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The GeniCon Laparoscope is available in 3.5mm, 5mm and 10mm diameters with working lengths of 28cm to 44cm. This device has applications in gynecologic, general, thoracic and urology Endoscopic procedures to establish visualization for viewing an interior cavity of the body.

The GeniCon Platinum Series Laparoscope is a reusable device with a glass rod lens assembly that connects an eyepiece to a viewing lens on the distal end of the scope encompassed within a stainless steel shaft. Surrounding the glass rod assembly and contained with the stainless steel shaft is a series of light fibers that transfer light energy to illumination into the body cavity being viewed.

The provided text is a 510(k) Summary for the GeniCon Platinum Series Laparoscope. This document focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria and specific performance metrics for the GeniCon device itself.

Therefore, the document does not contain the information requested in the prompt, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, training sets, or data provenance.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• How ground truth was established for training sets.

The relevant sections of the document explicitly state:

• "Performance: The FDA has not adopted performance standards for this product." (Page 0)
• "Conclusion: Based on the indications for use and technological characteristics, the GeniCon Platinum Series Laparoscope has been shown to be effective for its intended use and substantially equivalent to the predicate device." (Page 0)

This indicates that the submission relies on substantiating similarity to an already approved device rather than providing new performance data against a set of acceptance criteria.

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The GeniCon Clip Applier and implantable clips are intended for use during laparoscopic procedures for the purpose of approximating soft tissue, closing off vessels and other structures in order to stop bleeding or to connect internal tissues to aid in healing.

The Genicon Clip Applier is a disposable device with a plastic handle and a working shaft that is approximately 32cm in length. Within the shaft are 20 titanium clips. The handle of the instrument is depressed and a titanium clip, which resides in the distal iaw of the instrument. is pressed together around whatever structure is within the jaw of the instrument.

The GeniCon Clip Applier is a disposable device used in laparoscopic procedures for approximating soft tissue, closing off vessels and other structures to stop bleeding, or connecting internal tissues to aid in healing.

Here's an analysis of its acceptance criteria and the study that proves its performance:

1. Acceptance Criteria and Reported Device Performance

Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific performance metrics against pre-defined acceptance criteria. The "Performance" section lists general categories of testing but does not provide quantitative results or explicit acceptance thresholds. The conclusion states that the device is "effective for its intended use" based on these tests and design characteristics.

2. Sample Size and Data Provenance

The document does not describe a clinical study with a "test set" in the conventional sense of human or animal subjects for evaluating clinical effectiveness. The performance tests mentioned ("Stress/Exposure Testing" and "Cleaning/Disinfection/Sterilization Testing") appear to be laboratory-based validation tests performed on the device itself. Therefore, information regarding sample size used for a test set, countries of origin of data, or retrospective/prospective nature is not applicable in this context.

3. Number of Experts and Qualifications for Ground Truth

For the performance tests described (Stress/Exposure, Cleaning/Disinfection/Sterilization), the concept of "ground truth" derived from expert consensus on medical images or pathology is not applicable. These are engineering and sterilization validation tests. The results would likely be evaluated against pre-defined engineering specifications or industry standards by qualified technical personnel rather than medical experts establishing a diagnostic ground truth.

4. Adjudication Method

As there is no described clinical study involving human assessment of outcomes or imaging, an adjudication method like 2+1 or 3+1 is not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was mentioned. The 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device through technological characteristics and performance testing, rather than a direct comparison of human reader performance with and without AI assistance. Therefore, information on effect size of human reader improvement with AI assistance is not applicable.

6. Standalone Performance Study

The document describes "performance tests" on the GeniCon Clip Applier itself. These tests (Stress/Exposure, Cleaning/Disinfection/Sterilization) are essentially evaluations of the standalone device's physical and functional properties. However, these are not clinical standalone performance studies in terms of diagnostic accuracy or a specific clinical endpoint typically seen with AI-powered devices. The clinical effectiveness is inferred through substantial equivalence to a predicate device.

