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510(k) Data Aggregation
(92 days)
System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether Regulation Number: 21 CFR 876.1310
Classification Code: Name: Magnetically maneuvered capsule endoscopy system Product Code: QKZ Regulation No: 876.1310
The NaviCam Xpress Stomach Capsule is intended for visualization of the stomach of patients >= 6 years old with BMI =
NaviCam® Xpress Stomach Capsule Endoscope System enables the operator to control the capsule endoscope inside the stomach. The capsule endoscope can be moved in any direction during examination. The direction and angulation of the capsule camera head can be adjusted in real-time, hence realizing complete control of capsule endoscope movement and attitude during examination in the X left and right, Y forward and backward, Z up and down directions as well as rotation clockwise and counterclockwise.
This document (K231960) describes a 510(k) premarket notification for the NaviCam Xpress Stomach Capsule Endoscope System. The filing is an expansion of the Indications for Use for an already cleared device, primarily expanding age and BMI limitations. As such, the performance study focuses on demonstrating that the device's performance is not adversely affected by these expanded patient characteristics.
Here's an analysis of the acceptance criteria and study information provided:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in terms of metrics like sensitivity, specificity, or accuracy for a specific diagnostic task from an AI component. This is because this 510(k) notification is for an expanded indication for use of an existing device, not for the clearance of a new AI-powered diagnostic algorithm.
The "performance data" section focuses on demonstrating that the existing device's performance is not affected by the expanded age and BMI patient populations. Therefore, the "acceptance criteria" are implicitly that the device continues to perform as intended and safely within the expanded patient population.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device performance is not adversely affected by increased BMI up to 65. | "The company provided technical data demonstrating capsule and system performance would not be affected by increasing the BMI of the patient up to the limitations stated in the report." |
| Device performance is not adversely affected by lower age patients (down to 6 years old). | "The clinical data demonstrate using the system on lower age patients... doesn't affect performance of the device." |
| Device remains safe in expanded patient populations. | "This real-world evidence demonstrates the safety..." and "does not pose any new risks to the patient as demonstrated using the device in clinical settings." |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document mentions "clinical data" and "real-world evidence" but does not provide a specific sample size for a test set. This suggests that a formal, prospective, rigorously controlled "test set" in the context of an AI study was not conducted. Instead, they relied on existing clinical literature and internal reports.
- Data Provenance: The document does not specify the country of origin. The data is described as "published in the scientific literature along with unpublished clinical reports" and "real-world evidence." This implies a mix of retrospective and possibly ongoing observational data.
3. Number of Experts and Qualifications
The document does not mention the number or qualifications of experts used to establish ground truth. This is expected given that the filing is not for an AI diagnostic algorithm requiring this type of ground truth establishment for its performance evaluation. The "ground truth" seems to be the continued functionality and safety of the device itself in the expanded population.
4. Adjudication Method
No adjudication method is mentioned, as it's not applicable to this type of device modification submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done, as this submission is not about the effectiveness of a diagnostic algorithm or how it improves human reader performance.
6. Standalone (Algorithm Only) Performance Study
No standalone algorithm performance study was done. This device is a capsule endoscope system, and while it has software, the submission is not for a new AI-driven diagnostic or analytical algorithm.
7. Type of Ground Truth Used
The "ground truth" implicitly used for this submission is clinical experience and technical (bench) data demonstrating the continued functional performance and safety of the existing device when used in the expanded age and BMI populations. It is not about diagnostic accuracy against a specific disease state.
8. Sample Size for Training Set
No training set sample size is mentioned. This is not a submission for a new AI/ML algorithm that would undergo a training phase.
9. How Ground Truth for Training Set was Established
Not applicable, as no training set for an AI/ML algorithm is discussed.
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(31 days)
Trade/Device Name: NaviCam Xpress Stomach System, NaviCam Xpress System Regulation Number: 21 CFR 876.1310
Classification Code: Name: Magnetically maneuvered capsule endoscopy system Product Code: OKZ Regulation No: 876.1310
The NaviCam Stomach Capsule is intended for visualization of the stomach of adults (>/=22 years) with BMI
The NaviCam Xpress Stomach System is a novel endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule within the stomach to be controlled by an operator.
