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Telescopes for adults
KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults.

Telescopes for adults and pediatrics
KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults and pediatrics.

The KARL STORZ HOPKINS Telescopes for Urology are rigid cystoscope systems, which provide visualization and operative access during urological procedures in adults and pediatrics. Urological devices consist of sheaths, obturators, accessories, and instruments, which are combined into a cystoscope system for diagnostic or therapeutic procedures in the lower urinary tract such as prostate, bladder, and urethra. The sheath provides a working channel for therapeutic instruments, as well as ports for irrigation and aspiration. The obturator is inserted through the sheath for atraumatic insertion to the surgical site, then removed after placement. The telescope is inserted through the sheath for visualization of the surgical site. All instruments subject to this submission are optical instruments, and compatible with telescopes; the optical instruments are only compatible with adult systems. Compact telescopes are all-in-one cystoscopes with built-in sheaths, obturators, and optics, they do not require device compilation for use.

The provided text is an FDA 510(k) clearance letter and its accompanying summary for the KARL STORZ HOPKINS Telescopes for Urology. This document details the regulatory pathway for a medical device, specifically rigid endoscopes, not an AI software or system. Therefore, most of the questions regarding acceptance criteria and study design for AI performance are not applicable.

Here's an analysis of the provided information:

Analysis of Acceptance Criteria and Study for a Medical Device (Endoscope):

Given that this is a medical device (endoscope), the "acceptance criteria" are typically related to meeting established performance standards for such devices. The "study" refers to non-clinical bench testing to demonstrate compliance with these standards and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of acceptance criteria with specific numerical performance targets and reported values in the way you might see for an AI algorithm's accuracy or sensitivity/specificity. Instead, the acceptance criteria are implicit in the adherence to international and national standards for medical devices, particularly endoscopes. The reported device performance is that it complies with these standards.

2. Sample Size for the Test Set and Data Provenance:

• Sample Size: Not applicable in the context of an endoscope's non-clinical bench testing. The "test set" here refers to the actual device prototypes or representative samples tested in a laboratory setting to verify compliance with engineering and safety standards. The number of units tested isn't specified but typically involves a sufficient number to ensure reproducibility and meet statistical requirements for the specific test (e.g., several samples for biocompatibility, multiple cycles for reprocessing).
• Data Provenance: The testing is non-clinical bench testing, meaning it does not involve human subjects or real-world patient data. It is performed in a controlled laboratory environment by the manufacturer (KARL STORZ SE & Co. KG), likely in Germany given their address.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Experts for Ground Truth: Not applicable. For a rigid endoscope, "ground truth" is defined by established engineering specifications and compliance with recognized national and international standards. The "truth" is whether the device performs according to these measurable standards, not a subjective interpretation by experts.
• Qualifications of Experts: Not applicable. The "experts" involved are likely engineers, quality assurance personnel, and regulatory specialists within Karl Storz and external testing laboratories who are qualified to conduct and interpret the specified tests according to the standards.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in medical image diagnosis). For physical device testing, the results are typically quantitative measurements that either pass or fail against predefined criteria in the standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• MRMC Study: No. MRMC studies are used to evaluate the impact of a new diagnostic aid (like an AI system) on human reader performance across multiple readers and cases. This is not relevant for a rigid endoscope, which is a physical visualization and access tool.

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

• Standalone Performance: Not applicable. This device is a physical endoscope, not an AI algorithm. Its function is to provide visualization, which inherently involves a human user (the clinician) in the loop.

7. The type of ground truth used:

• Type of Ground Truth: The "ground truth" is adherence to established engineering specifications, safety standards (e.g., thermal safety), optical performance metrics (e.g., field of view, resolution), biocompatibility requirements, and validated reprocessing protocols as defined by the numerous ISO, IEC, AAMI, ASTM, and ANSI standards listed. It is a technical and regulatory compliance "ground truth."

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This is a physical medical device, not an AI algorithm that undergoes training.

