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Found 1377 results
510(k) Data Aggregation
(161 days)
The Tuned Self-Fitting Mobile App is a software-only mobile medical application that is intended to be used with compatible wireless air-conduction hearing aids. The feature is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. The Tuned Self-Fitting Mobile App utilizes a self-fitting strategy and is adjusted by the user to meet their hearing needs without the assistance of a hearing healthcare professional. The device is intended for Over-the-Counter use.
The Tuned Self-Fitting Mobile App is a software-only, over the counter (OTC) medical application designed to support adults (18+) with perceived mild to moderate hearing loss. Available on both iOS and Android platforms, the app allows users to independently tune and personalize the settings of compatible wireless air-conduction hearing aids without requiring assistance from a hearing healthcare professional.
The Tuned Self-Fitting Mobile App utilizes calibrated pure-tone audiometry to conduct a self-administered hearing test and computes individualized amplification targets based on the NAL-NL2 prescription algorithm. It automatically configures connected hearing aids according to the results and enables additional fine-tuning by the user through intuitive controls for volume, frequency bands (low/mid/high), and preset sound environments such as everyday use, speech enhancement, music, and outdoor noise reduction.
The reason for this submission is to expand the use of the Tuned Mobile App, which was previously cleared under K223848 for use with the Lumen155 hearing aids (Intricon, USA), to include an additional compatible wireless air-conduction hearing aid, the NoviOne (Novidan, USA).
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(95 days)
The sterile single-use flexible video bronchoscopes are designed to be used with the Himaging endoscopic video processor, monitor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Himaging bronchoscope system is applicable to hospital environment or medical office environment.
The Himaging bronchoscopes are sterile single-use devices designed for use in adults.
The subject device, Himaging Bronchoscope System, is consisting of a single-use flexible video Bronchoscope and an endoscopic video processor. The subject device has been designed to be used for endoscopy within the airways and tracheobronchial tree.
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(85 days)
Bipolar applicator CelonProBreath is intended for use with a compatible electrosurgical generator. This method of treatment is also called bipolar Radiofrequency Induced Thermotherapy (RFITT).
Bipolar applicator CelonProBreath is indicated for ablation and coagulation of soft tissue in otorhinolaryngeal surgery, specifically:
- Shrinkage of submucosal tissue in nasal airway obstruction by reduction of hypertrophic nasal turbinates.
The product is intended to be used for patients from 2 years and up.
Bipolar applicator CelonProSleep plus is intended for use with a compatible electrosurgical generator. This method of treatment is also called bipolar radiofrequency induced thermotherapy (RFITT).
Bipolar applicator CelonProSleep plus is indicated for ablation and coagulation of soft tissue in otorhinolaryngeal surgery, specifically:
- Shrinkage of submucosal tissue and tissue coagulation in the soft palate for the treatment of snoring.
The product is intended to be used for patients from 18 years up.
The devices subject to this submission are sterile, single-use devices: the bipolar applicator CelonProBreath (WB990210 and WB990310) and the bipolar applicator CelonProSleep plus (WB990211 and WB990311). The devices are for use with a compatible electrosurgical generator. This method of treatment is also called bipolar radiofrequency induced thermotherapy (RFITT). The devices are intended for the ablation and coagulation of soft tissue in otorhinolaryngeal surgery.
Bipolar applicator CelonProBreath (WB990210 and WB990310) is specifically used for shrinkage of submucosal tissue in nasal airway obstruction by reduction of hypertrophic nasal turbinates.
Bipolar applicator CelonProSleep plus (WB990211 and WB990311) is specifically used for shrinkage of submucosal tissue and tissue coagulation in the soft palate for the treatment of snoring.
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(85 days)
The Ion™ Endoluminal System (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use.
The PlanPoint™ Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion™ Endoluminal System.
The Ion Endoluminal System, Model IF1000, is a software-controlled, electro-mechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. It consists of a Planning Laptop with PlanPoint Software, a System Cart with System Software, a Controller, Instruments, and Accessories.
The IF1000 Instruments include the Ion Fully Articulating Catheter, the Ion™ Peripheral Vision Probe, and the Flexision Biopsy Needles.
The Planning Laptop is a separate computer from the System Cart and Controller. A 3D airway model is generated from the patient's chest CT scan using the PlanPoint Software.
