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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.

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The NaviAid™ ICVI device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope in the small intestine (i.e., an endoscope that is used for standard intestinal endoscopic visualization and has a compatible instrument channel as defined in the instructions for use)

The modified NaviAid™ ICVI is an on-demand disposable that is inserted through the instrument channel of the endoscope in order to enable advancement and positioning of a standard endoscope in the small intestine. The modified NaviAid™ ICVI Device comprises a disposable balloon system and an air supply control unit for inflating and deflating the balloon system. The role of the ICVI disposable is to facilitate advancement of a standard endoscope into the small intestine. The modified NaviAid™ ICVI disposable includes the ICVI Balloon and the ICVI inflation tube. The balloon is inflated by ambient air. Either the Air Supply Unit ("ASU") or Single Balloon Air Supply Unit ("SB ASU") may operate and control the inflation and deflation of the balloon through a foot-pedal. The balloon is connected to a dedicated inflation tube that runs inside the instrument channel of the endoscope, and is connected at its proximal (user) end to the ASU or SB ASU.

The ICVI balloon can be advanced ahead of the endoscope tip or pulled back through pushing/pulling action on the ICVI inflation tube at its proximal side, outside the patient's body. When the ICVI balloon is advanced and then inflated, it functions as a distal anchor, to which the endoscope tip is advanced, and the ICVI inflation tube serves as a rail that leads the endoscope as it is pushed towards the anchoring ICVI balloon.

The balloon and tube negligibly compromise the endoscope's flexibility, or its field of view. Additionally, the ICVI disposable negligibly compromise the maneuverability of the endoscope's tip and does not limit the usage of any standard endoscopy tools, such as biopsy forceps, snare, needle etc. The ICVI disposable can be pulled back at any time during the procedure in order to allow use of therapy tools.

The NaviAid™ ICVI disposable is intended for-single use, while the ASU and SB ASU are re-usable.

The provided text describes a 510(k) submission for the NaviAid™ ICVI device, focusing on its substantial equivalence to a predicate device and non-clinical performance data. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/ML performance evaluation. The document confirms that clinical performance data was "Not Applicable" for this submission.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a breakdown of what can be extracted or inferred based on the document's content:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or a table of reported device performance in the way a typical AI/ML study would. Instead, it refers to "design and performance specifications" being met through non-clinical tests.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample size for test set: Not applicable, as clinical performance data was "Not Applicable" and only non-clinical (in vitro, mechanical) tests were performed.
• Data provenance: Not applicable.

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)

• Number of experts: Not applicable.
• Qualifications of experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Adjudication method: Not applicable.

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

• MRMC study: No. The document explicitly states "Clinical Performance Data: Not Applicable." The device is an accessory to an endoscope, not an AI/ML diagnostic tool for human readers.
• Effect size: Not applicable.

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

• Standalone study: No. The device is a physical accessory to an endoscope, not a standalone algorithm.

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

• Type of ground truth: Not applicable in the context of clinical studies. For non-clinical tests, the "ground truth" would be established engineering specifications and physical measurements (e.g., balloon inflation, material properties, compatibility with endoscope channels).

8. The sample size for the training set

• Sample size for training set: Not applicable, as this is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• How ground truth for training set was established: Not applicable.

Summary of available information:

The document describes the NaviAid™ ICVI device's non-clinical performance testing. These tests focused on ensuring the device meets engineering specifications and functions as intended, rather than evaluating performance against a clinical ground truth or human reader performance.

• Acceptance Criteria & Device Performance: The document generally states that "The non-clinical tests demonstrated that the modified NaviAid™ ICVI device meets its design and performance specifications." Specific criteria are implied by the types of tests conducted:

  • ICVI-In Vitro Validation
  • PU Balloon (material properties/functionality)
  • AB Tip (material properties/functionality)
  • Irrigation Cap (functionality)
  • AB Compatibility with 3.2mm Working Channel using a Handle (fit and function)
  • ICVI Tube Length (dimensional accuracy)
  • Set Point Pressure Tolerance (for the SB ASU)
  • Inflation/Deflation Cycles (durability/functionality)
  • Electrical & Mechanical Safety, Electromagnetic Compatibility, Software Validation, Biocompatibility (compliance with recognized standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, FDA Guidelines, ISO 10993)

• Study Proving Acceptance Criteria: The study described is a series of non-clinical performance tests conducted on the modified NaviAid™ ICVI device. These tests focused on the device's physical and mechanical properties, compatibility, and safety.

