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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trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port.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.

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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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