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The Outlook Surgical Versa One System is intended for use in examination and visualization in otolaryngology and head and neck procedures.

The Outlook Surgical Versa One System is a video nasopharyngoscopy system that provides illumination and live video stream of a patient's internal anatomy during otolaryngology and head and neck examinations and procedures. The device is composed of an endoscope, a connection cable available in 6ft or 12ft lengths, a wireless enabled display unit, and a wireless HDMI receiver. Users attach accessory instruments to the semi-flexible shaft of the endoscope enabling the user to visualize with the instrument attached.
The device will be used by clinical practitioners in a sterile field in an operating room, healthcare clinic, or medical office. The Outlook Surgical Versa One System is a reusable device initially supplied as non-sterile to the user and requiring the user to process (i.e., clean and sterilize) the device for initial use, as well as to reprocess the device after each use.
The Versa One Endoscope has a semi-flexible shaft that enables the user to attach instruments. The semi-flexible shaft is rigid near the adapter end and semi-flexible at the distal end to conform the shape of the attached instrument. When an instrument is attached to the scope, the flexible portion becomes rigid and the scope functions as a rigid endoscope. The Versa One endoscope is compatible with Versa One straight and curved sheaths.
The Outlook Surgical Versa One System live stream video can be viewed on the display unit and an off-the-shelf monitor connected to the display unit via an HDMI cable or wirelessly. The off-the shelf monitor is not provided with the device. The device operates off rechargeable battery power.
The Versa One Endoscope uses an integrated LED light source to illuminate glass fiber bundles in the shaft and a CMOS sensor at the distal tip to send the signal to a custom PCB in the endoscope handle that converts the signal to live video.

Based on the provided FDA 510(k) Clearance Letter, the "Outlook Surgical Versa One System" is a medical device for examination and visualization in otolaryngology and head and neck procedures, and not an AI/ML powered device. Therefore, the information typically required for an AI/ML device's acceptance criteria, such as a table of performance metrics (sensitivity, specificity, AUROC), sample size for test/training sets, expert qualifications, and comparison to human readers, is not present in this document.

The document discusses the substantial equivalence of the "Outlook Surgical Versa One System" to a predicate device (Stryker Precision S 4K Sinuscope) based on physical and functional characteristics, and a range of non-AI/ML specific performance tests.

Here's an analysis of what information is provided regarding the device's performance and acceptance, and why the requested AI/ML specific details are absent:

Acceptance Criteria and Device Performance (as per the document):

The acceptance criteria for this device are demonstrated through various performance tests, with the reported device performance consistently being "Passed. All acceptance criteria were met."

Regarding the specific AI/ML and clinical study requirements you listed, the document does not provide the following information:

1. Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML device with a test set of data. The "test sets" here refer to physical devices undergoing various engineering and biological tests.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an imaging device like this is primarily about validating its physical performance against standards and its ability to capture high-quality images, not expert interpretation of AI outputs. "User Validation" involved multiple users, but their qualifications are not specified beyond being "clinical practitioners" in the "use environment."
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For this device, "ground truth" is established through engineering specifications, international standards (ISO, IEC, ANSI/IEEE), and regulatory guidance documents (FDA). For instance, optical performance is validated against ISO standards, and biocompatibility against ISO 10993. The "User Validation" involved using anatomical models and cadaver models, which serve as a form of ground truth for assessing usability and visualization capability.
7. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) clearance letter details the substantial equivalence of a medical imaging device (a nasopharyngoscope) by demonstrating its physical, electrical, and performance characteristics meet established safety and effectiveness standards, and are comparable to a predicate device. It is not an AI/ML device, and therefore the specific criteria, studies, and data provenance related to AI/ML device performance are not present in this document.

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EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-XP190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-P190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-XT190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 is intended to be used with an Olympus video system center, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 is intended to be used with an Olympus video system center, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

The EVIS EXERA III BRONCHOVIDEOSCOPES (OLYMPUS BF-XP190, OLYMPUS BF-P190, and BF-XT190) and BRONCHOVIDEOSCOPE BF-H1100 and BF-1TH1100 are used for endoscopic diagnosis and treatment within the respiratory organs. These endoscopes consist of three parts: the control section, the insertion section, and the connector section.

