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510(k) Data Aggregation
(55 days)
SCHOELLY IMAGING, INC.
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(67 days)
SCHOELLY IMAGING, INC.
The FSC 2 is intended to be used in conjunction with endoscopic devices to provide illumination and video visualization of optical images to visualize and observe body spaces.
The Schoelly FSC 2 is a camera hand piece with built-in LED illumination intended to be used with Schoelly endoscopes. The light source provides illumination to the area under endoscopic examination. The compact camera component attaches to the proximal eyepiece of the endoscope via the Flexilock connector. Optically captured images are transferred to the camera. converted to an electrical signal, and amplified for output to accessories such as a computer.
The provided text is a 510(k) Summary for a medical device called "FSC 2," which is an endoscope camera and illumination system. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided text. The submission explicitly states "Performance: NA" for both the device and its predicate, indicating that a dedicated performance study for clinical efficacy, as typically understood for AI/algorithm devices, was not performed or deemed necessary for this type of device.
Here's a breakdown of the information that can be extracted from the provided text, along with notes on what is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly Stated or Implied) | Reported Device Performance |
|---|---|
| General Design: Camera with LED lamp type | Camera with LED lamp type |
| Intended Use: Provide illumination and video visualization of optical images in conjunction with endoscopic devices. | "Use in conjunction with endoscopic devices to provide illumination and video visualization of optical images" |
| Target Population: Any patient population | Any patient population |
| Anatomical Sites: Any where endoscopic devices are used | Any where endoscopic devices are used |
| Where Used: Hospitals, clinics, and physician offices | Hospitals, clinics, and physician offices |
| Biocompatibility: NA - no patient contacting surfaces | NA - no patient contacting surfaces |
| Sterility: NA - non-sterile | NA - non-sterile |
| Electrical Safety: Conforms with IEC 60601-1 | Conforms with IEC 60601-1 |
| Mechanical Safety: NA | NA |
| Performance: Substantially equivalent to predicate device K053412 (FSC 50 MH/50 MHC) in terms of general design and technology, indication for use, and function. | Substantially Equivalent to FSC 50 MH/50 MHC (K053412) |
Study that proves the device meets the acceptance criteria:
The "study" presented is a comparison to a predicate device (Schoelly FSC 50MH K053412) to demonstrate substantial equivalence, rather than a clinical performance study with specific device-centric acceptance criteria. The basis for meeting the criteria is the direct comparison of features and adherence to recognized standards for safety where applicable.
Information Not Available in the Provided Text:
- Sample size used for the test set and the data provenance: Not applicable. No test set for algorithm performance was mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set for algorithm performance or ground truth establishment was mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI/algorithm-based interpretive tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a hardware component.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable. This device is not an AI/algorithm-based interpretive tool.
- How the ground truth for the training set was established: Not applicable. This device is not an AI/algorithm-based interpretive tool.
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(46 days)
SCHOELLY IMAGING, INC.
The Schoelly Naso-Laryngo-Pharyngoscope is intended to be used by qualified surgeons and physicians to visualize and observe the pharynx and the larynx.
The Schoelly Naso-Laryngo-Pharyngoscope is a flexible and steerable fiberoptic endoscope for diagnostic purposes. Manufactured in two resolutions, 12,000 and 16,000 pixels.
The provided text describes a Special 510(k) submission for a medical device, the Schoelly Naso-Laryngo-Pharyngoscope. This type of submission is for modifications to a legally marketed device that do not significantly alter its safety or effectiveness. The core of the submission, and therefore this response, is a comparison to a predicate device to demonstrate substantial equivalence, rather than a de novo clinical study with strict acceptance criteria and performance metrics typically seen for new devices or algorithms.
Therefore, the "acceptance criteria" here are implicitly linked to demonstrating substantial equivalence to the predicate device, K991560, by showing that any changes do not adversely affect safety or effectiveness. The "study" proving this largely revolves around the provided comparison table and the assertion that validation was performed under design control.
