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Instalief is a single use device for the treatment of hemorrhoids by applying it directly to the swollen hemorrhoidal tissues. By applying cold to the tissue, the inflammation is reduced. The device can be used for the treatment of external hemorrhoids and internal hemorrhoids. The device is for adults only.

Instalief™ is a device designed for the treatment of internal and external hemorrhoids by the application of cold directly to the swollen hemorrhoidal tissue. The device consists of an outer bag which houses an endothermic salt, a smaller water-containing frangible bag, an insertion tip with an attached compliant balloon, as well as a separate component that aids in the usage of the device, known as the squeezer. To use the device, the user first bursts the frangible bag by pressing on it, initiating an endothermic process between the water and endothermic salt. The user then inserts the shaft of the device into the anal canal (for internal hemorrhoids) or applies to the outer tissues (for external hemorrhoids), and squeezes the bag with the aid of the squeezer. This action transfers the cold fluid generated into the balloon, which provides targeted cold therapy to the hemorrhoids. Instalief™ is meant to be used for 6 - 8 minutes.

This document describes information about the Instalife Hemorrhoidal Cooling Device, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each non-clinical test (e.g., number of devices tested for balloon burst or cold duration). The data provenance is derived from these non-clinical tests performed by the manufacturer, Privi Medical Pte Ltd. It is a retrospective evaluation of the device's performance against established test protocols. The country of origin for the data (where the tests were conducted) is not specified, but the company is located in Singapore.

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

Not applicable. The "ground truth" for the non-clinical tests was established by objective performance metrics derived from laboratory testing, not expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. As the tests were non-clinical performance and safety evaluations, there was no adjudication method involving human interpretation. The results were objectively determined based on test protocol criteria.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing is not applicable for establishing substantial equivalence of Instalief™."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This question is not applicable as the device is a physical medical device (a hemorrhoid cooling device), not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used

The ground truth used for demonstrating substantial equivalence was primarily based on:

• Performance Documentation (Test Protocols): Objective criteria for structural integrity, functional performance (like cold duration), and biocompatibility detailed in specific test protocols (e.g., VV0001P, VV0002P).
• Comparison to Predicate Device: Direct comparison of physical characteristics and functional performance against the predicate device (Anuice) also served as a "ground truth" for showing similar safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. The Instalief™ device is a physical medical device, 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 there is no training set, there is no ground truth establishment 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/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 Transvaginal Access Platform is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments while maintaining pneumoperitoneum during laparoscopic hysterectomy. The instrument is indicated for use in laparoscopic assisted vaginal hysterectomies. The instrument is also a conduit for the extraction of specimens.

The GelPOINT Transvaginal Access Platform is a sterile, single use instrument that allows access to the vagina to perform laparoscopic assisted hysterectomy. The device consists of a cannula with suture ties, and a cap made of a flexible gel-like material. The gel cap has two stopcocks that can be used for insufflation or smoke evacuation. Four trocars are included and may be placed through the gel cap. The trocars allow insertion of standard laparoscopic instruments into the vagina. Construction materials include various polymers, silicone and stainless steel.

Packaging consists of a PTEG tray that is placed in a Tyvek/Mylar pouch and shipped in a carton. Sterilization is via Gamma irradiation; sterility assurance level is 10°.

This document describes the GelPOINT Transvaginal Access Platform, Models: C2A00, C2A01, C2A02, and its substantial equivalence to a predicate device. However, the provided text does not contain the specific acceptance criteria, detailed study results, or information about the study design typically requested for a detailed AI device evaluation.

The document focuses on the regulatory submission (510(k)) for a medical device that facilitates laparoscopic hysterectomies and specimen extraction. The performance data presented is for biocompatibility and mechanical testing of the physical device, not for an AI algorithm.

Therefore, I cannot populate the requested table and sections with information about AI acceptance criteria, device performance, sample sizes, expert involvement, or ground truth for an AI algorithm, as this information is not present in the provided text.

Here's what can be extracted and what is missing, based on your request and the provided text:

Information based on the provided text (for a physical medical device, not an AI):

Study that Proves the Device Meets Acceptance Criteria (as described in the text):

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

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