The System Cart contains the Instrument Arm, electronics for the follower portion of the servomechanism, and two monitors. The System Cart allows the user to navigate the Catheter Instrument with the Controller, which represents the leader in the leader-follower relationship. For optimal viewing, the physician can position the monitors in both vertical and horizontal axes.
The Controller is the user input device on the Ion Endoluminal System. It provides the controls to command insertion, retraction, and articulation of the Catheter. The Controller also has buttons to operate the Catheter control states.
The Ion Endoluminal System integrates an optional Tomosynthesis feature, optimizes the existing Cone Beam CT workflow, improves the Navigation View, troubleshoots the airway tree, and enhances the control algorithm to provide an additional safety margin.
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(25 days)
The Ion™ Endoluminal System (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis. The system is indicated for use with adult and pediatric populations. Pediatric use is limited to patients who are 5 ft (152.5 cm) or taller and weigh 102 lbs (46 kg) or greater.
The PlanPoint™ Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion™ Endoluminal System.
The Ion™ Endoluminal System, Model IF1000, is a software-controlled, electromechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. It consists of a Planning Laptop with PlanPoint™ Software, a System Cart with System Software, a Controller, Instruments, and Accessories. The IF1000 Instruments include the Ion™ Fully Articulating Catheter, the Ion™ Peripheral Vision Probe, and the Flexision™ Biopsy Needles.
The Planning Laptop is a separate computer from the System Cart and Controller. A 3D airway model is generated from the patient's chest CT scan using the PlanPoint™ Software.
The System Cart contains the Instrument Arm, electronics for the follower portion of the servomechanism, and two monitors. The System Cart allows the user to navigate the Catheter Instrument with the Controller, which represents the leader in the leader-follower relationship. For optimal viewing, the physician can position the monitors in both vertical and horizontal axes.
The Controller is the user input device on the Ion™ Endoluminal System. It provides the controls to command insertion, retraction, and articulation of the Catheter. The Controller also has buttons to operate the Catheter control states.
The IF1000 System and PlanPoint Software are modified to enable Remote Software Updates from the Intuitive server via secure network communication.
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(79 days)
The Flexible Bronchoscopes have been designed to be used with the video processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Flexible Bronchoscope is for use in a hospital environment. The Flexible Bronchoscope is a single-use device designed for use in adults.
The Flexible Bronchoscope (Model: BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) is intended to be used with the Portable Video Processor (cleared via K243497). The Flexible Bronchoscope is inserted through the airways and tracheobronchial tree during bronchoscopy, and when used with the compatible video processor and monitor, the endoscope system can be operated as intended and indicated. The Flexible Bronchoscope is a single-use endoscope, which consists of a Handle, an Insertion Section, and an Endoscope Connector. The handle includes a deflection lever, a lever lock, a push button for picture taking/video recording, a push button for suction, a connector for suction tubing, a Luer port for insertion of accessory devices and irrigation to the working channel and a LED for illumination. The insertion section contains one working channel, wiring to transmit the image signals to the video processor, and two optical fibers to transmit illumination from the handle to the distal tip. The distal bending section of the insertion section is controlled by the user via the deflection lever on the handle. The distal end of the insertion section contains a CMOS sensor for capturing image and transmitting it to the video processor, optical fibers for transmitting illumination from the LED inside the handle, and the distal opening of the working channel. The Endoscope Connector connects the endoscope handle to the video processor, which provides power and processes video signals from the endoscope. Same as the predicate, the subject device is also provided in 2 deflection versions (US/EU deflection).
This document is an FDA 510(k) clearance letter for a Flexible Bronchoscope, indicating substantial equivalence to a predicate device. However, it does not contain the level of detail requested regarding acceptance criteria and a specific study proving the device meets those criteria, particularly in the context of an AI/algorithm-driven device.
The provided text focuses on the physical and performance characteristics of the bronchoscope itself, its intended use, technological comparison to a predicate device, and various non-clinical tests (electrical safety, photobiological safety, mechanical/optical performance, biocompatibility, sterilization, shelf life, and package validation).
There is no mention of an AI component, an algorithm, or any study involving human readers, ground truth establishment, or performance metrics like sensitivity, specificity, or AUC. The "device performance" in this context refers to the bronchoscope's mechanical and optical functionality, not the diagnostic accuracy of an AI algorithm.
Therefore, most of the requested information cannot be extracted from this document.
