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510(k) Data Aggregation
(125 days)
The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors ancillary equipment for gastrontestinal and pulmonary endoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes and bronchoscopes.
The PENTAX Medical Video Processor EPK-i8020c is intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. The video processor consists of a video system, integrated light source, monitor, and ancillary equipment.
The EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX Medical i-scan™) and an optical imaging enhancement technology (OE). These post-imaging functions are not intended to replace histopathological sampling.
The brand name "INSPIRA™" is provided for the EPK-i8020c video processor and the name is found in the instructions for use (IFU) and/or in the commercial materials such as brochures.
The provided text describes the 510(k) submission for the PENTAX Medical Video Processor EPK-i8020c. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with a defined ground truth.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth establishment are not explicitly provided in the document, as the submission relies on non-clinical performance data and a comparison to an already cleared predicate device.
However, I can extract information related to the device's performance testing and the nature of the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional and Safety Standards Compliance | The PENTAX Medical EPK-i8020c Video Imaging System has been successfully tested for its functions, performance, and safety as per FDA recognized consensus standards. This includes: |
| - Reprocessing Validation (for non-reprocessed devices) | Not required, as the subject device is not reprocessed and provided non-sterile. Reprocessing procedures for reference devices (video bronchoscopes) remain unchanged. |
| - Sterilization and Shelf Life (for non-sterile devices) | Not required, as the subject device is not reprocessed and is not provided sterile. |
| - Biocompatibility (for devices without direct/indirect patient contact) | Not required, as the subject device does not contain any direct or indirect patient contact components. Materials of reference devices (video bronchoscopes) remain unchanged. |
| - Software and Cybersecurity Compliance | Software verification and validation, including cybersecurity assessments, were conducted according to IEC 62304: 2006 + A1: 2015 and FDA Guidance for Industry and Staff documents on software and cybersecurity in medical devices. |
| - Electrical Safety (ES) and Electromagnetic Compatibility (EMC) | Confirmed by IEC 60601-1-2:2014; IEC 60601-1:2005+CORR 1:2006+CORR 2:2007+A1:2012; and IEC 60601-2-18:2009. |
| - System Performance Equivalence to Predicate | The system performance of the subject device demonstrated equivalence to the predicate device. |
| - Optical Performance Equivalence to Predicate and Reference | Optical properties of imaging and illumination performances were measured. All results show that the optical characteristics of the subject device are equivalent to those of the predicate device and the reference device. |
| - Ability to visualize vascularity and mucosal surface | An animal image capture study indicated that the subject device is able to visualize vascularity and mucosal surface for targeted anatomical areas as well as the predicate device and the reference device. This was performed as part of optical and color performance testing. "This study raised no issues of safety and effectiveness of the device as these differences have no effect on the performance, function or general intended use of the device." (From section 7) |
| - Substantial Equivalence to Predicate | The subject device is deemed "as safe and effective as the predicate device" with "no differences in indications for use and intended use" and "technological differences... are not substantive." |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not specified. The document refers to "performance testing" and an "animal image capture study" but does not quantify the number of cases or animals involved.
- Data provenance: For the "animal image capture study," the data provenance is from an animal study. The country of origin is not specified but implicitly assumed to be from within PENTAX Medical's research and development. This was a non-clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The animal study evaluated the device's ability to "visualize vascularity and mucosal surface," implying an objective assessment rather than a diagnostic interpretation requiring expert ground truth establishment for a specific medical condition. The study aimed to assess optical and color performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Given the nature of the "animal image capture study" for optical and color performance, an adjudication method for diagnostic agreement with a ground truth is not described as the primary objective was visualization capability comparison.
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 MRMC study was done. The device (PENTAX Medical Video Processor EPK-i8020c) includes "digital post-processing imaging enhancement technology (PENTAX i-Scan™)" and "optical imaging enhancement technology (OE)." However, the submission does not describe a human-in-the-loop study to evaluate the effectiveness of these enhancements or how human readers' performance improves with or without these features. The statement is that these technologies are "intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- A standalone performance assessment was done for various system components, including software and optical performance. The "animal image capture study" can be considered a standalone assessment of the device's imaging capabilities (optical and color performance) in a biological setting, comparing it to predicate/reference devices. This was an evaluation of device capability itself, not an algorithm's diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the "animal image capture study," the "ground truth" was the objective presence of vascularity and mucosal surface in the animal model. The assessment was likely based on the visual quality and clarity of these features as captured by the device, compared to the predicate and reference devices. It was not a ground truth for a diagnostic condition established by pathology or expert consensus.
8. The sample size for the training set:
- Not applicable/Not specified. This submission does not describe a machine learning algorithm that would require a distinct training set. The device contains "digital post-processing imaging enhancement technology (PENTAX i-Scan™)," which might involve algorithms, but the development and training of these are not detailed as part of this 510(k) submission.
9. How the ground truth for the training set was established:
- Not applicable/Not specified, as no training set is discussed in this context.
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The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes.
The PENTAX Medical Video Upper Gl Scope EG29-i20c is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes the organs; tissues; and subsystems: esophagus, stomach, and duodenum.
This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in patient populations with greater than 20 kg of body weight.
The PENTAX Medical Video Colonoscope EC38-120cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel.
This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 20 kg of body weight.
The PENTAX Medical Video Processor EPK-i8020c is intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. The video processor consists of a video system, integrated light source, monitor, and ancillary equipment.
The EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX Medical i-scan™) and an optical imaging enhancement technology (OE). These post-imaging functions are not intended to replace histopathological sampling.
The brand name "INSPIRA™" is provided for the EPK-i8020c video processor and the name is supposed to be found in the instructions for use (IFU) and/or in the commercial materials such as brochures.
The PENTAX Medical Video Upper GI Scope EG29-i20c is designed to be used with a PENTAX Medical Video Processor, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the upper gastrointestinal tract.
The PENTAX Medical Video Colonoscope EC38-i20cL is designed to be used with a PENTAX Medical Video Processor, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the lower digestive tract. The device is equipped with stiffness setting mechanism for the insertion tube. This feature enables the physician to choose the stiffness of the insertion tube, depending on the preferred level.
The document provides information on the PENTAX Medical EPK-i8020c Video Imaging System, including its components (Video Processor EPK-i8020c, Video Upper GI Scope EG29-i20c, and Video Colonoscope EC38-i20cL) and their intended uses. It also details the non-clinical performance data used to support the substantial equivalence determination to predicate devices.
However, the document does not contain the specific details required to answer all parts of your request, particularly regarding detailed acceptance criteria, reported device performance metrics in a table, an AI component, and the specifics of a study proving the device meets acceptance criteria in the way you've outlined.
The document primarily focuses on demonstrating substantial equivalence to existing predicate devices through various technical and performance tests, rather than setting and meeting a specific set of quantitative acceptance criteria for a new clinical performance claim or an AI algorithm.
Here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance Study (Based on provided document)
The document describes various non-clinical performance tests to demonstrate substantial equivalence, rather than a single study with specific acceptance criteria for a novel AI feature. The "acceptance criteria" here are generally compliance with recognized standards or demonstration of equivalence to predicate devices.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Description / Standard / Equivalence | Reported Device Performance |
|---|---|---|
| Reprocessing Validation | Effectiveness of reprocessing per FDA's 2015 Guidance; AAMI TIR 30:2011 for residual soil/extraction efficiency. | All acceptance criteria were satisfied for EG29-i20c and EC38-i20cL. |
| Sterilization and Shelf Life | Validation of System 1E liquid chemical sterilization. | Validated for EG29-i20c and EC38-i20cL. Device not provided sterile, shelf-life not applicable. |
| Biocompatibility | ISO 10993-1:2018 (cytotoxicity, sensitization, intracutaneous reactivity). | Risk levels of local toxicity determined as "Acceptable" by applying risk evaluation criteria. |
| Software and Cybersecurity | IEC 62304:2006 + A1:2015; FDA Guidances for Software/Cybersecurity. | Software verification & validation, including cybersecurity assessments, were conducted. (Implied compliance). |
| Electrical Safety and EMC | IEC 60601-1-2:2014; IEC 60601-1:2005+A1:2012; IEC 60601-2-18:2009. | Acceptable level of electrical safety (ES) and electromagnetic compatibility (EMC) confirmed. |
| System Performance | Equivalence to predicate device. | Demonstrated equivalence to the predicate device. |
| Mechanical Performance | Comparison of stiffness setting mechanism (EC38-i20cL) to OLYMPUS EVIS EXERA III Colonovideoscope CF-HQ190. | Verified by comparing to the reference device. |
| Optical Performance | Measurement of optical properties of imaging and illumination. | All results show optical characteristics are equivalent to predicate and reference devices. |
| Animal Image Capture Study | Ability to visualize vascularity and mucosal surface for each anatomical area, compared to predicate/reference. | Subject device can visualize vascularity and mucosal surface for each anatomical area as well as the predicate device and the reference device. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical images or patient data for an algorithm. The non-clinical tests mentioned rely on physical devices, simulated use, and animal models.
- For Reprocessing Validation: Simulated use testing. Sample size not specified.
- For Biocompatibility: Materials assessed in accordance with ISO standards. Sample size not specified.
- For Animal Image Capture Study: Animal model used. Sample size not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as there is no mention of a human-expert-annotated "test set" for an AI algorithm or clinical performance study. The ground truth for the non-clinical tests is based on objective measurements, standards, or comparison to established predicate devices/methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 MRMC study or AI assistance claim is described in the provided document. The device includes "digital post-processing imaging enhancement technology (PENTAX i-Scan™)" and "optical imaging enhancement technology (OE)", but this is described as an "optional adjunct following traditional white light endoscopy" and "not intended to replace histopathological sampling." It is not presented as an AI-assisted diagnostic tool that would typically undergo an MRMC study to compare human performance with and without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document does not describe the performance of a standalone algorithm for diagnostic purposes. The imaging enhancements (i-Scan, OE) are adjuncts for visual inspection by a clinician.
7. The type of ground truth used
For the non-clinical performance tests:
- Reprocessing Validation: AAMI TIR 30:2011 for residual soil accumulation and extraction efficiency.
- Biocompatibility: ISO 10993-1:2018 (toxicity, sensitization, intracutaneous reactivity).
- Electrical Safety and EMC: IEC and ISO standards.
- Optical Performance/Animal Image Capture Study: Comparison against predicate and reference devices' images and visualization capabilities.
No histological pathology or specific clinical outcomes data are mentioned as ground truth for a diagnostic performance study.
8. The sample size for the training set
Not applicable. There is no mention of an AI algorithm requiring a training set in this submission. The imaging enhancement technologies are likely rule-based image processing or optical filtering techniques rather than deep learning AI.
9. How the ground truth for the training set was established
Not applicable.
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