(332 days)
The KAPP Bari-Ring Endoscopic Marker is intended to radiographically (limited to xray) 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 stainless steel ring deployed during surgery supplied non-sterile for single long term use 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 provided text pertains to a 510(k) premarket notification for the KAPP Bari-Ring Endoscopic Marker. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving device efficacy through extensive clinical studies with specified acceptance criteria and measured performance in the way a Class III device or new technology would. Therefore, the information requested in the prompt, particularly points 2-7, which relate to detailed study design and statistical performance, is largely not applicable or present in this document.
The document primarily focuses on comparing the new device's intended use, design, and performance standards/specifications to those of legally marketed predicate devices to establish substantial equivalence.
Here's an attempt to address the prompt based on the available information:
1. Table of acceptance criteria and the reported device performance
Since this is a 510(k) for a substantially equivalent device, the "acceptance criteria" are not reported as specific performance metrics against a threshold. Instead, the acceptance criteria are met by demonstrating that the device is as safe and effective as the predicate device(s). The "performance" is described in terms of shared attributes and testing.
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance (KAPP Bari-Ring) |
|---|---|
| Intended Use Equivalence: | |
| Intended to be used for radiographically marking the site of surgery during the surgical procedure for future surgical procedures. | YES - Intended to radiographically mark the site of gastropexy performed during bariatric or other surgical procedures. |
| Single use device. | YES |
| Design Equivalence: | |
| Same materials for invasive contact, well-known biocompatible industry standard. | YES - Consists of a stainless steel ring. (Stainless steel is a well-known biocompatible material for implants). |
| Performance Standards / Specifications Equivalence: | |
| Biocompatibility testing, and bench testing support the fact that no new issues of safety, effectiveness, or performance are raised. | YES - Biocompatibility testing and bench testing were performed to support equivalence. |
Note: The document states "Biocompatibility testing, and bench testing support fact that no new issues of safety, effectiveness, or performance raised" which is the reported "performance" in the context of a 510(k) submission, confirming it meets the regulatory expectation for equivalence.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This document does not describe a clinical study with a "test set" in the context of device performance metrics. The demonstration of equivalence primarily relies on material properties, design, and intended use comparison, along with general biocompatibility and bench testing.
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 / Not provided. No specific "ground truth" establishment by external experts for a test set is described. The relevant "experts" would be the engineers and scientists at Kapp Surgical Instrument Co. responsible for design, testing, and regulatory submission, and the FDA reviewers themselves.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No adjudication method for a test set is described as there isn't a performance study with a test set in the clinical sense.
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 implantable radiographic marker, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an implantable radiographic marker, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided. For the purpose of a 510(k), the "ground truth" is that the predicate devices are legally marketed and have demonstrated safety and effectiveness for their intended use. The new device's "ground truth" is its physical and material properties (e.g., biocompatibility) meet recognized standards, which are evaluated through bench testing. No clinical "ground truth" derived from patient outcomes or pathology is detailed in this document.
8. The sample size for the training set
- Not applicable / Not provided. There is no "training set" as this is not an AI/machine learning device. The "training" for such a device would be based on established engineering principles, material science, and regulatory standards.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set, this question is not applicable.
§ 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.