Here's an attempt to answer based on the provided text, highlighting what is missing:
1. Table of acceptance criteria and reported device performance
The document does not present a formal table of "acceptance criteria" for a diagnostic algorithm with corresponding "reported device performance" in terms of clinical accuracy metrics (like sensitivity, specificity, AUC). Instead, it states that various non-clinical tests were performed to demonstrate compliance with recognized standards and that the device is "as safe, as effective, and performs as well as the legally marketed device identified above."
Below is a table summarizing the types of tests and the general conclusion, but without specific quantitative acceptance criteria or performance metrics related to diagnostic accuracy.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|---|
| Electrical Safety | Compliance with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC/TS 60601-4-2 standards. | In compliance with the specified FDA recognized standards. |
| Photobiological Safety | Compliance with IEC 62471:2006. | Tested according to IEC 62471:2006. |
| Mechanical Performance | Compliance with applicable parts of ISO 8600 (e.g., leakage tightness, bending, deflection endurance, tensile strength). | Tested for leakage tightness, bending, deflection endurance, and tensile strength; implied compliance. |
| Optical Performance (Direct) | Compliance with applicable parts of ISO 8600. | Optical measurements performed according to ISO 8600; implied compliance. |
| Optical Performance (Comparative) | Image quality parameters (direction of view, field of view, MTF/DOF, color performance, SNR/Dynamic Range, Distortion, Image intensity uniformity) comparable to reference device K173727 and K243857. | Comparative testing performed, results demonstrated subject device is as safe and effective as predicate. |
| Biocompatibility | Compliance with ISO 10993-1 and FDA Guidance. Absence of cytotoxicity, sensitization, irritation, pyrogenicity, acute systemic toxicity. | Evaluated for Cytotoxicity, Sensitization, Irritation, Material-mediated pyrogenicity, Acute systemic toxicity; implied compliance. |
| Sterilization & Shelf Life | Validation to ISO 11135:2014; EO/ECH residual test per ISO 10993-7:2008; Shelf life determined by stability study per ASTM F1980-21. | Sterilization method validated; EO/ECH residual test performed; shelf life determined through aging test. |
| Package Validation | Compliance with ISO 11607-1:2019, ISO 11607-2:2019, ASTM F88/F88M-21, ASTM F1929-15, ASTM D4169-22. | Conducted according to specified standards. |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not applicable/Not mentioned. This document describes a medical device (bronchoscope) itself, not an AI algorithm performing a diagnostic task on a dataset. The "tests" mentioned are non-clinical engineering and biological safety tests, not tests on a dataset.
- Data Provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable/Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no mention of "ground truth" in the context of an AI algorithm's diagnostic performance for which experts would be needed. The "ground truth" for the non-clinical tests would be the established performance specifications and standards for a bronchoscope.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As no expert ground truth establishment for a diagnostic AI is mentioned, no adjudication method would be relevant.
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. This document describes the clearance of a flexible bronchoscope, a physical medical device. It does not mention any AI component or a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. There is no mention of an algorithm in this document that would perform as a standalone device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. Ground truth in the context of diagnostic AI is not mentioned. For the non-clinical tests, the "ground truth" is compliance with established engineering and safety standards.
8. The sample size for the training set
- Not applicable. There is no mention of an AI model or a training set.
9. How the ground truth for the training set was established
- Not applicable. There is no mention of an AI model or a training set.
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(266 days)
The NeuroEars-Anna™ system provides information to assist in the nystagmographic evaluation, diagnosis, and documentation of vestibular disorders. Nystagmus of the eye is recorded using a head-mounted display equipped with eye-tracking cameras. These images are measured, recorded, displayed, and stored in the software. This information can then be used by trained medical professionals to assist in diagnosing vestibular disorders.
The NeuroEars-Anna™ system is intended for use in individuals aged 12 years and older, based on the physical compatibility of the FOVE VR headset (FOVE Inc., Japan). While the ANSI S3.45 standard does not define age-based limitations, the FOVE VR headset is generally suitable for individuals aged 12 and above. For improved fit, soft materials such as sponge pads may be used in cases where the headset does not conform properly to the user's face. This applies to both pediatric and adult patients. Any additional padding should be used only if it does not interfere with eye-tracking performance or measurement accuracy and must follow the manufacturer's instructions for proper use.
NeuroEars-Anna™ is a standalone software device that analyzes eye movements to assist medical professionals in the nystagmographic evaluation, diagnosis, and documentation of vestibular disorders. The NeuroEars-Anna™ software is intended to be used with off the shelf hardware including the HMD, PC, and monitors.
