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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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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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The KARL STORZ H1 camera head, in combination with an appropriately indicated camera control unit (CCU), light source, and monitor, and with an appropriately indicated endoscope, or microscope, is used for real-time visualization in diagnostic and surgical procedures.

The camera head consists of an anodized aluminum, stainless steel enclosure containing a CMOS (Complementary metal-oxide-semiconductor) NTSC image sensor that converts light into electrons, the transistors in each pixel then amplify and move the charge using the more traditional wires forming conventional output signals. The camera head is intended to be attached to the proximal end of the endoscopes and is connected via cable to the compatible CCU for power and operational functions. The camera head is designed to be compatible for use with all standard KARL STORZ Endoscopes, Fiberscopes and Microscope for endoscopic observation in general endoscopic procedures.

The provided text describes a 510(k) submission for the KARL STORZ H1 Camera Head, which is an endoscope camera. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

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

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

The document lists several performance tests conducted for the subject device to ensure it meets its design specifications and is substantially equivalent to the predicate device. However, it does not explicitly state numerical acceptance criteria for each test or a direct comparison of the subject device's performance against those criteria in a table format. It generally states that the device "met all its design specification" and "performs as well as the predicate device."

Implied Acceptance Criteria Categories (from "Performance Testing" section):

• Color Reproduction and Color Contrast Enhancement
• Illumination
• Detection Uniformity
• Depth of field
• Spatial Resolution
• Dynamic Range & Detection Linearity
• Distortion
• Latency
• Signal-to-Noise Ratio (SNR) & Sensitivity
• Field of View

Reported Device Performance:

The document states, "The bench testing performed verified and validated that the H1 Camera Head has met all its design specification and is substantially equivalent to its predicate devices." It also concludes, "The conclusions drawn from the nonclinical tests demonstrate that the subject devices, the H1 Camera Head performs as well as the predicate device."

Without specific numerical acceptance criteria and performance data, a detailed table cannot be created.

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

The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications."

Therefore, there was no clinical test set in terms of human subjects or medical images. The testing was entirely non-clinical bench testing. The sample size for this non-clinical testing is not specified. The data provenance is also not applicable in the sense of country of origin for retrospective or prospective data, as it was bench testing.

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

As no clinical testing was performed and the ground truth was established through non-clinical bench testing against design specifications, no human experts were used to establish ground truth in the traditional sense of medical image interpretation.

4. Adjudication method for the test set

Since no clinical test set involving human experts was used for ground truth establishment, no adjudication method (like 2+1 or 3+1) was employed.

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

No MRMC study was done. The device is a camera head, not an AI-assisted diagnostic tool.

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

This question is not directly applicable. The device is a camera head, not an algorithm. The "standalone" performance was essentially the non-clinical bench testing of the device itself (hardware performance), which was done without human-in-the-loop in a clinical diagnostic context.

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

The ground truth for the non-clinical testing was based on design specifications and objective physical measurements during bench testing, ensuring the camera met its intended performance characteristics (e.g., spatial resolution measurements, color accuracy, brightness control functionality). This is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This question is not applicable as the H1 Camera Head is a hardware device and not an AI/machine learning algorithm requiring a training set.

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

This question is not applicable as the H1 Camera Head is a hardware device and not an AI/machine learning algorithm requiring a training set.

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The HD Mediastinoscope is intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during ENT endoscopic surgical procedures.

The HD Mediastinoscope is a reusable videoendoscope intended to be used in conjunction with the X-link module of the Image1 S Camera Control Unit. The HD Mediastinoscope is comprised of four main components: CMOS sensor at the distal end of the endoscope, an oval insertion portion (spatula), handle, and internal LED light source. The spatula can accommodate up to 2 x 5 mm instruments.

Here's an analysis of the provided text regarding the acceptance criteria and study for the HD Mediastinoscope:

Due to the nature of the device (a physical surgical instrument rather than an AI/software device), the provided document does not contain information typically found in acceptance criteria and studies for AI/ML devices, such as sensitivity, specificity, or AUC.