Here's an breakdown of the information requested, based on the provided text:
Acceptance Criteria and Reported Device Performance
Given this is a Special 510(k) for a hardware device, the acceptance criteria are not explicitly stated in terms of diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they are implicitly related to maintaining safety and effectiveness, as demonstrated by the comparison to the predicate device. The "reported device performance" is essentially captured by the specifications of the new device relative to the predicate.
| Acceptance Criteria Category (Implicit from 510(k) process) | Specific Criteria (Derived from comparison to predicate) | Schoelly Naso-Laryngoscope (New Device) Performance (Reported) | Predicate Naso-Laryngoscope (K991560) Performance |
|---|---|---|---|
| Intended Use | Must be the same as the predicate. | Visualize and observe the pharynx and the larynx. | Visualize and observe the pharynx and the larynx. |
| Design | Must be fundamentally the same technology as the predicate. | Flexible and steerable fiberoptic endoscope for diagnostic purposes. | Flexible and steerable fiberoptic endoscope for diagnostic purposes. |
| Tip Tubing Diameter | Changes should not negatively impact safety or effectiveness. (Smaller diameter is generally considered an improvement for patient comfort/access). | 3.2 mm | 3.8 mm |
| Working Length | Maintained for consistent application. | 300 mm | 300 mm |
| Angulation Up/Down | Acceptable range for maneuverability. (Slight reduction is noted, but likely deemed non-significant for its intended use). | Up: 140°, Down: 140° | Up: 150°, Down: 150° |
| Direction of View | Maintained for consistent visualization. | 0° | 0° |
| Field of View | Acceptable range for visualization. (Slight reduction is noted, but likely deemed non-significant). | 70° | 85° |
| Length of Distal Tip Deflection | Acceptable range for maneuverability. (Slight reduction is noted, but likely deemed non-significant). | 20 mm | 25 mm |
| Depth of Field | Acceptable range for clear imaging. (Widened range is an improvement). | 6 - 1000 mm | 3mm - 50mm |
| Total Fibers (pixels) | Acceptable resolution. (Reduction noted, but likely not considered significant enough to impact diagnostic capability for this type of device/intended use). | 7,000 (Later mentions 12,000 and 16,000 pixels manufactured in two resolutions) | 10,000 |
| Fiber Size | Maintained for consistent optical properties. | 83 µm | 83 µm |
| Magnification | Acceptable for visualization. (Significant increase noted, which would typically be an improvement). | 7X | 2.5X |
| Energy Used | Compliance with relevant electrical safety standards. | IEC601-1 and IEC 60601-2-18 2000 compliant. | Not explicitly stated for predicate in comparison table, but compliance expected. |
| Sterilization/Cleaning | Clear instructions and material compatibility for reprocessing. (Changes in specifications for EtO sterilization and cleaning solutions are detailed). | Detailed EtO and cleaning instructions, material compatibility for specific disinfectants. | Detailed EtO sterilization instructions, "mild cleaning substances." |
Study Details:
As this is a Special 510(k) for a physical device rather than an AI/software device, many of the requested categories (sample size for test set, data provenance, number of experts for ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable (N/A) in the context of the provided documentation. The "study" referred to is the design control and validation process undertaken by the manufacturer to ensure the modified device remains safe and effective and substantially equivalent to its predicate.
Here's why and what is relevant:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This document describes a medical device's physical and functional specifications. It is not a clinical study involving a test dataset for diagnostic performance evaluation. The "test set" would implicitly refer to the physical testing and verification/validation activities performed during design control to ensure the device meets its specifications and remains safe and effective (e.g., mechanical tests, optical performance tests, biocompatibility tests), but the sample sizes for these engineering tests are not detailed here.
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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):
- N/A. Ground truth in the context of diagnostic interpretation by experts is not relevant here as there's no diagnostic algorithm being evaluated. The "ground truth" for a physical device effectively refers to its design specifications, regulatory standards, and established performance characteristics of the predicate.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are relevant for resolving discrepancies in expert interpretations of data, which is not the subject of this 510(k).