The NeuroEears-Anna™ software is designed to perform the following vestibular tests:
- Spontaneous Nystagmus Test
- Gaze-Evoked Nystagmus Test
- Head Shaking Nystagmus Test
- Fistula Nystagmus Test
- Dix-Hallpike Test
- Positional Test
- Smooth Pursuit Test
- Random Saccade Test
- Saccadometry Test
- Optokinetic Nystagmus Test
- Subjective Visual Vertical/Subjective Visual Horizontal (SVV/SVH)
- Caloric Test
- Video Frenzel
NeuroEars-Anna™ is a software program that analyzes eye movements recorded from an eye-tracking camera mounted on a head-mounted display (HMD) with eye-tracking specifications suggested by ANSI/ASA S3.45-2009 (Reaffirmed by ANSI April 16, 2024 version). The HMD devices used can be commercial products such as the FOVE0 (powerd by FOVE Inc., Japan), which meet these minimum eye-tracking specifications. The software is intended to run on a Microsoft Windows PC platform.
Here's a breakdown of the acceptance criteria and study information for NeuroEars-Anna™, based on the provided FDA 510(k) Clearance Letter:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria | Reported Device Performance | Pass/Fail |
|---|---|---|---|
| Eye Tracking Camera Frame Rate | • Minimum 60 Hz | • Hardware specification standard 120 Hz | Pass |
| Eye Tracking Accuracy | • Horizontal error: 0.1° to 1.0°• Vertical error: 0.4° to 1.0° | • Hardware specification standard: 1.15° median accuracy for uniform distribution across screen (<1 degree in center)• Internal validation results: Error within 1.0° | Pass |
| Visual Fixation Point Requirements | • The visual fixation point should move in various ways and speeds (0.2 Hz – 0.4 Hz) within a sufficient field of view of approximately 20° horizontally• The visual fixation point should be green-yellow or red | • Internal validation results: The visual fixation point moves in various ways and speeds (0.2Hz – 0.4Hz) within a sufficient field of view of approximately 20° horizontally• Internal validation results: The visual fixation point is red | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for the non-clinical performance tests mentioned. The clinical study section mentions testing "across multiple oculomotor tests," but doesn't quantify the number of patients or cases.
- Data Provenance: Not explicitly stated for the non-clinical performance tests. For the clinical study, it's mentioned that NeuroEars-Anna™ was "tested side by side with its predicate device," but the location or whether the data was retrospective or prospective is not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided in the given document. The non-clinical performance tests likely relied on instrument calibration and established measurement standards (like ANSI 3S.45). For the clinical study, it states the data is for "interpretation by qualified medical personnel trained in vestibular diagnostic testing," implying expert review, but the number and qualifications are not detailed.
4. Adjudication Method for the Test Set
- This information is not provided in the given document. For the non-clinical performance tests, adjudication would likely involve comparing device outputs against known or standard measurements. For the clinical study, the method for comparing NeuroEars-Anna™'s measurements to the predicate's and determining agreement or clinical reliability is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- A MRMC comparative effectiveness study that explicitly measures how human readers improve with AI vs. without AI assistance is not explicitly described.
- The document states: "The NeuroEars-Anna™ was tested side by side with its predicate device across multiple oculomotor tests. The results of these tests confirm that the NeuroEars-Anna™ provides clinically reliable and equivalent measurements compared to the predicate..." This suggests a comparison of the device's output to a predicate, not necessarily a human reader performance improvement study. The "assist" nature of the device (providing information for trained medical professionals) implies human-in-the-loop, but the format of the study doesn't detail an explicit MRMC study measuring reader improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, the performance testing described in the "Performance Testing Results" table appears to be a standalone (algorithm only) evaluation against technical acceptance criteria. The "Eye Tracking Camera Frame Rate," "Eye Tracking Accuracy," and "Visual Fixation Point Requirements" are objective measurements of the device's technical capabilities, independent of human interpretation.
- Additionally, the device is described as "standalone software device that analyzes eye movements," reinforcing its independent algorithmic function.
7. The Type of Ground Truth Used
- For the non-clinical performance tests (Eye Tracking Camera Frame Rate, Eye Tracking Accuracy, Visual Fixation Point Requirements), the ground truth appears to be based on:
- Hardware specifications/standards: For frame rate and accuracy, referring to "Hardware specification standard" (e.g., 120 Hz, 1.15° median accuracy).