Based on the provided text, the "acceptance criteria" appear to be related to the device's technical specifications and safety/effectiveness in comparison to predicate devices, rather than specific performance metrics like those for an AI algorithm.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" are implied through the comparison with existing predicate and reference devices and compliance with recognized standards. The "performance" is demonstrated through non-clinical testing, particularly a cadaver test study.

Details of the Study (Non-AI/ML Device)

Since this is a traditional medical device (mediastinoscope) and not an AI/ML device, many of the requested points related to AI/ML studies (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable or not specified in this 510(k) summary.

However, based on the information provided:

1. Sample size used for the test set and the data provenance:

   • The primary non-clinical performance test mentioned is a cadaver test study.
   • The sample size (number of cadavers or tests performed) is not specified in the document.
   • The data provenance (country of origin, retrospective/prospective) is not specified.

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

   • The document mentions "a cadaver test study was conducted to demonstrate that the change in spatula design...". It does not specify the use of "experts" to establish a "ground truth" in the way an AI/ML study would (e.g., radiologists labeling images). Instead, the study likely involved technical assessment and observation by qualified personnel (e.g., surgeons, engineers).
   • Not explicitly stated in terms of "ground truth experts" for an AI/ML context.

3. Adjudication method for the test set:

   • Not applicable / Not specified for this type of device and study.

4. 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:

   • No, an MRMC study was not conducted. This is not an AI-assisted device.

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

   • Not applicable. This is a physical surgical instrument, not an algorithm.

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

   • For the cadaver study, the "ground truth" would likely be the direct observation and technical assessment of the device's performance in a cadaveric model (e.g., ease of introduction, visualization, ability to facilitate instrument use, assessment of tissue damage, etc.) by the study investigators. This is not a "ground truth" in the sense of a diagnostic label for an AI.

7. The sample size for the training set:

   • Not applicable. This device does not use a training set as it is not an AI/ML product.

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

   • Not applicable.

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The Flexible HD Cysto-Urethroscope System is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract including the urethra, bladder, ureters, and kidneys.

The Flexible HD Cysto-Urethroscope System (Part Number: 11272VH(U)-TL) is intended to be used with the IMAGE1 S CCU consisting of Connect / Connect II and X-Link modules (cleared in K201135). Identical to the predicates, the scope cannot be operated on its own because it produces image data output in the form of video signals which require external processing and display. When the scope is used with the compatible CCU, it becomes the Flexible HD Cysto-Urethroscope System, which can then be operated as intended and indicated.

The Flexible HD Cysto-Urethroscope System consists of the following key components:
11272VH-TL / 11272VHU-TL – Cysto-Urethroscopes with positive (VH-TL) / contra-positive (VHU-TL) deflection control and permanent T-Luer affixed to working channel
TC200US / TC201US / TC301US – Connect/Connect II/Link camera control unit (CCU) modules for image processing

The subject device is a lower cost alternative to the primary predicate and incorporates the following differences. Housing Plug: Due to lack of clinical need, the subject device replaces the suction channel of the primary predicate device with a permanent stainless steel housing plug. Fixed LUER: The subject device uses a removable T-Luer whereas the primary predicate supported a removable T-Luer or Stopcock.

The FDA 510(k) summary for the KARL STORZ Flexible HD Cysto-Urethroscope System (K212476) describes the acceptance criteria and supporting studies as follows:

This submission is a Special 510(k), indicating a modification to a previously cleared device. Therefore, the focus is on demonstrating that the modifications do not raise new questions of safety and effectiveness compared to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this Special 510(k), the acceptance criteria are largely based on adherence to recognized consensus standards and demonstrating that the modified device maintains the same technological characteristics and performance as the predicate devices, or that any differences do not impact safety or effectiveness.

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

The document does not detail specific "test set" sample sizes or data provenance in the context of clinical or image-based studies for the current 510(k). This submission relies on a comparison to predicate devices and adherence to established performance standards.

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

Not applicable. The submission focuses on engineering specifications and adherence to standards, not a clinical study requiring expert ground truth for image interpretation or diagnosis.