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

• Training Set Ground Truth: Not applicable. As this is not an AI device, there is no "training set" or "ground truth for the training set."

In summary, the provided document is a regulatory submission for a physical medical device (an endoscope) and not for an AI/software device. Therefore, the specific questions related to AI performance metrics, sample sizes for AI training/test sets, expert adjudication, and MRMC studies are not applicable to this submission. The "acceptance criteria" are demonstrated through non-clinical bench testing proving compliance with relevant industry standards and substantial equivalence to a predicate device.

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The HOPKINS Telescopes when used with sheaths are intended to be used to permit viewing of the cervical and uterine cavity for the purpose of performing diagnostic and surgical procedures.

The HOPKINS Telescopes are rigid telescopes that utilize the rod lens technology. At the distal end of the telescope's shaft is the lens and the other end of the shaft is attached to the eyepiece. Throughout the central lumen of the HOPKINS Telescopes, optical glass rods are used to transmit and magnify the image received from the lens. The HOPKINS Telescopes are available with 0°, 12° and 30° direction of view, 2mm, 2.9mm, 4mm diameter and 26cm, 30cm, 36cm working lengths.

The provided text is a 510(k) Summary for the HOPKINS Telescopes, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its own performance against pre-defined acceptance criteria for a novel AI/software component.

Therefore, the provided document does not contain the information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning AI/software performance.

The document states:

• "Clinical studies were not required to demonstrate substantial equivalence to the predicate device." (Page 9)
• "The conclusions drawn from the nonclinical test demonstrate that the subject device is as safe and effective as the predicate device to support a substantial equivalence determination." (Page 9)

This means the submission relies on bench testing and comparison of technological characteristics to a legally marketed predicate device, not on a clinical performance study with defined acceptance criteria and human readers (or AI algorithms) in the way your prompt describes.

To directly answer your questions based only on the provided text, the answer is that this information is not present for the HOPKINS Telescopes device.

If this were an AI/software device and the information was present, here's how I would answer each point:

1. Table of acceptance criteria and reported device performance: This would be a table detailing metrics like sensitivity, specificity, AUC, or agreement rates, with specific target thresholds (acceptance criteria) and the actual performance achieved in the study.
2. Sample size and data provenance: This would specify the number of cases/patients in the test set (distinct from training data), whether the data was collected retrospectively or prospectively, and from which countries or institutions.
3. Number of experts and qualifications: This would state how many experts (e.g., radiologists, pathologists) were involved in establishing ground truth and their relevant experience (e.g., board-certified, years of experience, subspecialty).
4. Adjudication method: This would describe how discordant readings or interpretations among experts were resolved (e.g., 2+1 means two initial readers, with a third if they disagree; 3+1 means three initial readers, with a fourth for adjudication if necessary).
5. Multi-reader multi-case (MRMC) comparative effectiveness study: If conducted, this would provide details on how the AI system impacted human reader performance, including statistical metrics like the effect size (e.g., mean increase in AUC, sensitivity, or specificity when AI assistance was used compared to no AI assistance).
6. Standalone performance: This would report the performance of the algorithm itself, without any human interaction, against the ground truth.
7. Type of ground truth: This would specify the reference standard used (e.g., expert consensus, pathology results, follow-up clinical outcomes, surgical findings).
8. Sample size for training set: This would state the number of unique cases/patients used to train the AI model.
9. Ground truth for training set: This would explain the methodology used to label or establish the ground truth for the data utilized during the training phase of the algorithm.

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For telescopes with diameter ranging from 3mm-5mm
The HOPKINS Telescopes are intended to provide visualization during laparoscopy and general surgery in adults and pediatrics.
For telescopes with diameter ranging from 5.5mm- 11mm
The HOPKINS Telescopes are intended to provide visualization during laparoscopy and general surgery in adults.

