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The Trocar, Model: Auto-Locking Trocar, Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
The Trocar Models: Auto-Locking Trocar, Bladeless Trocar and Visible Trocar, has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.

The Auto-Locking Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Auto-Locking Trocar is available in three kinds of diameter sizes: 5mm, 10mm and 12mm. The cannula assembly has a universal seal, a valve, and a stopcock. This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered. Auto-Locking Trocar 10 mm can accept 4 mm to 11 mm sized instruments with its built-in universal seal without the use of a converter. Auto-Locking Trocar 12 mm can accept 4 mm to 13 mm sized instruments with its built-in universal seal without the use of a converter.

The Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Bladeless Trocar is available from 5-12mm: The cannula assembly (10mm to 12mm type) has a universal seal, a valve, and a stopcock. The cannula assembly (5mm type) has a stopcock.

The Visible Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. This device has a blunt tip,, which is designed for open Laparoscopy. The visible trocar is available in three sizes: 5mm, 10mm and 12mm. This device allows direct visualization of the abdominal wall layers when the trocar is traversed, which offers a safe and rapid option of primary trocar. The cannula assembly has a universal seal, a valve and a stopcock.

The provided document is a 510(k) summary for a medical device (Trocar), not a study proving an AI device meets acceptance criteria. It focuses on demonstrating substantial equivalence to predicate devices based on design, intended use, and non-clinical performance testing. Therefore, it does not contain the information requested about acceptance criteria, test sets, expert involvement, and statistical analyses typical for AI/ML device validation studies.

Specifically, the document does not provide information on:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample sizes for a test set (it mentions in-house non-clinical tests, but not a large-scale clinical test set for AI).
3. Data provenance for a test set.
4. Number of experts or their qualifications for establishing ground truth for a test set.
5. Adjudication method for a test set.
6. Multi-reader multi-case (MRMC) comparative effectiveness study, nor the effect size of human readers improving with AI assistance.
7. Standalone performance of an algorithm (as it's a physical device).
8. Type of ground truth used (e.g., pathology, outcomes data).
9. Sample size for a training set (not an AI/ML device).
10. How ground truth for a training set was established.

Instead, the document states:

Acceptance Criteria & Device Performance (for the physical Trocar device):

• Acceptance Criteria (Implied): The device is expected to meet various performance requirements related to its function, biocompatibility, and sterilization. Specifically, the document mentions:

  • Biocompatibility as per ISO 10993 standards (e.g., Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Material-Mediated Pyrogenicity).
  • Sterilization validation per ISO 11135:2014.
  • Specific performance aspects: Obturator Compatibility, Insertion & Cannula Stability, Air Leakage, Trocar Insertion/Removal force.

• Reported Device Performance: The document states, "All the test results demonstrate Trocar meet the requirements of its pre-defined acceptance criteria and intended uses." However, it does not provide specific numerical or qualitative results for each criterion; rather, it makes a general statement of compliance.

Study Proving Device Meets Acceptance Criteria:

• Type of Study: Non-clinical testing (bench testing, biocompatibility testing, sterilization validation). This is conducted by the manufacturer, WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.
• Sample Size Used for Test Set: Not specified. The document only mentions that "a series of tests were performed" and "The performance testing conducted on subject device is listed below." No quantitative sample sizes for these tests are provided.
• Data Provenance: Implied to be in-house testing conducted by the manufacturer in China, as per their address. It's non-clinical, so "retrospective or prospective" is not directly applicable in the same way it would be for patient data.
• Number of Experts/Qualifications & Adjudication Methods: Not applicable, as this is a physical medical device undergoing bench and biocompatibility testing, not an AI/ML assessment involving human interpretation of data.
• MRMC Comparative Effectiveness Study/Standalone Performance: Not applicable for a physical surgical instrument.
• Type of Ground Truth: The ground truth for this device's performance is objective measurements against established engineering specifications, biocompatibility standards (e.g., ISO 10993), and sterilization standards (e.g., ISO 11135).
• Training Set/Ground Truth for Training Set: Not applicable, as this is not an AI/ML device.

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The U-IGNITE Bladeless Trocar has applications in endoscopic procedures to provide a port of entry for endoscopic instruments.

It is a rigid hand-held surgical instrument with a rounded conical point used to manually puncture a bodily entry point to assist in the location and positioning of gently part the surrounding soft tissue. The trocar assembly punctures the muscle and tissue layers in the body. The trocar assembly's obturator is removed leaving the cannula to provide a port through which laparoscopes and other laparoscopic instruments can be introduced. The cannula sealing system shall be able to maintain pneumoperitoneum.