- Internal validation results: Comparing measurements against expected or reference values derived during internal testing, aligning with the ANSI 3S.45 standard.
- For the clinical study, the ground truth is implicitly established by comparison to a "predicate device" which is "clinically reliable." This suggests the predicate device's measurements serve as the reference standard for "equivalent measurements."
8. The Sample Size for the Training Set
- The document does not provide information on the sample size used for the training set. It focuses on the clearance process based on comparisons and specific performance tests.
9. How the Ground Truth for the Training Set Was Established
- The document does not provide information on how the ground truth for the training set was established, as the training set details are not included.
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(420 days)
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."
| Test | Test Method Summary | Results (Device Performance / Acceptance) |
|---|---|---|
| Performance Testing: Simulated Use/Cycling | Versa One endoscope tested through multiple simulated use procedures and repeated instrument attachment/detachment cycles. | Passed. All acceptance criteria were met. Demonstrated intended performance as a rigid scope and safe use throughout its minimum expected life. |
| User Validation | Multiple users followed IFU to set up and use the system with an anatomical model and confirmed results in a cadaver model, following FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" and IEC 62366-1. | Passed. All users were able to choose appropriate attachment, attach instrument, and perform simulated procedure as intended. |
| Performance Testing: Optical Performance | Tested according to ISO 8600-X, ISO 12233, and ISO 15739 for optical performance. Evaluated signal to noise ratio, dynamic range, image quality (geometric distortion, MTF, FOV), image intensity uniformity, color accuracy, and endoscope image latency. | Passed. All devices met performance criteria. |
| Performance Testing: Simulated Use (Specifics) | Tested automatic exposure control, wireless link distance, Display power up, battery charge, battery status indicator, image rotation, HDMI port activity. Evaluated shaft durability and bend radius using an automated process. | Passed. All systems met performance criteria. Demonstrated reliable performance and wireless link reliability. |
| Performance Testing: Electrical Requirements (non 60601-1) | Inspected Versa One Display and Wireless HD Receiver for electrical requirements not included in IEC 60601-1 or IEC 60601-2-18 testing. Inspected Device charger, Display MOPP, isolation barriers, and HDMI connectors. | Passed. All devices met criteria. Demonstrated safe and reliable electrical performance. |
| Performance Testing: Dimension, Material, Environmental | Tested patient-contacting surface temperature, water splash, ambient temperature, dimensional and material requirements, cable force measurement, and leak testing of the distal end. | Passed. |
| Electrical Safety, electromagnetic compatibility (EMC), and RF Safety | Tested in compliance with IEC 60601-1, IEC 60601-2-18 (electrical safety), IEC 60601-1-2 (EMC), IEC 63195-1, and ANSI/IEEE C95.1-1 (RF Safety). | Passed. |
| Photobiological Safety | Tested in accordance with IEC 62471. | Passed. |
| Cleaning Validation | Tested per FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," AAMI TIR12 and AAMI ST98. | Passed. |
| Biocompatibility Testing | Tested per FDA Guidance, "Use of International Standard ISO 10993-1," ISO 10993-5, ISO 10993-10, ISO 10993-23. | Passed. Non-cytotoxic, non-sensitizing, non-irritating, non-systemically toxic, and non-pyrogenic. |
| Sterilization Validation | For scope: ISO 22441:2022 (low temp vaporized hydrogen peroxide). For sheaths: ISO 11135:2014 (ethylene oxide). Overkill test method used for scope. | Passed. |
Regarding the specific AI/ML and clinical study requirements you listed, the document does not provide the following information:
- 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.
- 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."
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 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.
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
- 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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(59 days)
UE BRONCHO Single-Use Bronchoscope: The UE BRONCHO Single-Use Bronchoscopes has been designed to be used with the UE Display, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The UE BRONCHO Single-Use Bronchoscopes is for use in a hospital environment. The UE BRONCHO Single-Use Bronchoscopes is single-use device designed for use in adults.
UE Display: The UE Display is reusable digital monitor, intended to display live imaging data from UE Medical visualization devices.
The bronchoscope system consists of UE BRONCHO Single-Use Bronchoscopes and UE Display. The UE BRONCHO Single-Use Bronchoscopes (the bronchoscopes) are sterile, single-use flexible video bronchoscopes available in three sizes (Slim, Regular, Large). The bronchoscopes have been designed to be used with the UE Display (reusable, non-sterile), endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The bronchoscope system is designed for use by adults in a hospital environment.
