(30 days)
The Connex Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters.
The Connex Gastrointestinal Suture Anchor Set consists of 2 introducer needles with preloaded anchors and a .018/.035 inch with a spring coil tip. It is supplied sterile and is intended for one-time use.
The provided text describes a 510(k) premarket notification for the Connex Gastrointestinal Suture Anchor Set. It focuses on the device's substantial equivalence to a predicate device through functional and material testing, rather than an AI/ML powered device. As such, many of the requested fields are not applicable to this submission.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Reliable design and performance under specified testing parameters via: | The tests ("Tensile Testing", "Insertion Testing", "Biocompatibility Testing") provide "reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a suture anchor." |
| Tensile Strength (Specific values not provided) | Met internal design requirements (implied by "reasonable assurance") |
| Insertion Performance (Specific metrics not provided) | Met internal design requirements (implied by "reasonable assurance") |
| Biocompatibility (Specific metrics not provided) | Biocompatible (implied by "reasonable assurance") |
2. Sample sized used for the test set and the data provenance
The document does not explicitly state the sample sizes used for the tensile, insertion, and biocompatibility testing. It also does not provide information on data provenance (e.g., country of origin, retrospective/prospective). This is typical for mechanical device testing where internal validation is usually sufficient for a 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The "ground truth" for mechanical testing is typically established by engineering specifications and objective measurements, not expert consensus.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert reviews, which are not relevant to the described 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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML-powered diagnostic or interpretive devices and not for a mechanical medical device like a suture anchor.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone evaluation was not done. This concept applies to AI/ML algorithms, which are not relevant to this device.
7. The type of ground truth used
The ground truth for the testing (tensile, insertion, biocompatibility) would be based on engineering specifications and objective measurements. For example, tensile strength would be compared against a defined load capacity. Biocompatibility would be assessed against established standards (e.g., ISO 10993).
8. The sample size for the training set
This information is not applicable. The device is a mechanical suture anchor, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of device.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.