(248 days)
The foam ring, with the hole in the center, may be used in conjunction with ports (e.g., chemotherapy, vascular, etc.), up to 1 3/8" (3.5 cm) in diameter and raising less than 3/8" above the skin.
The device is intended to cushion the localized area surrounding the port.
The thickness of the foam ring, along with the hole in the center of the ring, aids in preventing things, such as seat belts, bra straps, and clothing, from rubbing against the embedded port. The product consists of one element; an off-white colored flat ring made out of non-latex hypoallergenic foam, with a die cut hole in the middle, with non-latex adhesive backing.
The provided text describes the "Foam Ring Port Protector" by Inspired Ideas, Inc. and its 510(k) summary. However, it does not contain detailed acceptance criteria or a study proving the device meets those criteria in the format requested.
The document mentions that "Compression testing was conducted on the foam and peel strength testing was conducted with the adhesive," but it doesn't provide the specific acceptance criteria for these tests (e.g., minimum compression strength, minimum peel strength) or the results obtained.
Therefore, much of the requested information cannot be extracted from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document (Only mentions "Compression testing was conducted on the foam and peel strength testing was conducted with the adhesive," but no results or targets are provided.) |
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.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective).
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. The "ground truth" concept is more relevant to diagnostic devices that interpret data (like images). This device is a physical accessory. The performance testing described (compression, peel strength) would likely use objective measurements rather than expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically for subjective expert evaluations of diagnostic results, which is not the case here.
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. This is a physical accessory, not an AI or diagnostic device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical accessory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the conventional sense. The "ground truth" would be the objectively measured physical properties of the materials (e.g., actual compression resistance, actual peel strength, material composition). The document only states that "Compression testing" and "peel strength testing" were conducted, implying objective measurement, but doesn't detail the target values or methods beyond that.
8. The sample size for the training set
- Not applicable. This is not a machine learning/AI device, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.