The provided FDA 510(k) clearance letter details the clearance of the UE BRONCHO Single-Use Bronchoscopes and UE Display. However, it does not contain specific acceptance criteria or details of a clinical study that demonstrates the device's performance against such criteria. The document explicitly states "Clinical study: Not applicable."
The clearance is based on non-clinical data, specifically performance testing and compliance with voluntary standards, which demonstrates substantial equivalence to a predicate device (Ambu® aScope™ 4 Broncho, Ambu® aView™ Monitor - K173727).
Therefore, I cannot populate the requested table and answer questions 2-9 with the provided text. The document refers to "bench performance testing" which includes optical performance, color reproduction, geometric distortion, resolution, depth of field, image intensity uniformity, noise, dynamic range, and frame rate, comparing these aspects with the predicate device. However, it does not specify quantitative acceptance criteria for these tests nor provide the reported device performance against such criteria in the detail requested.
Here's an attempt to populate the table and address the questions based only on the information available in the provided text. Where information is missing, it will be stated as "Not provided in the text."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Expected Value/Range) | Reported Device Performance | Comments from Text |
|---|---|---|---|
| Optical Performance | Not provided in the text (but implies compliance with ISO 8600 series) | Complies with ISO 8600 series | Bench testing performed according to ISO 8600. |
| Color Performance | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Color reproduction: compared with the predicate device. |
| Geometric Distortion | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Geometric distortion: compared with the predicate device. |
| Resolution | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Resolution: compared with the predicate device. |
| Depth of Field | 6-50 mm (same as predicate device) | 6-50 mm (same as predicate device) | Depth of view is 6-50 mm. |
| Image Intensity Uniformity | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Image intensity uniformity: compared with the predicate device. |
| Noise | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Noise: compared with the predicate device. |
| Dynamic Range | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Dynamic range: compared with the predicate device. |
| Frame Rate | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Frame rate: compared with the predicate device. |
| Field of View | Not provided in the text (Predicate: 85°) | 90° | Field of view (degree): 90° (subject device) vs 85° (predicate). Deemed "Similar". |
| Deflection Angle | Up: 180°, Down: 180° (for Slim/Regular sizes) | 180° up, 180° down | "Same" as predicate for Slim/Regular, "Similar" for Large (predicate Large is 160° down). |
| Insertion Tube Outer Diameter | Matches predicate (Slim: 3.8mm, Regular: 5.0mm, Large: 5.8mm) | EBS-380C: 3.8 mm, EBS-500C: 5.0 mm, EBS-600C: 5.8 mm | "Same". |
| Insertion Portion Maximum Diameter | Equivalent to predicate (Slim: 4.3mm, Regular: 5.5mm, Large: 6.3mm) | EBS-380C: 4.4 mm, EBS-500C: 5.5 mm, EBS-600C: 6.5 mm | "Equivalent". |
| Minimum Working Channel Diameter | Equivalent to predicate (Slim: 1.2mm, Regular: 2.0mm, Large: 2.6mm) | EBS-380C: 1.15 mm, EBS-500C: 2.15 mm, EBS-600C: 2.75 mm | "Equivalent". |
| Average Working Channel Diameter | Matches predicate (Slim: 1.2mm, Regular: 2.2mm, Large: 2.8mm) | EBS-380C: 1.2 mm, EBS-500C: 2.2 mm, EBS-600C: 2.8 mm | "Same". |
| Minimum ETT Inner Diameter Size | Matches predicate (Slim: 5.0mm, Regular: 6.0mm, Large: 7.0mm) | EBS-380C: 5.0 mm, EBS-500C: 6.0 mm, EBS-600C: 7.0 mm | "Same". |
| Minimum DLT Inner Diameter Size | Similar to predicate (Slim: 35 Fr, Regular: 41 Fr, Large: N/A) | EBS-380C: 35 Fr, EBS-500C: N/A, EBS-600C: N/A | "Similar". |
| Biocompatibility | Compliance with ISO 10993-1 | Evaluated and in accordance with ISO 10993-1 and FDA guidance. | Biocompatibility testing performed. |
| Sterilization Process | Compliance with ISO 11135:2014 | Validated in accordance with ISO 11135:2014. | Sterilization and shelf life testing performed. |
| EO/ECH Residual | Compliance with ISO 10993-7 | Test performed according to ISO 10993-7. | Sterilization and shelf life testing performed. |
| Shelf Life | 3 years (based on accelerated aging) | 3 years | Shelf life determined by accelerated aging (ASTM F1980). |
| Package Validation | Compliance with ISO 11607-1 and ISO 11607-2 | Conducted according to ISO 11607-1 and ISO 11607-2. | Package validation performed. |
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-2-18 | System complies with IEC 60601-1 and IEC 60601-2-18. | Electrical safety and EMC testing performed. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | System complies with IEC 60601-1-2. | Electrical safety and EMC testing performed. |
| Software Verification and Validation | Compliance with FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions" | Conducted and documentation provided as recommended by FDA guidance. | Software V&V testing performed. |
2. Sample size used for the test set and the data provenance
Not provided in the text. The document refers to "bench performance testing" which typically uses a limited number of physical units or simulated conditions, rather than a "test set" of patient data as might be relevant for AI/ML devices. No human patient data was used for testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical study or expert-based ground truth establishment for a test set is mentioned. The testing was non-clinical bench testing.
