(38 days)
The Axiom Fascial Closure Device is used in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
A single-use medical device used to close laparoscopic trocar site defects. Closure of laparoscopic trocar site defects is used to reduce the risk of herniation which results in adverse effects to the patient and costly surgical revision by the healthcare provider. The Axiom Fascial Closure System provides mechanical assistance to assure reliable suture placement during fascial closure procedures.
The Axiom Fascial Closure System is a single-use medical device designed to close laparoscopic trocar site defects by providing mechanical assistance for reliable suture placement. The provided documents highlight that the device's approval through a 510(k) premarket notification is based on its substantial equivalence to predicate devices, namely the Covidien EndoClose and the Cooper Surgical Carter-Thomason CloseSure System. Rather than a clinical study with specific acceptance criteria and performance metrics typically associated with AI/software devices, the safety and effectiveness of the AXIOM Fascial Closure System were demonstrated through device qualification testing comparing it to these predicate devices.
Here's the breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Functional Equivalence to Predicate Devices) | Reported Device Performance |
|---|---|
| Structural Integrity: Device must withstand loading conditions. | Demonstrated structural integrity when subjected to loading. |
| Penetration Force: Forces required to penetrate a bench model with the suture passer for suture placement must be acceptable. | Demonstrated acceptable forces required to penetrate the bench model with the suture passer for placement of suture. |
| Biocompatibility: Materials used in construction must be biocompatible. | Demonstrated biocompatibility of materials used. |
| Suture Placement Acceptability: Ability to achieve acceptable suture placement in a bench model. | Study demonstrated acceptability of suture placement in the bench model. |
| Substantial Equivalence: With regard to indications for use, general technological characteristics, principle of operation, and materials, the new device must be substantially equivalent to predicate devices. | The Axiom Fascial Closure System is substantially equivalent to the Covidien EndoClose and the Cooper Surgical Carter-Thomason CloseSure System. |
2. Sample size used for the test set and the data provenance
The provided text only refers to "bench models" for testing. There is no specific sample size or data provenance (country of origin, retrospective/prospective) mentioned as this was likely bench testing, not human or animal studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not mentioned in the provided text. The testing appears to be primarily engineering and materials-based, not involving expert interpretation of "ground truth" as would be relevant for diagnostic AI devices.
4. Adjudication method for the test set
This information is not mentioned in the provided text. Adjudication methods are typically relevant for studies involving human interpretation or subjective outcomes, which is not the nature of the described tests.
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-powered diagnostic or assistive technologies, not for a mechanical fascial closure device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This device is a mechanical tool, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.
7. The type of ground truth used
The "ground truth" in this context is the successful demonstration of:
- Structural integrity (engineering standard)
- Appropriate penetration forces (biomechanical standard)
- Biocompatibility (materials science standard)
- Acceptable suture placement (functional performance standard in a bench model).
This is based on objective measurements against engineering and performance specifications, not on expert consensus, pathology, or outcomes data in the typical sense for diagnostic devices.
8. The sample size for the training set
Not Applicable. The Axiom Fascial Closure System is a mechanical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data for model development.
9. How the ground truth for the training set was established
Not Applicable, as there is no training set for a mechanical device.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.