertaining to AI/ML acceptance criteria or studies.
However, I can provide available information regarding the device's performance as described in the document in a table format:
1. A table of acceptance criteria and the reported device performance
| Test Parameter | Acceptance Criteria / Predicate Performance | Reported Device Performance (Q2 Low Pressure Power Injection Extension Set) |
|---|---|---|
| Particulate Testing | Per ISO 8536-4:2010 | Successfully demonstrated device performs as intended and meets manufacturer specification. |
| Simulated Shipping | (Not explicitly stated but implied to meet functional requirements) | Successfully demonstrated device performs as intended and meets manufacturer specification. |
| Package Burst | (Not explicitly stated but implied to meet functional requirements) | Successfully demonstrated device performs as intended and meets manufacturer specification. |
| Priming Volume | Predicate: < 1 mL | 1.0 mL |
| Backpressure Leak | (Not explicitly stated but implied to meet functional requirements) | Successfully demonstrated device performs as intended and meets manufacturer specification. |
| Flow Rate | Maximum pressure of 325 psi at a flow rate of 10 mL per second | Successfully demonstrated device performs as intended and meets manufacturer specification. Meets 325 psi at 10 mL/second. |
| Simulated Maximum Use | (Not explicitly stated but implied to meet functional requirements) | Successfully demonstrated device performs as intended and meets manufacturer specification. |
| Sterilization (Method) | Predicate: Irradiation; E-Beam | 100% EtO (Ethylene Oxide) |
| Sterilization (Minimum SAL) | Predicate: 1 x 10^-6 | 1 x 10^-6 |
| Ethylene Oxide Residuals | Per ISO 10993-7:2008 | Tested and met established guidelines. |
| Shelf Life | Predicate: 5 year | 1 year (qualified) |
| Biocompatibility | Per ISO 10993-1:2009 (Hemocompatibility, Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Subchronic Toxicity, Material-mediated Pyrogenicity) | Test results successfully verified materials are biocompatible for clinical application. |
| Pyrogen (Bacterial Endotoxins) | Established guidelines (via LAL method) | Materials do not introduce a level of endotoxin that exceed established guidelines. |
| Pressure Rating | Max pressure of 325 psi at a flow rate of 10 mL per second | Use with low pressure power injectors up to 325 psi and maximum flow rate of 10 mL/second. |
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 specify the exact sample sizes used for each benchmark test. It only states that functional performance testing was "completed." No information is provided regarding the country of origin of the data, nor whether the tests were retrospective or prospective. These are bench tests, not clinical studies involving patient data.
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 section is not applicable as the device is a physical medical device (extension set) and the studies described are bench tests for functional performance, sterilization, shelf life, and biocompatibility, not studies requiring expert interpretation or ground truth establishment in the context of diagnostic or prognostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the type of bench testing described in the document.
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
This is not applicable as the device is an intravascular administration set and not an AI/ML-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical medical device and not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This is not applicable for the type of bench testing described. The "ground truth" for the bench tests would be defined specifications, industry standards (e.g., ISO standards), and manufacturer's established criteria for performance (e.g., maximum pressure, flow rate, SAL).
8. The sample size for the training set
This is not applicable as the device is a physical medical device and does not involve AI/ML requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is a physical medical device and does not involve AI/ML requiring a training set.
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