The NaviCam Xpress Stomach System includes the following key components:
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- Ingestible capsule (CP-US-7005) for obtaining images.
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- Data recorder (MC-US-1006) for logging image data.
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- Locator (SB-US-2006) for turning on the capsule and for determining if the capsule is still in the body.
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- Controller, NaviEC-2000 (MC-US-1002) with the NaviCtrl software that allows the navigation of the capsule within the stomach.
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- ESView software for review of the images obtained by the capsule and generating reports.
- Optional Accessory: NaviCam Tether (ES-US-7005) for aiding the capsule in visualizing 6. the esophagus.
This document is a 510(k) summary for a software addition, not a comprehensive clinical study report. Therefore, much of the requested information about clinical performance, ground truth, and expert involvement is not present in this document.
Here's a breakdown of what can be extracted based on the provided text:
Device: NaviCam Xpress Stomach System (addition of GastroScan feature to NaviCtrl software)
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for the device's diagnostic capabilities. Instead, it focuses on demonstrating that the software addition does not negatively impact the existing cleared device's performance or introduce new risks. The reported "performance" is that the device "performs as intended based on the non-clinical bench testing."
| Acceptance Criteria (Implied by the submission) | Reported Device Performance |
|---|---|
| Software updates function as intended | Verified through Software Verification Testing |
| Device remains safe and effective (no new risks introduced by software update) | Demonstrated by Human Factors Engineering/Usability Testing/Evaluation, performance bench testing, software risk analysis, and cybersecurity FMEA risk analysis. |
| No changes to existing indications for use | The device retains the same Indications for Use as the predicate device. |
| No degradation in performance compared to the predicate device | Not explicitly quantified, but implied by successful non-clinical testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified for any performance testing related to diagnostic accuracy. The non-clinical performance and bench testing would have used specific test cases, but the number of such cases is not provided.
- Data Provenance: The new software features were evaluated through non-clinical performance and bench testing. This is typically internal testing. No information about country of origin for this testing or whether it was retrospective or prospective is provided. The document states that "No additional Animal and clinical performance testing were conducted."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this submission, as no new clinical performance testing was conducted. Ground truth for previous clinical evidence (mentioned in point 9) would have been established, but details are not provided here.
4. Adjudication Method for the Test Set
Not applicable for this submission, as no new clinical performance testing was conducted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done for this submission. The document explicitly states "No additional clinical literature has been provided in this submission." It refers to previous clinical evidence from predicate devices but does not provide details of those studies in this document.
6. Standalone Performance Study
A standalone study of the algorithm's core diagnostic performance (e.g., sensitivity/specificity for detecting stomach abnormalities) was not performed as part of this specific submission. The submission focuses on the safety and efficacy of a software addition to an already cleared device. The "performance bench testing" mentioned would assess the functionality of the new software feature (GastroScan) rather than clinical diagnostic accuracy.
7. Type of Ground Truth Used
For this specific submission, the "ground truth" for the non-clinical performance and bench testing would be defined by the expected outcomes of the software functions and hardware interactions as specified in design documents and testing protocols. No clinical ground truth (e.g., pathology, expert consensus on patient cases) was used for this particular submission's evaluation.
8. Sample Size for the Training Set
No training set information is provided, as this submission is for a software feature addition to a previously cleared device. It's unlikely that machine learning model training was a primary component of this specific update.
9. How the Ground Truth for the Training Set Was Established
Not applicable for this submission (see point 8).
Summary of this Submission's Focus:
This 510(k) submission (K230694) is for a software update (GastroScan feature) to an already cleared device (NaviCam Xpress Stomach System, K203192). The primary goal of this submission is to demonstrate that this software addition does not change the indications for use, does not introduce new risks, and does not negatively impact the performance of the existing device. Therefore, the evidence focuses on non-clinical software verification, human factors, and risk analysis, rather than new clinical trials or diagnostic performance metrics. The clinical evidence for the overall system's diagnostic capabilities would have been established in previous submissions (DEN190037 and K203192).
