Search Results

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. The device is indicated to ensure complete positioning of an endoscope during navigation in the large intestine, while assisting with optical visualization, diagnosis, tissue manipulation, 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 and DiLumen are navigated to the target zone with the balloons deflated. At the area of interest, the Aft Balloon, which is attached to the DiLumen sleeve, is inflated until it contacts the tissue 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 intestine tissue, and in combination with the Aft Balloon, creates an isolated diagnostic / therapeutic zone. Both balloons are controlled using an Inflation Handle with a squeeze bulb to manually inflate and deflate them (independently) with ambient air as they assist in stabilizing the endoscope and the therapeutic area. The Suture Loops attached to the Fore Balloon of the DiLumen allow clinicians to manipulate tissue when used with an endoscopic clip. The endoscope flexibility, maneuverability and functionalities (such as visualization, suction, insufflation, etc.) are unaffected by the presence of the DiLumen is designed to permit the usage of any standard tool through the endoscope working channel.

The provided text is a 510(k) summary for the DiLumen Endolumenal Interventional Platform, detailing modifications to a previously cleared device. It primarily focuses on demonstrating substantial equivalence to the predicate device rather than presenting a full de novo clearance study with extensive clinical performance data against specific acceptance criteria.

Therefore, many of the requested elements for a study proving a device meets acceptance criteria (like a large human reader study, detailed ground truth establishment for a test set, etc.) are not present in this document. The document states that the changes "do not raise different questions of safety or effectiveness," and therefore, "the bench testing to support this 510(k) notice is limited."

However, I can extract the information that is present and indicate where the requested information is not available.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) typical for a new AI/diagnostic device. Instead, the "acceptance criteria" are implied by the nature of a 510(k) for a modified device – demonstrating that the modifications do not negatively impact the device's original performance and that it remains substantially equivalent to its predicate. The "performance" is largely demonstrated through bench testing and verification studies.

2. Sample Size Used for the Test Set and Data Provenance

This document primarily describes bench and user validation testing for design changes, not a clinical trial with a "test set" in the sense of patient images or data for an AI algorithm. Therefore:

• Sample size for test set: Not applicable in the context of an AI/diagnostic algorithm testing on patient data. The "test set" would be the modified device itself, subjected to various physical and functional tests. Specific sample sizes for bench tests (e.g., number of devices tested for pull force) are not detailed.
• Data Provenance: Not applicable in terms of patient data. The "data" comes from engineering bench tests and potentially user feedback on the device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of experts: Not applicable. Ground truth for an AI/diagnostic algorithm using expert reads is not relevant here. The "experts" would likely be the engineers, quality assurance personnel, and potentially clinical users (e.g., endoscopists) involved in the design verification, validation, and user testing. Their specific number and qualifications are not detailed.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable. This concept applies to consensus reading for ground truth in diagnostic studies, which is not the nature of the tests described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC study: No, an MRMC comparative effectiveness study was not done. The document states that the changes "do not raise different questions of safety or effectiveness," implying that extensive clinical re-evaluation of diagnostic accuracy or comparative effectiveness was not deemed necessary for this 510(k) Special submission. The study is focused on the device's technical and physical performance after minor modifications.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone performance: Not applicable. This device is a mechanical accessory to an endoscope, not a software algorithm, so the concept of standalone performance does not apply.

7. The Type of Ground Truth Used

• Type of ground truth: For mechanical and functional performance, the "ground truth" would be established engineering specifications, design parameters, and relevant ISO/USP standards (e.g., ISO 10993 for biocompatibility, predetermined values for pull/push force). For user validation, the "ground truth" would be the subjective and objective feedback from clinical users regarding the ease of use and functionality of the modified device compared to the predicate.

8. The Sample Size for the Training Set

• Training set sample size: Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Ground truth for training set: Not applicable.

