Search Results

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.

Modifications to the design of the current VersaOne™ Bladeless Trocar (K151548) include diameter change to the cannula and obturator components to accommodate an 8mm instrument.

Here's a breakdown of the acceptance criteria and the study proving the device's performance, based on the provided text.

Important Note: The provided document is a 510(k) summary for a VersaOne™ Bladeless Trocar, a surgical instrument. It is NOT an AI/ML medical device submission. Therefore, many of the typical acceptance criteria and study elements associated with AI/ML systems (such as sample size for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance, and training set ground truth establishment) are not applicable to this type of device. The document focuses on demonstrating substantial equivalence to a predicate device through engineering performance testing and biocompatibility.

Acceptance Criteria and Device Performance for VersaOne™ Bladeless Trocar

Since this is a traditional medical device (trocar), the "acceptance criteria" are not based on metrics like accuracy, sensitivity, or specificity as seen in AI/ML systems. Instead, they are comparative performance metrics against a predicate device and adherence to relevant standards.

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is demonstrated through comparative testing against its predicate, the VersaOne™ Bladeless Trocar (K151548), and adherence to standards.

Conclusion: The regulatory submission asserts that "The results of testing demonstrated the modified VersaOne™ Bladeless Trocar 8mm is substantially equivalent to the legally marketed device."

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

This information is not provided in the 510(k) summary. For a traditional device, "sample size" would refer to the number of devices or test repetitions in bench-top and animal studies. Data provenance (country, retrospective/prospective) is also not specified, as the studies are likely internal engineering and animal model testing, not human clinical trials.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable for this type of device submission. Ground truth for an AI/ML system involves expert labeling of data. For a surgical instrument, "ground truth" is established through engineering specifications, validated test methods, and compliance with industry standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in AI/ML studies for resolving discrepancies in expert labeling. For this device, performance is measured against objective engineering parameters and physical tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC study was not done. MRMC studies are specific to evaluating the impact of AI on human reader performance, which is not relevant for a surgical trocar.

6. If a Standalone Performance (Algorithm Only Without Human-in-the Loop) was Done

No, a standalone performance study was not done. This concept applies to AI algorithms operating independently, not to a physical surgical instrument. The performance testing described (bench top, animal) assesses the physical characteristics and function of the device itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Engineering Specifications and Design Requirements: The device must meet predefined physical dimensions, material properties, and functional performance targets.
• Predicate Device Performance: The modified device must perform equivalently to its legally marketed predicate.
• Compliance with Standards: Adherence to international standards like ISO 11135 (sterilization) and ISO 10993-1/7 (biocompatibility and EO residuals).

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning, so there is no "training set."

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

Not applicable. As there is no training set, there is no corresponding ground truth establishment process.

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

indicated for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry.

VersaOne™ Bladed Trocar is available in 11mm fixation and smooth standard. 12mm fixation and smooth standard, and 12mm fixation and smooth long. VersaOne™ Bladed Trocar consists of an obturator component with a bladed tip and a cannula assembly. VersaOne™ Bladeless Trocar is available in 5mm fixation short. standard, and long, 11mm fixation standard, 12mm fixation short, standard, and long, and 12mm smooth standard. VersaOne™ Bladeless Trocar consists of an obturator component with a bladeless tip and a cannula assembly. The devices are supplied sterile single-use.

Here's a breakdown of the acceptance criteria and study information for the VersaOne™ Bladed Trocar and VersaOne™ Bladeless Trocar, based on the provided FDA 510(k) summary:

This submission is for a medical device (surgical trocar) and the documentation primarily focuses on demonstrating substantial equivalence to predicate devices through performance testing and material compliance. As such, concepts like "acceptance criteria" for a diagnostic algorithm, "expert ground truth," "MRMC studies," or "training sets" are not applicable in this context. The "performance data" here refers to engineering and biocompatibility testing, not diagnostic accuracy.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria in the way one might for an AI/diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the performance is evaluated against the specifications of the proposed devices and comparability to predicate devices for aspects like mechanical function and biocompatibility.

Study Details (as inferable from the document)

Given this is a 510(k) for a physical medical device (trocar), the "study" is a series of engineering tests and biocompatibility assessments, not a clinical trial or AI performance study.

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

   • The document does not specify exact sample sizes for the performance tests (e.g., how many trocars were tested for insertion force, seal integrity, etc.).
   • The data provenance is not mentioned, but these types of tests are typically conducted in a laboratory setting, often by the manufacturer or a contracted lab. They are prospective in the sense that the tests are designed and executed to evaluate the new device.

2. 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 concept is not applicable here. "Ground truth" in this context would be engineering specifications and standards (e.g., ISO 10993-1). The evaluation is objective, based on measurable physical properties and material responses, rather than expert interpretation.

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

   • This is not applicable. Performance tests for physical devices are generally evaluated against pre-defined engineering criteria, not through expert adjudication.

4. 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 is not applicable. The device is a surgical instrument, not an AI or diagnostic tool.

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

   • This is not applicable. The device is a surgical instrument, not an algorithm.

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

   • For performance testing, the "ground truth" consists of engineering specifications, regulatory standards (e.g., ISO 10993-1 for biocompatibility), and established performance characteristics of the predicate devices. The device's performance is compared against these objective benchmarks rather than expert interpretation of medical images or pathology.

7. The sample size for the training set:

   • This is not applicable. There is no machine learning or AI component to this device, and thus no "training set."

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

   • This is not applicable as there is no training set.

Ask a specific question about this device