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The VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 is intended to process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, light sources, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

The VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 is intended to provide light to an endoscope/video endoscope in order to process electronic signals transmitted from them and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, video system centers, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

The 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA is intended to be used with endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

The VISERA ELITE III Surgical Imaging System is intended to be used with ancillary equipment for endoscopic diagnosis, treatment, and observation and supports the function of high definition (HD) videoscopes and is Camera Head (CH) compatible.

The following devices of the VISERA ELITE III Surgical Imaging System are the subject of this premarket notification submission:

• VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 (Model: OLYMPUS OTV-S700) - A video system center that processes electronic signals transmitted from a video endoscope or a camera head and outputs the image signal to a monitor.

  • VISERA ELITE III 3D Upgrade Pack (Model: MAJ-2511) - A function activation portable memory key accessory that unlocks the 3D software function when connected with OTV-S700 to enable the observation of 3D mode.

• VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 (Model: OLYMPUS CLL-S700) - A LED light source provides examination light to a video endoscope and a camera head.

• 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA (Model: OLYMPUS CH-S700-XZ-EA) - A 4K Inline camera head is intended to be used with Olympus endoscopes, the video system center, and other ancillary equipment for the visualization of internal organs (endoscopic diagnosis), treatment and observation.

Based on the provided FDA 510(k) clearance letter and documentation for the Olympus VISERA ELITE III Surgical Imaging System, here's a description of the acceptance criteria and the study proving the device meets them:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed "acceptance criteria" and exhaustive study results as might be found in a full clinical trial report or a PMA submission. For a device like this (endoscopic video imaging system), performance is typically evaluated through a combination of internationally recognized standards, bench testing, and comparison to predicate devices, rather than clinical efficacy studies in the way you might see for an AI diagnostic tool. Therefore, some of the requested information (especially regarding statistical metrics like sensitivity/specificity, sample sizes for training/test sets, expert adjudication, or MRMC studies) is not explicitly stated or applicable in the context of this 510(k) summary for an imaging system that primarily focuses on image quality and safety.

The summary emphasizes "substantial equivalence" based on similar intended use and technological characteristics, and that the differences do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

For an endoscopic video imaging system, acceptance criteria are primarily related to image quality, safety (electrical, EMC, photobiological, laser), and functional performance in accordance with recognized industry standards. The reported "performance" is generally that the device meets these standards and functions as intended, with specific measurements taken during bench testing.

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

• Test Set Sample Size: The document does not provide details on specific "sample sizes" in terms of number of patients or images for the performance tests. The testing described (bench testing, electrical safety, EMC, software V&V, reprocessing validation) typically involves testing of the physical devices themselves and their components, rather than a dataset of patient images.
• Data Provenance: The testing was conducted in support of a 510(k) submission from Olympus, with manufacturing in Japan. The testing described is bench testing and laboratory validation, not human clinical data. Therefore, the concept of "country of origin of the data" or "retrospective/prospective" does not apply in the typical sense of clinical studies.

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

• Ground Truth Experts: Not applicable in this context. The "ground truth" for an imaging system like this is its ability to accurately capture and display images according to objective physical and electrical parameters, as measured through engineering and quality control tests (e.g., resolution targets, color charts, electrical signal analysis). It's not about expert interpretation of medical images.
• Qualifications of Experts: The testing would be performed by qualified engineers, technicians, and quality assurance personnel with expertise in electrical engineering, optics, software testing, and medical device regulations.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no human rating or judgment that requires adjudication for the types of tests described (bench tests, safety, EMC). The results are objective measurements against predefined engineering specifications and regulatory standards.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically performed for AI-driven diagnostic tools to assess how human reader performance (e.g., diagnostic accuracy) changes with and without AI assistance. This device is a foundational imaging system, not an AI diagnostic tool, so such a study would not be relevant for its clearance.