The U-IGNITE Bladeless Trocar is a sterile single patient use instrument consisting of a radiolucent sleeve and obturator in various sizes diameter. The obturator contains a clear, taped optical element. The obturator accommodate an appropriate sized 0 degree endoscope and provide visibility of individual tissue layers during insertion. Basic type do not have the optical element for its obturator.

In addition, the U-IGNITE Bladeless Trocar with Endo-assistant part is a design enhancement that reduces the incidence of trocar-induced endoscope lens smudging during endoscope insertion. Endoscope smudging occurs when bodily fluids and debris smear across the endoscope lens during a laparoscopic procedure. Trocarinduced smudging occurs when these bodily fluids and debris are deposited within the trocar's seal system when an endoscope or instrument has been exchanged through the trocar.

The trocar sleeves for the 12 mm devices contain two seals, an outer integrated removable self-adjusting seal that accommodates instruments ranging from 5mm to 12 mm in diameter where indicated and an internal seal. Together, these two seals minimize gas leakage when instruments are inserted or withdraw through the trocar. The 5 mm trocar sleeve does not contain an integrated removable outer seal and accommodates only 5 mm instruments.

A stopcock valve is compatible with standard luer lock fitting and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.

This is an irradiation sterilized single use disposable device to avoid cross infection.

The provided text describes the U-IGNITE Bladeless Trocar and its substantial equivalence to predicate devices, but it does not contain a table of acceptance criteria and reported device performance for a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study, nor does it provide sample sizes, ground truth details for such studies.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics for an AI/algorithm-based device.

Here's a breakdown of what is available in the text regarding acceptance criteria and studies for the U-IGNITE Bladeless Trocar, specifically focusing on its non-clinical performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states: "All the test results demonstrate U-IGNITE Bladeless trocar meet the requirements of its predefined acceptance criteria and intended uses." However, it does not provide a specific table detailing these acceptance criteria alongside the quantitative reported device performance for each test. The "Performance Testing Item" section lists the types of tests conducted:

2. Sample Sizes and Data Provenance (for test set of performance tests):

The document mentions "animal simulation test" for "Trocar System Puncture Performance" and "Trocar sleeve retention force". However, it does not specify the sample sizes (number of animals or test replicates) used for these or any other performance tests.
The data provenance is not explicitly stated beyond "animal simulation test", but given it's a premarket submission from Tianjin UWell Medical Device Manufacturing Co. Ltd. (China), the tests were likely conducted internally or by a contracted lab. It is a retrospective summary of non-clinical bench testing.

3. Number of Experts and Qualifications:

Not applicable to the non-clinical performance tests mentioned. These are bench tests, not expert-read image analysis.

4. Adjudication Method:

Not applicable.

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

No MRMC comparative effectiveness study is mentioned for human readers improving with AI vs. without AI assistance. This device is a surgical instrument, not an AI-enabled diagnostic tool.

6. Standalone (Algorithm Only) Performance:

No standalone algorithm performance study was done, as this is a physical medical device (trocar), not a software algorithm.

7. Type of Ground Truth Used (for performance tests):

For the performance tests, the "ground truth" would be established by the physical and engineering properties being measured against predefined specifications or industry standards. For example:

• Obturator & Cannula Compatibility: Physical fit and function.
• Air Leakage: Measurement against specified leakage rates.
• Puncture Performance/Retention Force: Measurement against biomechanical force thresholds.
• Endoscope Visualization: Likely subjective assessment or objective measurement of clarity/obstruction.

The document does not detail the exact methodology for establishing these ground truths, but they would derive from engineering specifications and testing protocols.

8. Sample Size for Training Set:

Not applicable, as this is not an AI/ML device.

9. How Ground Truth for Training Set Was Established:

Not applicable.

Summary of what the document focuses on:

The entire document (510(k) summary) serves as a study to demonstrate substantial equivalence to existing legally marketed predicate devices, particularly the ENDOPATH XCEL Bladeless Trocar with OPTI VIEW Technology (Ethicon Endo-Surgery, LLC) and the Unimicro Trocar Kit (Unimicro Medical Systems). This is achieved through:

• Comparison of Indications for Use, design, materials, dimensions, and classification.
• Demonstration of compliance with biocompatibility standards (ISO 10993 series).
• Conducting a series of non-clinical performance tests on the subject device and the predicate device to show comparable performance. These tests include Obturator & Cannula Compatibility, Insertion & Cannula Stability, Air Leakage, Puncture Performance, Trocar sleeve retention force, Endoscope Visualization Image Quality, and Endo-Assistant Part Liquid Absorbing Performance.

The "acceptance criteria" referred to are the predefined internal specifications and expected performance benchmarks for these non-clinical tests, which the device "met." The "study" proving this involves the execution of these listed performance tests and the declaration that the results "demonstrate U-IGNITE Bladeless trocar meet the requirements of its predefined acceptance criteria and intended uses."

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