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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 Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar.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 Together, these two seals minimize qas leakage when instruments are inserted or withdrawn through the trocar.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 Medline ReNewal Reprocessed Carter-Thomason Needle-Point Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery.

The Medline ReNewal Reprocessed Carter-Thomason Suture Passer Set (models CTI-512N, CTI-1015N, PG-15S, and PG-5/10) is a sterile, single-case use, hand-held suture grasping device that is designed to pass suture through soft tissue.

The provided text describes a 510(k) submission for a reprocessed medical device, the "Medline ReNewal Reprocessed Carter-Thomason Needle-Point Suture Passer Instrument Set." This submission aims to prove substantial equivalence to an existing predicate device, not necessarily to meet specific performance criteria as one might find for novel AI/software as a medical device (SaMD) products.

Therefore, the structure of the acceptance criteria and the study that proves the device meets them will differ significantly from what would be expected for an AI-based diagnostic tool. The "acceptance criteria" here are based on demonstrating that the reprocessed device performs functionally identically and safely to the original, legally marketed device.

Here's an analysis based on the provided text, using the requested categories where applicable:

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

The document doesn't provide a quantitative table of acceptance criteria with specific numerical thresholds for performance metrics. Instead, it describes a series of tests conducted to demonstrate equivalence. The "acceptance criteria" are implicitly that the reprocessed device performs equivalently to the original device in key functional and safety attributes.

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

• Sample Size: The document does not specify the number of individual reprocessed devices tested for each category (e.g., how many devices were subjected to simulated use, or cleaning tests). It simply lists the types of tests performed.
• Data Provenance: Not explicitly stated regarding the origin of the reprocessed devices used for testing (e.g., country of origin of the used devices before reprocessing). The tests are described as being performed by the reprocessor, Medline ReNewal. The nature of the study is retrospective in the sense that existing used devices are collected for reprocessing and subsequent testing, although the testing itself is prospective on those reprocessed units.

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

This is not applicable in the context of this device type and submission. Ground truth, in the sense of expert consensus on medical images or patient outcomes, is primarily relevant for diagnostic devices (especially AI/SaMD). For a reprocessed surgical instrument, the "ground truth" is its functional performance and safety profile, which is established through objective, standardized engineering and biological testing, not expert interpretation of clinical data.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human readers or algorithms interpret data and discrepancies need to be resolved. For evaluating the physical and biological properties of a reprocessed surgical instrument, such methods are irrelevant. Test results are based on objective measurements against predefined specifications.

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. An MRMC study is relevant for diagnostic devices that involve human interpretation of medical data (e.g., radiologists reading X-rays). This device is a surgical instrument used to pass suture, not a diagnostic tool, and involves no "human readers" in the context of interpretation or AI assistance.

6. 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.

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

The "ground truth" for this reprocessed device is established through:

• Engineering Performance Specifications: The device must meet the original manufacturer's specifications for mechanical function, integrity, and dimensions.
• Cleaning Efficacy Standards: Demonstrated by the absence of significant biological residues.
• Sterility Assurance Levels: Proven through sterilization validation.
• Biocompatibility Standards: Proven through direct testing on the reprocessed materials.

These are objective, measurable criteria, not subjective interpretations requiring expert consensus or pathology, nor are they based on patient outcomes data for the pre-market submission (though post-market surveillance would track adverse events).

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI model. Therefore, there is no "training set."

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

Not applicable. As there is no training set for an AI model, this question is irrelevant to the reprocessing of a surgical instrument.

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The Reprocessed Ethicon Bladeless Trocars are intended for use in thoracic, gynecologic, laparoscopic and other abdominal or minimally invasive surgical procedures to establish a path of entry for endoscopic or minimally invasive instruments. The reprocessed optical trocar may be used with or without visualization for primary and secondary insertions.

The Reprocessed Ethicon Universal Trocar Sleeves are intended for use in thoracic, gynecologic, laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.