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(172 days)
NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether Regulation Number: 21 CFR 876.1310
Classification Code: Name: Magnetically maneuvered capsule endoscopy system Product Code: QKZ Regulation No: 876.1310
The NaviCam Stomach Capsule is intended for visualization of the stomach of adults (>/=22 years) with BMI
The NaviCam Capsule and NaviCam Tether are disposable sterile products, which serve as an accessory to the NaviCam Capsule Endoscope System and the NaviCam Xpress Stomach Capsule Endoscope System to allow for examination of the esophagus prior to releasing the NaviCam Capsule into the stomach. The NaviCam Tether is comprised of a tube which on one end is attached to a capsule cradle and on the other end is attached to a syringe connector. The capsule cradle holds the capsule in place while examining the esophagus. The tube is used to control the downward speed of the capsule in the esophagus. The syringe connector serves for releasing the capsule by attaching to it a standard syringe filled with air. After the examination of the esophagus is accomplished, the syringe piston is pushed to release the capsule for examining the stomach with the NaviCam Capsule Endoscope System or the NaviCam Xpress Stomach Capsule Endoscope System.
The provided text does not describe an AI-powered device or a study proving its performance against specific acceptance criteria. Instead, it is a 510(k) summary for a NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether. This system is a medical device for visualizing the stomach and esophagus, and the submission focuses on demonstrating its substantial equivalence to previously cleared predicate devices.
Therefore, I cannot provide the information requested in the prompt, as it pertains to AI-specific performance criteria and studies, which are not present in the provided document.
Here's an analysis of why the requested information cannot be extracted from the given text:
- No mention of AI/ML: The document does not describe the device as having any artificial intelligence or machine learning components. It's a hardware device (capsule endoscope and tether) for aiding visualization.
- No acceptance criteria for AI performance: Since there's no AI, there are no acceptance criteria related to its performance (e.g., sensitivity, specificity, AUC).
- No study proving AI performance: Consequently, there's no study described that would prove the device meets AI-specific acceptance criteria. The performance data section focuses on non-clinical (biocompatibility, bench testing) and clinical experience (references to scientific literature demonstrating safety and value, and a meta-analysis on battery life), not AI performance.
- No data provenance for AI testing: Without AI, there's no test set, training set, or related data provenance for AI models.
- No experts for AI ground truth: The concept of experts establishing ground truth for AI model performance isn't applicable here.
- No MRMC study: The document does not describe a multi-reader multi-case study, which is typically done to assess the impact of AI assistance on human readers.
- No standalone algorithm performance: As it's not an algorithm, there's no standalone performance to report.
- No ground truth type for AI: The "ground truth" discussed in the context of AI (e.g., pathology, expert consensus for disease detection) is not relevant for this device's submission.
In summary, the provided FDA 510(k) summary is for a physical medical device (capsule endoscopy system) and does not involve AI. Therefore, the questions related to AI-specific performance criteria and studies cannot be answered from this text.
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(188 days)
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) Regulation Number: 21 CFR 876.1310
Code: Name: Magnetically maneuvered capsule endoscopy system Product Code: QKZ Regulation No: 21 CFR 876.1310
The NaviCam Xpress Stomach System is intended for visualization of the stomach of adults (≥22 years) with BMI
The NaviCam Xpress Stomach System is a endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule within the stomach to be controlled by an operator. The NaviCam Xpress Stomach System includes the following key components: Ingestible capsule (AKEM-11SW) for obtaining images, Data recorder (AKR-1) for logging image data, Locator (AKS-1) for turning on the capsule and for determining if the capsule is still in the body, Controller (NaviEC-2000) with the NaviCtrl software that allows the navigation of the capsule within the stomach, ESView software for review of the images obtained by the capsule and generating reports.