The HOPKINS Telescopes are rigid telescopes that utilize the rod lens technology. At the distal end of the telescope's shaft is the lens and the other end of the shaft is attached to the eyepiece. Throughout the central lumen of the HOPKINS Telescopes, optical glass rods are used to transmit and magnify the image received from the lens. The HOPKINS Telescopes are available with 0°, 6°, 30° and 45° direction of view, diameters ranging from 3mm to 11mm and working lengths from 18cm- 50cm.

The provided text describes the submission of a 510(k) summary for the HOPKINS Telescopes, comparing it to a predicate device. It details non-clinical performance data and references published literature for clinical performance, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria, especially in the context of an AI/ML device.

The device described, "HOPKINS Telescopes," is a rigid endoscope that utilizes rod lens technology for visualization during surgery. There is no mention of AI or machine learning components. Therefore, many of the requested points, such as sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, and standalone AI performance, are not applicable to the information provided in this document.

However, based on the non-clinical performance data section, we can infer some "acceptance criteria" related to standards compliance and general performance.

Here's an attempt to answer the questions based only on the provided text, recognizing that it does not pertain to AI/ML device performance:

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

Since this is not an AI/ML device, the "acceptance criteria" are related to compliance with recognized standards and successful bench testing. The document states:
"the HOPKINS Telescopes has met all its design specification and is substantially equivalent to its predicate device."

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

The document does not specify a "test set" in the context of data for an AI/ML model. The evaluation involves non-clinical bench testing and comparison to a predicate device. No specific sample sizes for these tests are mentioned, nor is there information about data provenance (country of origin, retrospective/prospective).

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

This is not applicable as the device is a physical endoscope, not an AI/ML diagnostic tool requiring expert ground truth for image interpretation.

4. Adjudication method 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, as 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, as this is not an AI/ML algorithm.

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

For the non-clinical testing, the "ground truth" would be established by physical measurements, chemical analyses, and adherence to the specified performance parameters outlined in the referenced standards. For the pediatrics indication expansion, the ground truth is based on "published literature" supporting safety and effectiveness, which would implicitly rely on clinical data outcomes.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device with a training set.

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

Not applicable.

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The HOPKINS Telescopes are intended to provide visualization during laparoscopy and general surgery in adults and pediatrics.

The HOPKINS Telescopes are rigid telescopes that utilize the rod lens technology. At the distal end of the telescope's shaft is the lens and the other end of the shaft is attached to the eyepiece. Throughout the central lumen of the HOPKINS Telescopes, optical glass rods are used to transmit and magnify the image received from the lens. The HOPKINS Telescopes are available with 0°, 25° and 45° direction of view, 5mm diameter and 29cm working lengths.

The provided text is a 510(k) summary for the KARL STORZ HOPKINS Telescopes. This document is a premarket notification for a medical device to demonstrate substantial equivalence to a legally marketed predicate device. As such, it focuses on comparing the new device to an existing one based on technical characteristics, rather than establishing acceptance criteria and proving performance through a clinical study for an AI/ML-driven device.

The document discusses the physical and optical characteristics of the endoscope, reprocessing methods, and non-clinical performance data (e.g., adherence to ISO standards, biocompatibility, thermal safety, reprocessing validation). It explicitly states: "There are no performance standards or special controls developed under Section 514 of the FD&C Act for endoscopes." This indicates that the regulatory pathway for this device does not require the kind of performance validation typically seen for AI/ML devices, which would involve acceptance criteria for metrics like sensitivity, specificity, or AUC, and detailed clinical study designs.

Therefore, the document does not contain the information required to answer the prompt questions regarding acceptance criteria for an AI/ML device. The HOPKINS Telescopes are a traditional optical medical device, not an AI/ML product.

To reiterate, the provided text does not contain any information about:

1. Acceptance criteria or reported device performance for AI/ML metrics.
2. Sample sizes for test sets or data provenance (as it's not an AI/ML study).
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance studies.
7. Type of ground truth (as it's not a diagnostic AI/ML device).
8. Sample size for training sets (no AI/ML training is mentioned).
9. How ground truth for a training set was established.

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