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The Faller Trocar is used to create an ante-grade subcutaneous tunnel for a peritoneal dialysis catheter from the initial implantation site to the preferred exit-site. It separates the tissue as it leads the catheter through to the skin exit-site.

The Faller Trocar is a surgical tool, made of either stainless steel or approved plastic, with a barbed section on one end and a sharp tip on the other end. The device is curved so that the physician using it can follow a tunnel path to lead the catheter from the initial catheter implantation site to the exit-site in an ante-grade manner.

This document describes a 510(k) premarket notification for the Faller Trocar Catheter Tunneling Device. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed performance metrics. Therefore, many of the requested data points (like sample sizes, ground truth establishment, MRMC studies, or standalone algorithm performance) are not applicable or not provided in the document for this type of medical device submission.

Here's an analysis of the provided information in relation to your request:

1. Table of acceptance criteria and the reported device performance:

Specific numerical acceptance criteria and reported performance metrics (e.g., sensitivity, specificity, AUC) are not provided in this 510(k) summary. The submission focuses on demonstrating substantial equivalence through material, design, and functional comparisons, along with a historical safety record of predicate devices.

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

• Test set sample size: Not applicable. The submission does not describe a clinical study with a "test set" in the context of an AI/ML device. Instead, "in-house testing" and "historical data of the predicate devices" are mentioned.
• Data provenance: "In-house" testing for barbed ends and cutting tip. "Journal articles and historical data of the predicate devices" for overall safety and effectiveness. The country of origin for the historical data is not specified, but the predicate devices have been on the market for 20+ years. This would be considered retrospective data.

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

• Not applicable. There is no mention of experts establishing ground truth for a test set in the context of an AI/ML device. The evaluation relies on comparisons to predicate devices and historical performance.

4. Adjudication method for the test set:

• Not applicable. No test set or adjudication method is described.

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 not an AI/ML device, and no MRMC study was conducted or described.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• The "ground truth" for this device's performance relies on:
  • Functional comparison: Direct comparison of the new device's components (barbed ends, cutting tip) with those of the predicate devices through "in-house testing."
  • Historical outcomes data: The safety and effectiveness of the predicate devices are based on their long history of use (more than twenty years) and cited "Journal articles and historical data." The new device is deemed safe and effective due to its "substantial equivalence" to these predicates.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, and no training set is described.

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

• Not applicable. This is not an AI/ML device.

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If a patient is a suitable adult candidate for peritoneal dialysis (PD) therapy, the Flex-Neck® ExxTended ™ peritoneal dialysis catheter can be implanted either surgically, laparoscopically, or peritoneoscopically for acute or chronic peritoneal dialysis. Stencils sold with the device, and marketed separately, will be used to assist the physician to locate the optimum primary implantation site and the optimum catheter exit site for the Flex-Neck® ExxTended™ Catheter.

This device consists of a two-part peritoneal dialysis catheter and accessories. The catheter is made of long-term, implantable grade silicone tubing with a radiopaque strip, and two cuffs made of polvester felt. The coiled lower catheter section (with one rectus cuff) connects to an arcuate upper catheter section (with one exit cuff) via a tube-to-tube titanium connector (included), secured with a nonabsorbable nylon suture (not included). Also included in the catheter package is a set of stencils (right and left) to assist the physician to locate the optimum primary implantation site and the optimum catheter exit site below the sternum. (Note: In addition to being packaged with each catheter, this stencil set will be sold sterile, packaged by itself, so the physician or other qualified personnel can use it in a clinical setting prior to the implantation.) Also included in the packaging will be a surgical grade marking pen, a tape measure, a plastic catheter connector and cap, a packet of water-soluble lubricating gel, and an ExxTended™ tunneling tool.

The provided text is a 510(k) summary for a medical device (Flex-Neck® ExxTended™ PD Catheter & Accessories). It focuses on device description, intended use, and substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a dedicated study proving the device meets those criteria.

510(k) submissions primarily demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and proving performance through a standalone study with specific metrics. The "study" in this context refers to the comparison of the new device with existing, legally marketed devices.

Therefore, many of the requested sections (acceptance criteria, reported performance, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance) cannot be filled with the provided information.