The provided text is a 510(k) summary for the NaviCam Xpress Stomach Capsule Endoscope System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the acceptance criteria or a study proving the device meets those criteria, especially in terms of diagnostic performance or clinical accuracy. The "Performance Data" section solely discusses bench/in-vitro testing related to the controller's functionality and compliance with electrical safety standards, not the diagnostic performance of the capsule endoscope system itself.
Therefore, most of the requested information regarding acceptance criteria, performance, sample sizes, expert involvement, and ground truth for a diagnostic study cannot be extracted from this document.
Here's what can be inferred or explicitly stated based on the provided text, alongside what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Diagnostic Performance: (e.g., Sensitivity, Specificity, Accuracy for detecting gastric abnormalities) | NOT PROVIDED IN THIS DOCUMENT. The document focuses on the controller's performance and system compliance, not the diagnostic capabilities of the capsule endoscope. |
| NaviCam Xpress Controller meets performance requirements in specifications and implements software functions. | Passed: Verified that the NaviCam Xpress Controller meets its specifications and implements software functions as stated in its User Manual. |
| Magnetic field intensity range meets specifications with various examination beds. | Passed: Verified that the magnetic field intensity range meets specifications when used with examination beds/tables provided by users. |
| Mechanical motion range meets specifications. | Passed: Verified that the mechanical motion range meets specifications. |
| Titanium clips do not affect data communication, and clips do not move during magnetic head rotation. | Passed: Data communication not affected, and clip position does not change. |
| Compliance with IEC 60601-1, ANSI/AAMI ES60601-1, CAN/CSAC22.2 No. 60601-1:14, EN 60601-1:2006, AAMIIEC 60601-1-2:2014, EN 60601-1-2:2015. | Passed: The system was found to comply with all applicable requirements of these standards. |
The following information cannot be extracted from the provided text:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- 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)
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- 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
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- 8. The sample size for the training set
- 9. How the ground truth for the training set was established
Reasoning for Missing Information:
This 510(k) summary focuses on demonstrating substantial equivalence for a modification to an already cleared device (the NaviCam Stomach System). The "Performance Data" section details bench/in-vitro testing and compliance with electrical safety and EMC standards. It explicitly states, "The NaviCam Xpress Stomach System successfully passed the following test," and then lists functional and safety-related tests for the controller. It does not discuss any clinical diagnostic performance studies comparing the NaviCam Xpress Stomach System's ability to detect stomach abnormalities against a ground truth, which would involve patient data, expert review, and metrics like sensitivity or specificity.
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(283 days)
NEW REGULATION NUMBER: 21 CFR 876.1310
CLASSIFICATION: Class II
PRODUCT CODE: QKZ
BACKGROUND
Code: OKZ Device Type: Magnetically maneuvered capsule endoscopy system Class: II Regulation: 21 CFR 876.1310
The NaviCam Stomach Capsule is intended for visualization of the stomach of adults (≥22 years old) with a BMI less than 38. The system can be used in clinics and hospitals, including ER settings.
The NaviCam Capsule Endoscopy System with NaviCam Stomach Capsule is an endoscopic capsule imaging system intended to obtain images of the stomach and duodenum. In contrast to passive capsule endoscopy systems, it uses external magnetic fields to allow the position of the capsule to be controlled by an operator. The NaviCam Capsule Endoscopy System with NaviCam Stomach Capsule consists of an ingestible capsule, a data recorder, a locator, and a controller.
This response focuses on the provided text to describe the acceptance criteria and the studies performed for the NaviCam Capsule Endoscope System.