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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:
- N/A. This is not an AI-assisted device, nor is it a multi-reader, multi-case clinical study.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This is a physical, fiberoptic endoscope, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A (in the diagnostic sense). For a physical device, the "ground truth" for its performance is its adherence to engineered specifications, validated through design verification and validation activities (e.g., measurements of tip diameter, angulation, field of view, depth of field, material compatibility for sterilization). The document states "All changes have been made under design control, and validation was performed and conformance assured," indicating that such engineering-level verification and validation activities were conducted.
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The sample size for the training set:
- N/A. No training set is applicable for this physical device.
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How the ground truth for the training set was established:
- N/A. No training set is applicable for this physical device.
In summary, the provided document is a regulatory submission for a hardware modification, demonstrating substantial equivalence to a predicate device. It does not involve the type of clinical study data or AI performance metrics typically requested for software or AI-enabled medical devices. The "study" is the manufacturer's internal design control and validation process, which presumably confirmed that the altered specifications do not compromise safety or effectiveness compared to the predicate.
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(333 days)
SCHOELLY IMAGING, INC.
The Flexilux II Cystoscope is - like the predicate device - used to permit direct viewing of the male urethra, prostate, and bladder for purpose of performing diagnostic and surgical procedures.
The Flexilux II Hysteroscope is - like the predicate device - used to illuminate and visualize the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The Cystoscope is used to visualize the body cavities, hollow organs and canals during diagnostic and, in conjunction with additional instruments, therapeutic procedures.
The Hysteroscope is used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The Flexilux II Hysteroscope and Cystoscope (herein after; Flexilux II Endoscope) are rigid type endoscopes with traditional compact objectives and rod-lens system.
The basic design of the Flexilux II Endoscope is similar to those legally available for sale in the U.S.A... It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical stainless steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.
The provided document is a 510(k) Premarket Notification for the Flexilux II Endoscope, which aims to demonstrate substantial equivalence to existing predicate devices. It does not present a study with specific acceptance criteria and performance data in the way typically seen for novel AI/ML devices or new performance claims.
Instead, the documentation focuses on comparing its design, materials, and intended use to already legally marketed predicate devices. The "performance" assessment is based on demonstrating that the new device is functionally identical to the predicates and adheres to relevant industry standards.
Here's an attempt to extract and frame the information you requested, based on the context of this 510(k) submission for a non-AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence claim for a traditional medical device, the "acceptance criteria" are not reported as quantitative performance metrics (e.g., sensitivity, specificity, AUC) but rather as compliance with existing standards and identity to predicate devices.
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Same specifications and intended use as predicate devices. | The specifications and intended use of the Flexilux II Endoscope are the same as those of the claimed predicate devices. No significant differences in design or conditions of intended use. (Section: Safety and Performance) |
| Biocompatibility | Constructed of materials of the same specifications as predicate devices. | The Flexilux II Endoscope is constructed of materials of the same specifications as the predicate devices to ensure biocompatibility. (Section: Safety and Performance & Conclusion) |
| Standards Compliance | Conforms to applicable ISO standards and medical electrical equipment standards. | The Flexilux II Endoscope conforms to applicable ISO standards (DIN 58105; IEC 60601-2-18). (Section: Safety and Performance & Conclusion) |
| Labeling | Consistent with legally marketed predicate devices. | Substantial equivalence for this device was based on a comparison of labeling. (Section: Safety and Performance) |
| Physical Design | Similar physical and performance design characteristics to predicate devices. | Substantial equivalence for this device was based on a comparison of physical and performance design characteristics as compared to the predicate devices. (Section: Safety and Performance) |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as there was no explicit "test set" in the context of an AI/ML algorithm evaluation. The assessment was based on comparing the device's design and materials to existing predicate devices and compliance with standards. There's no data provenance in terms of country of origin or retrospective/prospective studies mentioned for performance evaluation.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth, in the context of AI/ML, refers to definitively correct labels for a dataset. Here, the "truth" is established by adherence to manufacturing standards and functional equivalence to known safe and effective devices. There were no experts establishing ground truth for a diagnostic output.