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

• Standalone Performance: Not applicable. This is a hardware imaging system, not an algorithm, so the concept of "standalone performance" of an AI algorithm does not apply. Its "performance" is inherently tied to its function as a tool for human use.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device's performance relies on objective engineering specifications, standardized test targets (e.g., resolution charts, color references), and regulatory safety standards. It's not based on expert consensus, pathology, or outcomes data in a clinical sense. For example, to test resolution, a known resolution target is imaged, and the system's ability to resolve details is measured.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a hardware imaging system and does not involve machine learning or AI models that require a "training set" of data.

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

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

In summary, the 510(k) process for a device like the VISERA ELITE III Surgical Imaging System primarily relies on demonstrating technical performance, safety, and substantial equivalence to legally marketed predicate devices through rigorous engineering testing (bench testing, electrical safety, EMC, software validation) against established standards, rather than clinical studies or AI model validation studies. The "acceptance criteria" are compliance with these standards and the "proof" is the successful completion of these tests.

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VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE VA2, CYF TYPE V2R : These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney.

EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 : This video system center has been designed to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 : This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

The EVIS EXERA II 180 SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment. This system with the compatible cystscopes is intended for endoscopic diagnosis, treatment and video observation of the bladder, urethra, ureter, and kidney.

The primary components of the subject system are:
VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE VA2, CYF TYPE V2R (CYF-V2, CYF-VA2, CYF-V2R)
EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180
EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180

The provided document is a 510(k) premarket notification for the "EVIS EXERA II 180 SYSTEM". This document is a regulatory filing for a medical device and describes its intended use, technological characteristics, and a comparison to a predicate device to demonstrate substantial equivalence. It does not contain information about the performance or study results of a device in the context of acceptance criteria as would be found in a clinical study report or a robust performance evaluation for an AI/ML device.

The relevant sections are:

• Section 7. Summary of Non-clinical Testing: States that "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment."
• Section 8. Conclusion: States that the device is "substantially equivalent" to predicate devices and does not change fundamental scientific technology or intended use.

Based on the provided text, I cannot provide the specific details requested regarding acceptance criteria and a study proving the device meets them in the manner of an AI/ML device performance evaluation because:

1. The document is a 510(k) submission, not a performance study report. It aims to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to independently prove specific numerical performance metrics against defined acceptance criteria using a test set with ground truth.
2. The device appears to be a traditional endoscopic imaging system, not an AI/ML-powered device. The questions regarding AI/ML-specific details (like human reader improvement with AI assistance, standalone algorithm performance, training set size, etc.) are therefore not applicable to this document.
3. The "acceptance criteria" mentioned are related to design verification tests and risk analysis based on ISO 14971:2007, which pertains to quality management systems and risk management for medical devices, not clinical performance metrics for diagnosis or treatment. The document does not list specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) as acceptance criteria for functionality or effectiveness in the way an AI/ML device would.

Therefore, I must state that the requested information cannot be extracted from the provided text. The document describes a regulatory pathway for a conventional medical device (an endoscope system) and refers to manufacturing and risk management standards rather than specific diagnostic performance studies with acceptance criteria and test set details.

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The Crystaleye Spectrophotometer/Crystaleye Basic Set CE100-DC/US is intended for use in automated color shade-matching to assist in dental restoration. The targeted teeth for color analysis are the left and right central incisors, lateral incisors and canines.

The Crystaleye Device is an automated color shade-matching device, based upon a database of reference tooth shades. The Crystaleye Device is comprised of the following components: Spectrophotometer, AC Adapter, Cradle, Contact Cap (5 pcs.), AC Cable, USB Cable, Master CDs, and Instructions. A personal computer is also required to run the Master CDs. The reference color tooth shades of multiple dental restoration manufacturers are loaded into the computer. The spectrophotometer captures an image of the target tooth, and the software matches a patient's color tooth shade with the closest available shade in the computerized reference database.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: 5 shades per set * 3 measurement points per shade * 5 sets of manufacturer shades = 75 unique measurement points/combinations. Each of these was tested 3 times, leading to a total of 225 test evaluations.
• Data Provenance: The study was a non-clinical bench test performed on the device itself. No information is provided regarding the country of origin of the reference shades or if they are representative of any specific geographic region. The "data" being evaluated is the device's ability to match to pre-loaded digital representations of these shades.