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

Not applicable. No clinical or image-based test set with adjudication is described.

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 device is an endoscope system for visualization and operative access; it does not involve AI assistance for human readers in diagnostic interpretation.

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

Not applicable. This device is not an algorithm-only device. It is a medical instrument.

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

Not applicable in the context of diagnostic performance. The "ground truth" for this submission are the established performance parameters of the predicate device and the requirements of recognized consensus standards for medical devices.

8. The sample size for the training set:

Not applicable. As a medical device, and specifically a modification through a Special 510(k), there is no "training set" in the context of machine learning.

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

Not applicable. See point 8.

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The HD Mediastinoscope is intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during ENT endoscopic surgical procedures.

The components subject of this submission are: HD Mediastinoscope (Part Number: 10973HD), and the IMAGE1 S CCU. The CCU consists of the IMAGE1 S Connect Module (Model Number: TC200US) and IMAGE1 S X-Link (Model Number: TC301US).

This document describes the FDA's 510(k) clearance for the Karl Storz HD Mediastinoscope (K202272). The device is intended to aid surgeons in viewing the mediastinum and facilitating the introduction and removal of surgical instruments during ENT endoscopic procedures.

The information provided focuses on the substantial equivalence determination based on non-clinical performance data, rather than a study proving the device meets AI-specific acceptance criteria. Therefore, most of the requested information regarding AI model performance, ground truth establishment, expert review, and clinical study details is not present in the provided text.

Here is a breakdown of what can be extracted and what is not available based on the request:

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

The document does not specify quantitative acceptance criteria in a table format for performance. Instead, it states compliance with recognized standards and successful completion of various bench tests.

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

The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications." This means there was no clinical test set in the traditional sense for assessing device performance in a human population. All testing was non-clinical bench testing. Therefore, sample size and data provenance (country, retrospective/prospective) related to a clinical test set are not applicable here.

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, as no clinical test set or ground truth in the context of diagnostic interpretation (e.g., for an AI model) was established. The ground truth for bench testing would be metrology standards and physical measurements.

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

Not applicable, as no clinical test set involving human readers or interpretation was performed.

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 device is a mediastinoscope (a physical viewing instrument), not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm-only device.

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

For the non-clinical bench testing, the ground truth would be based on established engineering and optical metrology standards, and potentially manufacturer specifications for the device's components. For biocompatibility and reprocessing, the ground truth is compliance with the listed ISO and AAMI standards.

8. The sample size for the training set

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

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

Not applicable, as this is not an AI/ML device.

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The XR-MX/1000 system is a solid-state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimally invasive urological surgery). The system may be used for urological treatment, planning and diagnostic procedures, including but not limited to:
Querying and retrieving patient information and/or image from other modalities-
X-ray examinations of the urogenital area (e.g. cystoscopy, kidney, bladder, ureter, urethra) including KUB², IVP, reflux-cystogram, cystourethrogram, and micturition cystourethrogram combined with uroflow measurements.3
Endourological interventions (e.g. of the urethra, prostate, bladder, sphincter, ostium, kidney and ureter, catheter placement, penile implant placement, transurethral resection of prostate or bladder, alternative treatment of the BPH and brachytherapy).3
Percutaneous interventions (e.g. PCN nephrolithotomy, resection, percutaneous nephrostomy)2
Application of fistula (kidney/bladder)3
Simple procedures (e.g. urethra, testis, phimosis)3
Intracorporeal shock wave lithotripsy3
Uroflow/urodynamics3
Pediatric radiological and therapeutic applications3(ages 2 to 22 years)

