(14 days)
The Davol Delivery System is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.g. hernia repair).
The proposed device is designed to roll a soft tissue prosthetic in a tight uniform manner and provide a protective tube through which the rolled prosthetic can be delivered into the abdomen. The proposed device consists of four distinct parts, a rolling tines/plunger assembly which is used to roll the soft tissue prosthetic, a hollow plastic delivery tube to hold the rolled prosthetic, a "T" handle which is placed over the tines to facilitate the plunging motion to deliver the prosthetic, and an optional switching stick which can be used to maintain the tissue path created by a trocar sleeve. The proposed device will be provided as a sterile device for single patient use. It will be available in two sizes, a small size for the delivery of smaller soft tissue prosthetics and a large size for the delivery of larger prosthetics.
The provided text describes a 510(k) premarket notification for the Davol Delivery System, a device intended to facilitate the delivery of soft tissue prosthetics during laparoscopic hernia repair. The document focuses on establishing substantial equivalence to predicate devices and describes limited bench testing.
Therefore, it does not contain information about acceptance criteria or a study proving the device meets specific performance acceptance criteria in the way typically expected for an AI/ML medical device. Instead, the "study" described is limited bench testing to demonstrate functionality and address potential concerns.
Here's a breakdown of the available information based on your request, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The document does not define specific, quantifiable acceptance criteria (e.g., accuracy thresholds, failure rates) for the device's performance, nor does it provide a formal table of results against such criteria. The "performance" described is functional operation.
| Acceptance Criteria (N/A – Not specified) | Reported Device Performance |
|---|---|
| No explicit numerical or quantitative acceptance criteria are provided in the document. | Functionality: Demonstrated ability to roll soft tissue prosthetics, insert them into the delivery device, and plunge them out onto a tabletop. |
| Integrity: Prosthetics did not exhibit damage after use. | |
| Ease of Delivery: Wetting the prosthetic facilitates ease of delivery. | |
| No explicit numerical or quantitative acceptance criteria are provided in the document. | Safety/Effectiveness of Rounded/Slit Tip: The rounded shape facilitates entry into the incision, and the slit valve allows the prosthetic to exit. This design choice "does not affect the safety and effectiveness of the device" as it facilitates entry. |
| No explicit numerical or quantitative acceptance criteria are provided in the document. | Safety/Effectiveness of Adjustable Wing Component: Provides a visual gauge of insertion depth and a bracing point. This component "does not adversely affect the safety and effectiveness of the device" as it remains outside the body and provides an additional visual guide. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Several different large soft tissue prosthetics" were used. The exact number is not specified. The number of trials performed is also stated as "Several trials were repeated." This is a very small and undefined sample.
- Data Provenance: The testing was "Preliminary bench testing," indicating laboratory conditions rather than human or animal studies. No country of origin is mentioned, but it's implied to be within the Davol, Inc. R&D setting. The testing was prospective in the sense that it was conducted specifically for the 510(k) submission to demonstrate functionality.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There was no "ground truth" in the clinical or diagnostic sense with expert review. The "ground truth" was simply the observation of the device's mechanical function (rolling, delivery, lack of damage to prosthetics) during bench testing. This typically involves R&D engineers or technicians. No specific number or qualifications are mentioned.
4. Adjudication Method for the Test Set
Not applicable. There was no "adjudication" in the clinical sense. The results were likely observed and documented by the testing personnel.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a mechanical delivery system, not an AI/ML-based diagnostic or assistive technology. Therefore, no MRMC study or AI-related comparative effectiveness was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Not applicable. This device is a mechanical delivery system, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" was observational/functional. It involved direct observation of the device's ability to mechanically perform its intended function (rolling and delivering prosthetics without damage in both dry and wet conditions).
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical system, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is a mechanical system, not an AI/ML algorithm that requires a training set or associated ground truth establishment.
§ 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.