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

• The text does not explicitly state that human experts were used to establish the ground truth for the test set.
• The "ground truth" in this context appears to be the pre-defined, known shade from the reference shade guides that the device was designed to identify. The device's task was to match its spectrophotometer reading to one of these pre-loaded manufacturer shades. The test verified if the device's output matched the expected manufacturer shade, which themselves are standards.

4. Adjudication Method for the Test Set:

• None directly stated or implied. Given that the test involved the device identifying a specific, known manufacturer shade from its database, it's a binary outcome (correct/incorrect match to a pre-defined standard). There was no panel or group adjudicating discrepancies as the correct answer was already established by the shades themselves.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC study was NOT done. The document explicitly states: "The Premarket Notification does not rely upon any clinical performance data." The study described is a non-clinical bench test of the device's accuracy in matching pre-defined shades.
• Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance. The device is intended to assist humans, but its direct impact on human reader performance was not evaluated in this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Yes, a standalone test was done. The described "Bench testing" directly evaluates the "Crystaleye Device" without human intervention during the measurement and matching process. The device captures an image and then the software "matches a patient's color tooth shade with the closest available shade in the computerized reference database." The test then verifies if the device correctly identified the shade. While a human would visually evaluate the output of the device in clinical use, the test itself assesses the algorithm's performance in matching.

7. The Type of Ground Truth Used:

• The ground truth used was pre-defined manufacturer reference shades. These shades come from established commercial shade guides (e.g., VITAPAN CLASSICAL Shade Guide, VITA SYSTEM 3D-MASTER Tooth Guide). The device's database contains digital representations of these known shades, and the test verified the device's ability to correctly identify these known shades when presented with them.

8. The Sample Size for the Training Set:

• The document does not explicitly state the sample size for the training set. It mentions that "The Crystaleye Device utilizes the tooth shades from these shade guides in its shade-matching database," implying these shades form the database the device uses for matching, but it doesn't differentiate between training data for model development and the reference data used for operational matching.

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

• The "ground truth" for the device's internal database (which it matches against) was established from existing, legally marketed shade guides and shade teeth sets for manual color evaluation and matching. These are commercial standards from dental restoration manufacturers (e.g., VITAPAN CLASSICAL Shade Guide, VITA SYSTEM 3D-MASTER Tooth Guide, etc.). The device incorporates the "reference color tooth shades of multiple dental restoration manufacturers" into its computer. This suggests that the ground truth for its internal database is derived from these established physical shade guides.

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The EndoArm system consists of the EndoArm, a stabilizing fixation(adapter), Neuroendoscope (A1**A series). A number of components and accessories are also necessary for this system.

● EndoArm
This product has been designed for manipulation and positioning of the Neuroendoscope during neurosurgery and spinesurgery.

● Neuroendoscopes (A81000A, A81001A, A81002A, A81010A, A81011A, A81012A, A81031A, A81032A, A81041A, A81042A)
The Neuroendoscopes are intended for use in observation and diagnosis of the brain ventricles and brain parenchyma, such as observation and diagnosis of cerebral aneurysms, hypophysis tumors, hematomas, brain tumors, cerebral vascular systems, cranial nerve and vascular compression syndromes as well as observation and diagnosis of lumber and cervical spine, such as herniated disc material, nerve roots and nucleus material.

Subject device is a neurological endoscopy system, which consists of EndoArm, a stabilizing fixation component (adapter) and a family of rigid neurological endoscope. A number of component and accessories are also necessary for this system.