The operating principle of the subject devices, XR-MX/1000, manufactured by STORZ MEDICAL, AG., is identical to the predicate device, Uroview FD, manufactured by Pausch Medical GMBH, cleared via K161019. Both the subject and predicate devices include the following major X-ray components: Basic unit (C-MX C-Arc) X-Ray generator (source) X-Ray tube and housing (column) Collimator (image receptor) Measuring chamber (image receptor) Detector (image receptor) Digital image station (image receptor) The basic unit of the subject devices is comprised of an arm that is shaped in the letter “C” which gives the component its name “C-arc". One end of the C-arc includes an x-ray source and the opposite end includes an image receptor; while the basic unit of the predicate device is comprised of a urological table. The x-ray source emits the focused x-ray energy which is then transmitted through the body and is finally captured by the receptor, providing an image of the desired anatomy. The basic unit in both the subject and predicate devices is able to move, allowing the user to position the X-ray image chain at various angles and distances with respect to the patient anatomy being imaged. Additionally, the subject and predicate devices both include a workstation, which includes a monitor suspension arm that allows dual monitors for image display (radiologic and/or endoscopic) and space that allows other devices (e.g. camera control unit, documentation unit, etc.)

The provided text is a 510(k) summary for the KARL STORZ XR-MX/1000 device, which is an image-intensified fluoroscopic X-ray system. The document states that clinical performance data was not required to demonstrate substantial equivalence to the predicate device. Therefore, the information requested in points 1 through 9 (related to acceptance criteria derived from a clinical study, sample sizes, expert involvement, ground truth, and MRMC studies) is not available in this document.

The manufacturer, KARL STORZ Endoscopy America, Inc., demonstrated substantial equivalence primarily through non-clinical bench testing and by showing that the device complies with recognized consensus standards.

Here's the relevant information from the document regarding the device's testing and acceptance:

1. A table of acceptance criteria and the reported device performance:
* Acceptance Criteria (Implied): Compliance with recognized consensus standards and meeting design specifications.
* Reported Device Performance:
* "The XR-MX/1000 systems follow the FDA recognized consensus standards and is tested according to the following standards and FDA Guidance:
* Electrical Safety and EMC
* IEC 60601-1
* IEC 60601-1-2
* IEC 60601-1-3
* IEC 60601-1-6
* IEC 60601-2-28
* IEC 60601-2-54
* Software Verification and Validation Testing
* Guidance for the Content of Premarket Submissions for Software Contained in Medical Device
* Level of concern: Minor
* "Additional bench testing was performed to ensure the device met its design specifications. The bench testing performed verified and validated that the XR-MX/1000 systems have met all their design specifications and are substantially equivalent to the predicate device."

Summary of missing information:

Points 2 through 9 are not applicable or the information is not provided because the submission did not rely on clinical performance data for substantial equivalence. The document explicitly states: "Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish substantial equivalence."

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The CO2mbi LED SCB is a combination of an LED light source, intended to provide illumination, and an insufflation/ irrigation pump, intended to insufflate CO2 or air as a distention media in the gastronitestional tract or water irrigation for lens cleaning when used in conjunction with flexible endoscopes for GI endoscopic procedures.

CO2mbi LED SCB is a portable and compact all-in-one LED Light source and insufflation unit that includes a touchscreen control display, an insufflation pump and internal LED light source, intended to be connected to a compatible GI Videoendoscope and CCU for illumination and insufflation purposes. It is also equipped with a water bottle and lid with tube to provide irrigation for lens cleaning.

The provided text describes a medical device, the CO2mbiLED SCB, but it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of clinical performance. The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical data.

Therefore, many of the requested details cannot be extracted from this document, as the document explicitly states: "Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish substantial equivalence."

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document does not present a formal table of acceptance criteria for clinical performance because it did not conduct a clinical study. Instead, it refers to:

• Compliance with FDA recognized consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, IEC 62471).
• Software Verification and Validation Testing guided by "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device" with a "Level of concern: Moderate."
• Additional bench testing "to ensure the device met its design specifications."

The reported device performance, in terms of its functions, is stated as having:

• Different flow rates and flow rate settings compared to predicates.
• Slightly different operating pressures and pressure to activate the pressure relief valve (CO2) compared to predicates.

The summary then concludes that these differences "do not raise different questions of safety and effectiveness because the intended use, operating principles, technological characteristics, and features are significantly similar, if not identical. Both systems also comply with identical standards and safety testing, where applicable. Substantial equivalence on the effectiveness of the subject device is supported by the comparison of the flow rate, flow rate settings operating pressure and pressure to activate pressure relief valve (Table F) and bench testing to show that the subject device function as intended (Section 21 – Performance Testing)."

