(234 days)
The AbClose - Port Site Closure Device has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
The AbClose - Port Site Closure Device is a sterile, single-use device including 2 major components, Suture Guide and Suture Passer. The device is used with a commercially cleared suture, and is used as a manual instrument to pass needles with suture through soft tissues for suturing. The device is designed with a suture retrieval system for unassisted fascial closures. facilitating standard suture closure techniques. The Suture Guide is structured by a Handle and a Suture Catcher. The pyramid-shape Suture Catcher is controlled by a Push Button to fold the Suture Catcher into cylinder shape for insertion into the trocar wound. Once the Suture Guide is in position, Suture Catcher is expanded back to a pyramid shape to stabilize the device on the trocar wound site. The Suture Passer is a handheld suture grasping device designed to pass sutures through soft tissue. It features a Handle and a stainless steel Needle assembled with a Suture Shaft that grasps a suture. The Suture Passer is designed to work with the Suture Guide to penetrate through soft tissues and deploy suture ends into the Suture Catcher. Withdraw Suture Guide by fold the Suture Catcher into cylinder shape, the two suture ends are securely captured and are ready for user to type knots to close the trocar wound site.
The provided document indicates that the AbClose - Port Site Closure Device has undergone performance testing to demonstrate that it meets performance specifications for its intended use. However, it does not explicitly state acceptance criteria in a quantifiable manner (e.g., specific thresholds for success/failure rates, mechanical strength, etc.) or provide detailed device performance data in a table format.
Instead, the document broadly describes the types of studies conducted and their general conclusions regarding device functionality and safety.
Here's an attempt to structure the information based on your request, with missing information clearly noted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Study Type) | Reported Device Performance |
|---|---|
| Sterilization Validation: Achieve a Sterility Assurance Level (SAL) of 10-6. | Sterilization has been validated to achieve a SAL of 10-6. |
| Mechanical Testing: Demonstrate that design specifications are fulfilled; insertion portion remains intact during surgery; no safety concerns. | Mechanical function and structural integrity were tested and demonstrated that design specifications are fulfilled. Mechanical safety tests demonstrated the insertion portion remains intact during surgery and raises no safety concern. |
| Animal Test (Functionality): Demonstrate the device can deliver the intended function of application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites. | The intended use has been conducted by animal test to demonstrate the AbClose - Port Site Closure Device can deliver the intended function. |
Missing Information:
- Specific, quantifiable acceptance criteria for mechanical tests (e.g., force thresholds, cycles to failure).
- Specific, quantifiable acceptance criteria for animal tests (e.g., success rate of closure, absence of complications).
- Detailed performance results (e.g., numerical data, statistical analysis) from any of these tests.
2. Sample Size Used for the Test Set and Data Provenance
- Sterilization Validation: The document states "Sterilization validation was conducted." It does not specify the sample size (e.g., number of devices tested).
- Mechanical Testing: The document states "Abclose - Port Site Closure Device's mechanical function and structure integrity were tested." It does not specify the sample size (e.g., number of devices tested).
- Animal Test: The document states "The intended use has been conducted by animal test." It does not specify the sample size (number of animals, number of procedures).
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the submitter is in Taipei, Taiwan, it's plausible the studies were conducted there, but this is not confirmed. The context implies these were prospective studies designed to evaluate the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. The studies described (sterilization, mechanical, animal) do not typically involve human experts establishing "ground truth" in the same way, for instance, a clinical trial with diagnostic image interpretation would. For animal models, the "ground truth" would be established by the observed physiological and anatomical outcomes/observations by veterinary professionals/researchers, but their specific number and qualifications are not detailed.
4. Adjudication Method for the Test Set
- This information is not provided and is generally not applicable to the types of studies (sterilization, mechanical, animal) described in the document. Adjudication is typically used in studies involving subjective assessments or different interpretations (e.g., clinical trials, image reading).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The document describes sterilization validation, mechanical testing, and an animal test. These are not MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as the AbClose - Port Site Closure Device is a manual medical instrument, not an AI algorithm or a device with an automated "algorithm only" component. Performance is inherent to its mechanical function and interaction within an anatomical context.
7. The Type of Ground Truth Used
- Sterilization Validation: The "ground truth" is measured against industry standards (ISO 11135:2014) for sterility, achieving a specified SAL.
- Mechanical Testing: The "ground truth" is based on the device's design input specifications and the requirement for structural integrity and safety.
- Animal Test: The "ground truth" is the successful physical approximation of tissues and percutaneous suturing for closing incision sites, assessed through direct observation and potentially histological examination in an animal model.
8. The Sample Size for the Training Set
- This information is not applicable as the document describes a mechanical medical device, not a device that utilizes machine learning and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reason as above; there is no training set for this type of 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.