A trocar is a sterile device used in a variety of endoscopic procedures to establish and maintain a port of entry for surgical tools. Trocars consists of three primary components; the cannula which allows access into the abdominal cavity during the procedure; the seal, located at the top of the cannula allows instruments to pass through the cannula while preventing loss of pneumoperitoneum when instruments are inserted and withdrawn from the port, and; the obturator which is a mechanism that allows the cannula to penetrate the abdomen. The trocars contained in this submission are bladeless. There are also various configurations of diameter and length, but all models have the same basic design, materials, and technological characteristics.

The provided document is a 510(k) summary for a reprocessed medical device, specifically Reprocessed Ethicon Bladeless Trocars and Universal Trocar Sleeves. It does not describe an AI/ML-based device or a diagnostic algorithm, but rather a physical medical device that is reprocessed for reuse.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, ground truth, expert adjudication, MRMC studies, and training/test set data, which are typical for AI/ML-based diagnostic devices, is not applicable to this document.

The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (the new Ethicon trocar) through:

1. Comparison of Technological Characteristics: Indications for Use, Materials, Design, Energy Source.
2. Performance Testing: Benchtop functional tests (Seal Drag, Seal Leakage, Insertion, Fixation, Removal Force Test), Product Stability (Shelf Life Testing), Cleaning Validation (Residual Protein and Hemoglobin, Visual Inspection, Cleaning Performance Qualification), Sterilization and Packaging (EtO Sterilization Testing, Simulated Shipment Testing), and Biocompatibility Testing.

The "acceptance criteria" for this device are that its performance, once reprocessed, is equivalent to that of a new, original equipment manufacturer (OEM) device. The study proving this involves side-by-side benchtop testing and cleaning validation.

To directly answer your prompt's questions based on the provided document, where applicable:

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

The document describes the types of tests performed and the overarching goal of demonstrating "substantial equivalence" to the OEM device. It doesn't provide specific numerical acceptance criteria (e.g., "Seal Drag

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The Reprocessed Covidien Trocars are indicated for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry.

A trocar is a sterile device used in a variety of endoscopic procedures to establish and maintain a port of entry for surgical tools. Trocars consists of three primary components; the cannula which allows access into the abdominal cavity during the procedure; the seal, located at the top of the cannula allows instruments to pass through the cannula while preventing loss of pneumoperitoneum when instruments are inserted and withdrawn from the obturator, which is a mechanism that allows the cannula to penetrate the abdomen. There are also various configurations of diameter and length, but all models have the same basic design, materials, and technological characteristics.

This document describes the premarket notification for a Reprocessed Covidien Trocar (K172093). The study contained within this document evaluates the performance of the reprocessed device compared to the original equipment manufacturer (OEM) device.

Here's an analysis of the provided information according to your criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical targets for each parameter. Instead, the performance testing aims to demonstrate equivalence to the new OEM device. Therefore, the "acceptance criteria" here implicitly means "performance equivalent to the new OEM device."

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

• Sample Size: The document does not specify the exact sample size for the "test set" (i.e., how many reprocessed trocars were tested against how many new OEM trocars for each performance test). It only states that "side-by-side testing of the reprocessed devices to an identical new OEM device" was performed.
• Data Provenance: The data is based on benchtop performance testing conducted by ReNovo, Inc. It is prospective testing designed to demonstrate the performance of their reprocessed devices. The country of origin of the data is not explicitly stated but is implied to be where ReNovo, Inc. conducted its testing (USA).

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

Not applicable. This study does not involve human readers or interpretation of medical images/data where expert ground truth establishment would be required. The evaluation is based on objective physical and chemical testing.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as this is not a study involving subjective interpretation or consensus. The performance tests are objective laboratory measurements.

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. This is a study on the reprocessing of a physical medical device (trocar), not an AI imaging or diagnostic algorithm. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.

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

Not applicable. This is not an algorithm or AI device. The "standalone" performance refers to the reprocessed device itself, which was evaluated through benchtop testing.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this study is essentially the performance and characteristics of a new, legally marketed OEM Covidien Trocar. The reprocessed device's performance is compared against this established benchmark.

8. The Sample Size for the Training Set

Not applicable. This is not an AI or machine learning study, so there is no concept of a "training set" in this context. The study focuses on evaluating the reprocessing process and the final reprocessed product.