  • The ASU and SB ASU (Air Supply Units) components' performance tests were referenced from previous 510(k) submissions (K060923 and K110291, respectively), indicating reliance on prior established performance data for shared components.
  • The ICVI disposable's performance tests were also referenced from K101191.
  • New tests for the modified device specifically addressed the ICVI-R model's rotation capability, new tip material, irrigation cap, and modified working length.

• Clinical Performance Data: Explicitly stated as "Not Applicable," meaning no human clinical trials were conducted to establish safety or effectiveness for this 510(k) submission. The FDA cleared the device based on substantial equivalence to a predicate device and satisfactory non-clinical testing.

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The EndoFLIP® EF-800 is an external channel for an endoscope (9.0 to 12.2 mm in diameter) used to aid in the insertion, advancement, and removal of endoscopic devices during endoscopic procedures. The EndoFLIP® ECD is single patient use, disposable. Environments of use - Hospitals, Sub-acute care institutions, Surgery Centers, doctor's offices where endoscopic procedures may be performed.

The EndoFLIP® ECD EF-800 External Channel Device (ECD) is an endoscopic accessory designed to provide an additional channel external to the endoscope for inserting, advancing, and removing endoscopic devices thereby preserving the working channel of the endoscope for other instruments.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EndoFLIP® ECD EF-800, structured as requested.

The provided document is a 510(k) Summary, which is typically a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. In many cases, for devices of this type (an accessory to an endoscope), the "acceptance criteria" are demonstrating equivalence in technical characteristics and performance to predicate devices, rather than establishing new clinical thresholds. The "study" often refers to non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the K110531 submission, the "acceptance criteria" are implied by the comparison to predicate devices, focusing on demonstrating similar functional, material, and safety characteristics. The performance reported is primarily through compatibility and age testing to ensure the device performs as expected for its intended use.

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

For the "Performance Testing" mentioned (Age testing and Compatibility testing), the document does not specify:

• The exact sample size used for these tests.
• The origin of data (e.g., country of origin).
• Whether the data was retrospective or prospective.

These tests are typically bench or lab-based rather than clinical studies with human participants.

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

This type of information (number and qualifications of experts for ground truth) is typically relevant for studies involving subjective assessment (e.g., image interpretation). For a device like an endoscopic accessory undergoing performance testing (age testing, compatibility testing), the "ground truth" would be established by objective measurements and standardized test protocols, not by expert consensus on, for example, image interpretation. Therefore, this information is not applicable in the context of the provided regulatory submission.

4. Adjudication Method for the Test Set

As the performance testing described is objective (age testing, compatibility with endoscopes), there is no mention of an adjudication method (like 2+1 or 3+1). Such methods are typically used when subjective expert assessments need to be reconciled, which is not the case here.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are typically clinical trials designed to compare the diagnostic performance of different methods (e.g., AI vs. human readers, or human readers with vs. without AI assistance) across multiple readers and cases. This submission focuses on demonstrating substantial equivalence of a physical medical device accessory through comparison of technical specifications and non-clinical performance tests.

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

No, this is not applicable. The EndoFLIP® ECD EF-800 is a physical medical device accessory (an external channel for an endoscope), not a diagnostic algorithm or an AI-powered system. Therefore, the concept of "standalone algorithm performance" (without human-in-the-loop) does not apply.

7. The Type of Ground Truth Used

For the performance tests mentioned:

• Age testing: The "ground truth" would be the stability and integrity of the device materials and function over a specified period, verified by empirical observation/measurement (e.g., material degradation, functional checks after accelerated aging) against predefined engineering specifications.
• Compatibility testing: The "ground truth" would be the successful and unimpeded sliding of the device over various endoscope diameters, verified by direct observation/measurement (e.g., successful navigation, absence of damage to either device) against specified dimensional and functional tolerances.

