Search Results

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.

Ask a specific question about this device

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."

Ask a specific question about this device

The Medline ReNewal Reprocessed Versaport V2 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 Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar 5-mm, 11-mm and 12-mm, with transparent cannula and obturator, allows optical entry for visualization of tissue layers during insertion. It is available in standard (100 mm), short (70 mm) and long (150 mm) cannula lengths. The obturator housing contains a scope retention mechanism and 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 5-mm, 11-mm and 12-mm Versaport seal system accommodate instruments indicated as 5-mm up to 11-mm and 12-mm respectively.

The provided text is a 510(k) Summary for a reprocessed medical device, the Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar. It asserts substantial equivalence to a predicate device based on functional performance studies, cleaning performance, biocompatibility, and sterilization and packaging validations. However, it does not contain the specific acceptance criteria (thresholds) for each performance test, nor does it present detailed "device performance" in a comparative table against those criteria. It also does not describe a "study that proves the device meets the acceptance criteria" in terms of clinical trials or multi-reader multi-case studies, but rather product verification and validation testing.

Therefore, much of the requested information regarding detailed acceptance criteria, specific performance numbers, sample sizes for test sets (beyond the implied "models included in clearance"), data provenance, expert ground truth, adjudication methods, or MRMC studies is not available in the provided document. The document describes a technical testing scheme for reprocessing rather than a study evaluating diagnostic AI performance.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not explicitly stated as numerical thresholds in this document)
The document states that the functional characteristics were "evaluated and were found to be substantially equivalent to the predicate device based on the following tests." This implies that the acceptance criteria for the reprocessed device were to perform comparably to the original predicate device on these tests. Actual numerical or qualitative thresholds for "passing" these tests are not provided.

Reported Device Performance:
The document does not provide specific numerical or qualitative performance results for the reprocessed device. It only states that the device was "found to be substantially equivalent" based on the described tests.

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

• Sample Size for Test Set: The document lists 15 specific reprocessed device models (combinations of diameter, length, and fixation/smooth cannula) that were included in the clearance. For each of these models, it implies that representative samples were tested across the various performance evaluations. However, the exact number of units tested for each specific test (e.g., how many devices were tested for seal leakage) is not provided.
• Data Provenance: The studies are described as "Performance Testing" conducted by the submitter, Medline ReNewal. This implies the data were generated prospectively as part of this 510(k) submission process for the reprocessed device. The country of origin for the data is not explicitly stated, but Medline ReNewal is based in Redmond, Oregon, USA, suggesting the testing was likely conducted in the USA or supervised by their US-based QA/RA department.

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

• This information is not applicable and not provided. The device is a surgical trocar, not an AI/diagnostic imaging device where "ground truth" would typically be established by expert readers or pathology. The "ground truth" for this device's performance relies on engineering and biological safety standards for reprocessing and functional equivalence to the original device.

4. Adjudication method for the test set

• This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 typically refer to expert consensus in interpreting images or clinical data, which is not relevant to the described performance testing of 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 and not provided. This is not an AI-assisted diagnostic device, but a reprocessed surgical instrument. Therefore, MRMC studies and the concept of human reader improvement with AI are not relevant.

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

• This information is not applicable and not provided. This is not an algorithm or AI device.

7. The type of ground truth used

• As mentioned, the concept of "ground truth" in the context of expert consensus or pathology is not applicable. The "ground truth" for this device's substantial equivalence is based on meeting engineering performance specifications, cleaning efficacy, biocompatibility standards, and sterilization validation results, all benchmarked against the original (predicate) device's validated performance and relevant regulatory standards (e.g., ISO standards for biocompatibility).

8. The sample size for the training set

• This information is not applicable and not provided. This is not an AI/machine learning device that requires a training set. The "training" for this device would refer to the validated reprocessing procedures, not data used for an algorithm.

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

• This information is not applicable and not provided for the reasons stated in point 8.

