Search Results

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.

Ask a specific question about this device

The Unimicro Trocar kit,Model: Auto-Locking Trocar, and Bladeless 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 (3) 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.

The Hasson Trocar has application in a variety of endoscopic procedures to provide a port for entry for endoscopic instruments. The Hasson Trocar is available in two (2) sizes: 10mm and 12mm.This device has a blunt tip, which is designed for open Laparoscopy. The cannula assembly has a fixation device, a universal seal, a valve, and a stopcock.

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 document is a 510(k) summary for the Unimicro Trocar Kit. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "All the test results demonstrate Unimicro Trocar kit meet the requirements of its pre-defined acceptance criteria and intended uses." However, the specific numerical or qualitative acceptance criteria for each performance test (Obturator Compatibility, Insertion & Cannula Stability, Air Leakage) are not explicitly stated in this summary. It only indicates that they were met.

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

• Sample Size: Not explicitly stated. The document mentions "A series of safety tests were performed" and "The performance testing conducted on subject device and predicate device," but does not provide specific numbers for the devices tested.
• Data Provenance: The tests were non-clinical ("non-clinical testing") and likely conducted in-house or by a third-party lab affiliated with the manufacturer, Unimicro Medical Systems (ShenZhen) Co., Ltd. The manufacturer is based in Shenzhen, Guangdong Province, China. The data would therefore be retrospective in the context of the 510(k) submission, meaning the tests were completed before the submission.

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

Not applicable. This device is a medical instrument (trocar kit), not a diagnostic algorithm or image analysis device that requires expert ground truth for its performance evaluation in the way medical AI would. The performance is assessed through engineering and biocompatibility testing.

4. Adjudication Method for the Test Set

Not applicable. As this is not a diagnostic or AI-driven device, there is no "ground truth" established by human experts that would require adjudication. Performance is determined by objective physical and biological tests against established technical standards.

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

Not applicable. The Unimicro Trocar Kit is a physical medical device, not an AI or diagnostic tool that would involve human readers or image interpretation.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The Unimicro Trocar Kit is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance of the Unimicro Trocar Kit is established through adherence to recognized international standards (e.g., ISO 10993 series for biological evaluation, ISO 11135-1 for sterilization) and pre-defined engineering acceptance criteria for functional performance (e.g., obturator compatibility, insertion/cannula stability, air leakage). This is a technical ground truth, not an "expert consensus," "pathology," or "outcomes data" in the typical sense for diagnostic devices.

8. Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

Not applicable. As there is no training set for this device.

Ask a specific question about this device