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The products are used in invasive surgery or via natural orifices for diagnosis and therapy and serve to visualize the inside of the body.

The products are used for interventions in different medical disciplines, such as surgery and laparoscopic interventions e.g. in urology and gynecology.

The PANOVIEW Ultra telescopes (common name: telescopes) are rigid endoscopes which are used in invasive surgery or via natural orifices for diagnosis and therapy and serve to visualize the inside of the body.

The products are used for interventions in different medical disciplines, such as surgery and laparoscopic interventions e.g. in urology and gynecology.

The submitted devices can be grouped by working length (WL) and direction of view.

The PANOVIEW Ultra telescopes (common name: telescopes) are rigid endoscopes with a fixed eyepiece, integrated light guide, optical system, cold light connector, with screw-on adapter for fiber light cables and with color coding ring for direction of view.

The telescopes are constructed of a cladding tube, which is surrounded by a rigid sheath, a fixed eyepiece and an eyecup at the proximal end.

Within the cladding tube, images are transferred via a rod lens system to the fixed eyepiece. Illumination is provided via light guide bundles connected to a light source. Visualization can directly be performed via the fixed eyepiece (direct visualization method) or alternatively via a monitor and user interface (indirect visualization method). For the second option, a camera must be attached to the fixed eyepiece and must be connected to a monitor.

The provided document, K203226, is a 510(k) Premarket Notification for rigid endoscopes (Telescopes) manufactured by Richard Wolf Medical Instruments Corporation. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study results that would typically be associated with AI/ML devices or new diagnostic tests.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, MRMC studies, AI improvement effect size, training set details) are not applicable (N/A) because this submission pertains to a physical medical device (endoscope) and its manufacturing and performance validation, not a software-driven or AI-based diagnostic tool.

The document describes non-clinical performance testing (bench testing) to demonstrate the safety and effectiveness of the device, primarily by comparing its characteristics and performance to a legally marketed predicate device.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance for Rigid Endoscopes (K203226)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantifiable acceptance criteria with corresponding performance metrics in a way commonly seen for software or AI/ML device clearances. Instead, the acceptance criteria are implicitly or explicitly stated through the validation of various engineering and functional aspects, and performance is demonstrated by meeting these and showing equivalence to the predicate.

• Automated cleaning process: Must pass all acceptance criteria.
• Sterilization (moist heat/steam): Must achieve a Sterility Assurance Level (SAL) of 10⁻⁶ (according to AAMI TIR12, Annex B). | - Manual cleaning process: "passed all acceptance criteria."
• Automated cleaning process: "passed all acceptance criteria."
• Sterilization: SAL of 10⁻⁶ "was achieved" (sterility ensured). |
  | Biocompatibility | - Biological risk assessment performed according to ISO 10993-1:2018 and FDA guidance.
• Biological testing and chemical characterization to demonstrate safety (for materials with direct patient contact: optical glass, stainless steel, glue, soft solder, classified as external communicating device with contact to tissue, bone, and dentin for ≤24h). | - Biological testing and chemical characterization "proved that the PANOVIEW Ultra telescopes are as safe as the predicate devices." |
  | Performance Testing (Bench) | - Optical performance validation (according to ISO 8600-1/-3/-5 for parameters like spectral range, working lengths, working distance).
• Optical performance validation after simulation of aging.
• Performance testing addressing differences from predicate: different working length, shaft thickness, new material of light guide bundle, focal length, distortion.
• Functionality: ability to visualize inside the body, image transfer via rod lens system, illumination via light guide bundles.
• Packaging validation (specifically for 434 mm working length).
• Stability testing.
• Temperature testing (according to IEC 60601-2-18).
• Overall design, basic safety, and essential performance requirements and specifications met. | - Optical performance validated; parameters compared to predicate devices "to prove equivalence."
• Optical performance after aging validated.
• Confirmed that changed characteristics (e.g., working length) "do not question safety and effectiveness."
• Function as described (e.g., "images are transferred via a rod lens system," "illumination is provided via light guide bundles").
• Packaging validated for the 434mm subset.
• Stability testing performed.
• Temperature testing performed.
• "Testing confirms that the products meet all the requirements and specifications for overall design, basic safety and essential performance, and that the design inputs and specifications are met." |
  | Equivalence to Predicate | Functional and safety equivalence to the predicate device (Endoscope 0°/30°/50° Ø 10MM, K993103). | - "the submitted devices are as safe and as effective as the predicate devices."
• "submitted devices function as safe as effective as the predicate device"
• "deemed to be substantially equivalent to the legally marketed devices." |