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

This information is not available because no clinical test set was used for a substantial equivalence determination in this document. The evaluation was based on non-clinical bench testing and comparison to predicate devices.

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

This information is not available because no clinical test set requiring expert-established ground truth was part of this submission for substantial equivalence.

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

This information is not available because no clinical test set requiring adjudication was part of this submission.

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

An MRMC comparative effectiveness study was not done. The device is an endoscope accessory (light source and insufflation/irrigation pump), not an AI-powered diagnostic tool for human reader improvement.

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

This question is not applicable as the device is not an algorithm, but a hardware device (light source and pump).

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

For the non-clinical performance, the "ground truth" was established by design specifications for the device, and compliance with recognized consensus standards.

8. The sample size for the training set

This information is not available as the device is not an AI/machine learning algorithm that requires a training set. The evaluation was based on non-clinical bench testing.

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

This information is not available as the device is not an AI/machine learning algorithm requiring a training set with established ground truth.

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The TELE PACK + is an all-in-one Imaging System, which comprises a light source for illumination, Camera Control Unit (CCU) for use with compatible camera heads or video endoscopes for image processing, as well as a monitor for image display, intended for the visualization of endoscopic and microscopic procedures.

The Telepack + is a portable and compact all-in-one imaging system that includes a 18.5 inch screen display, a camera control unit and internal LED light source, that is intended to be connected to a compatible device (camera head or videoendoscope) for the purpose of visualization and documentation of endoscopic and microscopic procedures as well as stroboscopy. The Telepack + includes a LED illumination light source to illuminate the intended area and a 18.5 inch monitor for display. It also allows the users to redefine the functions that take place when a button is pressed. The Telepack + is a non-patient contacting and require only wipe down as needed.

The provided text is a 510(k) Summary for the Telepack + imaging system. It describes the device, its intended use, and the non-clinical performance data used to demonstrate substantial equivalence to a predicate device. However, it does not contain information about:

• Acceptance criteria in the context of an AI/algorithm-driven device's performance metrics (e.g., sensitivity, specificity, AUC).
• A study proving the device meets these acceptance criteria through a comparison of algorithm performance against a ground truth dataset, or human reader performance.
• Sample sizes for test sets where ground truth is established by experts.
• The number or qualifications of experts used for establishing ground truth.
• Adjudication methods for ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Effect sizes of human reader improvement with AI assistance.
• Standalone algorithm performance studies.
• Specific types of ground truth (e.g., pathology, outcomes data for a disease).
• Sample size for training sets.
• How ground truth for training sets was established.

The "Performance Testing" section within the "Non-Clinical Performance Data" discusses basic image quality characteristics like "Minimum Illumination," "Spatial Resolution," "Color Performance," "Latency," "White Balance," and "AE Step Response," along with "Head Button Functionality." These are engineering performance metrics for an imaging system, not performance metrics for an AI/algorithm diagnosing or assisting in diagnosis.

The document explicitly states: "Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish substantial equivalence." This indicates that the Telepack + is a hardware imaging system, and its approval was based on demonstrating that its image quality and functionality are comparable to its predicate, rather than on the diagnostic performance of an embedded AI algorithm.

Therefore, I cannot provide the requested information based on the given text.

In summary, the provided document does not contain the information required to answer your prompt because the device is an imaging system, not an AI/algorithm-driven diagnostic aid.

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The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging.

The KARL STORZ Endoscopic ICG System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, or at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the KARL STORZ Endoscopic ICG System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Additionally, the KARL STORZ Endoscopic ICG System enables surgeon to perform minimally invasive cranial neurosurgery in adults and pediatrics and endonasal skull base surgery in adults and pediatrics > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.

The KARL STORZ VITOM II ICG System is intended for capturing fluorescent mages for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures. The VITOM II ICG System is intended to provide a magnified view of the surgical field in standard white light.