This is based on engineering specifications and objective physical measurements, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical accessory, not an AI or machine learning model that requires a "training set."

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

Not applicable. As stated above, this device does not utilize a training set in the context of machine learning.

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The NaviAid™ ICVI device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope in the small intestine (i.e., an endoscope that has an instrument channel that is at least 3.7mm and is used for standard intestinal endoscopic visualization).

The NaviAid™ ICVI is an on-demand disposable that is inserted through the instrument channel of the endoscope in order to enable advancement and positioning of a standard endoscope in the small intestine. The NaviAid™ ICVI system comprises a disposable balloon system and an Air Supply Unit ("ASU") or a Single Balloon - Air Supply Unit ("SB ASU") for inflating and deflating the balloon system. The ICVI disposable includes the ICVI Balloon and the ICVI inflation tube. The balloon is inflated by ambient air. The ASU or SB ASU operate and control the inflation and deflation of the balloon through a foot-pedal. The balloon is connected to a dedicated inflation tube that runs inside the instrument channel of the endoscope, and is connected at its proximal (user) end to the ASU or SB ASU. The ICVI balloon can be advanced ahead of the endoscope tip or pulled back through pushing/pulling action on the ICVI inflation tube at its proximal side, outside the patient's body. When the ICVI balloon is advanced and then inflated, it functions as a distal anchor, to which the endoscope tip is advanced, and the ICVI inflation tube serves as a rail that leads the endoscope as it is pushed towards the anchoring ICVI balloon. The balloon and tube negligibly compromise the endoscope's flexibility, or its field of view. Additionally, the ICVI disposable negligibly compromise the maneuverability of the endoscope's tip and does not limit the usage of any standard endoscopy tools, such as biopsy forceps, snare, needle etc. though not simultaneously while the device is applied. The NaviAid™ ICVI disposable is intended for single use, while the ASU and SB ASU are re-usable.

The provided document is a 510(k) summary for the NaviAid™ ICVI device, focusing on a modification involving a new "Single Balloon - Air Supply Unit" (SB ASU). The document outlines non-clinical performance data but explicitly states "Clinical Performance Data: Not Applicable." Therefore, information regarding acceptance criteria met by a clinical study is not available in this text.

However, based on the provided text, here's a breakdown of the available information regarding non-clinical testing and ground truth:

1. A table of acceptance criteria and the reported device performance:

The document describes several non-clinical tests performed on the modified NaviAid™ ICVI Device with the new SB ASU component. It states that these tests "demonstrated that the modified NaviAid™ ICVI device with the new SB ASU component meets its design and performance specifications." However, specific numerical acceptance criteria and reported performance values are not detailed in this summary. Instead, it lists the types of tests conducted:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Test set sample size: Not specified. The document only mentions "performance tests were conducted."
• Data provenance: Not specified, but given the applicant's address (Israel), it's likely the non-clinical testing was conducted there. The testing is non-clinical, so the terms "retrospective" or "prospective" are not applicable in this context.

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):

• Not applicable as no human experts were involved in establishing ground truth for the non-clinical performance and safety tests. The ground truth for these tests would be defined by engineering specifications and recognized international standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable as no human experts or adjudication were involved in these non-clinical 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 MRMC or comparative effectiveness study was done as this is a non-clinical submission for a device modification, and the product is a mechanical accessory, not an AI-driven diagnostic or assistive tool for human readers.
• The document explicitly states: "Clinical Performance Data: Not Applicable".

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

• Not applicable. This device is a mechanical accessory, not an algorithm. The "software validation" refers to the control software for the SB ASU, but its performance is validated against engineering specifications, not as a standalone diagnostic tool.

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

• For the non-clinical performance tests (SB ASU Performance Test), the ground truth would be the design and performance specifications set by the manufacturer (Smart Medical Systems Ltd.).
• For the Electrical & Mechanical Safety Testing, Electromagnetic Compatibility Testing, and Software Validation, the ground truth is defined by recognized international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4) and FDA Guidelines.

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not an AI/ML algorithm that requires a "training set."

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

• Not applicable. (See point 8)

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