Ask a specific question about this device

The VersaOne™ 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 VersaOne™ bladeless trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.

VersaOne™ Optical Trocar 15mm is available in 15mm diameter with a transparent fixation cannula and standard (100mm) length. The VersaOne™ Optical Trocar 15mm consists of an obturator component with a bladeless tip and a cannula assembly. The obturator has a dolphin nose (conical) shaped bladeless tip with transparent window at distal end. The transparent window at distal end of the obturator allows optical entry for visualization of tissue lavers during insertion. The obturator housing contains a scope retention mechanism. The cannula assembly is composed of a seal system, trocar housing, transparent cannula sleeve, and a stopcock. The seal system prevents loss of pneumoperitoneum when instruments are inserted or withdrawn. The seal system accommodates instruments ranging from 5mm to 15mm in diameter. The 15mm trocar housing is removable for specimen retrieval. The cannula sleeve has a bevel shape at the distal end to reduce penetration forces during insertion and transparent for better visualization. The stopcock valve is for insufflation and desufflation. The devices are supplied single-use. The VersaOne™ Optical Trocar 15mm is sterilized via Ethylene Oxide (EtO) sterilization method. The packaging configuration is one device packed in a sealed Nylon / Tyvek breather pouch, six pouches per display box, and both pouch and display box have appropriate labeling.

VersaOne™ Bladeless Trocar 15mm is available in two lengths (long (150mm) and standard (100mm)); both are 15mm in diameter and contain transparent fixation cannulas. VersaOne™ Bladeless Trocar consists of an obturator component with a bladeless tip and a cannula assembly. The obturator has a dolphin nose (conical) shaped bladeless tip. The cannula assembly is composed of a seal system, trocar housing, transparent cannula sleeve, and a stopcock. The seal system prevents loss of pneumoperitoneum when instruments are inserted or withdrawn. The seal system accommodates instruments ranging from 5mm to 15mm in diameter. The 15mm trocar housing is removable for specimen retrieval. The cannula sleeve has a bevel shape at the distal end to reduce penetration forces during insertion and transparent for better visualization. The stopcock valve is for insufflation and desufflation. The devices are supplied sterile single-use. The VersaOne™ Bladeless Trocar 15mm is sterilized via Ethylene Oxide (EtO) sterilization method. The packaging configuration is one device packed in a sealed Nylon / Tyvek breather pouch, six pouches per display box, and both pouch and display box have appropriate labeling.

The provided document is a 510(k) summary for medical devices (trocars) and does not describe an AI medical device. Therefore, it does not contain the specific information requested about acceptance criteria, study details, ground truth, sample sizes, or expert adjudication that would be relevant to an AI/ML medical device.

The document discusses:

• Device Name: VersaOne™ Optical Trocar 15mm and VersaOne™ Bladeless Trocar 15mm
• Intended Use: To create and maintain a port of entry in various endoscopic procedures.
• Modifications: Larger diameter (15mm) and a new seal system.
• Testing: Sterilization assessment, shelf-life assessment, biocompatibility testing, and performance testing (ex vivo and in vivo).

Since the device is a physical medical instrument (trocar) and not an AI/ML-based diagnostic or therapeutic tool, the requested information categories (e.g., sample size for test set, data provenance, number of experts, MRMC studies, standalone performance, training set sample size, ground truth for training set) are not applicable.

The acceptance criteria mentioned are general performance tests for a physical device, such as:

• Leak rate
• Insertion force
• Removal force
• Penetration force
• Fixation force

The conclusion states that "The results of testing demonstrate the modified VersaOne™ Optical Trocar 15mm and VersaOne™ Bladeless Trocar 15mm are substantially equivalent to the legally marketed" predicate devices. This implies that the device met performance criteria comparable to the existing predicate devices. However, specific numerical acceptance criteria (e.g., "leak rate must be below X ml/min") and reported performance values are not detailed in this summary.

Ask a specific question about this device