The provided FDA 510(k) clearance documentation for the Olympus Bronchovideoscopes (K250862) primarily demonstrates substantial equivalence based on technological characteristics and bench testing. It does not contain information about comparative effectiveness studies (like MRMC studies for AI devices), expert ground truth establishment, or typical performance metrics associated with AI/software-as-a-medical-device (SaMD) clearances.

This submission focuses on:

• Technological Equivalence: Showing that the devices (BF-XP190, BF-P190, BF-XT190, BF-H1100, and BF-1TH1100) are fundamentally the same as their predicates, with the primary change being compatibility with a new video system center (CV-1500) and updated labeling related to laser/high-frequency/APC systems.
• Bench Testing: Verification of physical and imaging performance parameters (e.g., thermal safety, color performance, resolution, noise, video latency) to ensure they meet specifications, particularly when combined with the new video system.
• Animal Testing: To assess the imaging modes (WLI, NBI, TXI, BAI-MAC) with the new video processor.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/software performance (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts) is not present in this document. The document explicitly states that "Software Testing and Cybersecurity" was "not performed" due to "no design, material, sterilization, reprocessing, packaging, shelf life, or software changes" (Page 29). This implies that the device itself is a hardware endoscope, and any software associated with it is considered an intrinsic part of its established functionality, not a new or significantly changed software component requiring a separate performance study with clinical endpoints or AI evaluation.

The "acceptance criteria" here relate to the successful completion of the listed bench (and limited animal) tests, demonstrating that the new combination (endoscope + CV-1500) functions as intended and safely, similar to the predicate combinations.

Below is a table summarizing the "acceptance criteria" and "reported device performance" as derived from the document's comparison tables and performance data section, which are primarily about technical specifications and functional verification, not software/AI performance metrics.

Acceptance Criteria and Reported Device Performance (Summary based on provided text)

Since this 510(k) is for existing endoscopes with a new video system and updated labeling, the "acceptance criteria" are implied by the extensive comparison tables (Tables 1-5) which show the subject devices having nearly identical technical specifications to their predicate devices, and the successful completion of specified bench and animal testing. The performance data section doesn't list specific quantitative acceptance criteria for each test but rather states that tests were conducted to "ensure that the subject device performs as intended and meet design specifications."

Study Details (based on provided text)

The document describes performance testing rather than a comparative clinical study for AI/software-as-a-medical-device.

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

   • See table above. The acceptance criteria are largely implied by the equivalence to the predicate devices in terms of physical, optical, and functional characteristics, and the successful completion of specified bench and animal tests. Quantitative metrics for these tests are not provided in this summary but would have been part of the full submission.

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

   • Test set sample size: Not specified. The document mentions "bench testing" and "animal testing." For bench tests, it typically refers to a small number of devices or engineered test setups. For animal testing, the number of animals or studies is not provided.
   • Data provenance: Not specified. It can be inferred that the testing was conducted by or on behalf of Olympus Medical Systems Corp. in Japan, given the manufacturing site and submitter location. It does not state if the data is retrospective or prospective, or from which country/region the "animal" data would originate.

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

   • Not applicable / Not specified. This type of information is typically provided for studies evaluating AI algorithms or diagnostic accuracy, where human experts establish a ground truth for imaging interpretation. The present submission is for a hardware endoscope system, and its performance evaluation relies on engineering specifications and functional testing, not expert interpretation of diagnostic images.

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

   • Not applicable / Not specified. Adjudication methods are relevant for human reader studies or expert ground truth establishment, which are not detailed here.

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, not performed / Not applicable. This submission is not for an AI companion diagnostic or an AI-software-as-a-medical-device. It's for an endoscope system. The document explicitly lists "Software Testing and Cybersecurity" and "Clinical" as "not performed" because there were no fundamental software changes beyond integration with a new video system, which itself does not constitute an AI component in the context of this 510(k) summary. The NBI, RDI, TXI, and BAI-MAC modes are imaging enhancements, not AI algorithms.

