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The Reprocessed Endoscopic Trocars and Sleeves (B11LT, B12LT, B5LT, CB11LT, CB12LT, CB5LT, CB5ST, D11LT, D12LT, D5LT, D5ST, H12LP, 2B5LT, 2B5ST, 2D5LT, 2CB5ST, 2CB5LT) have applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The Bladeless Trocars may be used with or without visualization for primary and secondary insertions.

The Reprocessed Endoscopic Trocars and Sleeves (B11LT, B12LT, B5LT, B5ST, CB11LT, CB12LT, CB5LT, CB5ST, D11LT, D12LT, D5LT, D5ST, H12LP, 2B5LT, 2B5ST, 2D5LT, 2D5ST, 2CB5ST, 2CB5LT) are sterile, single patient use instruments consisting of a radiolucent sleeve (cannula) and obturators in sizes ranging from 5-12 mm in diameter. There different obturators; Bladeless, Dilating Tip (Bladed) and Blunt Tip. The bladeless obturator contains a clear, tapered optical element, and when used with an endoscope provides visibility of individual tissue layers during insertion. The Dilating Tip (Bladed) obturator has a sharp, flat-bladed tip and spring-loaded shield. The shield is designed to cover the flat-bladed tip to protect internal structures from puncture or laceration once the abdominal or thoracic cavity has been entered. The Blunt Tip obturator has a blunt plastic tip which gently moves aside any viscera that may be adjacent to abdominal or thoracic wall.

The trocar sleeve contains two seals that accommodate instruments. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. Please note that the 5mm bladeless trocar cannula without Optiview Technology does not have the outer integrated self-adjusting seal and only accommodates 5mm instruments. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.

Trocars with Optiview Technology incorporates a design enhancement that reduces the incidence of trocar induced endoscope lens smudging during endoscope insertion.

The Reprocessed Sleeves are sterile, single patient use devices with a radiolucent sleeve (cannula). The trocar sleeve contains two seals that accommodate instruments. Together, these two seals minimize qas leakage when instruments are inserted or withdrawn through the trocar. Please note that the 5mm trocar cannula without Optiview Technology does not have the outer integrated self-adjusting seal and only accommodates 5mm instruments. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.

The provided text is a 510(k) summary for the reprocessing of endoscopic trocars and sleeves. It outlines the device description, indications for use, and a comparison to predicate devices, focusing on the equivalence of the reprocessed devices to the original, new devices. However, the document does NOT contain information about a study proving the device meets acceptance criteria in the way one might expect for a digital health or AI/ML-enabled medical device, as it's not evaluating algorithm performance.

Instead, this document describes the validation of reprocessing for a physical medical device. The "acceptance criteria" here refer to the performance standards that the reprocessed physical device must meet to demonstrate it is "at least as safe and effective" as the original, new device.

Therefore, I will interpret the request in the context of the provided document, addressing the closest equivalents to the requested information. It's important to note that many of the requested fields (e.g., number of experts for ground truth, MRMC study, training set sample size) are not applicable to the type of device and study described in this 510(k) summary.

Acceptance Criteria and Study for Reprocessed Endoscopic Trocars and Sleeves

The document describes the regulatory submission for the reprocessing of Endoscopic Trocars and Sleeves, asserting their substantial equivalence to predicate (new) devices. The acceptance criteria and the "study" proving this equivalence are based on a set of bench and laboratory tests designed to demonstrate that the reprocessed devices maintain their original performance, safety, and effectiveness.

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

The document does not provide a quantitative table of acceptance criteria and reported numerical performance values for each test. Instead, it lists the types of performance tests conducted and then makes a general statement about their outcome. The implicit acceptance criterion for each test is that the reprocessed device performs comparably to the new device and maintains its safety and effectiveness.

