(153 days)
TIPCAM 1S 3D: The Rigid Videoendoscope is intended to be used together with the camera control unit for use in the visualization of ventricles and structures within the brain during neurological surgical procedures.
IMAGE 1S is a camera control unit (CCU) for use with camera heads of videoendoscopes for the visualization and documentation of endoscopic and microscopic procedures.
The TIPCAM®1S 3D System is intended for use during diagnostic and/or surgical procedures when endoscopic video assistance is required for visualization within ventricles and structures within the brain during neurological surgical procedures. The TIPCAM®1S 3D System is a medical device system which consists of a 4mm Tipcam®1S and a previously 510k cleared camera control unit (CCU), K150525.
The provided document details the 510(k) summary for the TIPCAM®1S 3D System. The information focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than a clinical study evaluating diagnostic performance against acceptance criteria. Therefore, I cannot fully answer all aspects of your request as it pertains to a clinical study with acceptance criteria often seen in AI/ML medical device submissions.
However, I can extract information related to performance testing and equivalence to the predicate device.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the typical sense of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it lists technical specifications and performance parameters that were compared to the predicate device to demonstrate substantial equivalence. The reported device performance is presented as its specifications, not as a result of a study against a specific numerical acceptance criterion.
| Performance Parameter | TIPCAM®1S 3D System (Subject Device) | VS3 Stereoscopic High Definition Vision System (Primary Predicate) | "Acceptance Criteria" (Implied Equivalence) | Reported Performance (Subject Device) |
|---|---|---|---|---|
| Depth of Field | 7 – 44 mm | 7 – 30mm and 15 – 60 mm | Comparable to predicate | 7 – 44 mm |
| Direction of View | 0° & 30° | 0 - 70° | Comparable to predicate | 0° & 30° |
| Field of View | 80° | 70 - 95° | Comparable to predicate | 80° |
| Working Length | 175 mm | 175 – 300 mm | Comparable to predicate | 175 mm |
| Diameters | 4mm | 4mm & 5.5mm | Comparable to predicate | 4mm |
| Light Source Compatibility | Xenon & LED | Xenon | Comparable to predicate | Xenon & LED |
| Zoom | Yes | Yes | Functional | Yes |
| Image Enhancement | Yes | Yes | Functional | Yes |
| Image Capture | Yes | Yes | Functional | Yes |
| Video Recording | Yes | Yes | Functional | Yes |
| Switch Between 2D and 3D Image | Yes | Yes | Functional | Yes |
| Scope Diameters | 4 mm | 4mm & 5.5mm | Comparable to predicate | 4 mm |
| Resolution | HD | SD | Equivalent or better than predicate | HD |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states "No clinical information is required for this submission." Therefore, there is no clinical test set, sample size, or data provenance from a clinical study to report. The "Performance Testing" mentioned under Non-Clinical Performance Data likely refers to bench testing and engineering verification, not a clinical study on patient data.
3. 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)
Not applicable, as no clinical study with a test set requiring expert ground truth establishment was conducted for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study with a test set requiring adjudication was conducted.
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 submission is for an endoscopic camera system, not an AI/ML diagnostic algorithm. Therefore, an MRMC study and effects on human reader performance with AI assistance are not relevant or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm requiring standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical study requiring ground truth was conducted. For the non-clinical performance testing, the ground truth would be against established engineering standards and technical specifications.
8. The sample size for the training set
Not applicable. This device is an imaging system, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
Summary of Device and Evidence:
The TIPCAM®1S 3D System sought 510(k) clearance by demonstrating substantial equivalence to existing predicate devices (VS3 Stereoscopic High Definition Vision System K131434 and SPIES 3D System K150525).
The evidence for substantial equivalence was primarily based on:
- Non-Clinical Performance Data: This included tests for electrical safety and EMC (e.g., IEC 60601 series), ISO endoscopes standards (e.g., ISO 8600 series), biocompatibility testing (ISO 10993-1), software verification and validation, performance testing (White Balance, Brightness, Image Enhancement, Video Output Format, Zoom, Image Quality, Image Capture Latency, Interface Control, 3D-2D mode), and reprocessing (cleaning and steam sterilization).
- Comparison of Technical Characteristics: A direct comparison of key specifications between the subject device and the predicate device, showing similar or superior characteristics (e.g., Resolution: HD for subject device vs. SD for predicate).
The submission explicitly states, "No clinical information is required for this submission," indicating that the FDA determined that non-clinical testing and comparison to a predicate device were sufficient to establish safety and effectiveness for this device, which is a hardware-based imaging system, not a diagnostic AI/ML software. Therefore, the "acceptance criteria" and "study" are framed within the context of regulatory substantial equivalence, not a clinical performance trial.
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).