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

   • Not applicable. This relates to AI/software performance, which is not the focus of this 510(k).

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

   • Not applicable. For this device (endoscope), ground truth typically relates to engineering specifications (e.g., accurate measurements, clear image quality as determined by reproducible test patterns, proper functionality of mechanical parts). For the animal testing of imaging modes, the "ground truth" would be the direct observation of the animal's internal anatomy via the endoscope itself and comparison to expected/known characteristics, not an independent "pathology" or "outcomes" ground truth in a diagnostic sense.

8. The sample size for the training set:

   • Not applicable. This submission is not for an AI system that requires a "training set."

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

   • Not applicable. As above, no AI training set is described.

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The Grumpy Innovation PORTARE System is intended to endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is intended to provide visualization via a monitor. The endoscope is intended for use in a hospital or clinical environment. It is intended for use in adults.

The Grumpy Innovation PORTARE System is a flexible endoscope with steerable navigation and a built-in image and video processing system that wirelessly transmits images and video to a tablet application. The PORTARE System is comprised of a:
• Sterile, single-use disposable endoscope handle, steering mechanism, and steerable insertion tube with chip-on-tip camera and LED light source.
• Reusable module comprising the primary circuit board with wireless unit and rechargeable battery.
• Tablet viewer that runs a software application.

The reusable module attaches to the single-use disposable endoscope handle to create a functional endoscope.

The provided FDA 510(k) clearance letter and summary for the PORTARE System (FA-001) does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria, in the context of an AI/ML-driven medical device performance evaluation.

The document primarily focuses on establishing substantial equivalence to a predicate device for a flexible nasopharyngoscope system. The performance tests listed are non-clinical and relate to the physical, optical, mechanical, software, electrical, and biocompatibility aspects of the device, typical for hardware and software components of an endoscope.

Therefore, I cannot provide the requested information, which typically applies to AI/ML device performance studies. The document explicitly states:

"Performance Data – Clinical: Not applicable"

This confirms that no clinical performance study, which would typically involve human subjects and outcome measures against a pre-defined ground truth, was conducted or submitted for this particular clearance, at least not in a way that would generate acceptance criteria and performance metrics for an AI component.

If the PORTARE system did include an AI component, the provided document does not detail its performance characteristics or the study design used to validate it.

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The VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500, when used with endoscopes, video endoscopes, camera heads, monitors and other ancillary equipment for endoscopic surgery, is intended to receive and process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor.

Also, the VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500, when used with rhinolaryngeal stroboscopes, is intended to observe the intralaryngeal phenomenon of phonation (speech) for endoscopic observation to examine the correct functioning of the vocal apparatus (glottis) and to examine voice disorders.

The OLYMPUS OTV-S500 is a "universal platform" which offers compatibility with various endoscopes for different medical specialties and enables efficient operation to meet the clinical needs of the ENT field; the device has been cleared by FDA for use with OLYMPUS urology/gynecology endoscopes (including CYF-VH, CYF-VHR, URF-V2, URF-V2R, URF-V3. URF-V3R. WA2T400A. WA2T412A. WA2T430A. WA2T43WA. WA2T470A. WA2UR11A, WA2UR12A, WA2UR13A, WA2UR14A, WA2UR21A, WA2UR22A, WA2UR23A, WA2UR31A, WA2UR32A, CYF-5, CYF-5R, URF-P6, URF-P6R, URF-P7, URF-P7R and HYF-XP) under K241371.

The OLYMPUS OTV-S500 consists of electrical circuit boards, electrical units (cooling fan, unit power supply, and control panel), harnesses between circuit boards, and optical components (lens and optical filter). A microprocessor is built into the OLYMPUS OTV-S500 which controls processing of observation images, user interface (front panel switch, indicator LEDs, warning buzzer etc.) and menu. These functions are implemented in the embedded software. Scopes including flexible videoscopes or fiberscopes and rigid videoscopes with camera heads and light source are directly connected to the Subject system. When connected, the endoscope (fiberscopes and rigid videoscope without camera head) acquires and displays images directly to the user or output onto a monitor when using a flexible endoscope or scope and camera head.