4. Adjudication Method
Not applicable. No diagnostic outputs or images required adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a traditional endoscope, not an AI/ML system, so no MRMC study was performed to assess human reader improvement with AI assistance.
6. Standalone Performance Study (Algorithm Only)
Not applicable. There is no algorithm to evaluate in a standalone manner.
7. Type of Ground Truth Used
The "ground truth" for this submission is implicitly established by:
- Predicate Device Performance: The core argument is that the Flexilux II Endoscope functions equivalently to legally marketed and proven predicate devices.
- Industry Standards: Compliance with relevant ISO and IEC standards (e.g., DIN 58105; IEC 60601-2-18) serves as the "ground truth" for certain physical and safety performance aspects.
- Material Specifications: The use of materials identical to those in predicate devices ensures biocompatibility, relying on the known safety of those materials.
8. Sample Size for the Training Set
Not applicable. There is no AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
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(78 days)
SCHOELLY IMAGING, INC.
The FlexiScope 50MH / 50MHC is indicated for use in conjunction with endoscopic devices to provide illumination and video visualization of optical images.
The Schoelly FlexiScope 50MH / 50MHC system is comprised of a camera handpiece and a combination light source / video processor; the system is intended for use with currently marketed endoscopes. The light source utilizes visible light to provide illumination of the area under endoscopic examination. The compact camera system component attaches to the proximal eyepiece of the user-supplied flexible or rigid endoscope. Images are optically captured via the endoscope. The image is transferred to the camera's CCD (charge coupled device) sensor through the scope objective lens, where it is converted to an electrical signal and amplified for output to accessories such as a monitor, printer, etc.
The provided 510(k) summary for the Schoelly FlexiScope 50MH / 50MHC does not contain information related to acceptance criteria, device performance metrics, or a study proving the device meets specific performance criteria in the way a diagnostic AI device would.
This device is a light source and video camera system for endoscopy, not a diagnostic AI or image analysis tool. Its approval is based on establishing substantial equivalence to predicate devices through comparisons of labeling, physical, and performance design characteristics, and compliance with electrical safety and electromagnetic compatibility standards.
Therefore, many of the requested categories are not applicable to the information provided in this 510(k) summary. I will address the relevant points and indicate when information is not available.
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). The "acceptance criteria" for this type of device are primarily related to safety, electrical performance, and functional equivalence to predicate devices. The document states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: | |
| Electrical Safety | Compliance with IEC 60601-1-1 |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-1; IEC 60601-1-2 |
| Functional Equivalence: | |
| Provides illumination | "light source utilizes visible light to provide illumination" |
| Provides video visualization of optical images | "Images are optically captured via the endoscope... converted to an electrical signal and amplified for output to accessories such as a monitor, printer, etc." |
| Compatibility with endoscopes | "intended for use with currently marketed endoscopes" |
| Predicate Device Comparison: | Substantial equivalence to AngioLaz Video Endoscopic System (K933868) and AMD Telemedicine AMD-300s Illumination & Imaging System (K940270) based on "labeling, physical and performance design characteristics." |
2. Sample size used for the test set and the data provenance
Not applicable. This device is not a diagnostic tool that relies on a "test set" of patient data for performance evaluation in the conventional sense of AI. Its "testing" involved electrical and electromagnetic compatibility standards and functional verification, not analysis of clinical images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI validation (e.g., expert consensus on clinical findings, pathology results) is not relevant for the regulatory approval of an endoscopic light source and camera system.
4. Adjudication method for the test set
Not applicable for the same reasons as points 2 and 3.
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. This is a medical device for visualization, not an AI-powered diagnostic system. MRMC studies demonstrating human reader improvement with AI assistance are not relevant to this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device itself is a "standalone" hardware component, in the sense that it functions to provide light and video. It does not employ an algorithm for independent diagnostic performance.
7. The type of ground truth used
For the safety and performance claims, the "ground truth" used would be the compliance with recognized electrical and electromagnetic standards (IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-18) and the functional equivalence to its predicate devices. This is ascertained through engineering tests and direct comparison, not clinical pathology or outcomes data in the way an AI diagnostic would be evaluated.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
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