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510(k) Data Aggregation
(203 days)
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is intended to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is indicated for use within the nasal and nasopharyngeal lumen.
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is intended to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is indicated for use within the nasal and nasopharyngeal lumen.
This document describes the premarket notification (510(k)) for the RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP. The device is a flexible nasopharyngoscope indicated for endoscopic diagnosis within the nasal and nasopharyngeal lumen, to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | Acceptance Criteria (Compliance to Standards / Bench Performance) | Reported Device Performance |
|---|---|---|
| Regulatory & Safety | ||
| Intent (Predicate Equivalence) | Substantially equivalent to predicate device (ENF-GP2, K181240) | Claimed Substantially Equivalent: The device is claimed to be substantially equivalent based on similarities in indications for use, design, materials, technological characteristics, and operational characteristics. |
| Thermal Safety | Compliance to IEC 60601-2-18:2009-08 | Thermal safety performance test verified compliance. |
| Photobiological Safety | Compliance to IEC 62471:2006-07 | Test confirmed light emitted is low enough not to cause injury to skin and eye. |
| Biocompatibility | Compliance to ISO 10993 series and FDA Guidance | Testing conducted per guidance; deemed acceptable for intended use. |
| Sterilization (EO) | Compliance to ISO 11135:2014 & ISO 10993-7:2008 & FDA Guidance | Validated as safe and effective for reprocessing with EO Gas. |
| Reprocessing Methods | Compliance to FDA guidance: "Reprocessing Medical Devices..." | Validated as safe and effective for manual cleaning, manual disinfection, and with OER-Pro/Mini/Elite. |
| Electrical Safety | Compliance to IEC 60601-1:2005+A1:2012 & IEC 60601-2-18:2009 | Found to be in compliance with relevant requirements. |
| Risk Analysis | Compliance to ISO 14971:2007 | Performed in accordance with ISO 14971:2007; risks considered acceptable and mitigated. |
| Imaging Performance | ||
| Composite Durability | Device retains safety and effectiveness against expected stresses | Durability test against composite stress demonstrates the device retains its safety and effectiveness against the stresses expected in its use-life. |
| Color Performance | Substantially equivalent to predicate devices | Confirmed as substantially equivalent to the predicate devices. |
| Image Intensity Uniformity | Substantially equivalent to predicate devices | Confirmed as substantially equivalent to the predicate devices. |
| Resolution | Similar to predicate device, no new safety/effectiveness issues | Resolution is similar to predicate device and does not raise new issues of safety or effectiveness. |
| Direction of View | Compliance to ISO 8600-1, consistent with design specs | Test verified compliance and confirmed consistency with design specifications, introducing no new safety/effectiveness questions. |
| Field of View | Compliance to ISO 8600-1, consistent with design specs | Test verified compliance and confirmed consistency with design specifications, introducing no new safety/effectiveness questions. (Note: different from PD but area adjustable and difference does not affect safety/effectiveness). |
| Depth of Field | Covers predicate device's depth of field | Increased range covers the predicate's depth of field. Not affected by variations in compatible systems. |
| Compatibility | Compatibility with new processors, light sources, monitors, camera heads does not raise new safety/effectiveness questions | Demonstrated with bench performance testing in Section 18 (not fully detailed here), confirming no new safety or effectiveness questions for OTV-S200/S300, OEV-262H, LMD-X310ST, CH-S200-XZ-EA/EB. |
2. Sample Size Used for the Test Set and Data Provenance:
The document focuses on "Non-Clinical Bench Testing" for the device, which typically involves testing of the physical device components and its performance characteristics in a controlled environment. It does not mention specific 'test sets' in the context of clinical images or patient data. Therefore, information regarding sample size used for a test set (e.g., number of cases/images) and data provenance (country of origin, retrospective/prospective) is not provided as it is not applicable to the type of testing described (bench testing on the physical device).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided and is not applicable, as the evaluation described is non-clinical bench testing of a physical medical device (fiberscope), not an AI or diagnostic software based on image interpretation by experts.