7. Type of Ground Truth Used

For the described performance tests (Stress/Exposure, Cleaning/Disinfection/Sterilization), the ground truth would be based on:

• Engineering specifications: For stress/exposure testing, ensuring the device meets predefined strength, durability, and material integrity criteria.
• Regulatory standards: For cleaning/disinfection/sterilization, ensuring the device meets established standards for sterility and biocompatibility.

There is no mention of ground truth derived from expert consensus (beyond the designers/engineers establishing specifications), pathology, or outcomes data for these specific tests.

8. Sample Size for the Training Set

Since the GeniCon Clip Applier is a medical device (surgical clip applier) and not an AI/machine learning algorithm, the concept of a "training set" for an algorithm is not applicable.

9. How Ground Truth for the Training Set Was Established

As there is no AI/machine learning component or a "training set" in the context of this device, this question is not applicable.

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The GeniCon Pnutemo - Needle is intended for percutaneous insertion into the peritoneal cavity for the purspose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

The GeniCon, Pneumo-Needle is a sterile, disposable Veress needle which is available in 120mm length. The device is equipped with a spring-loaded, round-tipped obturator. In addition, there is a "slide switch" which permits easy ON-OFF control of the gas flow. The most proximal end contains a malue luer lock connector for secure CO2 gas line connection.

The provided text describes a 510(k) premarket notification for the GeniCon Pneumo-Needle. This device is a sterile, disposable Veress needle intended for insufflation with carbon dioxide to establish pneumoperitoneum during laparoscopic procedures. The documentation focuses on demonstrating substantial equivalence to a predicate device and outlines performance tests conducted, but it does not include a study or detailed acceptance criteria for an AI/CADe device.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/CADe device, a study proving it meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details as this information is not present in the provided text.

The "Performance" section explicitly states:

Performance:
A series performance tests were performed on the GeniCon Pneumo-Needle to inspect such areas as:

• Tip Pull Test
• Switch Operation
• Spring Obturator Operation
• Needle Puncture Force Test

These are mechanical performance tests for a physical medical device, not a study evaluating algorithm performance or clinical effectiveness in the context of AI/CADe.

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The intended use of this device is for laparoscopic surgery by general, thoracic, gynecologic and urological surgeons.
The GeniCon trocar is available in 2.5, 5, 7/8, 10 and 12mm diameter with a mono-slit stainless tip. This trocar has application in gynecologic, general, thoracic and urology endoscopic procedures to establish a port of entry for instrumentation.

This device incorporates several design features which facilitate the surgeons use both during insertion and while instrumentation is being inserted and manipulated.
Trocar Tip:

• A modified single slit tip to provide easier insertion for the surgeon by enabling the tip to . minimally incise the tissue while providing a lower profile transition from the stainless tip to the cannula.
  Trocar Handle:
• Enlarged to provide a more positive fit in the surgeon's palm during insertion, and provides a . groove to provide a more positive fit for the thumb during removal or re-insertion.
  Cannula:
• Trapezoidal fascia threads, they provide an easier insertion while a positive anchoring during . instrument use.
• CO2 port with male luer cap provides a "finger grip" during device insertion while the male luer . cap is easier to remove and replace than the Apple silicone cap.
• . Double wall valve lock, assists in maintaining the valve position and to alleviate the premature release sometimes experienced by the Apple product.

The provided text describes a medical device submission (510(k)) for a trocar/cannula system, not an AI or software device. Therefore, many of the requested criteria such as sample size for test/training sets, expert qualifications, and MRMC studies are not applicable.

However, I can extract the information that is relevant to the device validation as described.

Device: GeniCon Trocar/Cannula System
Predicate Devices: LifeQuest Point Gard and Dexide trocars

Acceptance Criteria and Reported Device Performance

Study Details (Applicable to a Mechanical Device)

1. Sample size used for the test set and the data provenance: Not explicitly stated as a numerical sample size. The text mentions "Engineering testing" that incorporated "a simulated human abdominal cavity" and observed "the method of insertion of the device and use with various common laparoscopic instruments." No information on data provenance (country of origin, retrospective/prospective).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The testing was engineering-based, not involving human expert assessment for "ground truth" in the diagnostic sense.
3. Adjudication method: Not applicable. The testing was engineering-based performance comparison.
4. 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 surgical device, not an AI or diagnostic imaging device with human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical surgical device.
6. The type of ground truth used: Performance comparison against predicate devices in a simulated environment using engineering metrics (e.g., pressure, ease of use/insertion observations).
7. The sample size for the training set: Not applicable. This is a mechanical device, so there is no "training set" in the context of AI/machine learning.
8. How the ground truth for the training set was established: Not applicable.

