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510(k) Data Aggregation
(27 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 are used in gastropexy procedures. The Entuit™ Secure Gastrointestinal Suture Anchor Set and the Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set consist of 2 or 3 stainless steel silicone coated introducer needles with pre-loaded suture anchors and a wire guide. An additional sterile prepackaged red adjustable plunger is packaged with the Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set.
The Entuit™ Secure Gastrointestinal Suture Anchor Set and the Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set are supplied sterile and are intended for one-time use.
The provided text describes a 510(k) premarket notification for a medical device, the "Entuit Secure Gastrointestinal Suture Anchor Set" and "Entuit Secure Adjustable Gastrointestinal Suture Anchor Set". This submission focuses on demonstrating substantial equivalence to a predicate device, primarily by showing that a modification (adding a silicone coating to the introducer needles) does not raise new questions of safety or effectiveness.
Therefore, the studies and acceptance criteria are related to the performance of the modified component (silicone-coated needles) rather than a comprehensive evaluation of the entire device's clinical efficacy in anchoring. The document does not describe acceptance criteria or studies performed for a diagnostic or AI-driven device. It's for a physical interventional device, and the "device performance" mentioned refers to mechanical characteristics.
Given this context, here's the information requested, adapted to the content provided:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Met the requirements of ISO 10993-1. | Testing showed that the devices met the requirements of ISO 10993-1. |
| Insertion Force Testing | Reduced the insertion force to less than 1.5 N (specific criteria for reduction are implied, but "less than 1.5 N" is stated as the met criterion after applying silicone). | Applying silicone to the outer surface of the needle reduced the insertion force to less than 1.5 N. The acceptance criterion was met. |
| Ease of Insertion Testing | Needles coated with silicone lubricant are easier to advance (specific quantitative criteria are not provided in the summary, but the acceptance criterion was "met"). | Needles coated with silicone lubricant are easier to advance. The acceptance criterion was met. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes for the mechanical tests (Biocompatibility, Insertion Force, Ease of Insertion). It also does not provide information regarding country of origin or whether the data was retrospective or prospective. These studies would typically be conducted in a laboratory setting.
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)
This is not applicable to the type of device and studies described. The tests are for mechanical and material performance, not diagnostic interpretation by experts. Ground truth here would be derived from laboratory measurements and adherence to international standards (like ISO 10993-1).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in diagnostic studies. The described tests are laboratory-based, objective 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
This is not applicable. The device is an interventional medical device, not a diagnostic imaging device or an AI-powered system designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the described tests would be:
- Biocompatibility: Adherence to the specified international standard (ISO 10993-1).
- Insertion Force: Objective measurement of force (e.g., in Newtons) using a force gauge or similar equipment.
- Ease of Insertion: Objective or semi-objective evaluation of the effort required for insertion, likely through mechanical testing or a predefined scoring system, compared to a control or predicate.
8. The sample size for the training set
This is not applicable. The described tests are for a physical medical device and do not involve machine learning models that require training sets.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for a mechanical device.
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