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510(k) Data Aggregation
(166 days)
Contra Healthcare Solutions, LLC
The LumiRex Bronchoscope is a single-use flexible endoscope designed to be used with Contra Healthcare Solutions video processors, endotherapy accessories, and ancillary equipment for endoscopy and endoscopic procedures within the airways and the tracheobronchial tree in a hospital environment.
The LumiRex Single-Use Bronchoscope is a flexible video-based medical device designed for insertion through the mouth or nose into the trachea and bronchial tubes. It comprises a long, thin tube equipped with a light source and a camera to provide real-time visualization of the airways. The bronchoscope also features a working channel that allows for the passage of various instruments, such as biopsy forceps, brushes, and suction devices, facilitating endoscopic procedures. The device is available in different diameters to accommodate a range of patient anatomies and clinical needs.
The Bronchoscope can be used wired or wireless through a Wired Scope Adapter or Wireless Scope Adapter. The adapters transmit images from the bronchoscope to the Video Processor Unit where the user can view the image from the bronchoscope, control the LED, and save and export images from the bronchoscope onto USB removable media.
The provided text is a 510(k) clearance letter and a 510(k) Summary for the LumiRex Bronchoscope. While it details numerous non-clinical validation tests (sterilization, biocompatibility, software, cybersecurity, electrical safety, wireless latency, and various bench tests related to mechanical and optical performance), it does not include information about an AI component or a study proving device performance against acceptance criteria for an AI algorithm.
The document focuses on the equivalence of the LumiRex Bronchoscope as a physical medical device (endoscope with camera) to a predicate device. It describes its mechanical and optical functions, wireless capabilities, and basic image display. There is no mention of an algorithm or AI specifically designed to interpret or analyze images for diagnostic or assistive purposes, which would typically be the focus of the "acceptance criteria and study" described in your prompt.
Therefore, I cannot create the table or answer the specific questions related to an AI algorithm's acceptance criteria and performance study based on the provided text. The information simply isn't present in this 510(k) submission summary.
If this was a misunderstanding and you were expecting information about the bronchoscope's general performance acceptance criteria, I can provide a general interpretation based on the bench testing listed, but it would not involve the AI-specific details you requested.
For example, if we were to infer "acceptance criteria" from the bench testing section without an AI component, it would look something like this:
Inferred Acceptance Criteria for LumiRex Bronchoscope (Non-AI)
| Acceptance Criteria Category | Reported Device Performance (Summary from text) |
|---|---|
| Sterilization & Shelf-Life | Evaluated to ISO 11135:2014 (Sterilization), ISO 11607-2:2019 and ASTM F1980 (Sterile Barrier), and validated for shelf-life. |
| Reprocessing | Evaluated per FDA Guidance, AAMI TIR12:2020, AAMI/ANSI/ISO 11737-1:2018, ANSI/AAMI ST79:2017, ANSI/AAMI/ISO 17665-1:2006/(R)2013, AAMI ST98:2022. |
| Biocompatibility | Evaluated to ISO 10993-1 (FDA Guidance), covering Cytotoxicity (10993-5:2009), Sensitization (10993-10:2021), Systemic Toxicity (10993-11:2017), Pyrogenicity (10993-11:2017), Irritation (10993-23:2021). |
| Software | Verification and validation testing conducted in compliance with IEC 62304, ANSI/AAMI/IEC ES60601-1, and FDA guidance documents ("General Principles of Software Validation," "Premarket Submissions for Device Software Functions"). |
| Cybersecurity | Evaluated in conformance to "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." |
| Electrical Safety & EMC | Undergone testing complying with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18. |
| Wireless Performance (Latency) | Latency tested referring to "Radio Frequency Wireless Technology in Medical Devices – Guidance for Industry and Food and Drug Administration Staff." Latency comparable between wired and wireless modes and within acceptance range. |
| Mechanical Connectivity | Bench tested to ISO 80369-7:2021 (Small-bore Connectors). |
| General Endoscope Requirements | Bench tested to ISO 8600-1:2015 (General Requirements). |
| Optical - Field & Direction of View | Bench tested to ISO 8600-3:2019. Comparative testing showed wider field of view and larger depth of view than predicate. Results met standard requirements and showed substantial equivalence. |
| Mechanical - Insertion Portion Width | Bench tested to ISO 8600-4:2014. |
| Photobiological Safety | Bench tested to IEC 62471:2006. |
| Camera Image Quality | Spatial Resolution MTF (ISO 12233), Signal to Noise Ratio (ISO 15739), Dynamic Range, Depth of Field, Geometric Distortion, Image Intensity Uniformity, Color Performance. Comparative testing showed results met standard requirements and demonstrated substantial equivalence to predicate. |
| System Functional Testing | Leaking, irrigation, bending, articulating bending angle, endurance of bending section, instrument and accessory compatibility, bending section radius. Performance characteristics met defined requirements. |
| Maneuverability (Bending Performance) | Tested per ISO 8600-1:2015. Met specified requirements. (Smaller insertion tube bend radius than predicate.) |
| Image Controls | Automated White balance, no image enhancement control. Simplifies UI, no new risks. |
| Video Format Compatibility | Different input/output formats from predicate, but VPU processes and displays similarly to predicate. No new risks. |
Regarding the other questions:
- Sample size for the test set and data provenance: Not applicable or not specified for an AI algorithm evaluation. The document discusses bench testing of physical characteristics, not a clinical test set of patient data for algorithm performance.