(1) EndoArm:
Mechanical: The Endoarm counter balance arm is designed to deliver smooth endoscope movement and steady fixation by use of compressed nitrogen gas to control the arm movement. The shape of the stand differs from the predicate device in that the predicate device is a bedside fixed design and subject device is a floor stand type. This allows physicians to move the endoscope near the target site only.
Illumination: The illumination is supplied by the Neuroendoscope through the light guide cable connected to the separate high intensity light source, OLYMPUS CLV-S40. This light source utilizes a Xenon 300W bulb.
Imaging: Another significant difference from the predicate device is the ability of the EndoArm to manage image data from the Neuroendoscope and allow the user to adjust zoom, focus and manage intego adda resiste the EndoArm from fine adjustment of the endoscope potion to image adjustment by one hand. This feature is accomplished by the connection of the Neuroendoscope through the adapter (A81020A) on the EndoArm. The image from the distal end of Neuroendoscope is transmitted to the monitor via the CCD of OTV-S7V camera head, mounted in the EndoArm.

(2) Neuroendoscope ( model: A81000A, A81001A, A81002A,A81010A, A81011A, A81012A, A81031A, A81032A, A81041A, A81042A): Ten telescope models are discussed in this premarket notification. The range of specifications covers two different insertion diameters ( ø 2.7mm / ø 4mm), five different working lengths (107mm/ 110mm / 112mm/134mm/ 137mm) and five different fields of view (0/ 30/ 70/ -30/-70 ( rorme). The crank shaped endoscope offers the largest operation space and microscopic dog. The craint on onail. In one doscope models are substantially equivalent to the predicate Neuroendoscope (#K971340).

(3) Adapter ( model: A81020A): The subject device is an adapter for connecting the Neuroendoscope A810**A series to the EndoArm stabilizing fixation device.

This submission is a 510(k) premarket notification for the OLYMPUS EndoArm, a neurological endoscopy system. The provided document does not contain specific acceptance criteria or a study proving the device meets acceptance criteria in the manner typically associated with clinical performance studies for AI/ML devices.

The submission is a declaration of substantial equivalence to previously marketed predicate devices (K971340, K982133, K991989). For such devices, acceptance criteria are primarily related to safety, operational specifications, and performance being equivalent to the predicate devices, rather than a clinical performance study with specific metrics like sensitivity or specificity.

Here's an analysis based on the information provided, highlighting why certain questions cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The document explicitly states: "Therefore the clinical data is not necessary for its evaluation of safety or effectiveness of the subject device." This indicates that a formal clinical study to prove acceptance criteria in the context of diagnostic or treatment efficacy was not performed or required for this 510(k) submission. Instead, the "study" is a technical comparison and demonstration of substantial equivalence to existing legally marketed devices, primarily focusing on design, materials, and functional specifications, along with compliance to relevant safety standards.

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

• Not applicable / Not provided. No clinical test set or data for performance evaluation (e.g., diagnostic accuracy) was used. The submission relies on technical specifications and comparison to predicates.

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 / Not provided. No ground truth establishment related to clinical diagnostic accuracy was performed.

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

• Not applicable / Not provided. No test set requiring expert adjudication was used.

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 / Not provided. This device is a neuroendoscopy system, not an AI/ML diagnostic or assistive device. No MRMC study was mentioned.

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

• Not applicable / Not provided. This is a medical device (endoscopy system), not a standalone algorithm.

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

• Not applicable / Not provided for clinical performance. The "ground truth" for this submission revolves around established engineering and material standards (e.g., IEC standards, ISO 10993-1) and the functional specifications of the predicate devices.

8. The sample size for the training set

• Not applicable / Not provided. 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 / Not provided. This is not an AI/ML device that requires a training set.

Summary of the "Study" for this 510(k) Submission:

The "study" presented in this 510(k) summary is a technical comparison against predicate devices and adherence to recognized safety standards. The manufacturer asserts that the OLYMPUS EndoArm is substantially equivalent to the identified predicate devices by demonstrating:

• Similar Intended Use: The intended uses for manipulation and positioning of neuroendoscopes and for observation/diagnosis are clearly stated and aligned with the general use of neurological endoscopes.
• Technological Characteristics Comparison: Detailed tables compare the EndoArm and Neuroendoscopes to their respective predicates, highlighting similarities and differences in features like support systems, driving power, imaging capabilities (zoom, rotation), directions of view, working lengths, and outer diameters. Differences are argued not to affect safety or effectiveness.
• Materials Equivalence and Biocompatibility: Patient-contacting materials are stated to be identical to previously cleared devices and confirmed with ISO 10993-1.
• Safety Standards Compliance: The device meets international safety standards (IEC60601-1, IEC60601-1-1, IEC60601-2-18).

