(186 days)
Over a long period of time Used intravenously for chemotherapy, anti-biotics; anti-viral drugs, and for parenteral nutrition. They are also used for blood transfusions or blood sampling in small quantities.
The Celsite® Implantable Port with Valved Catheter is composed of materials that have been tested in accordance with the ISO Standard 10993-1 and have been determined to be suitable for the intended use of this product.
This looks like a 510(k) summary for a medical device (Celsite® Implantable Port with Valved Catheter) and not a study with acceptance criteria for device performance in the way you might expect for an AI/Software as a Medical Device (SaMD).
Here's an analysis based on the provided text, addressing your points as much as possible:
Analysis of Provided Text for Acceptance Criteria and Study Information:
This document is a 510(k) Pre-market Notification, which focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical or performance study in the way a diagnostic AI might. The "safety and effectiveness" section provided describes quality control and manufacturing processes, not a performance study against predefined metrics.
1. A table of acceptance criteria and the reported device performance
Based on the provided text, there are no specific numerical acceptance criteria or reported device performance metrics in the context of a diagnostic or predictive device's accuracy (e.g., sensitivity, specificity, AUC).
The document states:
- "All finished products are tested and must meet all required release specifications before distribution."
- "The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product)."
- "The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications."
These statements refer to manufacturing quality control and product design specifications, which are internal acceptance criteria for the manufacturing process to ensure the product is built correctly, rather than external performance criteria for a diagnostic function. The document confirms that these tests are performed and the product must meet them, but it doesn't list the specific criteria (e.g., tensile strength, flow rate) or the exact reported performance values from these internal tests.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document does not describe a performance study involving a "test set" of data in the context of a diagnostic or AI device. The "testing" mentioned refers to manufacturing quality control of the physical device.
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. There is no diagnostic "ground truth" establishment described, as this is a physical medical device (implantable port) and not a diagnostic AI system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No diagnostic ground truth or test set adjudication method is described.
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 a physical device, and no MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. There is no diagnostic ground truth mentioned. The "ground truth" for this type of device would generally be conformance to engineering specifications and biological compatibility (as indicated by ISO 10993-1 testing). The document mentions material testing according to ISO 10993-1, which is a standard for biocompatibility evaluation of medical devices.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" as this is not an AI/ML device.
Summary based on the provided text:
The provided document is a 510(k) submission for a physical medical device. It focuses on demonstrating "substantial equivalence" to a predicate device and adherence to manufacturing quality control processes. It does not present acceptance criteria or study results in the manner one would expect for a diagnostic device or an AI/ML-based medical device. The "testing" referred to is manufacturing quality control to ensure the device meets its design specifications and is biologically compatible.
§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.