- Number of experts used to establish ground truth: Not applicable, as there's no AI component or clinical ground truth established for an algorithm.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not mentioned and not typically performed for a purely hardware device without an AI interpretive component.
- Standalone (algorithm only) performance: Not applicable, as no algorithm is described.
- Type of ground truth used: Not applicable, as no AI algorithm requiring ground truth is described.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
In summary, the provided 510(k) documentation focuses on the substantial equivalence of "LumiRex Bronchoscope" as a medical device to a predicate based on its mechanical, electrical, software validation (for device operation, not AI), and optical characteristics, but does not contain information related to artificial intelligence performance studies.
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(164 days)
Contra Healthcare Solutions, LLC
The LumiRex Single-Use Digital Flexible Ureteroscope is a single-use video endoscope designed for use with Contra Healthcare Solutions video processors, urology accessories, and other ancillary equipment used in urology and urological procedures.
The LumiRex Single-Use Ureteroscope is a flexible video-based medical device designed for insertion through the urethra into the urinary tract. It comprises a long, thin tube equipped with a light source and a camera to provide real-time visualization of the urinary tract and interior of the kidney. The ureteroscope also features a working channel that allows for installation of fluids, the passage of various instruments, such as biopsy forceps, cytology brushes, biopsy brushes, and stone retrieval baskets to facilitate urology and ureteroscopy procedures.
The ureteroscope can be used wired or wireless through a Wireless Scope Adapter or Wired Scope Adapter. The adapters transmit images from the ureteroscope to the Video Processor Unit where the user can view the image from the ureteroscope, control the LED, and save and export images from the ureteroscope onto USB removable media.
The provided FDA 510(k) Clearance Letter for the LumiRex Ureteroscope does not detail a clinical study with acceptance criteria and device performance in the way typically expected for an AI/software as a medical device (SaMD) clearance. The document focuses on hardware aspects of the ureteroscope, such as sterilization, biocompatibility, electrical safety, and basic bench testing (e.g., field of view, depth of field, image quality).
Specifically, there is no mention of an AI component, an algorithm, or any study involving human readers or ground truth for diagnostic accuracy. The "Software" section primarily refers to verification and validation of the device's operating software (e.g., for image processing, LED control) according to IEC 62304, not an AI or diagnostic algorithm.
Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves the device (in the context of an AI/diagnostic algorithm) meets acceptance criteria, an MRMC study, or the establishment of ground truth for a diagnostic task. The document provided does not contain this information.
Based on the provided text, the LumiRex Ureteroscope is a physical medical device (endoscope) and not an AI/SaMD product that would typically involve the type of diagnostic performance studies you are asking about.
To answer your prompt with the available information:
Acceptance Criteria and Device Performance for LumiRex Ureteroscope (as per 510(k) Summary)
Based on the provided FDA 510(k) Premarket Notification (K243532) for the LumiRex Ureteroscope, the "acceptance criteria" and "study" described are primarily focused on the physical and functional performance of the medical device itself, rather than the diagnostic performance of an AI algorithm. The rigorous detail for AI/diagnostic studies (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies) is not present because this is not an AI-driven diagnostic device.
The clearance is for a ureteroscope, which is a tool for visualization and intervention. Its performance is evaluated against engineering standards and comparison to a predicate device, not against clinical diagnostic accuracy metrics established by human experts reading images with or without AI assistance.
