(161 days)
The Entuit™ Secure 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 Entuit™ Secure Adjustable 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 Entuit™ Secure Gastrointestinal Suture Anchor Set and the Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set consist of 2 or 3 introducer needles with pre-loaded suture anchors and a wire guide. A notch is located on the distal tip of the introducer needle. The coil anchor is placed in the notch prior to placement. The proximal end of the suture anchor contains the suture retention mechanism.
The retention mechanism of the Entuit Secure Gastrointestinal Suture Anchor consists of an extension spring which is glued on the proximal end within a suture retention housing. The suture is threaded through the coils of the extension spring. When the suture retention mechanism is pushed towards the anchor, tension is applied to the spring, which causes the coils of the spring to open. This allows the suture to slide through the spring and allows the retention mechanism to slide along the suture. When the retention mechanism is pulled away from the anchor, the coils of the spring compress and clamp down on the suture. This does not allow the suture to slide through the spring and maintains tension on the suture anchor.
The adjustable suture retention mechanism of the Entuit Secure Adjustable Gastrointestinal Suture Anchor Set consists of a suture retention housing, a compression spring, a compression jaw, and a removable adjustable tab. The suture is threaded through the suture retention housing and held in place by the compression jaws and the compression spring. The adjustable tab must be compressed for the suture to be adjusted. When the adjustable tab is compressed, the spring and compression jaws do not contact the suture. This allows the suture retention mechanism to slide along the suture. Once the suture retention mechanism is in place, the compression jaws will maintain tension on the suture anchor, and the adjustable tab can be removed.
Both of the proposed devices are supplied sterile and are intended for one-time use.
The provided text describes a 510(k) summary for the Entuit™ Secure Gastrointestinal Suture Anchor Set and its adjustable counterpart. This summary focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial or algorithm performance study would.
Based on the document, here's what can be extracted and inferred regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria":
The "device" in this context refers to the Entuit™ Secure Gastrointestinal Suture Anchor Set and the Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set.
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states that the devices met predetermined acceptance criteria for various tests. However, the specific numerical acceptance criteria themselves are not provided, nor are precise quantitative performance results. Instead, it offers qualitative statements about meeting these criteria.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Tensile Testing | Device met all predetermined acceptance criteria. Testing shows that the tensile strength during proper clinical use should be capable of maintaining the proper tensile force requirements to anchor the anterior wall of the stomach to the abdominal wall. |
| Fatigue Testing | Testing shows that under normal clinical use of the devices there should be no mechanism or suture failure. |
| Biocompatibility Testing | In conformance with the applicable sections of ISO 10993-1, the predetermined acceptance criteria were met. Testing (i.e., cytotoxicity, sensitization, intracutaneous and systemic toxicity, and pyrogenicity) shows that the devices are biocompatible. |
| Torque Testing (for Adjustable Set only) | Testing shows that the device can withstand the torsional forces seen during proper clinical use. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the tensile, fatigue, biocompatibility, or torque testing. It also does not mention country of origin of data or whether the studies were retrospective or prospective, as these are typically bench tests or in-vitro tests for a device of this nature, not clinical studies involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and therefore not provided in the document. The tests performed are engineering and biological tests (tensile, fatigue, biocompatibility, torque) on the device components or the entire device, not clinical evaluations that require expert interpretation of results or ground truth established by medical professionals.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the document. Adjudication methods are relevant for studies where multiple expert opinions are reconciled, typically in clinical evaluations or image interpretation. The tests described are objective, physical measurements.
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
An MRMC comparative effectiveness study was not done, as this device is a medical instrument (suture anchor set) and not an AI-powered diagnostic or interpretive tool. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation was not done, as this device is a medical instrument and does not involve any algorithms or AI.
7. The Type of Ground Truth Used
For the engineering tests (tensile, fatigue, torque), the "ground truth" would be defined by engineering specifications and standards (e.g., minimum tensile strength required for anchoring the stomach wall, acceptable levels of fatigue over a certain number of cycles, biocompatibility standards per ISO 10993-1). These are objective, measurable criteria. For biocompatibility, it's about meeting established biological safety levels.
8. The Sample Size for the Training Set
This section is not applicable as the device is not an AI/algorithm and therefore does not have a "training set."
9. How the Ground Truth for the Training Set was Established
This section is not applicable as the device is not an AI/algorithm.
§ 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.