However, based on the information available, here's what can be extracted:

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

This information is not provided in the given text. 510(k) summaries for devices like this typically focus on demonstrating substantial equivalence to predicate devices, often through material comparisons, design similarities, and sometimes limited bench testing or animal studies, rather than a clinical trial with specific performance metrics and acceptance criteria.

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

This information is not provided in the given text. There is no mention of a "test set" in the context of a performance study. The 510(k) process for this type of device usually relies on demonstrating equivalence through design and material comparisons to legally marketed predicate devices.

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

This information is not provided. There is no mention of a "test set" or experts establishing a ground truth.

4. Adjudication method for the test set

This information is not provided. There is no mention of a "test set" or adjudication.

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

There is no indication of an MRMC study or any AI component in this device's description. This device is a physical medical implant (peritoneal dialysis catheter and accessories).

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

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

7. The type of ground truth used

This is not applicable as there is no specific performance study with a "ground truth" described in the provided text. The primary "ground truth" for a 510(k) submission is the pre-market status and clinical use of the predicate devices.

8. The sample size for the training set

This information is not provided. This device is a physical medical device and would not typically have a "training set" in the context of an algorithm.

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

This is not applicable.

Summary of available information related to "study":

The document describes a substantial equivalence comparison study, which is the core of a 510(k) submission.

• Study Goal: To demonstrate that the Flex-Neck® ExxTended™ PD Catheter & Accessories is substantially equivalent to legally marketed predicate devices.
• Predicate Devices:
  • K950042 Swan-Neck™ Presternal PD Catheter
  • K970159 Flex-Neck® PD Catheter
  • K823331 Tunnelor
• Method of comparison: The submission likely compared design, materials, manufacturing processes, and intended use of the new device to the predicate devices. The "Product Description" section details the components and materials (implantable grade silicone tubing, radiopaque strip, polyester felt cuffs, titanium connector, nylon suture). This information, along with the intended use statement, forms the basis of the substantial equivalence argument.
• Conclusion: The FDA determined the device is "substantially equivalent" to the predicate devices, indicating that it is safe and effective for its intended use. This determination serves as the "proof" that the device meets the necessary regulatory standards for market entry, not necessarily against predefined performance acceptance criteria in a clinical trial.

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If a patient is a suitable candidate for peritoneal dialysis (PD) therapy, the Flex-Neck® ARC ™ peritoneal dialysis catheter can be implanted either surgically, laparoscopically, or peritoneoscopically for acute or chronic peritoneal dialysis.

This device consists of a peritoneal dialysis catheter and accessories. The catheter is made of long-term, implantable grade silicone tubing with a radiopaque strip, and one or two cuffs made of polyester felt. The coiled catheter has a permanent bend and is available in three adult variations, three pediatric/adolescent variations, and two infant variations. Included in the catheter package is a set of stencils (right and left) to help determine which configuration of catheter to implant and to assist the physician to locate the optimum primary and secondary incision sites. (Note: In addition to being packaged with each catheter, this stencil set will be sold sterile, packaged by itself, so the physician or other qualified personnel can use it in a clinical setting prior to the implantation.) Also packaged with the catheter will be a surgical grade marking pen, a plastic catheter connector and cap, and a packet of water-soluble lubricating gel.

The provided document is a 510(k) summary for the Medigroup, Inc. Flex-Neck® ARC™ PD Catheter & Accessories. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a new study.

Therefore, many of the requested categories for a new study are not applicable or cannot be extracted directly from this submission. The submission explicitly states: "Because of the longevity and success of the two predicate devices, no further studies have been done for this submission."

However, I can extract the rationale for substantial equivalence which serves as the "study" in this context, demonstrating that the device is believed to meet expected performance criteria based on predicate devices.