Here's an interpretation of the "acceptance criteria" and "reported device performance" based on the document, framed by the categories you requested, but noting where information is absent due to the nature of the device:
1. Table of Acceptance Criteria & Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test Description | Reported Device Performance/Conclusion |
|---|---|---|
| Sterilization & Shelf-Life | Sterilization validated to ISO 11135:2014. | |
| Sterile Barrier evaluated to ISO 11607-2:2019 & ASTM F1980. | ||
| Shelf life validated. | Ethylene Oxide Sterilization evaluated successfully. | |
| Sterile Barrier evaluated successfully. | ||
| The shelf life of the LumiRex Single-Use Bronchoscope (Note: document inconsistently states Bronchoscope, likely a typo for Ureteroscope) has validated. | ||
| Reprocessing | Reusable components reprocessing evaluated per:** Guidance for Industry & FDA Staff, | |
| ** AAMI TIR12:2020, | ||
| ** AAMI/ANSI/ISO 11737-1:2018, | ||
| ** ANSI/AAMI ST79:2017, | ||
| ** ANSI/AAMI/ISO 17665-1:2006, | ||
| ** AAMI ST98:2022. | Reprocessing evaluation performed in accordance with listed standards. | |
| Biocompatibility | Evaluation per ISO 10993-1, including Cytotoxicity, Sensitization, Systemic Toxicity, Pyrogenicity, Irritation. | Biocompatibility evaluation conducted in accordance with referenced FDA guidance and ISO 10993-1. |
| Software | Verification & validation per IEC 62304, ANSI/AAMI/IEC ES60601-1, FDA guidance "General Principles of Software Validation," & "FDA Guidance for the Content of Premarket Submissions for Device Software Functions." | Software verification and validation testing conducted in compliance with listed standards and guidance. (Note: This refers to operational software, not AI/diagnostic algorithms). |
| Cybersecurity | Conformance to "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" (September 2023). | Cybersecurity evaluated in conformance to the listed guidance. |
| Electrical Safety & EMC | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18 for the Ureteroscope, Adapters, and Video Processor. | Electrical Safety and Electromagnetic Compatibility testing performed, complying with listed standards. |
| Bench Testing - Connectors | ISO 80369-7:2021 Small-bore Connectors. | Conformance to ISO 80369-7:2021. |
| Bench Testing - Endoscopes | ISO 8600-1:2015 General Requirements. | |
| ISO 8600-3:2019 Field of View & Direction of View. | ||
| ISO 8600-4:2014 Max Width of Insertion Portion. | LumiRex Bronchoscope (typo for Ureteroscope) met requirements defined in the standard. Comparative testing showed a wider field of view than the predicate, with the same depth of view. | |
| Bench Testing - Photobiol. | IEC 62471:2006 Photobiological Safety. | Compliance with IEC 62471:2006. |
| Bench Testing - Image Quality | Spatial Resolution MTF (ISO 12233), Signal to Noise Ratio (ISO 15739), Dynamic Range, Depth of Field, Geometric Distortion, Image Intensity Uniformity, Color performance. | Comparative testing performed; results met requirements and demonstrated substantially equivalent performance to the predicate device. Specific numerical performance values are not provided in this summary. |
| Bench Testing - System Functional | Leaking, Irrigation, Bending, Articulating Bending Angle, Endurance of Bending Section, Instrument & Accessory Compatibility, Bending Section Radius. | System Functional Testing performed. LumiRex Bronchoscope (typo for Ureteroscope) met the requirements defined in the standard. |
| Design Verification (Wireless) | Evaluation for Reprocessing, Software, Electrical Safety, EMC, System Functional Testing for wired/wireless scope adapters (FDA Guidance, IEEE/ANSI C63.27-2021). | Demonstrated that the device design met requirements in referenced standards or matched predicate performance. Wireless functionality validated. |
Since the device is a ureteroscope and not an AI/SaMD, the subsequent points of your request are not applicable or details are not provided in this type of 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable in the context of an AI diagnostic test. The "test set" here refers to physical product units subjected to bench testing (e.g., specific endoscopes for image quality testing, or multiple cycles for endurance testing). No specific "sample size" for patient data or cases is mentioned because this is not an AI diagnostic device.
- Data Provenance: Not applicable for diagnostic data as described. The testing is laboratory-based and engineering-focused.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. "Ground truth" in this context (pathology, clinical outcome) is not established or used for the clearance of an endoscope's basic imaging and physical functionality. Experts might be involved in evaluating usability or design, but not for "ground truth" to validate a diagnostic algorithm.
4. Adjudication Method for the Test Set:
- Not Applicable. No diagnostic test set requiring adjudication (e.g., 2+1, 3+1) is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:
- No. Such a study is typically performed for AI-assisted diagnostic tools. This 510(k) does not describe any MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
- No. There is no standalone diagnostic algorithm described for this device.
7. The Type of Ground Truth Used:
- Not Applicable. No diagnostic ground truth (e.g., pathology, outcomes data) is used for the clearance of this device as described. Performance is measured against engineering standards and comparison to a predicate device's physical and functional attributes.
8. The Sample Size for the Training Set:
- Not Applicable. There is no AI/machine learning component described that would require a "training set" of diagnostic data.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As there is no training set for an AI algorithm, no ground truth establishment method is mentioned.
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