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The GelPOINT® Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.

GelPOINT Path is inserted into the anal canal to establish access to the rectum and lower sigmoid colon in preparation for transanal endoscopic surgery. The access channel lumen may be closed off with an airtight cap. The cap allows for insufflation of the surgical site. The cap is constructed of a gel material through which multiple sleeves may be placed. These sleeves establish ports that allow passage of a laparoscope and laparoscopic instruments without loss of insufflation. GelPOINT Path was previously cleared in access channel lengths ranging from 4.5cm to 15cm. The proposed clearance for the access channel length is 3.5cm to 15cm.

This document is a 510(k) summary for the GelPOINT® Path Transanal Access Platform, a medical device. It's a regulatory submission to the FDA, not a study report that details acceptance criteria and performance data in the typical sense of a clinical trial.

Therefore, many of the requested categories simply do not apply to this type of document because it describes a line extension of an already cleared device, not a new device requiring extensive de novo performance testing. The main argument for substantial equivalence is based on the lack of impact of the new feature (shorter access channel length) on already established safety and effectiveness.

Here's an attempt to answer the questions based on the provided text, with clear indications where information is not available or not applicable:

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

This document does not provide a table of acceptance criteria or reported device performance in terms of specific metrics like sensitivity, specificity, or accuracy. This is because the submission is for a line extension of an already cleared device (K110792 and K133393). The argument is that the proposed change (shorter access channel length) does not impact the performance specifications already established for the predicate devices.

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

Not applicable. This submission is for a line extension of a device. It refers to performance testing done for the predicate devices (K110792 and K133393) but does not provide details on their sample sizes or data provenance. No new testing of this nature was conducted or reported for this specific submission (K171701).

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. This type of information is not relevant to a 510(k) submission for a line extension of an existing mechanical device. There is no "ground truth" to establish through expert review in the context of diagnostic accuracy for this device.

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

Not applicable. There was no test set requiring adjudication in the context of this 510(k) submission.

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 device is a transanal access platform, not an AI-powered diagnostic tool. MRMC studies are not relevant.

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

Not applicable. This device is a transanal access platform, not an AI algorithm.

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

Not applicable. There is no concept of "ground truth" in the context of diagnostic accuracy for this mechanical device's 510(k) submission. Safety and effectiveness would be established through performance testing related to its mechanical function, biocompatibility, sterility, etc. (as mentioned for the predicate devices), not through comparison to a diagnostic ground truth.

8. The sample size for the training set

Not applicable. This device is a transanal access platform; there is no "training set" in the context of machine learning or AI.

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

Not applicable. As there is no training set for this mechanical device, there is no ground truth to establish for it.

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The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and therapeutic procedures by using additional accessories.

The subject device is inserted into the rectum to establish an access port into the lower sigmoid colon in preparation for transanal endoscopic microsurgery. The port lumen measures 40mm in diameter and may be capped off with an airtight lid. The lid allows the colon to be insufflated, thus enlarging the operative space. The airtight lid is constructed of a gel material through which multiple trocars may be placed. These trocars establish multiple ports that allow passage of laparoscopes and laparoscopic instruments without loss of insufflation. The design has all the functionality of a simple, two-piece proctoscope but with significant additional versatility, capability and effectiveness.

The provided text is a 510(k) summary for the GelPOINT Path Transanal Access Platform, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data to prove novel performance criteria. Therefore, many of the requested details about acceptance criteria and study design are not explicitly available in this document as would be for a de novo device or a more complex medical AI/ML product.

However, I can extract information related to the demonstration of "substantial equivalence," which is the core of this submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document describes the device's technological characteristics and its comparison to a predicate device for the purpose of demonstrating "substantial equivalence." It does not define specific quantifiable acceptance criteria in the way one might for a diagnostic test (e.g., sensitivity, specificity thresholds) or for a new therapeutic intervention. Instead, the "acceptance criteria" are implied by the regulatory standard of substantial equivalence, meaning the device performs similarly to or better than a legally marketed predicate device without raising new questions of safety or effectiveness.

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

The document explicitly states: "There are no recognized standard tests that can challenge and compare these technological differences. Therefore, substantial equivalence was established based on a dimensional analysis of each device."

This indicates that a "test set" in the traditional sense of patient data or clinical samples was not used for this submission. The evaluation was based on a dimensional analysis and comparison of technological characteristics between the new device and the predicate device.

• Sample Size: Not applicable as no clinical test set was used for this specific comparison to demonstrate substantial equivalence.
• Data Provenance: Not applicable.

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

As no clinical test set was used, there were no experts used to establish ground truth for a test set. The comparison was based on engineering and design specifications.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

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

No, an MRMC comparative effectiveness study was not done. The submission is focused on demonstrating substantial equivalence based on design and function, not on comparative clinical effectiveness with human readers.

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

Not Applicable. This device is a physical surgical access platform, not an algorithm or AI/ML device. Therefore, the concept of "standalone performance" for an algorithm doesn't apply.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the predicate device (Sapimed S.P.A. Disposable Sigmoidoscope/proctoscope; K070915 and Applied Medical Resources GelPOINT Path Transanal Access Platform; K110792), combined with engineering and design specifications for both devices. The "dimensional analysis" served as the primary method to compare the new device to this established baseline.

8. The Sample Size for the Training Set

Not applicable, as this is a physical medical device and not an AI/ML system requiring a training set.

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

Not applicable, as this is a physical medical device and not an AI/ML system requiring a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Substantial Equivalence):

The "study" in this 510(k) submission is a non-clinical comparison based on technological characteristics and dimensional analysis between the new GelPOINT Path Transanal Access Platform and its predicates (especially the Sapimed proctoscope and the previously cleared GelPOINT Path K110792).

The key points of this "study" are:

• Objective: To demonstrate that the GelPOINT Path Transanal Access Platform is "substantially equivalent" to legally marketed predicate devices.
• Methodology:
  • Identification of Predicate Devices: K070915 (Sapimed S.P.A. Disposable Sigmoidoscope/proctoscope) and K110792 (Applied Medical Resources GelPOINT Path Transanal Access Platform). The submission states the current device's design is unchanged from K110792.
  • Comparison of Intended Use: The intended use of the current device is unchanged from K110792, and it is compared to the Sapimed proctoscope.
  • Comparison of Technological Characteristics: A detailed comparison was made on features like:
    • Dilation of the anus
    • Insertion method (dilator)
    • Ability to allow instrument insertion (including endoscopes)
    • Materials (polymers)
    • Disposability
    • Insufflation capability
  • Identification of Differences and Their Impact: The differences (e.g., larger cannula, CO2 pump insufflation, suturing capability, more access ports) were analyzed. The conclusion was that these differences provided "superior technological capabilities" and "increased effectiveness" (e.g., larger operative field via better insufflation) without raising new questions of safety or effectiveness, essentially making the device a more versatile and capable proctoscope.
  • Lack of Clinical Testing: The document explicitly states, "There are no recognized standard tests that can challenge and compare these technological differences. Therefore, substantial equivalence was established based on a dimensional analysis of each device." This means no new clinical trials or patient data studies were conducted as part of this specific submission to demonstrate performance against acceptance criteria.
• Conclusion: The subject device is substantially equivalent in performance to the Sapimed proctoscope but has numerous technological advantages that increase effectiveness. Therefore, the indications for use could be updated by incorporating the indications of the Sapimed device.

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