(92 days)
The KAPP Bari-Ring Endoscopic Marker is intended to be used to radiographically (limited to x-ray) mark the site of gastropexy performed during bariatric or other surgical procedures, especially in those procedures where the stomach is not accessible by other diagnostic means (contrast or endoscopy).
The KAPP Bari-Ring Endoscopic Marker consists of a nickel titanium stainless steel ring deployed during surgery. It is supplied non-sterile for single long term (30 day) use to mark the spot expected to require further surgery within 30 days. The ring is homogenously constructed of a ring of nickel titanium conforming to ASTM F 2063-05.
The provided text describes a 510(k) summary for the KAPP Bari-Ring Endoscopic Marker, focusing on its substantial equivalence to previously marketed devices. This type of submission relies on demonstrating that a new device is as safe and effective as a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies. Therefore, much of the requested information regarding acceptance criteria and performance studies for an AI/ML device is not applicable in this context.
Here's an breakdown of the available information and why other items are not present:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The submission does not specify numerical acceptance criteria for clinical performance for the new KAPP Bari-Ring Endoscopic Marker. Instead, the approach is to demonstrate substantial equivalence to predicate devices in specified areas.
- Reported Device Performance:
Performance Area Result / Conclusion Corrosion resistance Tests demonstrated substantial equivalence. Hardness Tests demonstrated substantial equivalence. Tensile Tests demonstrated substantial equivalence. Overall Conclusion The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices.
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission details the premarket notification for a physical medical device (an endoscopic marker), not an AI/ML diagnostic or predictive tool. Therefore, there is no "test set" in the context of AI/ML performance evaluation (e.g., images for classification). The "tests" mentioned are laboratory tests on the material properties of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As above, there is no "test set" requiring ground truth established by experts for an AI/ML algorithm.
4. Adjudication method for the test set
- Not Applicable. No test set in the AI/ML context.
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 device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI algorithm.
7. The type of ground truth used
- Not Applicable. Ground truth in the context of AI/ML performance is not relevant here. The evaluation of this device is based on laboratory test results (corrosion resistance, hardness, tensile strength) to demonstrate that its physical properties are comparable to legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set.
In summary: The provided 510(k) summary is for a physical medical device (KAPP Bari-Ring Endoscopic Marker) and focuses on demonstrating substantial equivalence to predicate devices through physical and material property testing, rather than performance of an AI/ML algorithm against specific acceptance criteria. Therefore, the questions related to AI/ML study design and metrics are not applicable to this document.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.