The Subject devices submitted for clearance include one (1) major component: the Video System Center (OLYMPUS OTV-S500) with Foor Holder (MAJ-2552), and five (5) optional accessories: an HDMI cable (MAJ-2551); the OTV-S500 Upgrade Pack Strobe (MAJ-2547), which activates the stroboscopy function of the OTV-S500; an Air Microphone (MAJ-2548); a Throat Microphone (MAJ-2549); and the Microphone Extension Cable (MAJ-2550).

The OLYMPUS OTV-S500 is compatible with the following OLYMPUS ENT endoscopes: ENF-VH, ENF-VH2, ENF-V3, ENF-V4, ENF-VT3, ENF-XP, ENF-GP2, WA4KS400, WA4KS430, WA4KS431, WA4KS445, WA4KS446, WA4KS471, WA4KS471, WA96100A and WA96105A.

The provided text is a 510(k) Summary for the OLYMPUS OTV-S500 (VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500).

The 510(k) Summary states that no clinical data were collected to support the performance of the subject device. Therefore, a study proving the device meets acceptance criteria in a clinical setting is not available from this document.

However, the document does describe non-clinical performance data and acceptance criteria based on standard compliance and specified tests.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly mentions performance testing, but does not provide specific acceptance criteria in numerical or qualitative form alongside reported device performance for each criterion. Instead, it states that "all testing passed/met the acceptance criteria."

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

This information is not provided in the document. The document refers to "Performance Testing Bench" with the subject device and compatible endoscopes, but does not specify the number of devices or endoscopes tested. Data provenance (country of origin, retrospective/prospective) is also not mentioned for the non-clinical tests.

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

This information is not applicable as the described tests are non-clinical, bench-top performance, electrical safety, and software validation tests, which do not typically involve human expert establishment of ground truth in the same way clinical or diagnostic studies do. The "truth" for these tests comes from objective measurements against defined standards and specifications.

4. Adjudication Method for the Test Set

This information is not applicable for the non-clinical tests described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed for ground truth.

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 document explicitly states: "No clinical data were collected to support performance of the Subject device." The device itself is a video system center for endoscopes, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable in the context of an "algorithm only" performance. The OLYMPUS OTV-S500 is a hardware device (video system center) with embedded software. The software validation tests mentioned would assess the functionality and safety of the embedded software itself, which is part of the device's standalone operation. However, this is not a standalone "algorithm" in the typical sense of a diagnostic AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the non-clinical tests described, the "ground truth" or reference for performance is established by technical standards and specifications. For instance:

• Performance Testing Bench: ISO standards (e.g., ISO 8600-3:2019 for Field of View, ISO 15739:2017 for Image Noise and Dynamic Range), and internal product specifications (e.g., for Brightness, Latency, etc.). The FDA Color Performance Review (CPR) Tool for Endoscopy Devices would provide a standard reference for color analysis.
• Electrical Safety/EMC Testing: Compliance with various IEC/ANSI AAMI standards (e.g., ES60601-1, IEC 60601-1-2).
• Software Validation/Cybersecurity: Compliance with IEC 62304, ISO 14971, and FDA guidance documents.

8. The Sample Size for the Training Set

This information is not applicable. As no clinical data was collected and the device is a hardware system with embedded software, there's no mention of a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable due to the absence of a training set as described above.

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MonoStereo is intended to be used together with 2D monoscopic endoscope systems to provide simulated 3D visualization for observation during ENT diagnostic and therapeutic procedures.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA clearance letter for a device called "MonoStereo", outlining regulatory information and general controls. It does not include details on performance metrics, study design, sample sizes, expert qualifications, or ground truth establishment.

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The endoscope is a sterile, single endoscope intended for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is intended to provide visualization via an Image Processor. The endoscope is intended for use in a hospital environment. It is designed for use in adults.