Ask a specific question about this device

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. The device is indicated to ensure complete positioning of an endoscope during navigation in the large intestine, while assisting with optical visualization, diagnosis, tissue manipulation, 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 and DiLumen are navigated to the target zone with the balloons deflated. At the area of interest, the Aft Balloon, which is attached to the DiLumen sleeve, is 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 them (independently) with ambient air as they assist in stabilizing the endoscope and the therapeutic area. This 510(k) notice encompasses a minor revision to the device's indications statement to specify that it can be used for tissue manipulation, as well as addition of suture loops to the Fore Balloon skirt to facilitate that functionality. The DiLumen is designed to permit the usage of any standard endoscopic tool through the endoscope working channel. The endoscope flexibility, maneuverability and functionalities (such as visualization, suction, insufflations, etc.) are unaffected by the presence of the DiLumen, including the sleeve, balloons, and suture loops.

Here's an analysis of the provided text regarding the DiLumen Endolumenal Interventional Platform, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary for a medical device (DiLumen Endolumenal Interventional Platform). 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than presenting entirely new, rigorous clinical trials for effectiveness. Therefore, the information related to studies proving new performance claims is limited, and much of the "proof" is based on the substantial equivalence argument, relying on prior clearances and bench testing. Questions related to AI algorithm performance (e.g., MRMC studies, training set details) are not applicable as this is a mechanical accessory, not an AI device.

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in the format of specific quantitative benchmarks (e.g., "Device must maintain position for X minutes" or "Force required to reposition must be Y"). Instead, the performance is demonstrated through its substantial equivalence to predicate devices and confirmation of its mechanical and functional specifications via bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

• Ability to securely fit over a standard endoscope (12.5 - 14.3 mm distal tip OD).
• Balloons can be inflated and deflated independently.
• Capable of positioning and stabilizing the endoscope within the large intestine.
• Creates an isolated diagnostic/therapeutic zone.
• Permits usage of standard endoscopic tools through the endoscope working channel.
• Endoscope flexibility, maneuverability, and functionalities (visualization, suction, insufflation) are unaffected.
• Facilitates tissue manipulation. | Relied upon testing from prior 510(k) (K162428).
  Confirmed through bench testing (for suture loops and overall functionality).
  "Performs to its pre-defined specifications." Note: No specific numerical performance metrics are provided in this summary. |
  | Mechanical Performance:
• Structural integrity of components (sleeve, balloons, push rods, inflation handle, suture loops).
• Durability for single-use. | Relied upon testing from prior 510(k) (K162428).
  Confirmed through bench testing (for suture loops and overall functionality). |
  | Safety: Device presents no new safety concerns compared to predicates. | Demonstrated through substantial equivalence argument and performance data (bench testing, biocompatibility). |

2. Sample Size Used for the Test Set and the Data Provenance

• The document states: "The testing submitted in that 510(k) notice [K162428] is relied upon to establish the device's biocompatibility and functional and mechanical performance."
• "In addition, the company has conducted bench testing to assess the performance and impact of the suture loops added to the Fore Balloon."
• Sample Size: Not explicitly stated for any of the bench tests. 510(k) summaries often do not detail the exact number of units tested.
• Data Provenance: The testing was conducted by or for Lumendi LLC. The location (country) of the testing is not specified. All testing described is retrospective (i.e., conducted before the 510(k) submission). No mention of prospective clinical studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• This device is a mechanical accessory, not an AI or diagnostic device that requires expert adjudication of images or outputs.
• "Ground truth" in this context would relate to the mechanical and functional performance specifications. These are established through engineering design, regulatory standards, and bench testing, not expert consensus on diagnostic interpretations.
• Therefore, this question is not applicable.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

• Not applicable, as this is not a diagnostic device requiring adjudication of human readings or algorithm outputs.

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 is a mechanical accessory, not an AI-powered device or a diagnostic aid that would involve human readers interpreting images.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a mechanical accessory, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For this device, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate device. For the new features (suture loops), the "ground truth" would be the successful demonstration via bench testing that they perform as intended and do not compromise safety or functionality. This is primarily engineering specifications and bench test results.

8. The sample size for the training set

• Not applicable. This is a mechanical accessory, not an AI device that requires a training set.

9. How the ground truth for the training set was established

• Not applicable.

Ask a specific question about this device

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."

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.

Ask a specific question about this device