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For multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures

Three laparoscopic trocars and an insufflation tube bound by a flexible port.

The provided text is a 510(k) summary for the SILS™ Port, a surgical trocar. It includes information about the device's intended use and performance data, but it does not contain the specific details required to answer your questions about acceptance criteria, study design, and ground truth establishment.

The document states: "In-vitro and in-vivo testing has been performed in support of the intended use of this device." However, it does not elaborate on the specific acceptance criteria, the results of these tests, sample sizes, expert qualifications, or how ground truth was established.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method for the test set: This information is not present.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size: This information is not present.
6. If a standalone study was done: While "in-vitro and in-vivo testing" is mentioned, the specific nature of these studies (e.g., standalone vs. human-in-the-loop) and their results are not detailed.
7. The type of ground truth used: This information is not present.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, material biocompatibility, and the general statement of performance testing, rather than a detailed breakdown of a specific clinical or performance study with acceptance criteria and ground truth methodology.

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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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