The Rhinolaryngoscope System consists of Single-Use Rhinolaryngoscope (six models shown in below) to be introduced within the nasal lumens and upper airway anatomy and Image Processor (model: VLM-02) for clinical image processing. The Image Processor provides power and processes the images for medical electronic endoscope. The Single-Use Rhinolaryngoscope is a sterile single used flexible Rhinolaryngoscope. The Image Processor is a reusable monitor.

The document provided is a 510(k) premarket notification for a medical device, the Rhinolaryngoscope System. It details the device's characteristics, intended use, and comparison to predicate devices, along with performance data. However, this document does not contain information about an AI/ML-based device or a comparative effectiveness study involving human readers and AI assistance.

The device described is a Rhinolaryngoscope system, which is an endoscope for visualization. The performance data provided are primarily related to the physical and electrical aspects of the device, such as biocompatibility, sterilization, electrical safety, EMC, and bench performance (optical performance, mechanical bending, photobiological safety, thermal safety). There is no mention of an algorithm or AI component that would require an acceptance criteria table for AI performance metrics, a test set with ground truth from experts, or multi-reader multi-case studies.

Therefore, I cannot fulfill the request for information on acceptance criteria and study proving an AI/ML device meets them based on the provided text. The questions regarding sample size, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth, training set size, and how training set ground truth was established are irrelevant to the information present in this 510(k) submission, as it does not pertain to an AI/ML component.

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ATMOS Scope is used for endoscopic diagnosis within the nasal lumens and airway anatomy and is intended to provide visualization via a monitor. The ATMOS Scope may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique.

The ATMOS Scope is a flexible nasopharyngo laryngoscope for endoscopic diagnosis within the nasal lumens and airway anatomy. The device is an electrical device and consists of a handle for the user and a flexible, steerable part that is inserted into the patient. The deflection lever can be easily operated with the thumb and enables precise control of the endoscope tip at an angle of 2 x 135°. This makes it easy to examine even hard-to-reach regions in the nose, or throat. The device contains two integrated LED light sources that provide bright and homogeneous illumination in the complete field of view. With the help of a 1280 x 800-pixel image sensor at the flexible part and the electronics built into the handle, a digital image is generated. For taking and saving photos and videos, the ATMOS Scope has two separate function keys located directly on the handle. This can be displayed as the endoscopic image on a connected PC with video software. The endoscopic image is used for visual diagnostics by the user. The ATMOS Scope is delivered in a non-sterile condition.

The provided text describes the ATMOS Scope, a flexible nasopharyngo laryngoscope, and its equivalence to a predicate device (Schoelly CMOS Video Nasopharyngoscope System K143673). However, the document does not contain information typically associated with acceptance criteria and a study design for evaluating the diagnostic performance of a medical device using an AI component.

Instead, the provided text focuses on demonstrating substantial equivalence through comparisons of technical characteristics and various non-clinical performance tests. These tests are primarily related to safety, functionality, and manufacturing compliance, rather than diagnostic accuracy or effectiveness in a clinical context that would require a human-in-the-loop or standalone AI performance study.

Therefore, I cannot directly answer your questions in the requested format as the provided document does not include such a study or information.

Here's what I can extract based on the document:

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

The document does not provide a table of acceptance criteria for diagnostic performance or reported performance in terms of diagnostic metrics (e.g., sensitivity, specificity, AUC). Instead, it lists various technical parameters and confirms successful testing against standards.

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

Not applicable. The document describes non-clinical performance and safety testing. There is no mention of a test set for diagnostic performance or data provenance for such a study.

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. There is no mention of a test set for diagnostic performance or experts establishing ground truth. The device provides "visualization via a monitor" for "visual diagnostics by the user," implying human interpretation, but no study is detailed to quantify this diagnostic performance.

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

Not applicable. No diagnostic performance test set or adjudication method 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. The ATMOS Scope is a visualization device, not an AI-assisted diagnostic tool. No MRMC study or AI assistance is mentioned.