The conclusion explicitly states that "When compared to the predicate devices, EndoArm does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness. Therefore the clinical data is not necessary for its evaluation of safety or effectiveness of the subject device." This confirms that the substantiation for this 510(k) relies on comparison to predicates and adherence to standards, not on new clinical performance data.

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This instrument has been designed to be used with an OLYMPUS compact i nici intrasound center, video system center, light source, documentation endoscopic uitraoound ochter, wtterrapy accessories and other ancillary equipment equipment, video mornior, Endo trony .
for endoscopic real time ultrasonic imaging, ultrasound guided needle aspiration and for ondoscopic rour and and within the airway and trancheobronchial tree and the gastrointestinal tract and surrounding organs.

The subject device has been designed to be used with the OLYMPUS EU-C60 EUS EXERA Compact Endoscopic ultrasound center, OLYMPUS video system center, light source, documentation equipment, display monitor, Endo-therapy accessories such as an aspiration biopsy needle.

The subject device is designed for endoscopic real-time ultrasonic imaging, for performing endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) within the airways and trancheobronchial tree and the gastrointestinal tract.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for a medical device (EVIS EXERA Ultrasonic Bronchofibervideoscope OLYMPUS BF type UC160F-OL8 and OLYMPUS EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center) seeking substantial equivalence to predicate devices.

Here's what the document does contain:

• Device Description: It describes the device, its intended use, design compliance with standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-18, CISPR11), and materials (biocompatibility testing for a new patient-contacting material).
• Comparison to Predicate Devices: It states that the subject device operates identically to a predicate device (K010591) and is basically identical in its imaging capabilities to another (K021024, K033225), except for the addition of a CCD in the control section for video signals.
• Conclusion: It concludes that because there are no significant changes in intended use, method of operation, or design that could affect safety and effectiveness compared to predicate devices, clinical data is not necessary for evaluation of safety and efficacy.

Since clinical data was deemed "not necessary," there is no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or expert ground truthing.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Training set details.

The 510(k) process often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than requiring new clinical studies to prove effectiveness, especially if the new device does not introduce significant changes in technological characteristics or indications for use.

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The "OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2)"has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, interfocking operation of the ancillary equipment.

The "OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) Software Version 2" has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, interlocking operation of the ancillary equipment.

Addition of the operating function for ancillary equipment (UES-40, OTV-SP1C, LUS-2, DSR-45, UPA-P100MD and SonoSuro-IU) enables the following:

• The operating function for ancillary equipment operates the additional ancillary equipment (UES-40, OTV-SP1C, LUS-2, DSR-45, UPA-P100MD and SonoSurg-IU) by Nurse's control panel and voice control.
  The voice control function enables the subject device to control the ancillary equipment by voice. You will find the details for voice commands and voice controllable equipment in "Standard set and ancillary equipment" and "Operation by voice control" in G. Device Description and Comparison.

The intended use of the EndoALPHA is to enable a central system to control various pieces of ancillary equipment. However, the approved indications for use for each separate ancillary device dictate the type of procedures that may be performed. This information is included in the instruction manual for each anciliary piece of equipment.

Here's an analysis of the provided text regarding the acceptance criteria and study for the OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) Software Version 2:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size:
  • For the voice recognition test: "some sample voice data." The exact number or duration of samples is not specified.
  • For the wrong recognition test: "some noise in operation room." The exact number or types of noise samples are not specified.
  • For the operating function tests (Nurse's control panel and Surgeon's controller): Not specified, though the phrasing "whether the... operation is performed correctly" implies testing of the various operations.
• Data Provenance: Not specified. It's likely an in-house test ("established in-house acceptance criteria") performed by the manufacturer, but the country of origin of the data is not mentioned. The study appears to be retrospective due to the focus on verification of developed features rather than prospective observation.

