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510(k) Data Aggregation
(179 days)
Vathin® Video Bronchoscope System
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 |
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(146 days)
Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00
The Single-use Flexible Bronchoscope has been designed to used with Vathin Display Units, endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Digital Video Monitor is specially designed to be used with Vathin medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
The Video Bronchoscope System is for use in professional Healthcare Facility Environment.
The Video Bronchoscope System consists of a Single-use Flexible Bronchoscope to be introduced within the airways or tracheobronchial tree and a Digital Video Monitor for endoscopic image processing and displaying. The flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Digital Video Monitor receives, processes the real-time image signal from the endoscope and displays the live image on the screen.
The Single-use Flexible Bronchoscope has six models: BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00. The main differences between product models are the size of the device channel, the color of the rotating sleeve, and whether it is self-locking.
The provided text is a 510(k) summary for the "Video Bronchoscope System" and does not contain detailed information about specific acceptance criteria and the study that proves the device meets those criteria in the format requested.
The document discusses substantial equivalence to predicate devices and lists various non-clinical tests performed, along with a general statement that "All tests were passed." However, it does not provide:
- A table of specific acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance for performance studies.
- Information about experts, adjudication methods, or MRMC studies.
- Details on standalone algorithm performance (as this is a physical device, not an AI algorithm).
- Specific ground truth types used for performance evaluation.
- Training set sample size or ground truth establishment for training.
The document focuses on:
- Biocompatibility testing: Evaluated according to ISO 10993-1:2018 (Cytotoxicity, Irritation, Sensitization, Pyrogenicity, Acute systemic toxicity). All evaluation acceptance criteria were met.
- Sterilization and shelf-life testing: Validated according to ISO 11135.
- Electrical safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1, IEC 60601-2-18, and IEC 60601-1-2 for EMC.
- Software Verification and Validation Testing: Conducted as recommended by FDA guidance.
- Performance testing: Included optical tests (color rendering index, illuminance, correlated color temperature, geometric distortion, color restoration, resolution, depth of field, field of view, direction of view, signal-to-noise ratio, dynamic range, geometric distortion, image brightness uniformity, field of view) and mechanical tests (working length, minimum instrument channel width, outer diameter of main hose, max. outer diameter, bending angle, water delivery capacity and attractive volume capacity test).
- Shelf-life verification test and Packaging verification test.
Without more specific detailed performance data from the confidential section of the 510(k) submission, it is not possible to provide the requested information in the specified format. The document only offers a high-level summary of tests conducted and their successful completion.
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(144 days)
Vathin® Video Bronchoscope System
The Vathin® H-SteriScopeTM I Single use flexible Video Bronchoscope has been designed to be used with the Vathin® Displaying Unit, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Vathin® Video Bronchoscope System is for use in a hospital environment.
Not Found
I am sorry, but the provided text from the FDA 510(k) clearance letter for the Vathin® Video Bronchoscope System does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The letter is a standard FDA clearance document that states the device has been found substantially equivalent to a legally marketed predicate device. It discusses regulatory aspects, such as general controls, potential additional controls for Class II/III devices, and compliance with various FDA regulations.
It does not include details on:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test or training sets, nor data provenance.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (e.g., expert consensus, pathology).
- How ground truth for any set was established.
Therefore, I cannot fulfill your request for this information based on the provided text. To obtain such details, you would typically need to refer to scientific publications, clinical trial reports, or other technical documentation directly submitted to the FDA, which are not part of this clearance letter.
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(447 days)
PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
PENTAX Medical Single Use Video Bronchoscope EB-S01 is sterile single use flexible endoscopes intended for use with PENTAX Medical mobile processor, therapeutic accessories, and other ancillary equipment for endoscopy and endo-therapeutic procedures within the airways and tracheobronchial tree.
PENTAX Medical Mobile Processor ONE-M is intended to be used with PENTAX Medical endoscopes and other peripheral devices for endoscopic diagnosis, treatment and video observation.
PENTAX Medical Mobile Processor Plug-in ONE-Dock is intended to be attached to the PENTAX Medical Mobile Processor to provide additional ports for hardware interface.
PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System is intended to provide the optical visualization of the airways and tracheobronchial tree for diagnostics and therapeutic applications. The PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System consist of the following three component devices:
- . PENTAX Medical Single Use Video Bronchoscope EB11-S01 / EB15-S01
- . PENTAX Medical Mobile Processor ONE-M
- . PENTAX Medical Mobile Processor Plug-in ONE-Dock
The EB11-S01 / EB15-S01 endoscopes are connected to the ONE-M and video images captured with the bronchoscope are displayed on the touch screen of the ONE-M. The ONE-M is also connected to the Plug-in ONE-Dock, which has several interfaces, such as an external monitor to display captured images by the bronchoscope and a connection with an external network.
Based on the provided text, the document is a 510(k) Premarket Notification for the PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving clinical effectiveness through extensive clinical trials for new indications or technologies. Therefore, the information provided focuses on demonstrating equivalence through non-clinical performance data and technological comparisons, rather than a clinical study with detailed acceptance criteria and a human-in-the-loop performance study as might typically be found for AI/ML device submissions.
The document does not describe a study that proves the device meets specific acceptance criteria related to an AI/ML algorithm's diagnostic performance, as it is a bronchoscope system, not an AI/ML diagnostic aid. It lists various non-clinical performance tests to demonstrate substantial equivalence to a predicate device.
Therefore, many of the requested fields regarding acceptance criteria, study design for AI/ML, human expert involvement, and ground truth establishment are not applicable or not detailed in this submission because it is not an AI/ML device submission for diagnostic accuracy.
However, I can extract the relevant information that is present and explain why other requested information is not available:
1. A table of acceptance criteria and the reported device performance:
The document describes general performance equivalency rather than specific quantitative acceptance criteria for image analysis or diagnostic performance of an AI system. The key "acceptance criteria" here relate to demonstrating equivalence to a predicate device and meeting recognized standards for safety and performance (e.g., electrical safety, biocompatibility).
| Category | Acceptance Statement (Implied Criteria) | Reported Device Performance |
|---|---|---|
| Intended Use/Indications | Must have the same or similar intended use and indications for use as the predicate device. | "The predicate and subject device have the same Intended use and Indications for Use..." (Page 4). "There are no differences in indications for use and intended use between the subject and predicate device and are therefore, substantially equivalent." (Page 9) |
| Technological Characteristics | Must have similar fundamental technology, operating principles, design features, and constituent materials. | "The components of the subject device have the same fundamental technology and operating principles as the predicate device, as well as the same intended use." (Page 7). Minor differences (i-Scan™ technology) evaluated. |
| Reprocessing Validation | Not required if device is single-use and sterile. | "EB-S01 scopes are provided sterile for single use and are discarded after use. Therefore, reprocessing validation is not required." (Page 8) |
| Sterilization & Shelf Life | Validation of EO sterilization in accordance with specified ISO standards; stated shelf life. | Validated per ISO 11135:2014, AAMI/ANSI/ISO 10993-7:2008, ISO 11737-1:2018, and ISO 11737-2:2019. Shelf-life is 1 year. (Page 8) |
| Biocompatibility | Confirmation of biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity) per ISO 10993 standards; risk level "Acceptable." | Confirmed per ISO 10993-1, 5, and 10. Risk levels of local toxicity determined as "Acceptable." (Page 8) |
| Software & Cybersecurity | Verification and validation per IEC 62304 and FDA guidance documents. | Conducted according to IEC 62304:2006 + A1:2015 and relevant FDA guidance documents ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," and "Post-market Management of Cybersecurity in Medical Devices"). (Page 8) |
| Electrical Safety & EMC | Confirmation of acceptable levels per specified IEC standards. | Confirmed per IEC 60601-1-2:2014; IEC 60601-1:2005+CORR 1:2006+CORR 2:2007+A1:2012; and IEC 60601-2-18:2009. (Page 9) |
| System Performance | Demonstrated equivalence to the predicate device. | "The system performance of the subject device demonstrated the equivalence to the predicate device." (Page 9) |
| Optical Performance | Measured and shown to be equivalent to the predicate device. | "All results show that the optical characteristics of the subject device is equivalent to those of the predicate device." (Page 9) |
| Animal Image Capture | Must be able to visualize vascularity and mucosal surface as well or better than the predicate device. | "The results indicate that the subject device is able to visualize vascularity and mucosal surface for each anatomical area as well or better than the predicate device." (Page 9) |
2. Sample size used for the test set and the data provenance:
- Test Set: Not applicable in the context of an AI/ML "test set" for diagnostic performance. Performance testing involved various engineering and animal studies. For the "Animal Image Capture Study," an animal model was used, but the specific number of animals is not provided. The data provenance is implied to be from internal testing by PENTAX Medical.