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

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

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The Medline ReNewal Reprocessed ENDOPATH XCEL Bladeless Trocar with OPTWIEW Technology has applications in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions. The Medline ReNewal Reprocessed ENDOPATH XCEL Universal Trocar Stability Sleeve with OPTIVIEW Technology has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.

The Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology devices are sterile, single-patient use endoscopic devices used to create an access port to the inside of the body cavity to perform endoscopic surgery. The trocars accommodate instruments that are 5-mm in diameter. The trocars contain two seals, an outer integrated removable self-adjusting seal and an integrated seal. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation. The trocars contain OPTIVIEW Technology that reduces the incidence of trocar-induced endoscope lens smudging during endoscope insertion. Endoscope smudging occurs when bodily fluids and debris smear across the endoscope lens during a laparoscopic procedure. Trocar-induced smudging occurs when these bodily fluids and debris are deposited within the trocar's seal system when an endoscope or instrument has been exchanged through the trocar.

This document describes a substantial equivalence determination for a reprocessed medical device, the Medline Renewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology. It does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria as typically found in an AI/ML medical device submission.

Instead, this submission focuses on demonstrating that the reprocessed device is "substantially equivalent" to an already legally marketed predicate device (Ethicon ENDOPATH XCEL Trocar with OPTIVIEW Technology). The performance testing outlined is to show that the reprocessed device maintains the same functional characteristics as the predicate device after reprocessing.

Therefore, many of the requested categories for AI/ML device studies (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, effect size) are not applicable to this type of traditional medical device submission.

Here's an attempt to extract relevant information given the context of a reprocessed traditional medical device:

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

The document does not explicitly present a table of acceptance criteria with specific numerical targets and results in the format typically seen for AI/ML performance. Instead, it lists various functional performance studies and concludes that the reprocessed device was "found to be substantially equivalent" to the predicate. The "acceptance criteria" for a reprocessed device are generally that its performance characteristics (functional, cleaning, biocompatibility, sterilization) meet or exceed those of the original device or established standards, ensuring safety and effectiveness are maintained post-reprocessing.

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

• Sample Size: Not explicitly stated in the provided text for each test. The document mentions "the proposed device" and "the predicate device" which implies comparative testing was conducted using a sufficient number of units to establish statistical equivalence for each functional and material characteristic.
• Data Provenance: The studies were conducted by Medline ReNewal as part of their 510(k) submission for a reprocessed device. This is prospective testing performed to support the regulatory submission. The country of origin of the data is implied to be the US, where Medline ReNewal is based and operates.

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

This is not applicable. For this type of traditional medical device, "ground truth" is established through engineering and scientific testing against defined specifications, industry standards, and comparison with the predicate device's known performance, rather than expert consensus on medical images or clinical outcomes.

4. Adjudication method for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or reader studies where human interpretation of data is being evaluated. For device performance testing, results are typically objective measurements (e.g., leakage rate, residual chemical levels) compared against defined criteria.

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 is not applicable. This submission concerns a traditional reprocessed surgical instrument, not an AI/ML device. Therefore, no MRMC study, AI assistance evaluation, or effect size related to human reader improvement is relevant.

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

This is not applicable. This submission is for a physical surgical device, not an algorithm.

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

For the functional and material tests:

• Engineering Specifications: Performance against predefined engineering and material specifications.
• Industry Standards: Compliance with relevant ISO, ASTM, or other industry standards (e.g., for biocompatibility, sterility).
• Predicate Device Performance: Direct comparison of measurements and characteristics to the performance of a new (un-reprocessed) predicate device. For example, a leakage test result on the reprocessed device would be compared to the leakage test result on the original device.

8. The sample size for the training set

This is not applicable. This is a traditional medical device, not an AI/ML device. There is no concept of a "training set" in this context.

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

This is not applicable as there is no training set for a traditional medical device.

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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 reprocessed closure systems are intended to pass sutures through soft tissue during endoscopic/laparoscopic surgery.

The closure system is a set of three components; consisting of one suture passer, one 5mm guide and one 10/12mm guide. The suture passer has a stainless steel shaft with a pointed tip that opens on one side to grasp the suture and a polycarbonate handle with a ring that actuates the tip. The 5mm and 10/12mm guides are made of polycarbonate with a cylindrical head on the proximal end connected to a shaft that tapers to a tip on the distal end. Each guide has two holes in the cylindrical head that pass through to opposite sides of the shaft. The holes allow the suture passer to be passed through the guide.

