(131 days)
The Reprocessed Bladeless Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
The Reprocessed Dilating Tip Trocar has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
The Reprocessed Stability Sleeve has application in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
Reprocessed Bladeless Trocar: The Reprocessed Bladeless Trocar, is a sterile single patient use instrument consisting of a radiolucent sleeve (cannula) and obturator. The obturator contains a clear, tapered optical element. The 5 mm obturator accommodates an appropriately sized 0° endoscope and provides visibility of individual tissue layers during insertion. The trocar sleeve contains two seals that accommodate instruments 5 mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
Reprocessed Dilating Tip (Bladed) Trocar: The Reprocessed Dilating Tip Trocar is a sterile, single patient use instrument consisting of a radiolucent sleeve (cannula) and obturator. The obturator has a sharp, flat-bladed tip and spring-loaded shield is designed to cover the flat-bladed tip to protect internal structures from puncture or laceration once the abdominal or thoracic cavity has been entered. The trocar sleeve contains two seals that accommodate instruments 5 mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
Reprocessed Stability (Universal) Sleeve (Cannula): The Reprocessed Stability Sleeve is a sterile, single patient use device with a radiolucent sleeve. The trocar sleeve contains two seals that accommodate instruments 5 mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
The document provided describes the reprocessing of surgical trocars and sleeves, and the performance data focuses on demonstrating that the reprocessed devices are as safe and effective as new (predicate) devices. This is not the type of medical device for which the requested acceptance criteria and study information (AI/radiology performance metrics, expert adjudication, etc.) would typically apply.
The device is a reprocessed medical instrument, not an AI or diagnostic imaging device. Therefore, the performance evaluation centers on its physical integrity, sterility, and functionality after reprocessing, rather than diagnostic accuracy or human-AI interaction.
Here's an analysis based on the provided text, highlighting why most of your requested points are not applicable in this context:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria for each test and reported pass/fail results. Instead, it lists the types of tests performed.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Tested and performs as originally intended. |
| Validation of Reprocessing | Tested and performs as originally intended. |
| Sterilization Validation | Tested and performs as originally intended. |
| Function Test(s) | Each individual device is tested for appropriate function of its components prior to packaging. Tested and performs as originally intended. |
| Packaging Validation | Tested and performs as originally intended. |
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 performance tests (biocompatibility, reprocessing validation, sterilization, function, packaging). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of these tests (bench and laboratory), these details are less critical than for clinical trials.
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 question is not applicable. The "ground truth" for a reprocessed medical instrument involves objective measurements of sterility, material integrity, and mechanical function, not diagnostic interpretations by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials, particularly in image interpretation, to resolve discrepancies between readers. This device undergoes bench and laboratory testing.
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 question is not applicable. An MRMC study is relevant for diagnostic devices (e.g., AI in radiology). This submission is for reprocessed surgical instruments. Human "improvement" or AI assistance is not a relevant metric here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned in point 3, the "ground truth" for this device relates to objective physical and biological properties. It includes:
- Sterility: Absence of viable microorganisms (validated through sterilization methods).
- Biocompatibility: Absence of adverse biological reactions (tested with accepted standards).
- Functional Performance: Mechanical integrity and operation of components (e.g., seals, bladed tip, stopcock valve, resistance to leakage, insertion force).
- Cleaning Efficacy: Absence of residual soil after reprocessing.
- Packaging Integrity: Maintenance of sterility barrier.
These are established through standardized laboratory methods and specifications, not expert consensus or pathology in the diagnostic sense.
8. The sample size for the training set
This question is not applicable. This device is a physical instrument, not an AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
§ 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.