(98 days)
The Lumendi DiLumen is an accessory to an endoscope. The DiLumen dual balloon accessory is intended for use with any standard endoscope that has a distal tip outer diameter of 12.5 – 14.3 mm and a working length of 1680 mm or greater. The device is indicated to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.
The DiLumen Endolumenal Interventional Platform is a non-sterile, single-use, close-fitting sleeve that fits securely over a standard endoscope. The DiLumen utilizes two balloons to position and stabilize the endoscope within a patient's large intestine. After the DiLumen is installed over the endoscope, the endoscope and DiLumen are navigated to the target zone with the balloons deflated. Once the clinician is at the area of interest, the Aft Balloon, which is attached to the DiLumen sleeve, will be inflated until it contacts the intestinal wall near the proximal end of the articulating section of an endoscope. The second balloon, the Fore Balloon, is also attached to the sleeve via two flexible extension push rods and is deployed at the distal end of the endoscope at a variable distance. Once extended and inflated, the Fore Balloon contacts the patient's intestinal wall, and in combination with the Aft Balloon, creates an isolated diagnostic or therapeutic zone. Both balloons are controlled using an Inflation Handle with a squeeze bulb to manually inflate and deflate the two balloons with ambient air. The balloons assist in stabilizing the endoscope and the therapeutic area and are inflated or deflated independently. The balloons and sleeve are designed to permit the usage of any standard endoscopic tool (such as biopsy forceps, snare, needle, etc.) through the endoscope working channel. The endoscope flexibility, maneuverability and functionalities (such as visualization, insufflations, etc.) are unaffected by the presence of the DiLumen.
The provided text describes the 510(k) summary for the DiLumen Endolumenal Interventional Platform, a medical device. However, it does not contain the specific details about the acceptance criteria or a dedicated study that rigorously proves the device meets specific performance criteria with quantitative metrics like sensitivity, specificity, or reader improvement. The document focuses on demonstrating substantial equivalence to predicate devices through various performance tests, but these tests are not presented as a formal study with detailed acceptance criteria and reported numerical performance.
Therefore, I cannot generate the exact table or detailed information requested without that specific data.
However, I can extract the types of performance tests conducted, which imply underlying acceptance criteria, and some general statements about the studies.
General Information Extracted:
- Device Name: DiLumen Endolumenal Interventional Platform
- Intended Use: Accessory to an endoscope, intended for use with standard endoscopes with specific distal tip outer diameter and working length. Indicated to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.
- Predicate Devices: Fujinon EC-450B15 Double Balloon Enteroscopy System (K090116), Smart Medical Systems NaviAID™ BGE (K060923), and Smart Medical Systems NaviAID™ BGC (K102616).
- Performance Data Provided: The document lists 18 performance tests conducted to support the premarket notification.
Here's how I can answer the prompt based on the available information, noting the absence of specific quantitative acceptance criteria and results:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific numerical acceptance criteria (e.g., "burst pressure must be > X psi") and reported quantitative performance values are not detailed. The document lists the types of performance tests conducted and generally states that the device "meets specifications" and "has substantially equivalent performance to the predicates."
| Performance Test Name | Implied Acceptance Criterion (General) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device materials must be biocompatible (non-cytotoxic, non-sensitizing, etc.) | Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications") |
| Balloon Burst Pressure Test | Balloons must withstand specified pressure without bursting | Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications") |
| Balloon Diameter, Inflation/Deflation, and Leakage Test | Balloons must inflate/deflate correctly, reach specified diameter, and not leak | Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications") |
| Relief Valve Test | Relief valve must function as intended | Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications") |
| Device Slip Relative to Scope Test | Device must not excessively slip on the endoscope | Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications") |
| Sleeve Buckling Test | Sleeve must not buckle under intended use conditions | Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications") |
| Fore Balloon Extension Test | Fore Balloon must extend as intended | Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications") |
| Colon Grip Test | Device must provide adequate grip in the colon | Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications") |
| Articulation Test | Endoscope articulation must not be impeded by the device | Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications") |
| Sleeve Leak Test | Sleeve must not leak | Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications") |
| Therapeutic Zone Creation Test | Device must effectively create an isolated therapeutic zone | Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications") |
| Fatigue/Cycling Test | Device must withstand repeated use cycles | Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications") |
| Extension Position Locking Test | Extension mechanism must lock in position | Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications") |
| Flexibility Test | Device must maintain appropriate flexibility | Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications") |
| Force/Bond Test | Bonds and components must withstand specified forces | Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications") |
| Insertion Force Test | Device must be inserted with acceptable force | Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications") |
| Packaging and Transit Test | Packaging must protect the device during transit | Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications") |
| User Validation | User interface and functionality must be acceptable | Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications") |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for any of the listed "Performance Data" tests. It also does not mention an explicit "test set" in the context of clinical data or patient images for algorithm evaluation. The tests listed are primarily bench tests and engineering validations. Data provenance (country of origin, retrospective/prospective) is not applicable or provided for these types of tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The listed performance data are mainly physical/mechanical bench tests. "User Validation" implies involvement of users, likely medical professionals, but their number and specific qualifications for establishing a "ground truth" (in the diagnostic sense) are not provided.
4. Adjudication method for the test set
Not applicable. The listed performance data are mainly physical/mechanical bench tests.
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 such study is mentioned or provided in the document. The device itself is an accessory for an endoscope, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used
For the bench tests, the "ground truth" is typically established by engineering specifications, physical measurements, and functional requirements of the device. For example, a burst pressure test would compare actual burst pressure to a pre-defined minimum specification. For "User Validation," the ground truth would be user feedback and ability to complete tasks effectively with the device.
8. The sample size for the training set
Not applicable. This is not an algorithm-based device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an algorithm-based device.
§ 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.