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The ASC TriPort+ Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

The ASC TriPort+ Laparoscopic Access Device is, like the parent TriPort and QuadPort devices cleared by the FDA under K101794, a laparoscopic multi-instrument port which performs the following two functions.

• Retracting a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen at the same time during laparoscopic surgery.
• Ensuring that pneumoperitoneum is maintained in the abdomen during the surgical procedure, whether or not one or more laparoscopic instruments are passing through the device.
  The ASC TriPort+ Laparoscopic Access Device is sterile and disposable. The proposed ASC TriPort+ Laparoscopic Access Device performs the same function as the TriPort and QuadPort parent devices.
  Like the parent ASC TriPort Laparoscopic Access Device, the proposed ASC TriPort+Laparoscopic Access Device is comprised of the following three components:
• An introducer component, which delivers the Distal Ring of the ASC TriPort+ through a premade incision, into the abdominal cavity.
• A retractor component, which retracts an abdominal incision to allow the passage of laparoscopic instruments.
• A valve component which maintains the pneumoperitoneum established for the surgical procedure.
  The ASC TriPort+ Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The ASC TriPort+ Laparoscopic Access Device is identical in function to the ASC TriPort & QuadPort Laparoscopic Access Devices, which have been cleared for marketing under K101794.

The provided text describes a 510(k) submission for the ASC TriPort+ Laparoscopic Access Device. The submission focuses on demonstrating substantial equivalence to a predicate device (TriPort & QuadPort Laparoscopic Access Devices, K101794) rather than presenting a study to prove the device meets specific acceptance criteria in a quantitative sense as might be expected for an AI/CADe device.

Therefore, the information required for a detailed acceptance criteria table and a study analysis is largely not present in the provided document, as the submission emphasizes functional equivalence and design verification rather than performance metrics from a comparative clinical trial.

However, I can extract the relevant information where available and note where specific details are missing based on the prompt's requirements.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a number of cases or subjects in a traditional clinical study sense. The document refers to "Performance Testing" which included "Validation testing of the TriPort+ in a porcine model" and "on a simulator." The number of porcine models or simulation runs is not specified.
• Data Provenance: Porcine model (animal study) and simulator. The country of origin for this testing is not specified, but the submitter is based in Ireland. The testing is prospective in nature, as it was conducted specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: "Clinicians with various levels of experience and expertise" were enrolled in the porcine model testing. The specific number is not provided.
• Qualifications of Experts: General description of "various levels of experience and expertise." No specific qualifications (e.g., "radiologist with 10 years of experience") are given. Their role appears to be operational and observational of the device's function rather than establishing ground truth in the sense of diagnostic interpretation.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not described. The testing involved direct observation of device function by clinicians. There's no mention of conflicting interpretations or a need for adjudication among multiple experts to establish a "ground truth" for diagnostic purposes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study was not performed as described in the document. This type of study is typical for assessing the impact of AI on human reader performance, which is not the focus of this device (a surgical access port).
• Effect Size: Not applicable, as no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable. The ASC TriPort+ is a physical medical device (laparoscopic access port), not an algorithm or AI software. Therefore, the concept of "standalone (algorithm only)" performance does not apply.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this context is the successful and safe operation of the physical device as assessed by observed performance and clinician feedback during the porcine model and simulator testing. This is analogous to "expert observation/assessment" of device functionality, rather than a diagnostic ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The device design was iteratively improved, but these are design and engineering processes, not algorithmic training.

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

• Training Set Ground Truth: Not applicable, as there is no training set. The "ground truth" for the device's design and modifications would be based on engineering principles, user feedback, predicate device performance, and internal design verification/validation testing.

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The ASC TriPort and QuadPort Laparoscopic Access Devices are intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

The modified ASC TriPort Laparoscopic Access Device, like the parent TriPort cleared by the FDA under K073719, is still comprised of the following three components:

• an introducer component which creates an abdominal incision (except in the case where the surgeon creates a Hasson cut-down incision) and delivers the Distal Ring of the ASC TriPort into the abdominal cavity
• a retractor component which retracts an abdominal incision to allow the passage of laparoscopic instruments
• a valve component which maintains the pneumoperitoneum established for the surgical procedure

The modified ASC TriPort Laparoscopic Access Device is still intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The modified ASC TriPort Laparoscopic Access Device is identical in function to the parent device, which has been cleared for marketing under K073719.

