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These devices are indicated for use in arthroscopic procedures to provide visualization during endoscopic diagnosis and treatment of joints such as the knee, shoulder, hip, ankle, foot, elbow.

The "ULTRA" Telescopes are rigid endoscopes. An image relay system of rod lenses transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image. The "ULTRA" Telescopes are delivered non-sterile. They are reusable and fully autoclavable. Before first and each subsequent use the device must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use. The "ULTRA" Telescopes are available with different directions of view to allow use for various applications in accordance with the intended use as submitted with this 510(k).

This document is a 510(k) summary for the "ULTRA" Telescopes, an arthroscope manufactured by Olympus Winter & Ibe GmbH. The document outlines the device's identification, predicate device, description, indications for use, comparison of technological characteristics, and performance data.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the standards and types of performance tests conducted. The "reported device performance" is a general statement of compliance rather than specific quantitative results.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for any of the performance tests. The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, but these studies are typically conducted internally by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable to the type of device (arthroscope) and the nature of the tests conducted. The tests are primarily engineering and material performance assessments (biocompatibility, electrical, thermal, optical, mechanical) against established international standards, not diagnostic performance studies requiring expert interpretation of images or data.

4. Adjudication method for the test set

This section is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are relevant for clinical studies or studies involving human readers, which is not the case for these safety and performance bench tests.

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 done. This type of study is relevant for diagnostic devices, particularly those involving AI or interpretation by multiple human readers, which is not the function of an arthroscope. The device ("ULTRA" Telescopes) is an imaging tool for direct visualization during surgery, not a diagnostic AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance evaluation (algorithm only) was not done. This concept applies to AI algorithms, which are not part of this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests in this submission are the specifications and limits defined by the referenced international standards. For example, the ground truth for biocompatibility is that the device should not elicit a toxic response as measured by ISO 10993 tests. For electrical safety, the ground truth is compliance with the safety limits defined in AAMI/ANSI ES 60601-1.

8. The sample size for the training set

This is not applicable. The "ULTRA" Telescopes are a mechanical optical device, not an AI-powered system that requires a training set.

9. How the ground truth for the training set was established

This is not applicable for the reasons stated above.

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Telescope for endoscopic observation, diagnosis and treatment during nasal endoscopy and sinuscopy.

The "ULTRA" Telescopes are rigid endoscopes. An image relay system of rod lenses transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image. The "ULTRA" Telescopes are delivered non-sterile. They are reusable and fully autoclavable. Before first and each subsequent use the device must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use. The "ULTRA" Telescopes are available with four different directions of view (0°, 30°, 45°, and 70°) to allow use for various applications in accordance with the intended use as submitted with this 510(k). To address surgeon's preferences, the 30°, 45°, and 70° models are available as an inverse version as well (the light guide cable adapter is at the bottom, instead of at the top of the telescope).

This document (K153009) describes the 510(k) premarket notification for the "ULTRA" Telescopes, which are rigid endoscopes. It outlines the performance data and testing conducted to demonstrate safety and effectiveness, and substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study proving de novo efficacy or significant improvement. Therefore, many of the specific details typically found in a clinical trial report (like MRMC study results, detailed ground truth establishment for a training set, or effect sizes for AI assistance) are not applicable or not present in this type of submission for a medical device cleared via the 510(k) pathway. The performance data presented here are primarily engineering and biocompatibility tests, not clinical performance data in the sense of an algorithm.

1. A table of acceptance criteria and the reported device performance

The document does not provide a direct table of acceptance criteria with corresponding performance metrics in a format like "Target Value | Achieved Value". Instead, it lists the types of tests conducted and states that the device "functions as intended and meets design specifications" and that "The performance data support the safety of the device and demonstrate that the subject devices comply with the intended use as specified."

Here's a breakdown of the performance tests areas, which implicitly define the acceptance criteria:

Summary of Reported Performance: The document generally states that the device "functions as intended and meets design specifications" and that the "performance data support the safety of the device and demonstrate that the subject devices comply with the intended use as specified." It concludes that the device is "substantially equivalent to the predicate devices with respect to the general design approach, function, and the intended use," and "raise no new concerns of safety or effectiveness."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in terms of "patient data" or "image data" as this is not a study assessing an algorithm's performance on patient-derived data. The "test set" here refers to the actual manufactured devices used for the bench and material testing. The specific number of devices tested for each performance test (e.g., how many telescopes were subjected to shipping tests or service life tests) is not provided in this summary.
• Data Provenance: Not applicable in the context of patient data. The tests were performed internally by Olympus Winter & Ibe GmbH (Germany) as the manufacturer, and potentially by third-party labs for specific certifications (e.g., biocompatibility). The summary implies the testing was prospective (i.e., conducted specifically for this submission).

