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The Xpan Universal Trocar System is a single use system that is intended to provide dilation access with or without visualization to the abdominal and thoracic cavities for performing diagnostic and operative abdominal and thoracic procedures. The system is indicated for the following uses:

• · Laparoscopic access to the abdominal cavity, both primary and secondary punctures.
• · Thoracoscopic access to the thoracic cavity, both primary and secondary punctures.

The Xpan Universal Trocar System provides a universal port solution wherein the 3mm expandable port is radially expandable from 3mm up to 12mm. Xpan is offered in three sizes and is a single use device. The 5mm and 12mm cannulas are supplied with an optical bladeless tip and include a detachable valve to allow for specimen removal or rapid desufflation. The 3mm expandable trocar can be assembled with the 5mm or 12mm Xpan obturators after tissue insertion or before tissue insertion if desired. The exterior shaft of the 3mm expandable trocar is ribbed to provide security in tissue once inserted in tissue.

The provided text is a 510(k) Premarket Notification for the "Xpan Universal Trocar System." This document is primarily concerned with demonstrating "substantial equivalence" of a new medical device to existing legally marketed devices, rather than establishing acceptance criteria or performing a study to prove a device meets specific performance metrics in the way one might for an AI/ML-based diagnostic device.

The document focuses on:

• Device Description: What the Xpan Universal Trocar System is and its components.
• Intended Use: The medical procedures it's designed for (laparoscopic and thoracoscopic access).
• Performance Data (Nonclinical): Bench testing (e.g., Insertion Force, Retention Force, Insufflation) and biocompatibility, as well as sterilization and shelf life.
• Comparison with Predicate Device: A detailed table comparing the new device's features to those of a predicate device (VersaStep Bladeless Trocar, K012539) and reference devices.

Crucially, the document explicitly states: "No animal studies were performed" and "No clinical studies were performed." This means there is no data presented in this document about:

• Acceptance criteria related to AI/ML performance (e.g., sensitivity, specificity, AUC).
• Sample sizes for test sets or training sets in the context of AI/ML.
• Expert involvement for ground truth establishment.
• Adjudication methods.
• MRMC studies or standalone algorithm performance.
• Ground truth types (pathology, outcomes data, expert consensus).

The "performance data" mentioned refers to engineering and material safety tests, not performance in a diagnostic or AI/ML context that would involve metrics like accuracy, sensitivity, or human reader improvement.

Therefore, based on the provided document, it is not possible to answer your questions regarding acceptance criteria and performance study details that relate to AI/ML or diagnostic accuracy, as this submission is for a physical medical device (a surgical trocar) and explicitly states no clinical or animal studies were performed.

The document's purpose is to show that the new trocar is substantially equivalent to existing trocars based on intended use, technological characteristics, and non-clinical bench testing, and that any differences do not raise new questions of safety and effectiveness. It does not involve any AI/ML components or comparative effectiveness studies with human readers.

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The Inno-Port Disposable Bladeless Trocars are in a variety of gynecologic, general thoracic and urologic endoscopic procedures to create and maintain a port of entry.

The Inno-Port Disposable Optical Trocars are intended for use in a variety of gynecologic, general thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.

The Inno-Port Disposable Bladeless Trocar and Inno-Port Disposable Optical Trocar are surgical trocars available in 5 mm, 5-11 mm, and 5-12 mm series. They consist of an obturator and a cannula with a self-adjusting seal and stopcock valve. The optical trocar obturator also contains a scope retention mechanism. The seal system accommodates instruments ranging from 5mm to 12mm in diameter depending on the trocar size.

The provided document is a 510(k) summary for the "Inno-Port Disposable Bladeless Trocar" and "Inno-Port Disposable Optical Trocar." It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the format requested for AI/ML performance.

Therefore, many of the requested details about acceptance criteria for AI/ML performance, sample sizes, expert qualifications, ground truth, and MRMC studies are not applicable or extractable from this document as it pertains to a medical device's physical performance, not an AI/ML algorithm.

However, I can extract the acceptance criteria and reported device performance for the physical device characteristics as presented.

Here's the information that can be extracted or inferred from the provided text:

1. A table of acceptance criteria and the reported device performance

The document provides a comparison of performance criteria between the proposed device and its predicate devices. The "reported device performance" is essentially that the proposed devices met these criteria, as stated in the conclusion: "The test results showed that both proposed devices have the similar device performance compared to the predicate device."

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The Spacemaker™ Pro dissection balloon is primarily indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.
The Spacemaker™ Pro blunt tip trocar is intended for use in establishing a port of access for insertion of endoscopic instruments into the abdominal cavity or extraperitoneal space in abdominal and extraperitoneal surgery.
The Spacemaker™ Pro structural balloon trocar is primarily indicated for patients undergoing laparoscopic surgical procedures requiring a sealed port of access and/or tissue retraction. This is also indicated in patients undergoing laparoscopic surgery requiring a sealed port of access and/or tissue separation in extraperitoneal procedures, such as in hernia repair, lymphadenectomy or bladder neck suspension procedures.

The Spacemaker™ Pro access and dissector system consists of combinations of three dissectors and two balloon access devices integrated into a single, modular device. There are a total of five Spacemaker™ Pro device combinations.
Blunt tip trocar with round dissection balloon
Blunt tip trocar with oval dissection balloon
Blunt tip trocar with cylindrical dissection balloon
Structural balloon trocar with round dissection balloon
Structural balloon trocar with oval dissection balloon
Each combination also includes two 5mm optical ports cleared under K112349, for use during the laparoscopic procedure, and also includes an Obturator accessory in a shorter length.