The modifications made to the parent device labeling to produce the proposed TriPort Laparoscopic Access device informs users and patients that the device does not contain Natural Rubber Latex. Additionally the labelling has been revised to extend the shelf life from three months to three years as notified in the original 510(k) and to make the device safer and easier to use. The changes made to the parent TriPort Laparoscopic Access Device to produce the proposed TriPort are minor and do not represent modifications to the indications for use, operating principles, or mechanism of action for the device.

The TriPort has additionally been modified resulting in the QuadPort device. The modifications to the TriPort comprise the following:

• A fourth valve was added to accommodate an additional laparoscopic instrument.
• The Boot is larger in diameter to accommodate the fourth instrument valve.
• An Introducer and Retaining Clips are not required.
• The Removal Ring is made from a different material (the same material as is used for the TriPort distal ring).

The ASC TriPort and QuadPort Laparoscopic Access Devices are laparoscopic multiinstrument ports which perform the following two functions:

• They retract a small abdominal incision to allow multiple laparoscopic instruments to pass through a small incision to the abdomen at the same time during laparoscopic surgery.
• They ensure that pneumoperitoneum is maintained in the abdomen during the surgical procedure, whether or not one or more laparoscopic instruments are passing through them.

The ASC TriPort and QuadPort Laparoscopic Access Devices apply radial force upon the incision creating an aperture though which the laparoscopic instruments pass. The ability to remove the boot, allows the clinician to deliver specimens without removing the entire port, and with the QuadPort, generally without the need to extend the incision.

The physical design and performance of the modified TriPort is unchanged. Materials changes relate to substitution with materials already used for the TriPort. The physical properties of the QuadPort differ from the TriPort in that the diameter of the boot is increased, allowing space for the addition of a fourth port.

The document provided describes the ASC TriPort and QuadPort Laparoscopic Access Devices, which are intended for use as multiple instrument and/or camera ports during minimally invasive abdominal laparoscopic surgery. This submission is a Special 510(k), indicating modifications to an already cleared device (the parent TriPort cleared under K073719).

Here's an analysis of the acceptance criteria and study information:

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

The document does not explicitly state quantitative "acceptance criteria" in terms of performance metrics (e.g., success rates, leak rates, specific force thresholds) against which the device was evaluated. Instead, the "acceptance criteria" can be inferred from the regulatory context of a 510(k) submission, which relies on demonstrating substantial equivalence to predicate devices and ensuring that modifications do not raise new issues of safety or effectiveness.

The reported device performance is described qualitatively in relation to these overarching goals.

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

• Test Set Description:
  • Modified TriPort: "Biocompatibility and performance verification testing." The document does not specify the sample size for this testing.
  • QuadPort: "Validation testing of the ASC QuadPort in a porcine model." The document does not specify the sample size (number of animals) used in this porcine model study.
• Data Provenance: The document does not explicitly state the country of origin for the testing data. The manufacturer is based in Ireland. The testing was "non-clinical performance testing," indicating it was conducted in a laboratory or animal setting, not on human patients. The study was likely prospective in design, as it describes a planned validation test of a new device modification.

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

• For the QuadPort porcine model study, it "enrolled clinicians with various levels of experience."
• The document does not specify the exact number of clinicians/experts used.
• It does not specify the exact qualifications beyond "various levels of experience" (e.g., number of years, surgical specialty).
• For the TriPort biocompatibility and performance verification testing, no explicit mention of human experts evaluating the "ground truth" is made, as this typically involves standardized technical testing.

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

• The document states that the QuadPort study "enrolled clinicians with various levels of experience" who demonstrated that it "functioned as intended."
• It does not describe an adjudication method (like 2+1 or 3+1 consensus) for establishing a "ground truth" based on expert opinion. The assessment appears to be a direct observation of the device's function by the clinicians during the porcine model procedure, rather than an interpretation of complex data requiring consensus.

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 comparative effectiveness study was done.
• This device is a physical surgical access port, not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

• This question is not applicable. The device is a physical surgical tool and does not involve an algorithm. Performance assessment inherently involves human interaction (clinicians using the device).

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

• For the TriPort modifications, the "ground truth" for demonstrating safety and effectiveness relies on standard performance verification testing (e.g., mechanical strength, seal integrity, material biocompatibility) and comparison to the known performance of the predicate device.
• For the QuadPort porcine model study, the "ground truth" was based on the direct observation and assessment by clinicians during a simulated surgical procedure that the device "functioned as intended" and "did not raise new issues of safety and effectiveness."