- Data Provenance: Implied to be from internal testing and validation studies conducted by PENTAX Medical (e.g., "PENTAX Medical coordinated with HA2 Medizintechnik GmbH (German company) to validate the use of EO sterilization"). The animal study location and specifics are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. The ground truth for this device's performance does not involve human expert adjudication of images for diagnostic purposes in the way it would for an AI/ML algorithm. The performance evaluation focused on physical, electrical, and optical properties as well as safety and biocompatibility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this is not an AI/ML diagnostic device requiring expert adjudication of results.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a bronchoscope system, not an AI-assisted diagnostic tool for image interpretation. 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, as this is a medical device for direct visualization and not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the AI/ML sense. The "ground truth" for this submission are the established performance specifications for medical devices, relevant ISO standards, and the performance of the predicate device, against which the subject device's non-clinical performance was compared (e.g., electrical safety standards, biocompatibility testing results, optical measurements, and visualization capabilities in an animal model).
8. The sample size for the training set:
Not applicable. 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.
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(103 days)
Vathin Video Bronchoscope System
The Vathin® H-SteriScopeTM I Single use flexible Video Bronchoscope has been designed to be used with the Vathin® Displaying Unit, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Vathin® Video Bronchoscope System is for use in a hospital environment.
Not Found
The provided text is an FDA 510(k) clearance letter for the Vathin Video Bronchoscope System. It does not contain any information about acceptance criteria, device performance studies, or details regarding AI algorithms.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, ground truth establishment, or multi-reader multi-case studies, as this data is not present in the given document.
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(185 days)
SPiN Vision Video Bronchoscope System
The Veran SPIN VisionTM Single-Use Flexible Bronchoscope is intended to be used with the SPiN Vision™ Digital Video Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Veran SPiN Vision™ Single-Use Flexible Bronchoscopes and SPiN Vision™ Video Processor are for use in hospitals, clinics, and/or urgent care centers by trained physicians.
The Veran SPiN Vision™ Bronchoscope System consists of the Veran SPiN Vision™ Single-Use Flexible Video Bronchoscope accessories (Model Nos. INS-7100 and INS-7130) and the Veran SPiN Vision™ Video Processor (Model: SYS-5100) for clinical image processing. The Veran SPiN Vision™ Single-Use Flexible Bronchoscope is introduced within the airways or tracheobronchial tree during Bronchoscopy. The Veran SPiN Vision™ Video Processor provides power and processes the images for medical electronic endoscope.
The Veran SPiN Vision™ Single-use Flexible Video Bronchoscope is a sterile, single use flexible bronchoscope. The Veran SPiN Vision™ Video Processor is a reusable device.
The light emitted by the LED cold light source of the Veran SPiN Vision™ Single-use Flexible Video Bronchoscope 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 Veran SPiN Vision™ Video Processor via the encoding circuit. The Veran SPiN Vision™ Video Processor 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.
The Veran SPiN Vision™ Single-use Flexible Video Bronchoscope 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
- Working channel
- Sterilized by Ethylene Oxide
- For single use
The differences between the Veran SPiN Vision™ Single-use Flexible Video Bronchoscope models are as follow:
- Working channel diameters
- Insertion tube outer diameter
The Veran SPiN Vision™ Video Processor has the following physical and performance characteristics:
- Provides images from the Veran SPiN Vision™ Single-use Flexible Video Bronchoscope for observation
- Can connect to an external monitor
- Reusable device
This document is a 510(k) Summary for the Veran SPiN Vision™ Bronchoscope System, which makes a claim of substantial equivalence to a predicate device. It does not contain the detailed acceptance criteria, device performance reports, or study methodologies typically associated with proving a device meets acceptance criteria through a standalone study or multi-reader multi-case comparative effectiveness study.