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)

• Number of Experts & Qualifications: Not applicable in the sense of medical experts establishing ground truth for diagnostic accuracy (e.g., reading images). The "ground truth" for this device relates to engineering specifications, safety standards, and functional performance. Experts involved would be engineers, usability specialists, and quality control personnel within the manufacturing company and potentially external certification bodies, but their number and specific qualifications are not detailed. Usability studies would involve medical professionals (surgeons/ENT specialists) but the extent of their involvement and their role in defining "ground truth" (beyond user feedback regarding intuitive design, handling, etc.) is not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable. This concept pertains to resolving discrepancies in expert interpretations (e.g., conflicting diagnoses from radiologists). For this device, "adjudication" would refer to the internal quality control processes and the interpretation of test results against predefined engineering specifications and regulatory standards.

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

• MRMC Study: No. An MRMC study is typically performed for AI-powered diagnostic devices to assess diagnostic accuracy or the impact of AI assistance on human readers. The "ULTRA" Telescope is a physical, optical endoscope, not an AI-powered device. Therefore, this type of study was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: No. This question again relates to AI algorithms. The "ULTRA" Telescope is an instrument that a human uses. Its "performance" is inherently linked to its physical characteristics and how it functions when operated by a human.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: The ground truth for this device's performance are engineering specifications, established international standards (e.g., ISO, IEC, AAMI/ANSI), and regulatory requirements. For example, the ground truth for biocompatibility is "no cytotoxicity" when tested per ISO 10993-5, or for electrical safety, it's compliance with IEC 60601-1. For optical and mechanical properties, the ground truth is adherence to the design specifications (e.g., specified field of view, clarity, light transmission, durability under specific loads).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is not an AI algorithm that requires a "training set."

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

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These endoscopes are intended to be used for endoscopic surgery within the thoracic and perioneal cavities including the female reproductive organs. The device is also indication of transanal and transvaginal applications.

The "ULTRA" Telescopes are rigid endoscopes. An image relay system of rod lenses transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image. The "ULTRA" Telescopes are delivered non-sterile. They are reusable and fully autoclavable. Before first and each subsequent use the device must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use. The "ULTRA" Telescopes will be marketed as individual telescopes. The "ULTRA" Telescopes are available in two different diameters (5.4 mm and 10 mm) with three different directions of view (0°, 30°, 45°) each to allow use for various applications in accordance with the intended use as submitted with this 510(k).

This document is a 510(k) premarket notification for the "ULTRA" Telescopes, a type of rigid endoscope. It details the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain a specific study demonstrating device performance against quantitative acceptance criteria for a diagnostic AI/ML device.

Here's why the requested information cannot be fully provided based on this document:

• Device Type: The "ULTRA" Telescopes are physical medical devices (endoscopes) used for visualization and endoscopic surgery, not a diagnostic AI/ML tool. The performance data presented focuses on physical safety and functional standards rather than diagnostic accuracy or AI performance.
• Nature of "Acceptance Criteria" and "Device Performance": For a physical device like an endoscope, acceptance criteria relate to compliance with established engineering and safety standards (e.g., biocompatibility, electrical safety, thermal safety, optical performance, mechanical integrity). "Device performance" in this context refers to successfully passing these tests. This is distinct from the statistical metrics (e.g., sensitivity, specificity, AUC) and clinical study designs typically used to evaluate AI/ML diagnostic tools.

Therefore, the sections requested about sample sizes, ground truth, experts, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this document as it does not describe an AI/ML device or a study evaluating its diagnostic accuracy.

The document does describe the performance data for the "ULTRA" Telescopes in terms of meeting various standards, which could be considered their "acceptance criteria" and "device performance" for a physical device.

Here's an attempt to structure the available information regarding "acceptance criteria" and "device performance" relevant to this physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance (for the physical endoscope):

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not applicable for this type of device and performance testing. The "test set" here refers to the actual devices undergoing physical tests, not a dataset for an algorithm.

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)

• Not applicable. Ground truth, in the context of diagnostic performance, is not relevant to the engineering and safety tests performed on an endoscope.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable.

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

• Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable. For this device, "ground truth" relates to objective measures against engineering standards, not diagnostic outcomes.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

• Not applicable.

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