• Peak Insertion Force
• Stability Plug Clip Integrity
• Stability Plug Clamp Integrity
• Trocar Leak Test
• Obturator Engagement
• Cannula Housing Integrity
• Obturator Housing Integrity
• Cannula Sleeve Integrity
• Insertion/Withdrawal Forces - Obturator to Cannula
• Device Integrity
• Peak Insertion Force
• Obturator Engagement
• Shield Lock Engagement Force
• Blade Shield Engagement | Bench and laboratory testing were conducted to demonstrate performance. The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate and operate as originally intended. |
  | Aging/Durability | (Implicit criterion: device functions after reprocessing and maintains properties for intended shelf life). | Reprocessed no more than one (1) time; implies that performance is maintained for this single reprocessing cycle. |
  | Packaging Validation | Packaging Validation. (Implicit criterion: packaging maintains sterility and device integrity). | Conducted. |

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

The document does not specify the exact sample sizes for each of the conducted tests (e.g., number of reprocessed trocars tested for leak, insertion force, etc.).
The data provenance is from bench and laboratory testing conducted by Stryker Sustainability Solutions. It is prospective in the sense that the tests were specifically performed to support this 510(k) submission, not retrospectively analyzed from existing data. The country of origin for the testing is not explicitly stated but can be inferred as the United States, given the FDA submission.

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

This question is not applicable in the context of this device and study. The "ground truth" for a reprocessed physical device is established by engineering specifications, material properties, and functional performance benchmarks derived from the original, new predicate devices. It does not involve expert readers reviewing images or clinical data for diagnosis. The "experts" involved are likely engineers, quality assurance personnel, and regulatory affairs specialists who designed and executed the tests and evaluated the results against objective performance standards.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiologists reviewing medical images) to establish a consensus ground truth. For physical device performance testing, acceptance is determined by meeting pre-defined quantitative or qualitative engineering specifications, not human consensus on a clinical outcome.

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 question is not applicable. This is a submission for a reprocessed physical medical device, not an AI/AI-assisted device. Therefore, no MRMC study looking at human reader improvement with AI assistance was performed.

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

This question is not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance is based on engineering specifications and functional performance characteristics of the original, new predicate devices. The reprocessed devices are tested to ensure they maintain these validated characteristics. This includes:

• Physical dimensions and integrity
• Mechanical function (e.g., insertion force, leak tests, engagement of components)
• Material properties (implied by biocompatibility and sterilization validation)
• Sterility

Essentially, the ground truth is the "performance profile of a new, unused device."

8. The sample size for the training set

This question is not applicable. This is a physical medical device undergoing reprocessing validation, not an AI/ML algorithm that requires a training set.

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

This question is not applicable for the same reason as point 8.

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The reprocessed endoscopic trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures such as observation, dissecting, cutting, repairing, and removal or manipulation of internal tissues and/or organs.

The reprocessed endoscopic trocar is a sterile instrument consisting of a sleeve and obturator that is available in varying lengths and diameters. The obturator may be bladeless or dilating tip. Reprocessed trocars are devices that provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic, or other minimally invasive surgical procedures.

This document describes the 510(k) premarket notification for Reprocessed Endoscopic Trocars by Sterilmed, Inc. The submission aims to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information, focusing on acceptance criteria, study details, and ground truth establishment:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding reported device performance metrics in the format typically seen for algorithm performance (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria are implicitly defined by demonstrating that the reprocessed devices perform "as originally intended" and are "substantially equivalent" to the predicate device in terms of functional and safety characteristics.

The reported device performance is described qualitatively and through validation studies.

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

The document states "Representative samples of reprocessed endoscopic trocars were tested to demonstrate appropriate functional characteristics." However, it does not provide a specific numerical sample size for the test set used for functional and safety testing. Similarly, the data provenance (country of origin, retrospective/prospective) is not explicitly stated, but the submission is from Sterilmed, Inc. in Maple Grove, MN, implying testing likely occurred in the US. The nature of the validation (cleaning, sterilization, functional bench testing) suggests these were performed in a controlled laboratory or manufacturing environment, rather than being clinical trial data.

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

This type of information is not applicable to this submission. The validation of reprocessed medical devices focuses on engineering and scientific testing (e.g., microbiology for sterilization, chemical analysis for residuals, mechanical testing for function), not on expert clinical interpretation of results against a "ground truth" established by human experts in the way AI/ML medical devices are assessed.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation relies on objective laboratory and bench testing rather than clinical interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically for diagnostic imaging. This submission concerns the reprocessing and functional validation of physical medical devices.