The provided text describes a 510(k) premarket notification for the "Spacemaker™ Pro Access and Dissector System." It details the device, its intended use, and compares it to a predicate device. The document lists various in vitro and in vivo tests conducted to demonstrate substantial equivalence, but it does not explicitly state specific acceptance criteria or report device performance details for these tests. It generally concludes that "The results of testing demonstrate that the modified Spacemaker™ Pro Access and Dissector System is substantially equivalent to the legally marketed Spacemaker™ Plus System(K042412)."

Therefore, I cannot provide a table of acceptance criteria and reported device performance as that specific information is not present in the provided text. I also cannot fulfill requests for sample sizes, data provenance, expert details, or multi-reader studies as these are not mentioned.

However, I can extract information related to the types of studies conducted:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in the provided text.
• Reported Device Performance: Not explicitly detailed in the provided text, beyond the general conclusion of substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: Not specified.
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable as no expert-established ground truth is mentioned for the testing described. The studies appear to be performance-based engineering and functional tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable.

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:

• No MRMC or AI-related studies are mentioned. This device is a medical instrument, not an AI diagnostic tool.

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

• No standalone algorithm performance is mentioned, as this is a physical medical device. The "in vitro" and "in vivo" performance studies described can be considered standalone performance for the device itself.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• For the performance studies listed, the "ground truth" would be established by objective measurements and observations of the device's physical and functional characteristics against predetermined engineering specifications and safety standards, rather than expert consensus on diagnostic images or pathology. For example, for "Balloon Inflation Force" or "Dissector Balloon Leak Test," the ground truth is a pass/fail against a quantifiable threshold.

8. The sample size for the training set:

• Not applicable, as this is a physical medical device, not a machine learning algorithm.

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

• Not applicable.

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The Versaport™ Bladeless Optical Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.

The Versaport™ V2 Bladeless Optical Trocar 11mm and 12mm with a transparent cannula is available in standard (100mm), short (70mm) and long (150mm) cannula lengths. The Versaport™ V2 Bladeless Optical Trocar with transparent cannula and obturator allows optical entry for visualization of tissue layers during insertion. The obturator housing contains a scope retention mechanism. The trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port. The 11mm and 12mm Versaport™ seal system accommodate instruments indicated as 5mm up to 11mm and 12mm respectively. These features are the same as the Versaport™ V2 Bladeless Optical Trocar (5mm) [K112349].

The proposed device (Versaport™ V2 Bladeless Optical Trocar, 11mm and 12mm) has similar design, lengths, and optical features as the predicate devices. The Versaport™ V2 Bladeless Optical Trocar, 11mm and 12mm, includes a transparent cannula, a bladeless obturator with a transparent optical window at the distal end, an obturator housing scope retention mechanism and external interlocking snaps. The scope retention mechanism is located within the obturator housing allowing for secured insertion and retention of an appropriately sized 0° laparoscope for visualization of tissue layers during insertion into the body cavity. There is a 3 way stopcock for insufflation and rapid desufflation. The external interlocking snaps secure the obturator to the cannula. The Versaport™ Bladeless V2 Optical trocar is equivalent to the predicate devices in terms of its intended use and fundamental technology.

The provided submission is a 510(k) Summary of Safety and Effectiveness for a medical device (Versaport™ V2 Bladeless Optical Trocar System). It describes the device, its intended use, and states that in-vitro and in-vivo tests were performed to verify performance and substantial equivalence to predicate devices. However, it does not provide specific acceptance criteria or detailed results of those studies.

Here's a breakdown based on the information available:

1. A table of acceptance criteria and the reported device performance

Note: The document only states that these performance aspects were "verified" and that the device performs "as intended" and is "substantially equivalent" to predicate devices. It does not provide the specific quantitative or qualitative acceptance criteria used for each test, nor the actual measured performance values that demonstrated compliance.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample sizes: Not specified in the provided document.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this type of device submission. This device is a surgical instrument (trocar), not an imaging or diagnostic device that requires expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as it pertains to methods for resolving discrepancies in expert interpretations, which is not relevant to testing a surgical instrument.

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

This information is not applicable. This device is not an AI-powered diagnostic tool, and therefore, MRMC studies involving human readers or AI assistance are not relevant.

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

This information is not applicable. This device is a physical surgical instrument and does not involve algorithms or AI.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the performance tests mentioned (e.g., leak resistance, forces, visualization), the "ground truth" would be established by objective measurements and functional requirements defined by engineering specifications and surgical practice standards, rather than expert consensus on diagnostic images or pathology. For example, "leak resistance" would be measured against a defined threshold of acceptable leakage. "Visualization of tissue layers" would be assessed through direct observation during in vivo testing.

8. The sample size for the training set

This information is not applicable. This device is not an AI/ML model that requires a training set.

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

This information is not applicable. As above, this device does not use a training set.

Summary of what the document does provide regarding the study:

The document (specifically "PERFORMANCE DATA" on Page 2) states that a study was performed, encompassing:

• Study Type: A combination of in-vitro (laboratory) and in-vivo (live subject) tests.
• Purpose: To verify that the performance of the Versaport™ V2 Bladeless Optical 11mm and 12mm trocars is substantially equivalent to the predicate devices and performs as intended.
• Tests Performed:
  • In Vitro Leak Resistance
  • In Vitro Instrument Insertion and Removal Forces
  • In Vitro Snap Feature Retention Force
  • In Vitro Scope Insertion and Retention Forces
  • In Vitro and In Vivo Penetration Force
  • In Vitro and In Vivo Fixation Force
  • In Vivo Visualization of Tissue Layers

Missing Information:

Crucially, this 510(k) summary provides a high-level overview of the tests conducted but lacks detailed quantitative results, specific acceptance criteria, and specific methodologies (e.g., sample sizes, experimental setup details) that would typically be found in a full study report. This level of detail is usually present in the full 510(k) submission, but not always in the publicly available summary.

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