4. Adjudication method for the test set
Not applicable, as no clinical study involving expert interpretation or adjudication is 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. The document explicitly states "Clinical study: Not applicable." Therefore, an MRMC study was not performed. This device is a bronchoscope system, 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 device is a bronchoscope system. While it has software and display capabilities, it is not an algorithm that performs a diagnostic or analytical function independently of a human operator, and no standalone performance study in this context was mentioned.
7. The type of ground truth used
For the non-clinical bench tests (e.g., optical performance, physical dimensions, electrical safety), the "ground truth" would be established by direct physical measurements, adherence to engineering specifications, and compliance with recognized international standards (e.g., ISO 8600, IEC 60601 series, ISO 10993 series). There is no "ground truth" in the clinical sense (e.g., pathology, outcomes data, expert consensus) as no clinical studies were performed.
8. The sample size for the training set
Not applicable. This device is a bronchoscope system and not an AI/ML device that requires a training set of data for model development.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
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(179 days)
The Vathin®H-SteriScopeTM single-use flexible video bronchoscope has been designed to be used with the Vathin display unit, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree in patients.
The Vathin® Video Bronchoscope System is for use in a hospital environment.
The Vathin®H-SteriScopeTM single-use flexible video bronchoscope is a single-use device designed for use in adults, with the BCV1-02 and BCV1-C2 also designed for pediatric use (BCV1-02: 6 months to 6 years; BCV1-C2: 6 years and older).
The Vathin® Video Bronchoscope System consists of Vathin®H-SteriScopeTM Single use flexible Video Bronchoscope (model: BCV1-02, BCV1-C2) to be introduced within the airways or tracheobronchial tree and Vathin®VisionCenterTM Digital Video Monitor (model: DVM-B1, DVM-B2) for clinical image processing.
The Vathin®H-SteriScopeTM Single-use flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Vathin®VisionCentereTM Digital Video Monitor provides power and processes the images for medical electronic endoscope.
Vathin®H-SteriScopeTM Single-use flexible Video Bronchoscope is a sterile single-use flexible bronchoscope. Vathin®H-SteriScopeTM Digital Video Monitor is a reusable monitor.
I regret to inform you that the provided FDA 510(k) clearance letter and accompanying 510(k) Summary for the Vathin® Video Bronchoscope System do not contain the specific information required to answer your detailed questions about acceptance criteria and the study proving device performance as it relates to AI/software functionality.
This document focuses on justifying Substantial Equivalence for a bronchoscope system based on its physical characteristics, safety standards (electrical, biocompatibility, sterilization), and basic performance (optical, mechanical). It mentions "Software verification and validation" in Section 7.4, citing the "FDA guidance: Content of Premarket Submissions for Device Software Functions," but does not provide any specific acceptance criteria, study data, or details about the software's functionality, especially regarding AI capabilities.
Therefore, I cannot populate the table or answer the specific questions about AI performance, test set details, ground truth establishment, or human reader studies.
Here's why the document is insufficient for your request:
- No AI/Algorithm Claims: The document describes a video bronchoscope and its display unit. It doesn't mention any AI or advanced algorithmic functions (e.g., automated lesion detection, image enhancement using AI, diagnostic support) that would necessitate performance criteria like sensitivity, specificity, or reader studies.
- Focus on Hardware/System Performance: The performance data section (7.1-7.6) primarily addresses the physical and electrical safety, biocompatibility, sterilization, and basic optical/mechanical functions of a medical device (bronchoscope). The "Software verification and validation" entry is generic and doesn't detail any specific software performance study.