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

This is not applicable. This is a submission for a reprocessed physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is established through objective scientific and engineering standards and methods. This includes:

• Established standards: ISO 11135, USP for sterilization, ISO 10993 for biocompatibility, ISO 10993-7 for ethylene oxide residuals, ASTM D 4169, ASTM F 88, ASTM F 2096 for packaging, ASTM 1980-07 for shelf life.
• Bench testing: Functional performance is assessed against the original performance specifications of the predicate device.
• Visual inspection: Conformance to physical and material specifications.
• Simulated use and fatigue testing: Evaluation of performance under conditions mimicking clinical use.

The ground truth is that the reprocessed device must meet the same performance, safety, and material characteristics as the new predicate device, and these are verified through the outlined non-clinical tests.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of validating a reprocessed physical medical device as there is no AI/ML model being developed. The processes (cleaning, sterilization) are validated, not trained.

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

This is not applicable for the reasons stated in point 8.

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The reprocessed endoscopic trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures.

The reprocessed endoscopic trocar is a sterile instrument consisting of a sleeve and obturator that is available in varying lengths and diameters. The obturator may be blunt, bladed, or shielded-bladed (blade covered by a retractable shield). Reprocessed endoscopic trocars are devices that provide a pathway for entry of minimally invasive instruments to a body organ or cavity during abdominal, thoracic or gynecologic surgical procedures.

The provided text is a 510(k) summary for SterilMed, Inc.'s reprocessed endoscopic trocars. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove device performance in the context of an AI/ML device.

Therefore, the information required for the requested output (acceptance criteria table, sample sizes, ground truth establishment, MRMC studies, etc.) is not present in the provided document. The document describes a traditional medical device reprocessing and its approval process, not an AI/ML device study.

Here's a breakdown of what is available vs. what is not:

What is present:

• Device Description: Reprocessed endoscopic trocar, consisting of a sleeve and obturator.
• Intended Use: To provide a pathway for entry of minimally invasive instruments to a body organ or cavity during various surgical procedures.
• Functional and Safety Testing mentioned: Cleaning validation, sterilization validation (ISO 11135, USP ), biocompatibility testing (ISO 10993), ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTM D4169, ASTM F88, ASTM F2096), shelf life validation (ASTM 1980-07), and functional performance validated using bench and laboratory testing.
• Conclusion: Substantial equivalence to predicate devices based on similarities in functional design, materials, indications for use, and methods of construction.

What is NOT present (and is required for your requested output, indicating this is not an AI/ML study report):

• Specific Acceptance Criteria (quantitative metrics like sensitivity, specificity, AUC, etc. for an AI model). The document mentions "appropriate functional characteristics" but doesn't quantify them.
• Reported Device Performance against specific quantitative criteria.
• Sample Size for a test set (in terms of cases/images for an AI model). The document mentions "representative samples" for functional testing but not a quantified test set for AI evaluation.
• Data Provenance (country of origin, retrospective/prospective for AI data).
• Number of experts and their qualifications for establishing ground truth. This typically applies to AI model evaluation where human experts label data.
• Adjudication method (2+1, 3+1, none) for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study, including effect size. This is specific to human-AI collaboration studies.
• Standalone (algorithm-only) performance data.
• Type of ground truth used (expert consensus, pathology, outcomes data). While "functional performance was validated" and "cleaning validation," etc., are mentioned, these are for a reprocessing procedure, not for establishing ground truth for an AI model's output.
• Sample size for the training set (for an AI model).
• How the ground truth for the training set was established (for an AI model).

In summary, the provided text describes the regulatory approval of a reprocessed physical medical device (endoscopic trocar) through a 510(k) submission, not the evaluation of an AI/ML medical device. Therefore, it does not contain the information requested in your bullet points, which are tailored for AI/ML device studies.

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Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.

