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510(k) Data Aggregation
(9 days)
PATTON MEDICAL DEVICES
The I-PORT™, Injection Port is indicated for patients who administer, or to whom is administered, multiple daily subcutaneous injections of physician prescribed medications, including insulin. The I-PORT™, Injection Port may remain in place for up to 72 hours to accommodate multiple drug injections without the discomfort of additional needle sticks. This device may be used on a wide range of patients, including adults and children.
The 1-PORT™, Injection Port is a sterile, single use, low profile injection port through which physician prescribed medications can be injected subcutaneously from a standard syringe and needle, pen or alternative manual iniection device. The device is designed to reduce the hardships of multiple daily subcutaneous injections by allowing users to receive physician prescribed medication, including insulin, without repeated needle punctures of the skin. The I-PoRT™, Injection Port may remain in place for up to 72 hours to accommodate multiple drug injections without additional needle sticks.
The provided text describes the 510(k) summary for the I-PORT™ Injection Port, not a study evaluating its performance against acceptance criteria using AI or human readers. The document focuses on regulatory approval, establishing substantial equivalence to predicate devices, and demonstrating compliance with standards.
Therefore, many of the requested categories for summarizing a study with AI and expert review are not applicable to this document. I will fill in the relevant information that is present.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format you've requested for typical AI or diagnostic device studies. Instead, it states:
| Criterion | Reported Performance |
|---|---|
| Internal Specifications & User Needs | "Laboratory testing verified that the performance of the I-PORT™, Injection Port met both internal specifications and user needs." |
| Functional and Performance Characteristics | "Representative samples of the device underwent bench testing to verify functional and performance characteristics." |
| Biocompatibility | "Materials used in the I-PORT™, Injection Port are biocompatible. These materials meet the requirements of ANSI/AAMI/ISO 10993-1:2003 Biological Evaluation of Medical Devices - Part 1:Evaluation and Testing for a prolonged body contact, external communicating device..." |
| Sterility Assurance Level (SAL) | "The I-PORT™, Injection Port will have a SAL of 10-6" |
| Pyrogen-free | "the fluid path will be Pyrogen free as tested by limulus amebocyte lysate (LAL)." |
| Packaging Integrity and Durability | "The packaging will be tested to applicable standards to ensure integrity and durability." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only mentions "Representative samples of the device" for bench testing.
- Data Provenance: Not specified. The testing described is laboratory/bench testing, not data collected from human subjects.
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 applicable. This is a medical device for drug administration, not an AI or diagnostic device with ground truth established by experts interpreting images or clinical data. The "ground truth" here is compliance with engineering and material specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method is described for this type of device testing.
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-assisted diagnostic device; it is a physical medical device.
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 an algorithm. Bench testing evaluates the device's physical properties and functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to engineering and material specifications, and compliance with recognized standards. For example:
- Internal specifications and user needs.
- Requirements of ANSI/AAMI/ISO 10993-1:2003 for biocompatibility.
- A Sterility Assurance Level (SAL) of 10-6.
- Pyrogen-free status as tested by LAL.
- Compliance with various ASTM and ISO standards for packaging, sterilization, and general requirements for intravascular catheters.
8. The sample size for the training set
Not applicable. No training set is relevant for this type of physical medical device and its associated testing.
9. How the ground truth for the training set was established
Not applicable. No training set is relevant.
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