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510(k) Data Aggregation
(182 days)
The EZ Regular set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. Prescription Use X
The EZ Regular consists of components commonly found on intravascular administration sets and extension sets. EZ Regular set consists of various components such as: air vented bag spike, drip chamber with filter or without filter, roller clamp, tubing, flow controller, Y-connector, needle-less Y-connector, luer lock end catheter, manifold filter.
The provided text describes a 510(k) premarket notification for a medical device called "EZ Regular," which is an intravascular administration set. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria in the typical sense for an AI/CADe device.
Therefore, many of the requested sections (e.g., specific acceptance criteria table, sample sizes, expert qualifications, MRMC study, ground truth details, training set size) are not applicable or extractable from this submission, as it pertains to a physical medical device (administration set) and not an AI/CADe system. The performance evaluation discussed is related to bench testing of a physical product.
Here's an attempt to answer the extractable information based on the provided text, with clear indications where information is not available or not relevant for an AI/CADe context:
1. Table of Acceptance Criteria and Reported Device Performance
For an intravascular administration set, the "acceptance criteria" are related to mechanical integrity, biocompatibility, and sterility, rather than metrics like sensitivity, specificity, or F1-score used for AI.
| Acceptance Criteria Category | Reported Device Performance (Summary) | Notes |
|---|---|---|
| Biocompatibility | Bench tests demonstrated "safe, effective" | The document states "Bench testing included biocompatibility." It implies the device met the necessary standards for biocompatibility for an intravascular device, allowing it to be considered substantially equivalent. Specific pass/fail criteria and results are not detailed. |
| Mechanical Testing | Bench tests demonstrated "safe, effective" | The document states "Bench testing included...mechanical testing." This would typically involve tests for tensile strength, leak integrity, flow rates, etc. The submission indicates these tests were successfully passed to demonstrate substantial equivalence. Specific details are not provided. |
| Sterility Testing | Bench tests demonstrated "safe, effective" | The document states "Bench testing included...sterility testing including EO residues." This would verify that the device is sterile and that residual ethylene oxide (EO) levels are within acceptable limits. Specific details are not provided. |
| Functional Equivalence | "Technological characteristics...identical...perform the same way as common intravascular administration sets." | This is the core claim for substantial equivalence, meaning the device functions as intended and similarly to the predicate device. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. "Bench tests were performed" typically refers to testing a certain number of manufactured units, but the exact count is not provided.
- Data Provenance: Not applicable in the context of clinical data. This refers to physical product testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: This is a physical device, not an AI/CADe algorithm where expert ground truth is established for image interpretation. The "ground truth" here is compliance with engineering and biological safety standards, verified through laboratory testing.
4. Adjudication method for the test set
- Not Applicable: Adjudication is relevant for reconciling expert disagreements in clinical data interpretation. For physical device testing, standards and test methods dictate pass/fail criteria.
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 an intravascular administration set, not an AI system. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical medical device, not a standalone AI algorithm.
7. The type of ground truth used
- Engineering Standards and Biocompatibility Test Results: The "ground truth" for this device's performance is adherence to established engineering specifications (e.g., mechanical strength, leak rates, flow rates) and successful completion of biocompatibility and sterility tests as per recognized standards (e.g., ISO, ASTM, USP).
8. The sample size for the training set
- Not Applicable: There is no "training set" in the context of physical medical device manufacturing and testing as described here.
9. How the ground truth for the training set was established
- Not Applicable: As there is no training set, this question is not relevant.
In summary: The provided document is a 510(k) summary for a relatively low-risk Class II physical medical device seeking substantial equivalence. It does not contain the type of AI/CADe-specific performance study details (e.g., clinical trial data, reader studies, AI metrics) that would necessitate the information requested in points 1-9 in that context. The "performance" section refers to standard bench testing for safety and effectiveness of the physical product.
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