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The SILS™ Port device is indicated for multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures, as well as through the anus to provide access for rectal procedures such as TEMS (Transanal Endoscopic Micro Surgery), flap revision and fistula repair.

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

The provided text describes the 510(k) summary for the Covidien SILS™ Port, a surgical trocar. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, device performance in a table format, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document primarily focuses on:

• Device Identification: Name, submitter, contact, date prepared, trade/proprietary name, common name, classification, and predicate devices.
• Device Description: Three laparoscopic trocars and an insufflation tube bound by a flexible port.
• Intended Use/Indications for Use: For multiple instrument or camera access to the abdominal cavity through a single incision for minimally invasive laparoscopic procedures, and through the anus for rectal procedures (TEMS, flap revision, fistula repair).
• Materials and Biological Evaluation: All components evaluated according to ISO 10993-1: 2009.
• Performance Data (General Statement): In-vivo (porcine) and in vitro evaluations were performed to support transanal access. This included in vitro suture pull-out testing and in vivo assessments of insertion force, port security, visualization, removal force, and resultant trauma. The conclusion is that the SILS™ Port is "safe and effective and provides equivalent performance to the predicate device(s)" for transanal access.
• FDA Clearance: A letter from the FDA stating K103253 has been determined substantially equivalent to predicate devices.

Therefore, I cannot fulfill the request to create a table of acceptance criteria and reported device performance or provide detailed information on sample sizes, expert qualifications, adjudication, or specific study types (MRMC, standalone) because this information is not present in the provided text.

The document states that in-vivo and in vitro evaluations were performed and that the device was found to be "safe and effective and provides equivalent performance to the predicate device(s)." This statement implies that certain acceptance criteria were met, but the specific criteria and the numerical results are not disclosed.

Summary of what can be extracted (and what cannot):

1. Table of acceptance criteria and reported device performance: Not available. The document states "in vitro suture pull out testing as well as in vivo (porcine) transanal evaluations including insertion force, port security, visualization, removal force, and resultant trauma" were performed and concluded the device is "safe and effective and provides equivalent performance," but does not provide specific criteria or results in a table.
2. Sample size used for the test set and data provenance:
   • Test Set Sample Size: Not specified.
   • Data Provenance: In-vivo studies were "porcine" (animal model), and in vitro studies were also conducted. This suggests the data is prospective, but the country of origin of the data is not specified beyond "Covidien" being located in North Haven, CT.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not specified. This device is a surgical instrument, not an AI or diagnostic device that requires expert ground truth for interpretation. The performance evaluation was based on physical and biological testing.
4. Adjudication method: Not applicable/Not specified.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No. This is not an AI or diagnostic imaging device.
6. Standalone (algorithm only) performance study: No. This is not an AI or algorithm.
7. Type of ground truth used: For the in-vivo and in vitro tests, the ground truth would be objectively measured physical properties (e.g., insertion force, pull-out strength) and biological observations (e.g., trauma). It's based on experimental measurements and observations rather than expert consensus or pathology in a diagnostic sense.
8. Sample size for the training set: Not applicable/Not specified. As this is not an AI device, there's no concept of a "training set."
9. How the ground truth for the training set was established: Not applicable.

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The SILS™ Port is indicated for multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures. The SILS™ Port provides the ability to use three conventional laparoscopic trocars and an insufflation port through a single incision while providing the ability to maintain pneumoperitoneum.

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

This document describes a 510(k) premarket notification for the Covidien SILS™ Port, a surgical trocar. The information provided is primarily for regulatory clearance and does not contain the detailed study results typically associated with establishing specific performance criteria for AI/ML devices. Therefore, I cannot fully complete all sections of your request based solely on the provided text.

Specifically, this submission is for a medical device (surgical port/trocar), not an AI/ML diagnostic or assistive device. The "performance data" section in the summary mentions "In-vitro and in-vivo testing has been performed in support of the intended use of this device," but it does not specify acceptance criteria, effect sizes, reader studies, ground truth, or sample sizes in the way one would for an AI/ML product.

However, I will extract and infer what I can from the provided text to address your points as best as possible.

Acceptance Criteria and Study for Covidien SILS™ Port (Surgical Trocar):

Based on the provided 510(k) summary, detailed acceptance criteria and a study design for AI/ML performance metrics are not applicable or provided, as this is a physical medical device (surgical port/trocar). The "acceptance" is primarily based on substantial equivalence to predicate devices and meeting safety and material biocompatibility standards.

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

Since this is a physical medical device and not an AI/ML algorithm, the concept of a "device performance" table as you might expect for an AI/ML product (e.g., sensitivity, specificity) is not present. Instead, performance relates to its functional use and safety. The document states:

For the remainder of your questions, the information is not present in the provided 510(k) summary as these questions are typically relevant to AI/ML device studies, not traditional medical device clearance.

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

• Not Applicable / Not Provided: This information is not typically part of a 510(k) summary for a physical medical device in the context of an AI/ML algorithm. The document mentions "in-vitro and in-vivo testing" but does not detail the sample sizes or provenance for these tests in this summary.

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)

• Not Applicable / Not Provided: As this device is not an AI/ML algorithm requiring expert interpretation of outputs, this information is not relevant or included in the 510(k) summary.

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

• Not Applicable / Not Provided: This concept is not relevant to the clearance of this physical medical device.

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

• Not Applicable / Not Provided: This type of study is specifically for AI/ML diagnostic or assistive devices and is not relevant to the SILS™ Port.

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

• Not Applicable / Not Provided: The SILS™ Port is a physical surgical tool, not an algorithm.

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

• Not Applicable / Not Provided (in the context of AI/ML): For a physical device, "ground truth" might relate to physical tests (e.g., material strength tests, leakage tests), but this is not specified in the summary nor is it the "ground truth" relevant to AI/ML performance.

8. The sample size for the training set

• Not Applicable / Not Provided: There is no AI/ML algorithm to train for this device.

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

• Not Applicable / Not Provided: There is no AI/ML algorithm to train for this device.

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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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