4. Adjudication Method:
This information is not provided and is not applicable for the same reason mentioned in point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
An MRMC comparative effectiveness study was not done. The device is a RHINO-LARYNGOFIBERSCOPE, a physical medical device for visualization, not an AI or software intended to assist human readers in interpretation or diagnosis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
A standalone performance study was not done. This refers to an algorithm's performance without human-in-the-loop, which is relevant for AI/software devices. The device in question is a hardware endoscopic tool.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance criteria in this submission is established through objective measurements and assessments against specified engineering and safety standards. For example:
- Thermal Safety: Adherence to temperature limits set by IEC 60601-2-18.
- Photobiological Safety: Adherence to light emission limits set by IEC 62471.
- Imaging Parameters (Resolution, Field of View, Depth of Field, Color Performance, Image Intensity Uniformity): Measured values are compared against design specifications and predicate device performance to ensure similarity and adequate functionality.
- Biocompatibility: Results of laboratory tests (e.g., cytotoxicity, irritation, sensitization) are compared against established biological evaluation criteria in ISO 10993 standards.
- Sterilization and Reprocessing: Demonstrated efficacy of cleaning/disinfection/sterilization methods through validated protocols according to FDA guidance and ISO 11135.
8. The Sample Size for the Training Set:
This information is not provided and is not applicable for this physical medical device. Training sets are relevant for machine learning algorithms, which this device does not utilize (it "does not contain any software").
9. How the Ground Truth for the Training Set was Established:
This information is not provided and is not applicable for the same reason mentioned in point 8.
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(105 days)
RHINO-LARYNGO VIDEOSCOPEs OLYMPUS ENF-V3 and ENF-VH are intended to be used with an Olympus video system center, light source, document, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGO VIDEOSCOPEs OLY MPUS ENF-V3 and ENF-VH is indicated for use within the nasal lumens and airway anatomy (including nasopharynx and trachea).
Rhino-Laryngo Videoscopes Olympus ENF-VH, ENF-V3 are intended to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. Rhino-Laryngo Videoscopes Olympus ENF-VH, ENF-V3 are indicated for use within the nasal lumens and airway anatomy (including nasopharynx and trachea).
The provided text describes a 510(k) premarket notification for two new medical devices, the Olympus RHINO-LARYNGO VIDEOSCOPE ENF-VH and ENF-V3. The primary goal of this submission is to demonstrate that these new devices are substantially equivalent to already legally marketed predicate devices (Olympus ENF-VH2 and ENF-V4).
It is crucial to understand that this document describes a submission for substantial equivalence of new endoscopes to existing predicate endoscopes. It is not a study proving the performance of an AI-powered diagnostic device against specific acceptance criteria for diagnostic accuracy. Therefore, many of the requested elements for an AI/ML-based device will not be found in this document.
The document focuses on demonstrating that the new endoscopes (ENF-VH and ENF-V3) have similar technological characteristics, intended use, and safety/effectiveness profiles to their respective predicate devices (ENF-VH2 and ENF-V4). The "performance testing" described is primarily bench testing to ensure the new endoscopes meet established medical device standards and perform comparably to the predicates in terms of physical and optical properties.
Here's an attempt to answer your questions based on the provided text, highlighting where the requested information for an AI/ML diagnostic study is not applicable or not present in this type of device submission:
1. Table of acceptance criteria and the reported device performance
For these endoscopes, the "acceptance criteria" are generally based on meeting established medical device standards and demonstrating performance comparable to the predicate devices. The "reported device performance" refers to the results of various bench tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | |
| - Similar Indications for Use | Stated as "Similar to predicate. Device name and model number are now included in the Indications for Use statement. The actual intended use is identical." (Tables 5-1 and 5-2) |
| - Similar Mode of Action | Stated as "Same as predicate" (Tables 5-1 and 5-2) |
| - Similar Optical System Parameters (Field of View, Direction of View, Depth of Field) | Stated as "Same as predicate" (Tables 5-1 and 5-2) |
| - Similar Imaging System (Type of Chip, No. of Image Sensor Chip, NBI observation) | Stated as "Same as predicate" (Tables 5-1 and 5-2) |
| - Similar Physical Dimensions (e.g., Insertion Tube Diameter, Working Length) | Stated as "Same as predicate" for most. Minor total length difference noted for control section design change, but deemed not to alter indications for use or safety/effectiveness. (Tables 5-1 and 5-2) |
| - Similar Sterilization Compatibility | Stated as "Available, Same as predicate" for EO, STERRAD NX, STERRAD 100S. (Tables 5-1 and 5-2) Reprocessing validation was conducted and devices validated as safe and effective for listed methods. |
