(87 days)
This product is intended to pass suture through soft tissue lavers (fascia, muscle and perioneum) of a trocar wound at the end of laparoscopic surgery.
It is to be used only by surgeons trained in endoscopic/laparoscopic surgery.
The CrossBow Fascial Closure System is a set of single-use instruments primarily intended for the use of closing soft tissue layers (fascia, muscle and peritoneum) of a trocar wound following laparoscopic surgery. The CrossBow Fascial Closure System has two basic components: (1) a suture passer component used to pass suture through the abdominal wall, and (2) a guide used to repeatedly direct the needle through the abdominal wall using visual markers to reference the needle puncture location off the inner wall of the abdomen. The guide has two deployable snare loops used to secure and retrieve the free ends of suture passed by the suture passer. The device also has an accessory adaptor to accommodate larger size port defects.
The provided document describes the CrossBow Fascial Closure System and its substantial equivalence determination. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Validation and/or Verification Method | Acceptance Value/Criteria | Verification and Validation Results |
|---|---|---|
| Mechanical Testing (Needle Penetration) | To require comparable or less penetration force than competitive devices | Acceptable |
| Mechanical Testing (Snare Loop Integrity) | To exceed the strength of the expected loading requirements | Acceptable |
| Mechanical Testing (Needle Security in Passer) | To exceed the strength of the expected loading requirements | Acceptable |
| Mechanical Testing (Guide Suture Security) | To exceed the strength of the expected loading requirements | Acceptable |
| Mechanical Testing (Targeting & No. of Uses) | To provide accurate performance and expected number of uses | Acceptable |
| Surgeon Validation Lab (Animal model) | Successful placement of suture and closure of defect | Acceptable |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each mechanical test. However, it indicates a "Surgeon Validation Lab (Animal model)" was performed as part of the non-clinical performance data. The exact number of animals or trials within this model is not stated. The data provenance is implied to be from the manufacturer's internal testing as part of their 510(k) submission. No specific country of origin for data or whether it was retrospective/prospective is mentioned, but typically such validation studies are prospective for regulatory submissions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document mentions "Surgeon Validation Lab (Animal model)" and that the device is "to be used only by surgeons trained in endoscopic/laparoscopic surgery." This indirectly suggests that surgeons were involved in validating the device, but it does not state the number of experts nor their specific qualifications (e.g., years of experience, board certification) for establishing ground truth in the animal model.
4. Adjudication method for the test set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set results. The acceptance criteria for the mechanical tests are objective (e.g., "to exceed the strength," "to require comparable or less penetration force"), and the animal model criterion is "Successful placement of suture and closure of defect," which would likely be a direct observation by the participating surgeons.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a surgical instrument, not an AI or imaging diagnostic tool that would typically involve "human readers" or AI assistance in the way described. The comparative effectiveness assessment was against a predicate device (Weck EFx Fascial Closure System, K132362) based on mechanical and performance testing.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This does not apply. The CrossBow Fascial Closure System is a physical surgical instrument, not an algorithm, and inherently requires human-in-the-loop performance (i.e., a surgeon). Standalone performance would refer to the device's mechanical integrity as tested, which was indeed evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the mechanical tests, the ground truth was based on objective measurements against defined criteria (e.g., strength, force, accuracy, number of uses). For the "Surgeon Validation Lab (Animal model)," the ground truth was direct observation and assessment of the successful placement of suture and closure of defect, likely by the surgeons performing the procedure in the lab. This could be considered a form of expert assessment based on procedural success.
8. The sample size for the training set
This information is not applicable as this is a physical medical device and not an AI or machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable as this is a physical medical device and not an AI or machine learning algorithm that requires a "training set."
§ 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.