This document is a 510(k) Premarket Notification submission for a reprocessed medical device, not an AI/ML device. Therefore, the questions regarding acceptance criteria and study specifically for an AI/ML device, such as sample size for test and training sets, expert ground truth establishment, adjudication methods, MRMC studies, and standalone algorithm performance, are not applicable.

However, I can provide information based on the device's functional and safety testing as described in the document.

Acceptance Criteria and Device Performance for Reprocessed Closure Systems

This document describes the premarket notification for Reprocessed Closure Systems by Sterilmed, Inc. The core claim is substantial equivalence to the predicate device, the Cooper Surgical Carter-Thomason CloseSure System® (K980123). The "acceptance criteria" here refer to meeting performance standards comparable to the original device and demonstrating that the reprocessing does not compromise safety or effectiveness.

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

• Visual Inspection: Visual inspection of the reprocessed devices.
• Fatigue Testing: To assess durability and integrity over repeated use (if applicable to the device's design life).
• Function Testing: Direct testing of the device's ability to perform its intended function. | "Performance testing shows the reprocessed closure systems to perform as originally intended." This implies that the reprocessed devices met the functional specifications of the original device under simulated conditions, passed visual checks, and demonstrated sufficient durability for their intended use. The document explicitly states: "The reprocessed closure systems are identical to the predicate devices in design, materials of construction, and intended use. There are no changes to the clinical applications, patient population, performance specifications, or method of operation." This suggests the performance standards for the reprocessed device are the same as the predicate. |
  | Cleaning Validation | Validation of the cleaning procedures to ensure removal of contaminants. | Performed. The implication is successful validation, meeting established standards for cleanliness. |
  | Sterilization Validation | ISO 11135: Validation of ethylene oxide sterilization.
  USP : Sterility tests. | Performed. The implication is that the sterilization process renders the devices sterile, meeting the requirements of ISO 11135 and USP . |
  | Biocompatibility Testing | ISO 10993 Part 18: Chemical characterization of materials to assess potential biological risks. | Performed. This implies that the materials, after reprocessing, remain biocompatible and do not pose unacceptable risks of toxicity or irritation to human tissue. |
  | Ethylene Oxide Residuals | ISO 10993-7: Testing for residual ethylene oxide after sterilization. | Performed. This implies that ethylene oxide levels are within safe limits after the sterilization process. |
  | Packaging Validation | ASTM D 4169: Performance testing of shipping containers and systems.
  ASTM F 88: Seal strength of flexible barrier materials.
  ASTM F 2096: Detecting gross leaks in medical packaging by internal pressurization (bubble test). | Performed. This indicates the packaging maintains the sterility of the device until point of use and withstands typical handling and shipping stresses. |
  | Shelf Life Validation | ASTM 1980: Accelerated aging to determine shelf life. | Performed. This confirms that the device and its packaging maintain integrity and functionality over its claimed shelf life. |
  | Manufacturing Process | Visual and validated functional testing of all products produced. | "The manufacturing process includes visual and validated functional testing of all products produced." This implies ongoing quality assurance ensuring individual reprocessed devices meet specifications. |

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

The document does not specify a numerical sample size for the functional and safety testing. It refers to "Representative samples" of reprocessed closure systems being tested. The testing appears to be prospective, carried out as part of the premarket notification process for the reprocessed device. Data provenance is not explicitly mentioned but is assumed to be from Sterilmed, Inc.'s internal testing facilities in the US (Maple Grove, MN).

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 section is not applicable as this is a submission for a mechanical medical device (reprocessed surgical instruments), not an AI/ML or diagnostic device that requires expert ground truth establishment in the traditional sense. The "ground truth" here is the established performance and safety profile of the original, new device.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing consensus among human readers for diagnostic image interpretation or similar tasks, which is not relevant for the functional and safety testing of a reprocessed mechanical 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 is not applicable. MRMC studies are used for evaluating diagnostic performance of imaging devices or algorithms with human readers. This submission is for a reprocessed surgical instrument.