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

• Not specified. The document does not mention the use of external experts or their qualifications for establishing ground truth for these performance tests. The ground truth for these functional tests would inherently be the correct operation and recognition as defined by the device's specifications.

4. Adjudication Method for the Test Set:

• Not applicable/Not specified. The tests described are functional verification tests ("Voice recognition test", "Wrong recognition test", "Nurse's control panel operation test", "Surgeon's controller operation test") rather than diagnostic or interpretative tests requiring adjudication of results between experts. The "ground truth" for these tests is the expected functional behavior based on specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a MRMC comparative effectiveness study was not done. The document describes functional verification tests for software and system operation, not a study involving human readers or cases to assess diagnostic performance or comparative effectiveness.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, in essence, standalone performance was evaluated. The "Voice recognition test" and "Wrong recognition test", as well as the "Operating function" tests, are evaluations of the system's performance (the algorithm/software) independent of continuous human intervention beyond initial commands or control inputs. The performance of the voice recognition and system functions is described as being directly from the device's actions.

7. Type of Ground Truth Used:

• Functional Specification/Expected Behavior. For the voice recognition and operation tests, the ground truth is implicitly defined by the device's design specifications and expected correct behavior as implemented by the manufacturer. For example, for the voice recognition test, the ground truth is simply whether the device correctly recognizes the specified words. For the wrong recognition test, the ground truth is that the device should not recognize noise as a command.

8. Sample Size for the Training Set:

• Training set information is not provided. The document describes verification tests for an existing software version and its new features. It does not mention the machine learning component (if any) or training data used in the development of the voice recognition capability.

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

• Not specified. As the training set size and details are not provided, how its ground truth was established is also not mentioned.

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This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

The subject device, Bronchovideoscope Olympus XBF-D160HM, is basically identical to the predicate device, EVIS EXERA Bronchovideoscope Olympus BF type 160, except that the subject device is equipped with an optical system for high magnification observation in addition to an optical system for normal observation.

When compared to the predicate device, this high magnification bronchoscope enables more detailed observation of the target area. For example, a run of the capillary blood vessel in the bronchial mucosa can be observed, which is not observable with the predicate device.

This is a 510(k) premarket notification for a medical device, the Bronchovideoscope Olympus XBF-D160HM. The document asserts substantial equivalence to a predicate device, the EVIS EXERA Bronchovideoscope Olympus BF type 160 (K023984). The core of a 510(k) submission is to demonstrate that a new device is as safe and effective as a legally marketed predicate device, not necessarily to prove absolute safety and effectiveness through extensive clinical trials.

Therefore, the information regarding acceptance criteria and a study proving the device meets them will be limited, as this type of submission relies on a comparison to an already approved device rather than new performance studies with specific statistical endpoints.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present specific quantitative acceptance criteria or detailed performance metrics against those criteria in the way a clinical trial for a novel device would. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device. The performance is assessed by comparing technological characteristics and intended use.

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

No specific test set or associated sample size is mentioned in this 510(k) summary. The submission relies on a comparison of technical specifications and intended use against a previously cleared device. There is no independent "test set" of data from patients to evaluate performance. Therefore, data provenance (country, retrospective/prospective) is not applicable in this context.

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

This is not applicable as there was no "test set" and thus no ground truth established by experts in the context of this 510(k) submission. The FDA reviews the provided technical documentation and comparisons to the predicate device.

4. Adjudication Method for the Test Set

Not applicable, as there was no "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a conventional medical device (bronchoscope), not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or required for this type of submission.

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

Not applicable. This is a hardware medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in a 510(k) for substantial equivalence is the safety and effectiveness of the legally marketed predicate device. The new device's performance is not directly measured against an independent ground truth but rather by its similarity and lack of new safety/effectiveness concerns compared to the predicate. Therefore, no pathology, outcomes data, or expert consensus specific to the subject device was used as a ground truth.

8. The Sample Size for the Training Set

Not applicable. This is a hardware medical device, not an algorithm that requires a training set.

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

Not applicable.

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