Reprocessed Endoscopic Trocars and Cannulas are designed to establish a port of entry for endoscopic instruments used during minimally invasive surgery. Endoscopic trocars and cannulas are available in a variety of configurations and materials as well as trocar and cannula sets. Trocar seals vary between single-port and multi-port seals.

Acceptance Criteria and Study for Reprocessed Endoscopic Trocars and Cannulas

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the submission as a "Traditional 510(k)" and focuses on demonstrating substantial equivalence to predicate devices rather than setting and meeting specific quantitative acceptance criteria for novel performance. Therefore, the "acceptance criteria" here are qualitative, based on the device performing "as originally intended" and being "safe and effective."

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

The document does not specify a numerical sample size for "test sets" in the traditional sense of a clinical trial. Instead, it refers to "bench and laboratory testing." The provenance of the data is from laboratory testing conducted by Ascent Healthcare Solutions. It is retrospective in the sense that the goal is to demonstrate that reprocessed devices match the performance of already-marketed devices. No information on country of origin of the data is provided beyond the applicant being a US-based company.

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

This information is not provided in the document. The nature of the testing (biocompatibility, reprocessing validation, sterilization validation, function tests, packaging validation) suggests internal engineering and scientific expertise rather than clinical expert consensus on a test set of cases.

4. Adjudication Method for the Test Set:

This information is not provided and is not applicable to the type of bench and laboratory testing described. Adjudication methods like 2+1 or 3+1 are typically used for clinical image interpretation or diagnostic decisions, which is not what was performed for this 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:

An MRMC comparative effectiveness study was not performed, nor is it applicable. This device is a reprocessed medical instrument (trocar and cannula), not an AI-powered diagnostic or assistive tool.

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

Standalone algorithm performance studies were not performed, nor are they applicable. This device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is implicitly the performance of the original, new predicate devices. The testing aims to demonstrate that the reprocessed devices achieve the same level of performance and safety characteristics as the original devices. This is established through:

• Biocompatibility testing: To ensure the materials remain safe after reprocessing.
• Validation of reprocessing: To confirm the reprocessing methods effectively clean and prepare the device.
• Sterilization Validation: To confirm the device is sterile after reprocessing.
• Function test(s): To ensure mechanical and operational integrity matches the original device.
• Packaging Validation: To ensure the device remains sterile and functional until use.

8. The Sample Size for the Training Set:

This information is not provided and is not applicable. This submission concerns a reprocessed medical device, not a machine learning model that requires a training set. The "training" for this device would refer to the validation of the reprocessing protocol itself, which would involve a sufficient number of devices to demonstrate consistency in the reprocessing method's effectiveness.

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

This information is not provided and not applicable as there is no "training set" in the machine learning sense. The "ground truth" for validating the reprocessing process would be established through industry standards, regulatory guidelines (e.g., for sterilization and cleaning), and laboratory measurements indicating the absence of contaminants, proper material integrity, and functionality that matches the new device.

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Reprocessed Endoscopic Trocars and Cannulas are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.

Reprocessed Endoscopic Trocars and Cannulas. The submission includes a list of specific Endoscopic Trocars and Cannulas from manufacturers US Surgical, Auto Suture, and Ethicon that will be reprocessed.

The provided document is a 510(k) clearance letter for reprocessed endoscopic trocars and cannulas. It does not contain information about acceptance criteria for an AI/device performance study, nor does it describe a study that proves a device meets such criteria.

The letter from the FDA (dated March 3, 2006) refers to a "supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002." This "validation data" would relate to the reprocessing of medical devices to ensure they are safe and effective for reuse, not to the performance of an AI or diagnostic device.

Therefore, I cannot provide the requested information as it is not present in the given text.

To be clear:

• 1. A table of acceptance criteria and the reported device performance: Not available. The document is about reprocessing medical devices, not an AI device or a performance study.
• 2. Sample sized used for the test set and the data provenance: Not available.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
• 4. Adjudication method: Not available.
• 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 available.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available.
• 7. The type of ground truth used: Not available.
• 8. The sample size for the training set: Not available.
• 9. How the ground truth for the training set was established: Not available.

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