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

This is not applicable. This is not an AI/ML algorithm.

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

The "ground truth" for this reprocessed device is primarily derived from the design specifications, performance standards, and safety profile of the original, new predicate device (Cooper Surgical Carter-Thomason CloseSure System®). The testing conducted (functional, cleaning, sterilization, biocompatibility, etc.) aimed to demonstrate that the reprocessed device meets these established standards, effectively performing "as originally intended."

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a reprocessed mechanical device. The "training" for the reprocessing process itself would involve process validation using a certain number of devices, but this is not analogous to an AI/ML training set.

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

This is not applicable for the reasons stated above. The "ground truth" for process validation would be the successful demonstration of the ability of the reprocessing methods to consistently return the device to its "as new" functional and safety state.

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The Reprocessed Bladeless Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.

The Reprocessed Dilating Tip Trocar has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.

The Reprocessed Stability Sleeve has application in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.

Reprocessed Bladeless Trocar: The Reprocessed Bladeless Trocar, is a sterile single patient use instrument consisting of a radiolucent sleeve (cannula) and obturator. The obturator contains a clear, tapered optical element. The 5 mm obturator accommodates an appropriately sized 0° endoscope and provides visibility of individual tissue layers during insertion. The trocar sleeve contains two seals that accommodate instruments 5 mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. 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.

Reprocessed Dilating Tip (Bladed) Trocar: The Reprocessed Dilating Tip Trocar is a sterile, single patient use instrument consisting of a radiolucent sleeve (cannula) and obturator. The obturator has a sharp, flat-bladed tip and spring-loaded 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 trocar sleeve contains two seals that accommodate instruments 5 mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. 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.

Reprocessed Stability (Universal) Sleeve (Cannula): The Reprocessed Stability Sleeve is a sterile, single patient use device with a radiolucent sleeve. The trocar sleeve contains two seals that accommodate instruments 5 mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. 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 document provided describes the reprocessing of surgical trocars and sleeves, and the performance data focuses on demonstrating that the reprocessed devices are as safe and effective as new (predicate) devices. This is not the type of medical device for which the requested acceptance criteria and study information (AI/radiology performance metrics, expert adjudication, etc.) would typically apply.

The device is a reprocessed medical instrument, not an AI or diagnostic imaging device. Therefore, the performance evaluation centers on its physical integrity, sterility, and functionality after reprocessing, rather than diagnostic accuracy or human-AI interaction.

Here's an analysis based on the provided text, highlighting why most of your requested points are not applicable in this context:

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

The document does not provide a table with specific quantitative acceptance criteria for each test and reported pass/fail results. Instead, it lists the types of tests performed.

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

The document does not specify the sample sizes for the performance tests (biocompatibility, reprocessing validation, sterilization, function, packaging). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of these tests (bench and laboratory), these details are less critical than for clinical trials.

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 question is not applicable. The "ground truth" for a reprocessed medical instrument involves objective measurements of sterility, material integrity, and mechanical function, not diagnostic interpretations by human experts.

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 clinical trials, particularly in image interpretation, to resolve discrepancies between readers. This device undergoes bench and laboratory testing.

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. An MRMC study is relevant for diagnostic devices (e.g., AI in radiology). This submission is for reprocessed surgical instruments. Human "improvement" or AI assistance is not a relevant metric here.

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

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

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

As mentioned in point 3, the "ground truth" for this device relates to objective physical and biological properties. It includes:

• Sterility: Absence of viable microorganisms (validated through sterilization methods).
• Biocompatibility: Absence of adverse biological reactions (tested with accepted standards).
• Functional Performance: Mechanical integrity and operation of components (e.g., seals, bladed tip, stopcock valve, resistance to leakage, insertion force).
• Cleaning Efficacy: Absence of residual soil after reprocessing.
• Packaging Integrity: Maintenance of sterility barrier.

These are established through standardized laboratory methods and specifications, not expert consensus or pathology in the diagnostic sense.

8. The sample size for the training set

This question is not applicable. This device is a physical instrument, not an AI algorithm, so there is no "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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