(180 days)
The Lumendi DiLumen C2 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.
The DiLumen C² consists of a sleeve including two inflatable balloons that fits over a standard endoscope to facilitate positioning and stabilization of the endoscope during surgical procedures. The C2 comes into limited (
The provided text describes a medical device called the DiLumen C2 and its accessory, the Tool Mount, and generally states their performance and equivalence to a predicate device. However, it does not contain the detailed acceptance criteria and the results of a specific clinical study in the format requested.
The document is a 510(k) Premarket Notification summary from the FDA, aiming to demonstrate substantial equivalence to a legally marketed predicate device (DiLumen Endolumenal Interventional Platform, K162428). This typically relies on comparing technological characteristics and demonstrating that any differences do not raise new questions of safety or effectiveness, often through bench testing rather than extensive clinical trials with specific performance metrics against pre-defined acceptance criteria.
The "Performance Data" section lists various tests performed (e.g., Biocompatibility, Balloon Diameter, Inflation/Deflation and Leakage Test, User Validation), but it does not provide quantitative acceptance criteria or the specific performance results from these tests. It merely states, "In all instances, the device functioned as intended and the results observed were as expected." It also explicitly states, "No animal or clinical testing was required to demonstrate substantial equivalence to the predicate."
Therefore, I cannot fill in the requested table and answer many of the specific questions about clinical study details (sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set) because this information is not present in the provided document.
Here's what I can extract and state based on the provided text, and where I must indicate information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., specific thresholds for force, leak rate, etc.) | Reported Device Performance |
|---|---|
| Not provided in the document. The document states: | "In all instances, the device functioned as intended and the results observed were as expected." |
| Specific criteria for: | |
| - Biocompatibility | |
| - Balloon Diameter, Inflation/Deflation and Leakage Test | |
| - Device Slip Relative to Scope Test | |
| - Fore Balloon Extension Test | |
| - Articulation Test | |
| - Colon Grip Test | |
| - Therapeutic Zone Creation Test | |
| - Tuohy Leak Force / Bond Leak Test | |
| - Insertion Force Test | |
| - Packaging and Transit Test | |
| - User Validation | |
| - EO residuals | |
| - Tool Mount Cleaning and Sterilization Validation | |
| - Tool Mount Positioning and Locking Test | |
| - Tool Mount Validation |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document indicates "No animal or clinical testing was required," implying that the performance data primarily comes from bench testing, for which sample sizes are not detailed in this summary.
- Data Provenance: Not applicable for a clinical study, as the document states no clinical testing was required. For bench testing, provenance details like country of origin or whether data was retrospective/prospective are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable as no clinical study or expert-adjudicated ground truth for a test set is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not applicable as no clinical study with a test set requiring adjudication is described.
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 MRMC comparative effectiveness study was done. The device (DiLumen C2 and Tool Mount) is an endoscope accessory, not an AI diagnostic or assistive imaging tool that involves "human readers" in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground truth in the traditional sense of clinical studies (e.g., pathology, outcomes) is not mentioned as "No animal or clinical testing was required." For the enumerated performance tests, the "ground truth" would be the engineering specifications and functional requirements of the device.
8. The sample size for the training set
- Not applicable as this is a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary of what the document does provide regarding performance:
The document states that "Performance testing has demonstrated that the DiLumen C2 meets specifications and is as safe and effective as the predicate." The listed tests (Biocompatibility, Balloon Diameter, etc.) are bench tests. The conclusion is that the device is "substantially equivalent" to its predicate based on these tests and similar technological characteristics, not based on a clinical trial with acceptance criteria for specific performance metrics against clinical outcomes.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.