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510(k) Data Aggregation
(92 days)
The NaviCam Xpress Stomach Capsule is intended for visualization of the stomach of patients >= 6 years old with BMI =< 65 and a waist circumference =< 77 inches. The system can be used in clinics and hospitals, including ER settings.
The NaviCam Tether is an accessory of the NaviCam Stomach Capsule. It is intended to aid the Capsule for visualizing the esophagus (not magnetically maneuvered) prior to the Capsule's release into the stomach capsule endoscopy (MCCE) procedure.
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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