Acceptance Criteria and Device Performance for NaviCam Capsule Endoscope System
The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule underwent various non-clinical (bench) and clinical studies to demonstrate its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
Non-Clinical Acceptance Criteria and Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bite Force | The capsule should withstand applied force up to (b) (4) | Passed |
| Temperature Safety | △T should not be more than (b) (4) | Passed |
| Magnetic Force Measurement | The acceptance criteria for this test are: (b) (4) | Passed |
| Magnetic Field Test | 1) The maximum value of magnetic flux density on the surface of the NaviCam stomach capsule must be less than or equal to (b) (4) 2) The magnetic field of the capsule at (b) (4) must be less than (b) (4) | Passed |
| Battery Life | The acceptable result of the battery test is at least (b) (4) pictures (equal to (b) (4) hours battery life time, (b) (4) captured by the capsule. | Passed |
| pH Test | 1) After soaking, there is no change in the capsule weight. Considering measurement error, the variation in weights obtained by the balance shall not exceed (b) (4) 2) After soaking, there is no change on the surface of the capsule front and rear shells. 3) Resolution and color reproduction are not affected. | Passed |
| Color Performance | For a capsule endoscope, because of its size, Field of View (FOV), small field size and the way of imaging based on the illumination of its built-in LEDs, for improved image color reproduction the total color difference of a sample (ΔE) should be kept as no more than (b) (4) | Passed |
| Image Resolution | For (b) (4) working distance, module transfer function (MTF) (b) (4) is not less than (b) (4) | Passed |
| Field of View | (b) (4) is accepted, that is (b) (4) (b) (4) degree. | Passed |
| Geometric Distortion | Distortion value not larger than (b) (4) is accepted. | Passed |
| Depth of View (DOV) | For reflectance USAF1951 angular resolution test, DOV is (b) (4) mm to (b) (4) in air or under water. | Passed |
| Peak Illuminance | (b) (4) is accepted, that is (b) (4) to (b) (4) lux. | Passed |
| Image Intensity Uniformity | (1) The two-dimensional distribution of the IIU space is basically a spatially symmetric distribution. (2) The four-dimensional distribution of the IIU at (b) (4) is basically symmetrical from the center. (3) The calculated minimum IIU value in the four directions of (b) (4) should not be less than (b) (4) | Passed |
| Photobiological Safety | The device must meet light hazard exposure limits per IEC 62471:2006. | Passed |
Clinical Acceptance Criteria and Performance (Comparative Studies):
While specific numeric acceptance criteria for sensitivity, specificity, PPV, and NPV are not explicitly stated as acceptance criteria in the clinical sections, the consistently high reported performance against the "gold standard" of gastroscopy is used to demonstrate effectiveness. The FDA's conclusion on benefit/risk references these results.
| Metric | Comparative Study (350 patients) | CFDA Study (99 subjects) |
|---|---|---|
| Sensitivity (for gastric focal lesions) | 90.4% (95% CI: N/A, see table for per-lesion sensitivity) | 90.9% |
| Specificity (for gastric focal lesions) | 94.7% (95% CI: 91.9% - 97.5%) | 94.8% |
| Diagnostic Accuracy (for gastric focal lesions) | 93.4% (95% CI: 90.8% - 96.0%) | 93.9% |
| Positive Predictive Value (PPV) | 87.9% (95% CI: 81.7% - 94.0%) | 83.3% |
| Negative Predictive Value (NPV) | 95.9% (95% CI: 93.4% - 98.4%) | 97.3% |
| Sensitivity for lesions ≥5mm | ≥87.5% (77.3-97.8%) | Not explicitly stated, grouped with overall sensitivity |
| No missed clinically significant lesions | MCE did not miss any lesions of significance (tumors, large ulcers) | Not explicitly stated, but high NPV implies this |
| Effective Visualization Rate (CFDA Study) | N/A (Comparative study focuses on lesion detection) | Dentate line: 92%, Cardia: 97%, Fundus: 94%, Gastric body: 99%, Gastric antrum: 99%, Pylorus: 99%, Duodenal bulb: 96% |
| Adverse Events | No adverse events or capsule retention | No adverse events or capsule retention |
2. Sample Sizes and Data Provenance
- Comparative Study:
- Test Set Sample Size: 350 patients.
- Data Provenance: Retrospective, conducted at a tertiary center in China.
- Chinese Food and Drug Administration (CFDA) Study:
- Test Set Sample Size: 99 subjects.