| Compliance with Voluntary Standards (Section 10) | Stated "The following voluntary standards have been applied to the subject devices respectively" with a comprehensive list of standards met (e.g., IEC 60601 series, ISO 10993 series, ISO 14971). |
| Specific Performance Bench Testing (Section 12) | |
| - Thermal Safety | Verified compliance to IEC 60601-2-18:2009-08 ("Protection against excessive temperature and other safety hazards"). |
| - Composite Durability | Demonstrated subject device retains safety and effectiveness against expected use-life stresses. |
| - Noise and Dynamic Range | Confirmed "substantially equivalent to the predicate device" and "compliant to ISO 15739:2017." |
| - Color Performance | Confirmed "substantially equivalent to the predicate devices in the WLI and NBI observation mode." |
| - Image Intensity Uniformity | Confirmed "substantially equivalent to the predicate devices." |
| - Resolution | Confirmed "substantially equivalent to the predicate device." |
| - Photobiological Safety | Verified compliance to IEC 32471:2006-07; confirmed light emitted is low enough not to cause injury. |
| - Biocompatibility | "Successfully validated by testing on the subject devices according to ISO 10993-1" for mucosal membrane contact. "Biological Risk associated with this device is acceptable." |
| - Electrical Safety and EMC | Found to be in compliance with relevant IEC 60601 series requirements. |
| - Software Verification and Validation Testing | Performed and documented to be in compliance with relevant FDA guidance. |
| - Risk Analysis | Performed in accordance with ISO 14971:2007. Outcomes considered acceptable. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the context of an "AI test set." The testing described is primarily bench testing of physical device properties and adherence to manufacturing and safety standards. For example, durability tests would involve a certain number of units, but this is not a "data set" in the AI sense.
- Data Provenance: Not applicable for an AI data set. The "data" here comes from results of physical and electrical safety testing, as well as characterization of optical properties, performed by Olympus. The countries of origin for manufacturing facilities are listed as Japan (Shirakawa Olympus Co., Ltd. and Aizu Olympus Co., Ltd.). The testing is presumably prospective as it's for a new product submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as there is no "ground truth" to be established by experts for a diagnostic AI model. The device is a direct visualization endoscope, not an AI diagnostic tool. The "truth" is whether the physical and optical properties meet specifications and are comparable to predicate devices, verified through engineering and laboratory testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept applies to human reader studies or expert labeling for AI training/testing data, neither of which are described for these endoscopes.
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 an endoscope for direct visualization, not an AI-assisted diagnostic tool. No MRMC study or assessment of human reader improvement with AI assistance was performed or needed for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This refers to AI algorithm performance. The device is a traditional endoscope.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For a medical device like an endoscope, "ground truth" relates to its physical, optical, and safety specifications being met, and its performance being comparable to a legally marketed predicate. This is confirmed through engineering testing and compliance with recognized standards.
8. The sample size for the training set
- Not applicable. There is no AI model or "training set" for this submission as it's for a physical endoscope.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
In summary, the provided document is a regulatory submission for medical device clearance (510(k)) that focuses on demonstrating "substantial equivalence" of new endoscopes to existing ones. It is not about an AI/ML-based diagnostic device, and therefore the criteria for evaluating such a device (e.g., AI performance, expert ground truth, reader studies) are not present or applicable here.
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(94 days)
VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V has been designed to be used with an Olympus video system center, light source, document, display monitor, and other ancillary equipment for endoscopic diagnosis within the uterus. Do not use the instrument for any purpose other than its intended use.
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the uterus.
The provided document does not describe an AI medical device. It is a 510(k) summary for a "VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V (HYF-V)", which is a hysterovideoscope for endoscopic diagnosis within the uterus.
The document discusses various non-clinical bench tests (e.g., thermal safety, photobiological safety, noise and dynamic range, composite durability, color performance, image intensity uniformity, resolution, direction of view, field of view), biocompatibility evaluation, sterilization/reprocessing validation, and electrical safety/EMC testing. It explicitly states that software verification and validation testing was not applicable and not performed because the HYF-V does not include any software.
Therefore, I cannot provide details on acceptance criteria and study proving device meets acceptance criteria for an AI device based on this document. The questions regarding sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable to the information provided for this hysterovideoscope.
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