Therefore, many of the requested details cannot be extracted from this document, particularly those related to a standalone algorithm performance, MRMC studies, or robust data provenance for AI/algorithm-based performance claims.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests conducted, but does not provide specific acceptance criteria or quantitative performance results for comparison. It only states, "All tests passed."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | All tests passed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The performance data mentioned are for non-clinical bench testing, not clinical test sets or patient data.
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)
This information is not applicable as the document describes non-clinical bench testing, not a clinical study involving experts establishing ground truth from patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document describes non-clinical bench testing, not a clinical study requiring adjudication of findings.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in this document. The device is a bronchoscope system, not an AI or imaging diagnostic algorithm designed to assist human readers in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm was not done or described. This submission is for a medical device (bronchoscope system) and its accessories, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests would be the established engineering and safety standards (e.g., ISO, IEC, and internal specifications) against which the device's physical and electrical performance was measured. It is not expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set
This information is not applicable as there is no mention of an algorithm requiring a training set for machine learning.
9. How the ground truth for the training set was established
This information is not applicable as there is no mention of an algorithm requiring a training set for machine learning.
Summary of available information:
The provided document is a 510(k) summary for the Veran SPiN Vision™ Bronchoscope System, focusing on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. It does not include details on clinical studies, AI algorithm performance, or human reader studies, which are typically where detailed acceptance criteria and performance metrics for AI-based medical devices are presented. The performance data provided relates to the physical, electrical, and sterile properties of the bronchoscope system itself.
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(220 days)
Vathin Video Bronchoscope System
The Vathin®H-SteriScopeTM I Single-use flexible Video Bronchoscope have been designed to be used with the Vathin@VisionCenterTM I Digital Video Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Vathin® Video Bronchoscope System is for use in a hospital environment.
The Vathin® Video Bronchoscope System consists of Vathin®H-SteriScope™ I Singleuse flexible Video Bronchoscope (eighteen models shown in below) to be introduced within the airways or tracheobronchial tree and Vathin®VisionCenter™ I Digital Video Processor (model: DVP-A1) for clinical image processing. The Vathin®H-SteriScope™ I Single-use flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Vathin®VisionCenter™ I Digital Video Processor provides power and processes the images for medical electronic endoscope.
Vathin®H-SteriScope™ I Single-use flexible Video Bronchoscope is a sterile single used flexible bronchoscope. Vathin®VisionCenter™ I Digital Video Processor is a reusable monitor.
The light emitted by the LED cold light source of the Vathin®H-SteriScope™ I Singleuse flexible Video Bronchoscope 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 Vathin®VisionCenter™ I Digital Video Processor via the encoding circuit. The Vathin®VisionCenter™ I Digital Video Processor 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.
Vathin®H-SteriScope™ I Single-use flexible Video Bronchoscope 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 Vathin®H-SteriScope™ I Single-use flexible Video Bronchoscope models are as follow:
- Presence or absence of working channel
- Working channel inner diameter
- Insertion tube outer diameter
- The length of insertion tube
Vathin®VisionCenter™ I Digital Video Processor has the following physical and performance characteristics:
- Provide image from Vathin®H-SteriScope™ I Single-use flexible Video Bronchoscope for observation
- Can connect to an external monitor
- Reusable device
This document describes the regulatory approval for the Vathin® Video Bronchoscope System. However, it does not contain a study that establishes acceptance criteria for direct device performance in a clinical context, nor does it provide details of a study specifically designed to prove the device meets such criteria.