The KARL STORZ ICG Imaging System is used to provide real-time high-definition (HD) endoscopic or telescopic images of visible (VIS) and near-infrared (NIR) indocyanine green (ICG) dye fluorescence during minimally invasive, neuro- and endonasal skull base surgery as well as plastic, micro- and reconstructive surgical procedures in general and pediatric populations.

The overall system includes a 4mm HOPKINS ICG/NIR Endoscope (0°, 30° or 45°) for use in neuro- and endonasal skull base surgery, a 5mm & 10mm HOPKINS ICG/NIR Endoscope (0° or 30°) for use in minimally invasive procedures and a VITOM II ICG/NIR Telescope for use in plastic, micro- and reconstructive surgical procedures for VIS and NIR illumination and imaging, a light source with foot switch for emission of VIS and NIR illumination, a color video camera head capable of capturing both VIS and NIR imaging, and a KARL STORZ ICG Kit. Additional accessories used with the KARL STORZ ICG Imaging System include two standards fiber-optic light cables for transmission of VIS and NIR light and the Image1 S Camera Control Unit (CCU). The KARL STORZ ICG Imaging System can be used with any medical grade HD monitor with a DVI-D or 3G-SDI input.

The provided text, K180146, describes the KARL STORZ ICG Imaging System, an endoscopic device for real-time visible and near-infrared fluorescence imaging, particularly for assessing vessels, blood flow, and tissue perfusion. The submission is a 510(k) for a modified device, primarily adding a 4mm endoscope for neuro- and endonasal skull base surgery in adults and pediatrics.

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to established standards for medical devices and demonstration of equivalence to predicate devices through bench testing and literature review. The document does not provide specific quantitative acceptance criteria for clinical performance (e.g., a specific sensitivity or specificity for detecting blood flow issues). Instead, it relies on demonstrating that the device meets its design specifications and performs comparably to the predicate devices and that the expanded indications are supported by existing clinical literature.

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

The document explicitly states: "Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish substantial equivalence."

Therefore, there appears to be no specific "test set" of patient data for evaluating algorithm performance in the way one would for an AI/ML device. The evaluation relies on:

• Bench testing: This refers to laboratory-based functional and safety testing of the device hardware and software. The sample size for this is not specified in terms of "patients" or "cases" but rather in terms of components or test conditions. The provenance is internal to the manufacturer's testing facility.
• Clinical Literature: Published studies from various sources were used to support the expanded indications for use in neuro- and endonasal skull base surgeries and in pediatric populations. The provenance of this data is from the respective published articles (e.g., Journal of Neurological Surgery Part B, Neurologia Medico-Chirurgica). These are retrospective studies conducted by various researchers, not specifically "prospective" studies for this particular 510(k) submission.

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

Since no specific clinical "test set" for algorithm performance was used, there is no mention of experts for ground truth establishment in that context. The "ground truth" for the device's functional performance was established through engineering and quality control testing against design specifications and relevant standards. For the expanded indications, the "ground truth" is derived from the established scientific and clinical evidence presented in the published literature.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring expert adjudication for ground truth was generated for this submission.

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

No MRMC study was conducted or referenced in this submission. This device is an imaging system (hardware and associated software), not an AI-based diagnostic algorithm intended to assist human readers in image interpretation. Its purpose is to generate the imaging data (visible and NIR fluorescence), not to interpret it in an AI-assisted manner.

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

Not applicable. The device itself is a tool for image acquisition, primarily used by surgeons for visual assessment during procedures. It does not perform an automated, standalone diagnostic algorithm.

7. The type of ground truth used

• For device performance validation: The ground truth was established by engineering design specifications and compliance with recognized industry standards (IEC, ISO, AAMI). This involved direct measurement and verification against established physical and electrical parameters.
• For expanded indications: The ground truth was established by published clinical literature related to the effectiveness and safety of NIR imaging using ICG in the specified surgical fields and pediatric populations. This relies on the expert consensus and evidence presented in those scientific publications.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data for learning. Its functionality is based on established optical and electronic principles.

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

Not applicable. As there is no AI/ML training set, there is no ground truth establishment for it.

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