2. Sample Size Used for the Test Set and Data Provenance:
* Sample Size: Not explicitly stated as a number of "cases" or "patients" as this is a physical device, not an AI/ML diagnostic. The testing involved various bench tests on the device units themselves. The number of physical units tested for each validation (reprocessing, biocompatibility, optical performance, etc.) is not specified in this summary.
* Data Provenance: Not applicable in the context of patient data (e.g., retrospective/prospective, country of origin). The data comes from internal laboratory/bench testing of the physical medical device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
* N/A. Ground truth, in the sense of expert consensus on medical images or patient outcomes, is not applicable here. The "truth" for this device's performance is established by objective engineering measurements against established standards (e.g., ISO, IEC) and manufacturer specifications in a laboratory setting. No medical experts were described as establishing a "ground truth" for the test set.

4. Adjudication Method for the Test Set:
* N/A. Given that this is bench testing of a physical device against engineering standards, an "adjudication method" involving human experts is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
* N/A. This device is an endoscope, not an AI/ML-assisted diagnostic tool or software. No MRMC study was performed as it is not relevant to the clearance of this type of device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Performance was Done:
* N/A. This applies to algorithms. The device itself is a standalone physical instrument used by a human operator for visualization. Its "standalone performance" refers to its optical and mechanical integrity, which was evaluated through bench testing.

7. The Type of Ground Truth Used:
* The "ground truth" for this device's performance is based on adherence to engineering specifications, international standards (e.g., ISO 8600-1/-3/-5 for optical performance, AAMI TIR12 for sterilization, ISO 10993-1 for biocompatibility, IEC 60601-2-18 for temperature testing), and validation against the characteristics of a predicate device. There is no "expert consensus," "pathology," or "outcomes data" ground truth in the traditional sense for this type of device clearance.

8. The Sample Size for the Training Set:
* N/A. This document describes a physical medical device, not a software or AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:
* N/A. As there is no training set mentioned or implied for this physical device, the concept of establishing ground truth for it is not applicable.

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Rigid Endoscopes

MSI MedServ International Deutschland GmbH rigid endoscopes and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs and canals.

A rigid endoscope is a tubular endoscopic device with any of a group of accessory devices which attach to the endoscope and is intended to provide access, illumination and allow observation or manipulation of body cavities, hollow organs, and canals. It is typically used with a Fiberoptic light source and carrier to provide illumination.

This is not an AI/ML device and therefore the requested information is not applicable.

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The endoscopes serve to visualize the inside of the patient via natural or surgically generated access. For examination, diagnosis, and / or therapy by personnel trained and qualified in connection with endoscopically used accessories in various medical disciplines, such as surgery, urology, gynecology, and ENT.

Rigid Endoscopes, 10mm diameter, Models 8934.431, 0°, 8934.432, 30°, and 8934.433, 50°

The provided document is a 510(k) premarket notification letter from the FDA regarding Rigid Endoscopes. It confirms the substantial equivalence of the device to legally marketed predicate devices.

However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested in the prompt. The letter is an administrative document confirming regulatory clearance, not a summary of a performance study.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and study details from the provided text.