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

Not applicable. The device is a direct visualization tool. There is no AI algorithm component described for standalone performance evaluation.

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

Not applicable. No diagnostic performance study requiring ground truth is described.

8. The sample size for the training set

Not applicable. There is no mention of an AI component or a training set for machine learning.

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

Not applicable. No AI component or training set is mentioned.

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The Patcom Distal Chip Endoscope is indicated when endoscopic visualization in the regions of mouth, nasal cavity, and upper airway is required.

The PatCom Distal Chip Endoscope is a portable video endoscope for visualization in the reqions of the mouth, nasal cavity, and upper airway. It is made up of the grip section and insertion tube. It requires connection via USB to a laptop computer, and gains power from the USB ports which supplies 5V of electricity with a maximum current of 0.5A. This is sufficient to power the endoscope. The endoscope does not need an external CCU for image processing, as the processing is done directly on the device on a small chip. It converts the light and color information received by the image sensor into binary numbers (patterns of zeros and ones). The USB Video Class (UVC) driver is a Microsoft-provided AVStream minidriver that provides driver support for USB Video Class devices. When a device uses UVC, it does not need to support their own driver, but instead works automatically with the system-supplied driver. It is compatible to all Windows and Mac computers, with a simple plug and play feature. The visualization from the distal chip is projected onto the computer monitor, at a resolution of 720px1280p high definition.

The insertion tube portion of the device is used for visualization within the natural orifices of the mouth and the nasal cavities and in the upper airway anatomy. The light emitted by the LED light source at the distal end of the tip is illuminated into the body cavity of the subject, and the image is displayed onto a screen.

The grip section of the device contains a control knob for moving the distal end of the insertion tube bend up or down, up to 130 degrees in either direction.

The proximal end of the grip section contains the USB connector, for plug and play with a computer, for power and to provide visualization of the camera chip found at the distal end of the insertion tube.

The provided text is a 510(k) summary for the "PatCom Distal Chip Endoscope," detailing its substantial equivalence to a predicate device. It primarily focuses on comparing the new device's technical specifications, materials, and performance characteristics to those of the predicate device, rather than presenting a study proving the device meets specific acceptance criteria for a new AI/algorithm system.

The document discusses performance characteristics from an engineering perspective (e.g., field of view, depth of field, noise, latency) and states that "extensive comparative imaging testing" was done against the predicate device to show substantial equivalence. However, it does not describe an AI/algorithm-based study with acceptance criteria related to clinical performance metrics like sensitivity, specificity, reader improvement, or expert adjudication. Therefore, most of the requested information regarding AI/algorithm study specifics (MRMC, standalone performance, ground truth establishment, sample sizes for training/test sets, expert qualifications, and adjudication methods) cannot be extracted from this document.

Here's what can be extracted and what is not available based on the provided text:

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

The document lists various performance testing categories and applicable standards, implying that the device was tested against criteria outlined in these standards and found to meet them, thereby supporting substantial equivalence to the predicate. However, it does not provide a specific table of acceptance criteria as clinical performance targets (e.g., minimum sensitivity or specificity) for an AI/algorithm, nor exact numerical results for each reported aspect explicitly stated as "device performance." Instead, it generally states that tests "support both devices to be substantially equivalent."

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

The document describes "extensive comparative imaging testing" against a predicate device. This is bench testing, not a clinical study on patient data. Therefore, there is no "test set" in the context of patient data, nor data provenance (country of origin, retrospective/prospective). The "sample size" would refer to the number of devices or test conditions, which is not specified.

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

Not applicable. This was not a study involving human interpretation of images to establish ground truth for clinical cases. The performance evaluation was technical bench testing of the endoscope's imaging capabilities.

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

Not applicable, as no human readers or clinical ground truth adjudication were involved in the described 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

No. The document explicitly describes bench testing to demonstrate substantial equivalence of a medical imagery device (endoscope), not an AI algorithm. Therefore, no MRMC study or AI assistance effect size is mentioned.

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

No. This document is about an endoscope, not an AI algorithm.