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The GeniCon trocar is available in 5, 7/8, 10 and 12mm diameter with either a pyramidal or conical tip. This trocar has application in gynecologic, general, thoracic and urology endoscopic procedures to establish a port of entry for instrumentation.

This device incorporates several design features which facilitate the surgeons use both during insertion and while instrumentation is being inserted and manipulated.
Trocar Tip:

• A modified pyramidal tip to provide easier insertion for the surgeon by enabling the tip to . minimally incise the tissue while providing a lower profile transition from the stainless tip to the cannula.
  Trocar Handle:
• Enlarged to provide a more positive fit in the surgeon's palm during insertion, and provides a . groove to provide a more positive fit for the thumb during removal or re-insertion.
  Cannula:
• Clear casing for visualization of instrument and tissue passage. .
• Reverse trapezoidal fascia threads, they provide an easier insertion while a positive anchoring . during instrument use.
• . Extended CO2 port with male luer cap provides a "finger grip" during device insertion while the male luer cap is easier to remove and replace than the Apple silicone cap.
• . Double wall valve lock, assists in maintaining the valve position and to alleviate the premature release sometimes experienced by the Apple product.
  Valve:
• . A tapered membrane assembly provides a more positive seal around the instrument, while the silicon membrane was designed to reduce friction during instrument use.
• . A pull-tab was added to facilitate removal of the valve during specimen retrieval.

The provided text is a 510(k) summary for the GeniCon Trocar/Cannula System, which describes the device, its intended use, and a comparison to predicate devices. However, it does not contain the detailed information needed to answer the questions about acceptance criteria and a study proving those criteria are met.

Here's a breakdown of why this information is missing from the provided document:

• Acceptance Criteria Table: The document states that "Engineering testing has demonstrated that the valve assembly performs better than that of the Apple and Core trocar valve assembly," and that it "performed equal to if not superior in pressure testing, ease of use and insertion." However, specific numerical acceptance criteria (e.g., "pressure testing must maintain X pressure for Y duration") and the corresponding reported device performance values are not provided.
• Sample Size and Data Provenance (Test Set): The document mentions "Engineering testing," but does not specify the sample size of devices tested or the data provenance (e.g., where the testing was conducted, if retrospective or prospective data was used, etc.).
• Number and Qualifications of Experts (Ground Truth): This type of device (trocar/cannula) is used for surgical access. Its performance is assessed through engineering tests and usability, rather than through interpretation of complex data by experts to establish a "ground truth" in the way, for example, a diagnostic AI would. Therefore, the concept of a "ground truth" established by experts in the context of radiology or pathology, and their number/qualifications, does not apply here.
• Adjudication Method: Since there isn't a "ground truth" established by multiple experts in a diagnostic context, there's no adjudication method described.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study is relevant for diagnostic devices where human readers interpret medical images or data. It is not applicable to a surgical instrument like a trocar/cannula system. Therefore, no information on an MRMC study or effect size is present.
• Standalone (Algorithm Only) Performance: A trocar/cannula system is a physical surgical instrument, not a software algorithm. Therefore, "standalone performance" in the context of an algorithm does not apply.
• Type of Ground Truth Used: As explained above, the "ground truth" for a surgical instrument's performance is typically established through objective engineering tests (e.g., pressure, friction, insertion force) and usability assessments rather than expert consensus on diagnostic interpretations or pathology.
• Sample Size for Training Set: Since this is a physical device and not an AI/ML algorithm, there is no "training set."
• How Ground Truth for Training Set was Established: Not applicable due to the nature of the device.

In summary, the provided document describes a traditional medical device (surgical instrument) and its performance relative to predicate devices through engineering tests and mentions of ease of use. It does not present information as would be expected for a diagnostic AI/ML device.

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