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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.

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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.

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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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