(244 days)
The KARL STORZ Holders are manually operated surgical devices intended to hold endoscopes (such as arthroscopes, etc) and accessories during general and neurologic diagnostic and therapeutic procedures.
The KARL STORZ Holder is a manually operated surgical instrument intended to hold scopes (such as endoscopes, arthroscopes, etc) in a desired position during diagnostic, therapeutic, and surgical procedures (including neurologic procedures). The holder is manufactured from Stainless Steel and functions by the user manually tightening or loosening a knob, which opens and closes around a surgical scope. The device is intended to attach to the several KARL STORZ holding systems, which are a Class 1, table-mounted, mechanical and electromechanical holding arms that have many general surgical functions in addition to scope holding; it can also be used for instrument holding, retraction, and positioning.
The provided text is a 510(k) summary for the KARL STORZ Holders, which are manually operated surgical devices intended to hold endoscopes and accessories. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about a clinical study with acceptance criteria for an AI/CAD-like device.
Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, ground truth establishment, and MRMC studies for an AI/CAD device is not available in the provided text. The document describes a traditional medical device (a mechanical holder) and its non-clinical performance testing.
However, based on the information that is available in the document, here's a summary of the non-clinical performance data and the demonstration of substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not detail specific quantitative acceptance criteria or reported values in a table format for a clinical outcome beyond demonstrating functional equivalence. The performance data is described qualitatively as meeting the needs for substantial equivalence.
| Performance Category | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Holding Performance | Sufficient to securely hold intended devices (scopes, accessories) during procedures and maintain position. | Testing was performed (Non-Clinical Performance Data: "Holding Performance testing"). Implied to be acceptable for intended use. Max loading weight of 3kg reported. |
| Direction of View/Image Stability | Maintain stable direction of view/image during use. | Testing was performed (Non-Clinical Performance Data: "Direction of view/Image stability testing"). Implied to be acceptable for intended use, as it contributes to substantial equivalence. |
| Material of Construction | Biocompatible and durable for surgical use. | Stainless Steel, same as predicate device. |
| Mode of Operation | Manual, user-friendly. | Manual, same as predicate device. |
| Cleaning & Reprocessing | Sterilizable and cleanable without degradation. | Manual cleaning and Steam Sterilization, same as predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
- The document describes non-clinical performance testing rather than a clinical test set involving human subjects or AI algorithm evaluation.
- The exact sample size for the "Holding Performance testing" and "Direction of view/Image stability testing" is not specified.
- Data Provenance: The testing was performed on the "subject device" (KARL STORZ Holders). The country of origin of the data is not explicitly stated beyond the submitter being KARL STORZ SE & Co. KG in Tuttlingen, Germany. The data would be considered prospective as it's testing of the new device for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- This information is not applicable as the document describes non-clinical performance testing of a mechanical device, not the evaluation of an AI algorithm requiring expert ground truth for image interpretation.
4. Adjudication Method for the Test Set:
- This is not applicable for the same reason as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the subject of this 510(k) submission for a mechanical endoscope holder.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a mechanical surgical instrument, not an AI algorithm.
7. The Type of Ground Truth Used:
- The concept of "ground truth" as typically used for AI/CAD devices (e.g., expert consensus, pathology, outcome data) is not applicable. For this mechanical device, performance is evaluated against engineering specifications and functional requirements (e.g., ability to hold weight, maintain stability).
8. The Sample Size for the Training Set:
- This is not applicable. The device is a mechanical instrument, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- This is not applicable for the same reason as point 8.
In summary, the provided FDA 510(k) summary (K240506) pertains to a mechanical endoscope holder, not an AI/CAD-enabled medical device. Therefore, the detailed requirements for acceptance criteria and study designs related to AI performance are not present in this document. The purpose of this 510(k) is to demonstrate substantial equivalence to a predicate mechanical device through non-clinical performance testing.
§ 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.