The provided text focuses on demonstrating substantial equivalence to a predicate device (Ambu® aScope™ 3 System) through non-clinical performance data and adherence to recognized standards.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document presents a comparison table (Page 6-7) of technological characteristics between the subject device (Vathin® Video Bronchoscope System) and the predicate device (Ambu® aScope™ 3 System). While these are not explicitly termed "acceptance criteria" in the context of a clinical performance study, they represent the design and performance specifications against which the device was evaluated for substantial equivalence. The "Remark" column indicates how the subject device's performance compares to the predicate.
| Specification | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Subject Device) |
|---|---|---|
| K Number | K173727 | K191828 |
| Manufacturer | Ambu A/S | Hunan Vathin Medical Instrument Co., Ltd. |
| Model | Ambu® aScope™ 3 Slim 3.8/1.2; Ambu® aScope™ 3 Regular 5.0/2.2; Ambu® aScope™ 3 Large 5.8/2.8; Ambu® aView™ Monitor; Ambu® aScope™ 4 Broncho Slim 3.8/1.2; Ambu® aScope™ 4 Broncho Regular 5.0/2.2; Ambu® aScope™ 4 Broncho Large 5.8/2.8 | Vathin®H-SteriScope™ I Single-use flexible Video Bronchoscope (18 models); Vathin®VisionCenter™ I Digital Video Processor DVP-A1 |
| Device Trade name | Ambu® aScope™ 3 System | Vathin® Video Bronchoscope System |
| Intended Use | The aScope 3 endoscopes have been designed to be used with the aView monitor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. | The Vathin™ Single-use video endoscope have been designed to be used with the Vathin®VisionCenterTM I Digital Video Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. |
| Working place/User | Use in a hospital environment by trained surgical physicians who are familiar with endoscopic procedures. | Use in a hospital environment by trained surgical physicians who are familiar with endoscopic procedures. |
| Population | Adults | Adults |
| Technology | The Flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. Anatomical images are transmitted to the user by the video processor with a CMOS chip at the distal end of the endoscope and the images showing on a monitor. | The Flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. Anatomical images are transmitted to the user by the video processor with a CMOS chip at the distal end of the endoscope and the images showing on a monitor. |
| Conical lock | 6 % (Luer) taper | 6 % (Luer) taper |
| Performance | Complies with: ISO 8600 | Complies with: ISO 8600 |
| Field of view (degree) | 85° | 110° ± 5% |
| Direction of view (degree) | 0 | 0 |
| Depth of view | 8 – 19mm | 3-30mm |
| Bending angle (degree) | Slim and Regular: Up: 130, Down: 130; Large: Up: 140, Down: 110 | Up: 210, Down: 210 |
| Endurance of the bending section | More than 1000 times, the maximum of 1700 times | More than 2000 times, the maximum of 5000 times |
| Radius of the bending section | Outer diameter about 2.7cm (Ambu® aScope™ 3 Slim 3.8/1.2) | Outer diameter about 2.2cm (Vathin® Video Bronchoscope BCV1-C1 3.2/1.2) |
| Distal end diameter (mm) | 4.3/5.5/6.3 | 2.2/3.2/4.1/4.7/4.9/5.2/5.8/6.0/6.2 |
| Maximum insertion portion width (mm) | 4.2/5.4/6.2 | 2.2/3.2/4.1/4.7/4.9/5.2/5.8/6.0/6.2 |
| Minimum insertion channel width (mm) | 1.2/2.0/2.6 | 0/1.2/1.7/2.0/2.2/2.4/2.8/3.0/3.2 |
| Working length (mm) | 600 | 600/700 |
| Digital video technology | CMOS | CMOS |
| Illumination source | LED | LED |
| Shutter speed | 1/60 sec - 1/10000 sec | 1/30 sec - 1/12000 sec |
| White balance | Automatic | Manual |
| Video format inputs (Camera) | analog signal RGB Bayer pattern | RAW |
| Output formats | Composite video | DVI/USB |
| Enhancement control | Yes | Yes |
| Image/Video capture | Yes | Yes |
| Storage | Yes, SD Card | Yes, SD Card |
| Single-use | Yes | Yes |
| Biocompatibility | No Cytotoxicity; No Irritation to Skin; No significant evidence of sensitization; No pyrogen | No Cytotoxicity; No Irritation to Skin; No significant evidence of sensitization; No pyrogen |
| Sterilization | EO | EO |
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 explicitly states: "no clinical studies were needed to support this 510(k) Premarket Notification." This means there was no designated "test set" in the context of a clinical trial or performance study involving human patients. The evaluation was based on non-clinical bench testing and comparison to the predicate device's specifications. Thus, there is no sample size for a test set, nor a data provenance in terms of country or retrospective/prospective nature.
