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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 Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

The Veress Needle is a sterile and single-use product. It incorporated a spring loaded blunt stylet mechanism similar to the needle. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Veress Needle, available in 120 mm and 150 mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.

This document is a 510(k) summary for the WickiMed Veress Needle and provides information on its substantial equivalence to a predicate device. It does not describe an AI/ML powered device, therefore no information about acceptance criteria and studies proving the device meets these criteria as would be relevant for an AI/ML system is available.

The document discusses the following types of non-clinical testing for the Veress Needle:

• Biocompatibility tests: Conducted in accordance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-11:2006, and ISO 10993-12:2012. These included Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, and Material-Mediated Pyrogenicity.
• Sterilization validation: Performed per ISO 11135:2014.
• Performance tests:
  • Tip Pull Test
  • Switch Operation
  • Spring Obturator Operation
  • Needle Puncture Force Test

The document states that "All the test results demonstrate the performance of Veress Needle meets the requirements of its pre-defined acceptance criteria and intended uses." However, it does not provide the specific numerical acceptance criteria for these tests, nor the reported device performance values. It also does not discuss any of the other specific items from your request (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) as these are not relevant to a traditional medical device submission like a Veress Needle.

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