- Substantial Equivalence Justification: The entire 510(k) submission aims to prove that the Vathin® Video Bronchoscope System is "substantially equivalent" to existing cleared bronchoscopes. This process typically focuses on demonstrating comparable safety and effectiveness, not necessarily advanced algorithmic performance.
To answer your questions, one would need a 510(k) that specifically addresses an AI/ML-enabled medical device. Such a submission would include detailed performance studies with metrics like sensitivity, specificity, AUC, and often include multi-reader, multi-case (MRMC) studies to demonstrate clinical impact.
If you had provided a 510(k) document for an AI-powered device, the table and answers would look something like this (conceptual example):
Conceptual Example - This section is not based on the provided document as it does not contain the necessary information.
For an AI-powered medical device, the acceptance criteria and study proving its performance would be detailed as follows:
1. Acceptance Criteria and Reported Device Performance
| Metric (for AI-enabled feature, e.g., Nodule Detection) | Acceptance Criteria (e.g., for standalone performance) | Reported Device Performance |
|---|---|---|
| Standalone Performance | ||
| Sensitivity (Recall) | ≥ 90% for nodules > 4mm | 92.5% |
| Specificity | ≥ 80% | 83.1% |
| FROC Score (Free-response ROC) | ≥ 0.85 | 0.87 |
| AI-Assisted Performance (If applicable) | ||
| Reader ROC AUC Improvement | Statistically significant improvement (p < 0.05) vs. unaided | Mean AUC improvement of 0.045 (p < 0.001) |
| Reading Time Reduction | Mean reading time reduction of ≥ 10% | 15% reduction |
2. Sample Size and Data Provenance for Test Set
- Test Set Size: 500 unique patient studies (e.g., Chest CT scans).
- Data Provenance:
- Country of Origin: Multi-centric from USA (40%), Europe (30%), Asia (30%).
- Retrospective/Prospective: Primarily retrospective, collected from hospital PACS archives. Data selection ensured diversity in pathology, image quality, and scanner types.
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: 3 independent expert readers.
- Qualifications: All were board-certified radiologists with subspecialty training in thoracic imaging and a minimum of 10 years of experience in interpreting chest CT scans for pulmonary nodules.
4. Adjudication Method for Test Set
- Method: 2+1 Adjudication.
- Initial reads by two independent expert radiologists.
- If their interpretations differed, a third, senior-most expert radiologist reviewed the case and made the final decision.
- Discrepancies were resolved through consensus or majority vote. All disagreements requiring a third read were documented.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? Yes.
- Effect Size (Human Readers Improvement with AI vs. Without AI):
- The MRMC study demonstrated a statistically significant improvement in diagnostic accuracy (measured by ROC AUC) for radiologists using the AI device compared to those reading without AI assistance.
- Mean ROC AUC: 0.85 (without AI) vs. 0.895 (with AI).
- Effect Size: Mean improvement in AUC was 0.045 (absolute difference), which corresponds to a relative improvement of approximately 5.3% in diagnostic accuracy. The 95% confidence interval for this improvement did not include zero, confirming statistical significance (p < 0.001).
- Additional Finding: Average reading time per case decreased by 15% when using AI.
6. Standalone Performance Study
- Was it done? Yes.
- Details: The algorithm's performance was evaluated independently against the established ground truth for nodule detection and characterization. Standalone metrics included sensitivity, specificity, and FROC analysis, as detailed in the acceptance criteria table above.
7. Type of Ground Truth Used for Test Set
- Type: Expert Consensus, supported by available pathology reports (where biopsy was performed) and longitudinal follow-up data (e.g., 2-year stability on subsequent CT scans for benign lesions, or growth for malignant lesions). Pathology or follow-up was prioritized when available.
8. Sample Size for Training Set
- Training Set Size: 50,000 unique patient studies (e.g., Chest CT scans).
9. How Ground Truth for Training Set was Established
- Method: A combination of automated data labeling (using existing radiology reports, structured data, and keywords) followed by expert review and annotation.
- An initial pass of automated labeling identified potential regions of interest.
- These regions were then reviewed and carefully annotated by a team of trained radiology residents and fellows under the supervision of experienced radiologists.
- For ambiguous cases, a consensus reading of at least two radiologists was required.
- Pathology reports and longitudinal follow-up data (when available) were also incorporated to refine annotations and confirm ground truth.
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