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)
Since no clinical studies were performed, there was no "ground truth" established by experts in a clinical setting for the purpose of validating the device's diagnostic or procedural effectiveness on human patients. The assessment relied on engineering and performance criteria established through bench testing and comparative analysis against the predicate device and relevant standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical 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. This device is a bronchoscope system, not an AI-powered diagnostic tool, and no MRMC studies were conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical instrument, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical bench testing, the "ground truth" was established by engineering specifications, recognized international standards (e.g., ISO 8600, ISO 80369-7, IEC 60601 series, ISO 11135), and the performance characteristics of the legally marketed predicate device. The product's compliance with these standards and equivalence to the predicate serve as the basis for its safety and effectiveness claims.
8. The sample size for the training set
Not applicable. This device does not have an AI component that undergoes a training phase with a dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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(208 days)
VIDEO BRONCHOSCOPE SYSTEM
The Schoelly Video Bronchoscope System is intended for use by physicians for diagnostic and therapeutic procedures in nasopharyngeal endoscopy, bronchoscopy, tracheoscopy, and laryngoscopy. The Schoelly Video Bronchoscope is intended to provide visualization via a video monitor.
The Schoelly Video Bronchoscope System consists of a flexible and steerable endoscope with an integral working/suction channel and a camera control unit (CCU) for regulation of light intensity and connection to a commercially available monitor, PC, and medical video and image capture unit for image display or image documentation.
The endoscope has outer surfaces mainly made from plastic. The endoscope handle incorporates a control lever to bend the distal tip and a working channel port enabling the insertion of instruments for access to the endoscope tip through the working channel.
For sampling of tracheobronchial secretion or irrigation, the endoscope further incorporates a suction channel with the suction valve port located at the endoscope handle and is accompanied by a suction valve/seal accessory . Suction and working channel converge within the endoscope handle, thus within the endoscope shaft there is only one lumen towards the endoscope tip. The suction power can be adjusted at the suction valve which is rotatable by 360°.
The endoscope further comprises a ventilation system to protect the endoscope shaft during sterilization. The exhaust valve at the endoscope handle can also be used for leakage testing. For this purpose the system is accompanied by a leakage tester and accessories.
LED light sources are integrated in the endoscope handle to illuminate the anatomy under investigation. Light is transmitted through fiberoptic bundles to provide standard dual wide angle illumination as well as a narrower light beam which acts as a focused spot light thereby allowing for an improved visualization of more distal anatomical structures (DeepVu illumination). The DeepVu function can be activated by pressing a button at the endoscope handle.
The video signal is captured by a CMOS imaging sensor located at the tip of the endoscope and transferred to the CCU. Images can be frozen and stored on a PC or medical video and image capture unit by pressing a button at the endoscope handle.
The Schoelly Video Bronchoscope System is delivered in a non-sterile condition and is already CE marked.
The provided document is a 510(k) summary for the Schoelly Video Bronchoscope System. It describes the device, its intended use, and its comparison to predicate devices, but it does not contain the specific details about acceptance criteria, device performance, and the study methodology asked for in the prompt.
The document states:
"Performance data demonstrated that the Schoelly Video Bronchoscope System has met pre-determined acceptance criteria and is substantially equivalent to the predicate device."
"Testing has been conducted in accordance with recognized consensus standards to demonstrate electrical safety. EMC, biocompatibility, and optical performance characteristics and to validate the software encompassed in the device."
"The Schoelly Video Bronchoscope System meets all the pre-determined testing and acceptance criteria to effectively demonstrate substantial equivalence to the predicate device"
However, it does not provide the acceptance criteria themselves, nor the reported device performance values, nor details about the study design (sample size, ground truth, experts, etc.). The document focuses on demonstrating substantial equivalence primarily through technological characteristics and adherence to recognized standards, rather than presenting a detailed clinical performance study with specific metrics.
Therefore, I cannot provide the requested information. The document indicates that such data exists and was used but does not disclose it.
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