- Data Provenance: Not explicitly stated as retrospective or prospective within the provided text for this specific study, but it's a "self-controlled comparative trial" suggesting a prospective design where subjects undergo both procedures. Country of origin is China (implied by CFDA).
- Literature Reviews:
- Screening study for gastric cancer: 3182 asymptomatic Chinese individuals.
- Superficial gastric neoplasia study: 10 subjects.
- Locator detection study: Not specified per subject, but performed on patients where the capsule was detected by X-ray.
3. Number of Experts and Qualifications for Ground Truth
- Comparative Study: The gastroscopy procedures were used as the gold standard. While the number and specific qualifications of the endoscopists performing the gastroscopy are not detailed in the provided text, it can be assumed that they were qualified medical professionals performing conventional gastroscopy. The interpretation of MCE and gastroscopy results to calculate performance metrics would have been done by clinicians.
- CFDA Study: Similar to the comparative study, gastroscopy was the ground truth. The determination of "complete," "incomplete," or "unable to be explored" for visualization rates was "based on the determination of the physician," indicating expert involvement. No specific number or qualifications are provided.
- Literature (Screening for gastric cancer): For the 7 suspected malignancies identified by MCE, the confirmation was "pathologically," indicating histopathologists provided the definitive ground truth. No specific number or qualifications are given for these pathologists.
- Literature (Superficial gastric neoplasia): Diagnostic agreement of MCE, ESD (endoscopic submucosal dissection), and pathology were compared. Pathology would be the ultimate ground truth here.
4. Adjudication Method for Test Set
The adjudication method is not explicitly described as a formal consensus process (e.g., 2+1, 3+1). The studies directly compared MCE findings to gastroscopy results, which served as the "gold standard" or control. Discrepancies would likely have been noted, but a formal adjudication process for discordant cases between MCE and gastroscopy is not elaborated upon in the text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No specific MRMC comparative effectiveness study, designed to measure the effect size of human readers improving with AI vs. without AI assistance, is detailed in the provided text. The studies compared the device's performance (MCE) directly against conventional gastroscopy (human readers performing a different procedure), not human readers reviewing MCE images with and without AI assistance.
6. Standalone (Algorithm Only) Performance
The "NaviCam Capsule Endoscope System with NaviCam Stomach Capsule" is described as an endoscopic system where an operator controls the capsule. The images captured by the capsule are then presumably reviewed by a human clinician. Therefore, the reported performance metrics (sensitivity, specificity, etc.) represent the performance of the system in use by a clinician, not a standalone algorithm that automatically detects lesions without human intervention. The text does not describe an "algorithm only" performance evaluation.
7. Type of Ground Truth Used
- Clinical Studies (Comparative and CFDA): The primary ground truth for lesion detection was conventional gastroscopy. For a subset of suspected malignancies, pathology was used for confirmation. For visualization rates in the CFDA study, it was physician determination.
- Literature (Screening for gastric cancer): Confirmed malignancies were referenced against pathology.
- Literature (Superficial gastric neoplasia): Comparisons were made between MCE, ESD, and pathology.
8. Sample Size for the Training Set
The provided text details clinical validation studies and refers to leveraging clinical data from two studies and 11 literature articles. It does not specify a dedicated training set size for the NaviCam's internal algorithms (e.g., image processing, magnetic control). The clinical studies are described as comparative evaluations against a gold standard, not as studies used to train the device's analytical aspects. The device itself (the capsule and its control system) is the subject of the performance and safety studies, not a developing AI algorithm that requires a distinct training set.
9. How the Ground Truth for the Training Set Was Established
As no distinct training set for an AI algorithm (in the context of automated lesion detection or diagnosis) is described, the method for establishing its ground truth is not applicable based on the provided text. The device's "training" in a broader sense would be through iterative engineering and testing during its development, informed by medical knowledge and clinical requirements, rather than a specific supervised learning approach on a labeled dataset. The clinical studies serve to validate the overall system's performance, using gastroscopy and pathology as the truth.
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