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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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The VECTEC Disposable Pneumoperitoneum Needle is a single-use, sterile device intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish a pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

The VECTEC Disposable Pneumoperitoneum Needle is a disposable, single-use, sterile surgical tool used in laparoscopy for insufflation of the abdominal cavity prior to use of a trocar during abdominal surgery. The device is sterilized using a traditional, validated ethylene oxide procedure per ISO 11135-1: 2007 to a SAL of 10t and with acceptable residual EO levels per ISO 10993-7: 2008.

The provided text describes a 510(k) submission for the VECTEC Disposable Pneumoperitoneum Needle, focusing on its substantial equivalence to predicate devices. The performance testing section details the types of tests conducted but does not specify numerical acceptance criteria or detailed performance metrics in the format you requested for AI/software devices. This document is for a physical medical device, not a software or AI device, which explains the absence of some of the requested information.

Here's an attempt to structure the available information according to your request, with an understanding that many fields will be "Not Applicable" or "Not Provided" due to the nature of the device and the document.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated for each test. For mechanical bench testing, it's implied that "the predicate" (Ethicon Endopath Veress Needle) was used for comparison. For in vivo testing, the text mentions "a full-sized porcine model," but the number of models or tests performed is not specified.
• Data Provenance:
  • Biocompatibility, Sterilization, EO Residuals: Laboratory testing.
  • Mechanical Bench Testing: Benchtop testing, likely in a lab setting, comparing to a predicate device.
  • In Vivo Testing: "full-sized porcine model," indicating animal testing. No country of origin is mentioned for the in vivo data.
• Retrospective or Prospective: These tests would be considered prospective for the purpose of this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: For the in vivo testing, it states "conducted by a general surgeon." This implies at least one expert.
• Qualifications of Experts: "a general surgeon with experience in laparoscopy."

4. Adjudication method for the test set

• Adjudication Method: Not applicable/Not provided. The tests described are primarily objective performance tests or animal studies, not requiring human consensus for ground truth on a test set in the way a clinical image analysis study would.

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

• MRMC Study: No, this is not an AI or software device. This section is not applicable.
• Effect Size of AI assistance: Not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Standalone Performance: No, this is not an AI or software device. This section is not applicable.

7. The type of ground truth used

• Ground Truth:
  • For biocompatibility, sterilization, and EO residuals: Established standards and validated laboratory methods (e.g., ISO standards).
  • For mechanical bench testing: Comparison against the established performance of a legally marketed predicate device (Ethicon Endopath Veress Needle).
  • For in vivo testing (needle puncture, gas flow): Direct observation and assessment by a qualified surgeon in a porcine model. This would be considered 'expert observation' or 'functional demonstration'.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a physical device submission; there isn't a "training set" in the context of an AI/ML algorithm. The "training" here would refer to the design and refinement of the physical device based on engineering principles and prior knowledge of medical devices, which isn't described in terms of a data set.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable, as there is no training set in the AI/ML sense. The "ground truth" for the device's design and engineering would be based on established medical device requirements, engineering standards, and the performance characteristics of predicate devices, which the VECTEC device was designed to emulate or be equivalent to.

Summary of Device Type:
It's crucial to reiterate that the VECTEC Disposable Pneumoperitoneum Needle is a physical medical device, not an AI/software device. Therefore, many of the questions related to AI/ML specific concepts (such as test sets for algorithms, human readers, AI assistance, training sets, etc.) are not applicable to this submission. The "study" referenced refers to standard medical device performance testing (biocompatibility, sterilization, mechanical, and in vivo animal testing) to demonstrate substantial equivalence to legally marketed predicate devices.

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The Pneumo-Matic Insufflation 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 Pneumo-Matic Insufflation Needle is a sterile, disposable Veress needle which is available in a 14 gauge, 120mm or 150mm length. The devices are packaged 10 per box. The needle is equipped with a spring-loaded, round-tipped obturator. In addition, there is a "window" and visual indicator in the proximal handle which will visibly confirm penetration of the inner abdominal wall. Integral to the proximal handle is a "slide switch" which permits easy ON-OFF control of the gas flow. The most proximal end contains a male luer lock connector for secure gas line connection.

This 510(k) Premarket Notification for the Apple Medical Corp. Pneumo-Matic Insufflation Needle does not contain the information requested in your prompt.

The document describes a medical device (a Veress needle for insufflation) and its premarket notification to the FDA. It outlines the device's description, indications for use, and summaries of biocompatibility and safety and performance tests.

However, the prompt is geared towards evaluating a system that would typically involve an algorithm or AI, requiring metrics like sensitivity, specificity, or improvement in human reader performance. None of that information is present in this filing.

Specifically, the following points from your prompt cannot be addressed by the provided text:

1. Table of acceptance criteria and reported device performance: While there are lists of "tests performed," there are no specific numerical acceptance criteria or performance metrics reported that would be relevant to evaluating an AI or algorithm. For example, there's a "Needle Puncture Test" but no pass/fail criteria or results like "penetration achieved 99% of the time."
2. Sample size used for the test set and the data provenance: Not applicable; this is a physical medical device.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable; there is no AI or human reader involved in the performance of this physical device in the context described.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable in the AI/algorithm sense. The "ground truth" for these tests would be objective physical measurements or observations (e.g., did the spring obturator operate correctly), not expert consensus on an image or data.
8. Sample size for the training set: Not applicable; no AI or algorithm for this device.
9. How the ground truth for the training set was established: Not applicable.

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The Neonatal/Pediatric Thoracic Catheter is a sterile, single use indwelling catheter, used to create a patent open passageway between the chest cavity and atmosphere or a Chest Drainage Unit (CDU). The catheter is intended to prevent pressure from developing in the chest, averting lung collapse and providing a means for fluid to drain from the chest cavity.

The Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray will include all components commonly required to perform a chest drainage procedure in a single procedure-ready package. This procedure tray will be available in several configurations of tray components. The Neonatal/Pediatric Thoracic Catheter is a sterile, single use indwelling catheter, used to create a patent open passageway between the chest cavity and atmosphere or a Chest Drainage Unit (CDU). The catheter will be available in 8, 10 and 12 fr sizes. The device incorporates a blunt, multi-sideholed, springloaded inner cannula coaxially housed within a conventional sharp-beveled hollow needle. This entire assembly is housed within polyurethane tapered catheter, which is used as a standard small bore percutaneously placed thoracic catheter. The tapered catheter incorporates four distal side-holes to facilitate drainage.

This document is a 510(k) summary for a medical device (Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray), which focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain the kind of information requested in your prompt (acceptance criteria, device performance metrics, study design, expert evaluation, etc.).

The information you are looking for is typically found in clinical studies, validation reports, or performance testing summaries, which are distinct from a 510(k) summary. A 510(k) summary primarily addresses the device's intended use, technological characteristics, and comparison to a predicate device to establish that it is as safe and effective.

Therefore, I cannot fulfill your request using the provided input because it does not contain the necessary details about acceptance criteria or a study proving device performance.

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