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

For the imaging performance, the "ground truth" would be the known physical properties and measurements from the test targets and laboratory setups used for the imaging evaluations (e.g., resolution charts, color targets). For biocompatibility, it's the results from the specific ISO 10993 tests themselves. For electrical safety, it's compliance with standard electrical safety measurements. These are not clinical ground truths (e.g., pathology, outcomes).

8. The sample size for the training set

Not applicable. There is no AI/algorithm training set mentioned.

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

Not applicable. There is no AI/algorithm training set mentioned.

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The Single-use Flexible Rhinolaryngoscope is designed to be used with the Digital Video Monitor, for examination of nasal cavity and upper respiratory tract. For Rhinolaryngoscope models that include a working channel and permit the use of a compatible 3rd party accessory, treatment is also possible.

The Digital Video Monitor is specially designed to be used with endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.

The Vathin® Video Rhinolaryngoscope System is for use in a hospital environment.

The Vathin® Video Rhinolaryngoscope System consists of Single-use flexible Rhinolaryngoscope (eight models shown in below) and Digital Video Monitor (model: DVM-A1, DVM-A2, DVM-B1, DVM-B2) for clinical image processing and display.

The Single-use Flexible Rhinolaryngoscope is designed for use with Vathin Display Units, for examination of nasal cavity and upper respiratory tract. For Rhinolaryngoscope models that include a working channel and permit the use of a compatible 3rd party accessory, treatment is also possible.

The Digital Video Monitor is specially designed to be used with compatible Vathin endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.

There are eight subject nasopharyngoscope models: RL-S1800, RL-S1801, RL-E1800, RL-E1801, RL-S1E00, RL-S1E01, RL-E1E00, RL-E1E01. The main differences between product models are in the working channel inner diameter (whether channel is present or not), outer diameter, and rotate function.

Single-use flexible Rhinolaryngoscope is a sterile single Rhinolaryngoscope. Digital Video Monitor is a reusable monitor.

The light emitted by the LED cold light source of the Single-use flexible Rhinolaryngoscope lens is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is imaged on the CMOS (complementary metal oxide semiconductor). The CMOS acquisition image is controlled by the CMOS drive circuit, and the standard color video signal is output to the Digital Video Monitor via the encoding circuit. The Digital Video Monitor adjusts the brightness of the light source or corrects the image according to the video signal output from the CMOS, and outputs the corrected standard color video signal.

Single-use flexible Rhinolaryngoscope has the following physical and performance characteristics:

• Maneuverable tip controlled by the user .
• Flexible insertion cord .
• Camera and LED light source at the distal tip .
• . Sterilized by Ethylene Oxide
• For single use

The differences between the Single-use flexible Rhinolaryngoscope models are as follow:

• . Have or haven't working channel
• . Working channel inner diameter
• . Insertion tube outer diameter
• . The length of insertion tube

Here's an analysis of the provided text regarding the acceptance criteria and study for the device, organized according to your requested information:

Device: Vathin® Video Rhinolaryngoscope System (includes Single-use Flexible Rhinolaryngoscope and Digital Video Monitor)

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

The provided document describes the device's technical specifications and reports that all evaluation acceptance criteria were met for the non-clinical tests. However, it does not explicitly state numerical acceptance criteria for each performance parameter, nor does it provide a direct comparison table of "acceptance criteria vs. reported performance" in a quantitative manner. Instead, it lists the tests performed and implies compliance.

Below is a table summarizing the reported device performance characteristics where numerical values are given, and notes where general compliance is stated without specific numerical acceptance criteria.

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

The document comprehensively lists various non-clinical tests conducted (Biocompatibility, Electrical Safety/EMC, Performance testing including Appearance, Dimensions, Weight, and Functional Performance). However, it does not specify the sample size used for any of these test sets, nor does it provide information on the country of origin of the data or whether the studies were retrospective or prospective. These were non-clinical, bench-top tests.