8. The sample size for the training set:

• This concept is not directly applicable to a physical medical device submission for regulatory clearance. There is no "training set" in the context of machine learning or AI algorithms. The device design and manufacturing processes are refined through engineering and iterative testing, not by training an algorithm on a dataset.

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

• Not applicable, as no "training set" in the AI/ML context exists for this device.

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The ASC TriPort Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

The ASC TriPort Laparoscopic Access Device is a laparoscopic multi-instrument port which performs the following two functions:

• t It retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen at the same time during laparoscopic surgery
• . It ensures that pneumoperitoneum is maintained in the abdomen during the surgical procedure, whether or not one or more laparoscopic instruments are passing through the TriPort
  The ASC TriPort Laparoscopic Access Device is sterile and disposable. The proposed ASC TriPort Laparoscopic Access Device performs the same function as other legally marketed port systems and standard trocars.
  Like the parent ASC R-Port II Laparoscopic Access Device, the proposed ASC TriPort Laparoscopic Access Device is comprised of the following three components:
• an introducer component which creates an abdominal incision (except in the . case where the surgeon creates a Hasson cut-down incision) and delivers the Distal Ring of the ASC TriPort into the abdominal cavity
• a retractor component which retracts an abdominal incision to allow the . passage of laparoscopic instruments
• . a valve component which maintains the pneumoperitoneum established for the surgical procedure
  The ASC TriPort Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The ASC TriPort Laparoscopic Access Device is identical in function to the ASC R-Port II Laparoscopic Access Device, which has been cleared for marketing under K073170.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ASC TriPort Laparoscopic Access Device:

Acceptance Criteria and Reported Device Performance

The provided text does not list explicit, quantifiable acceptance criteria (e.g., "device must maintain pneumoperitoneum with less than X ml/min gas leakage"). Instead, it describes the device's functions and states that it performs them "as intended." The performance is largely framed by its similarity and improvements over predicate devices.

Study Details:

The document is a Special 510(k) Summary. For such submissions, the primary "study" is demonstrating substantial equivalence to a previously cleared predicate device. This is typically achieved through comparative analysis of technological characteristics and performance testing.

1. Sample Size used for the test set and the data provenance:

   • The document states, "Biocompatibility, verification and validation testing have been performed which demonstrate that the ASC TriPort Laparoscopic Access Device functions as intended and is safe and effective for its intended use." (page 5)
   • However, specific details on the sample size for these tests, the type of data (e.g., in-vitro, ex-vivo, animal, human), or the country of origin are not provided in the given text. The testing appears to be internal validation by the manufacturer, rather than external clinical trials.

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

   • This information is not provided in the text. Given the nature of mechanical/performance testing for a device modification, "ground truth" would likely be established through engineering specifications, validated test methods, and direct measurement, rather than expert consensus on a dataset.

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

   • This information is not provided. The concept of adjudication methods is typically relevant for studies involving subjective human interpretation (e.g., image reading), which doesn't seem to be the primary focus here.

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:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/imaging devices, which this laparoscopic access device is not. The document focuses on the mechanical and functional equivalence/improvements of a surgical instrument.

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

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

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

   • The "ground truth" for this device would be its ability to meet engineering specifications for mechanical properties, seal integrity (for pneumoperitoneum), material biocompatibility, and functional performance (e.g., allowing instrument passage, specimen removal). This would be based on direct physical measurement and testing against predefined criteria. No mention of expert consensus, pathology, or outcomes data for establishing ground truth is made, nor would it typically be expected for this type of device in a 510(k) summary.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

   • Not applicable, as there is no training set for this type of device.

Summary of Study Approach for the 510(k) Special Submission:

Given that this is a "Special 510(k)," the core "study" is a demonstration that the modifications to the device (TriPort from R-Port II) "are minor and do not represent modifications to the indications for use, operating principles, or mechanism of action for the device." This is achieved by:

• Detailed comparison to predicate devices: Highlighting how the TriPort is similar to the R-Port II (K073170) and other predicates (K070158, K010007, K032676, K010711) in function and intended use.
• Description of modifications: Explaining the changes (outer diameter increase, removable valve section, separate instrument valves, material change) and arguing that these are improvements rather than fundamental changes.
• Performance Testing Statement: A general statement on "Biocompatibility, verification and validation testing" having been performed to confirm it "functions as intended and is safe and effective." This suggests in-house testing to validate the engineering design and functionality. Specific results or detailed methodologies are not included in this summary document, as is common for 510(k) summaries which focus on demonstrating substantial equivalence rather than presenting full clinical trial results.

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