(116 days)
The Kronner Low Profile Scope Holder is used to hold rigid endoscopes during endoscopic surgery and to allow rapid position changes by the pressing of a control button by the operator.
KLH-100 Kronner Low Profile Scope Holder For abdominal, thoracic, arthroscopic and nasal endoscopic surgical procedures.
HPL-2-30 High pressure flexible gas line set, double output For abdominal, thoracic, arthroscopic endoscopic surgical procedures.
HPL-3-30 High pressure flexible gas line set, triple output For nasal endoscopic surgical procedures.
KLH-200 Arm assembly For abdominal, thoractic, arthroscopic and nasal" endoscopic surgical procedures. *requires the Small Endoscope Accessory
C-100 Arm assembly For abdominal, thoracic, anthroscopic and nasal endoscopic surgical procedures.
C-101 Control strap, replacement For abdominal, thoracic, arthroscopic and nasal endoscopic surgical procedures.
SG-101 Scope grip strap, replacement For abdominal, thoracic, anthroscopic and nasal endoscopic surgical procedures.
SMA-100 Small Endoscope Accessory For nasal endoscopic surgical procedures
The Kronner Low Profile Scope Holder consists of mechanical linkages that connect between the operating table side rail and the shaft or head of a rigid endoscope. A telescoping arm distinguishes the device from other endoscope holders. Inert nitrogen gas at 100-150 psi is used to provide the energy to multiple joints to lock the holder in position when a control button is released by the operator.
The provided text describes a 510(k) submission for the "Kronner Low Profile Scope Holder," a medical device designed to hold rigid endoscopes during surgery. However, the document does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, or details about sample sizes, expert involvement, or ground truth establishment.
The document is a regulatory submission for substantial equivalence to a predicate device (Leonard Arm, K951854). It focuses on describing the device, its intended use, and comparing its technological characteristics to the predicate device. The FDA's response confirms substantial equivalence, allowing the device to be marketed, but this process does not inherently involve detailed performance studies against explicitly stated acceptance criteria in the way a clinical trial or algorithm validation study would.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: No such criteria or performance data are provided.
- Sample sized used for the test set and the data provenance: No test set is described or analyzed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment process is mentioned.
- Adjudication method for the test set: No test set is described.
- 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 device is a mechanical endoscope holder, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: As above, this is a mechanical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is mentioned in the context of device performance.
- The sample size for the training set: No training set is relevant or mentioned for this type of mechanical device.
- How the ground truth for the training set was established: No training set or ground truth is mentioned.
In summary, the provided 510(k) summary document focuses on demonstrating substantial equivalence to a predicate device and does not include the type of detailed performance criteria, study design, and results typically found for AI/software devices or clinical studies that would generate the information you requested.
§ 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.