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The OmniSonics Endoscopic Deflector is designed to assist in the placement and deflection of I he Onlinoomiss indoscopic Donector atheters and endoscopes used in surgical procedures in body cavities, hollow organs and canals.

The OmniSonics Endoscopic Deflector is designed to be introduced through natural body openings, surgical incisions and through introducers, needles, trocars, catheters, sheaths and other devices with lumens having an inside diameter larger than the outside diameter of the OmniSonics Endoscopic Deflector shaft selected. The OmniSonics Endoscopic Deflector is sold sterile and is intended for single patient use. The OmniSonics Endoscopic Deflector is indicated for the following applications:

Ureteroscopy Thoracoscopy Nasopharyngoscopy Sinuscopy General laparoscopy Urology Gynecology Bronchoscopy

The OmniSonics Endoscopic Deflector assists in the delivery of small diameter flexible; instruments, catheters, probes, and endoscopes. The device deflects these instruments to aid in the direction and delivery of the product to a specific surgical site that is not in line with the axis of the instrument. The purpose of the OmniSonics Endoscopic Deflector is to provide a means to deliver small diameter instruments to areas that would be difficult to access with a straight instrument.

The OmniSonics Endoscopic Deflector works in a similar fashion to steerable endoscopes. This instrument is different in that it only contains lumens for the introduction of ancillary instrumentation and does not possess an integral visualization system. The user must insert all of the additional capabilities desired through the OmniSonics Endoscopic Deflector central lumen.

Products that are capable of working with the OmniSonics Endoscopic Deflector are flexible, malleable or bendable and must be capable of obtaining a bend radius of 30 mm or less. They must also have an outer diameter compatible with the inner diameter of the unit selected. The actual deflection produced at the end of the device will depend upon the stiffiess of the inserted instrument.

The OmniSonics Deflector is constructed with the following major components:
Outer sheath tube: A rigid, stainless steel tube that provides rigidity for insertion into the body
Deflection tube: A flexible, polyurethane, kink resistant tube that bends when the deflection handle is activated.
Deflection wire: A stainless steel wire that pulls the tip of the deflection tube to cause deflection.
Deflection handle: An ABS handle that has mechanisms for rotation of the shaft, articulation of the deflection tube, movement of the inserted device in and out and sealing of the inserted device.

The provided text does not contain information about acceptance criteria or a study that proves the specified device (OmniSonics Endoscopic Deflector) meets them.

The document is a 510(k) premarket notification summary from the FDA, detailing the device's substantial equivalence to other legally marketed devices. It focuses on the device's intended use, description, and comparison to predicate devices, but lacks details on performance testing or clinical study results as they relate to acceptance criteria.

Specifically, the document states: "Performance Testing The OmniSonics Deflector conforms to IEC 60601-18 All materials used are biocompatable". This is a very high-level statement and does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study details, standalone performance, or type of ground truth for any test set.
3. Sample size or ground truth establishment for a training set.

The document's purpose is to establish substantial equivalence for market clearance, not necessarily to provide detailed performance study results against specific acceptance criteria.

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The KSEA Set for Endoscopic Assisted Intubation is designed to be used by qualified surgeons and physicians to view the larynx during intubation.

The KSEA Set for Endoscopic Assisted Intubation is comprised of a Rigid Telescope and a BUMM Clip. KSEA Rigid Telescopes for Endoscopic Assisted Intubation are rigid, straight-shafted, panoramic telescopes which utilize Hopkins rod-lens technology. The KSEA BUMM Clip is used to secure the KSEA rigid telescope to a laryngoscope. The body contact portions of the KSEA Set for Endoscopic Assisted Intubation are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details (sample sizes, data provenance, ground truth establishment, expert involvement, adjudication methods, MRMC studies, or standalone performance), or training set information for any device. The document is a 510(k) summary for a "Karl Storz Set for Endoscopic Assisted Intubation," outlining its description, indications, and substantial equivalence to predicate devices, but lacks the specific performance study data you are requesting.

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