(447 days)
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.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.