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)

The document describes non-clinical, bench-top testing. For such tests, the "ground truth" is typically established by industry standards, engineering specifications, and validated measurement methods, rather than by human expert consensus or qualifications in the medical sense for diagnostic performance. Therefore, no information on the number or qualifications of experts for establishing ground truth is provided or relevant in this context.

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

Since the study described involves non-clinical engineering and performance testing, rather than human interpretation of medical data, the concept of an "adjudication method" (like 2+1 or 3+1 for resolving discrepancies in expert interpretations) is not applicable and not mentioned.

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 comparative effectiveness study was mentioned or performed. This submission is for a medical device (endoscope system) and not an AI-powered diagnostic tool. The focus is on the substantial equivalence of the hardware's performance and safety.

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

No standalone algorithm performance study was mentioned or performed. This device is a physical Rhinolaryngoscope and Digital Video Monitor, not a software algorithm.

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

For the non-clinical tests conducted:

• Biocompatibility: Ground truth was established by adherence to ISO 10993-1:2018 standards and validated laboratory tests (Cytotoxicity, Irritation, Sensitization, Pyrogenicity, Acute systemic toxicity).
• Electrical Safety and Electromagnetic Compatibility (EMC): Ground truth was established by compliance with international standards (IEC 60601-1, IEC60601-2-18, IEC 60601-1-2).
• Performance Testing (Appearance, Dimensions, Weight, Functional Performance): Ground truth was established by engineering specifications and validated measurement methods as defined in the test protocols (e.g., measuring angles, lengths, diameters, image quality parameters).

8. The sample size for the training set

Not applicable. This submission describes a hardware medical device, not a machine learning or AI model that requires a "training set."

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

Not applicable. As above, no training set was used.

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RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is intended to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is indicated for use within the nasal and nasopharyngeal lumen.

RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is intended to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is indicated for use within the nasal and nasopharyngeal lumen.

This document describes the premarket notification (510(k)) for the RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP. The device is a flexible nasopharyngoscope indicated for endoscopic diagnosis within the nasal and nasopharyngeal lumen, to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment.

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:

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

The document focuses on "Non-Clinical Bench Testing" for the device, which typically involves testing of the physical device components and its performance characteristics in a controlled environment. It does not mention specific 'test sets' in the context of clinical images or patient data. Therefore, information regarding sample size used for a test set (e.g., number of cases/images) and data provenance (country of origin, retrospective/prospective) is not provided as it is not applicable to the type of testing described (bench testing on the physical device).

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

This information is not provided and is not applicable, as the evaluation described is non-clinical bench testing of a physical medical device (fiberscope), not an AI or diagnostic software based on image interpretation by experts.

4. Adjudication Method:

This information is not provided and is not applicable for the same reason mentioned in point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and 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 a RHINO-LARYNGOFIBERSCOPE, a physical medical device for visualization, not an AI or software intended to assist human readers in interpretation or diagnosis.

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

A standalone performance study was not done. This refers to an algorithm's performance without human-in-the-loop, which is relevant for AI/software devices. The device in question is a hardware endoscopic tool.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance criteria in this submission is established through objective measurements and assessments against specified engineering and safety standards. For example:

• Thermal Safety: Adherence to temperature limits set by IEC 60601-2-18.
• Photobiological Safety: Adherence to light emission limits set by IEC 62471.
• Imaging Parameters (Resolution, Field of View, Depth of Field, Color Performance, Image Intensity Uniformity): Measured values are compared against design specifications and predicate device performance to ensure similarity and adequate functionality.
• Biocompatibility: Results of laboratory tests (e.g., cytotoxicity, irritation, sensitization) are compared against established biological evaluation criteria in ISO 10993 standards.
• Sterilization and Reprocessing: Demonstrated efficacy of cleaning/disinfection/sterilization methods through validated protocols according to FDA guidance and ISO 11135.

8. The Sample Size for the Training Set:

This information is not provided and is not applicable for this physical medical device. Training sets are relevant for machine learning algorithms, which this device does not utilize (it "does not contain any software").

9. How the Ground Truth for the Training Set was Established:

This information is not provided and is not applicable for the same reason mentioned in point 8.

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