Explanation of how this device meets acceptance criteria (implied through substantial equivalence):

The acceptance criteria for the Flex-Neck® ARC™ PD Catheter are implicitly defined by the successful performance and validated design of its predicate devices: the Swan-Neck™ PD Catheter (with a 20-year history) and the Flex-Neck® PD Catheter (with a 10-year history). The new Flex-Neck® ARC™ catheter combines features of both predicate devices which have a long history of safe and effective use.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not applicable. No new test set was used for a prospective study. The "test set" is the cumulative clinical experience from twenty years of the Swan-Neck™ catheter and ten years of the Flex-Neck® "classic" catheter.
• Data Provenance: Retrospective, derived from the long-term clinical history and usage of the predicate devices. The document also references three articles/studies from 1985, 1995, and 1996 (Appendices F.1, F.2, F.3) that "confirm the benefit of a permanently bent peritoneal dialysis catheter," further validating the design. The specific countries of origin for this long-term data are not specified but would be global, given the widespread use of such medical devices.

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

• Number of Experts: Not applicable in the context of a new, controlled study. The "ground truth" is established by the widespread acceptance and successful clinical outcomes experienced by many medical professionals over decades with the predicate devices.
• Qualifications of Experts: Thousands of physicians globally who have implanted and managed patients with the predicate Swan-Neck™ and Flex-Neck® catheters over a 20-year and 10-year period, respectively. These would be experienced nephrologists, surgeons, and other healthcare professionals involved in peritoneal dialysis. The referenced articles also involve expert clinicians and researchers in the field.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No new, isolated test set requiring adjudication was used. The validation comes from broad clinical acceptance and published literature over an extended period.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done

• MRMC Study: No. No such comparative effectiveness study was performed for this submission. The device's perceived benefit is a combination of known advantages from existing devices (faster flow rates from Flex-Neck®, permanent bend from Swan-Neck™).

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

• Standalone Performance Study: Not applicable. This is a medical device (catheter), not an algorithm or AI system.

7. The type of ground truth used

• Type of Ground Truth: Clinical history and validated performance of legally marketed predicate devices, supported by published literature (Appendices F.1, F.2, F.3, F.4). This constitutes real-world outcomes and expert consensus over an extended period.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for this device's design comes from the accumulated knowledge and design iterations based on the predicate devices.

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

• Ground Truth for Training Set: Not applicable. The "ground truth" that informed the design of the Flex-Neck® ARC™ catheter was the clinical feedback, performance data, and design iterations from the 20-year history of the Swan-Neck™ catheter and the 10-year history of the Flex-Neck® "classic" catheter. This includes physician preferences for specific features (e.g., faster flow rates, permanent bend) derived from their extensive use of these devices.

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This device can be used to embed most known brands and styles of PD catheters when the nephrologist determines this action is in the best interest of the patient, however, only immediately after successful catheter implantation.

The Embedding™ Tool is indicated for embedding the external portion of most PD catheters subcutaneously in anticipation of future retrieval of that part of the catheter, provided that:

• The embedding procedure is done immediately following PD . catheter implantation.
• Catheter patency has been completely established. .
• The normally external part of the PD catheter can be embedded. .
• The patient is a candidate for delayed onset of PD treatment. .
• The patient is a candidate for PD. .

The Embedding™ Tool consists of a gently curved handle portion made of rigid PVC with a detachable titanium tip and a separate titanium cap.

The Medigroup, Inc. Embedding™ Tool (TE-1000) is a device used to temporarily embed the external portion of a peritoneal dialysis catheter subcutaneously following initial implantation, for later retrieval and initiation of peritoneal dialysis.

Here's an analysis of the provided information regarding its acceptance criteria and supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly state quantitative acceptance criteria or specific performance metrics (e.g., minimum tensile strength, specific success rate percentage). The statements are qualitative.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated. The document mentions "Clinical evaluation at a dialysis center," implying human subject participation, but no numbers are provided for this evaluation.
• Data Provenance: Not explicitly stated. The "clinical evaluation at a dialysis center" suggests prospective clinical use, but the specific country of origin is not mentioned.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not stated.
• Qualifications of Experts: The clinical evaluation was conducted at a "dialysis center," implying involvement of medical professionals familiar with peritoneal dialysis and catheter procedures. The intended users are "physicians familiar with proper catheter tunneling techniques" and "nephrologist." These suggest that the experts involved would likely be nephrologists or surgeons experienced in implanting and managing PD catheters. Specific years of experience or board certifications are not provided.

4. Adjudication Method for the Test Set

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The "clinical evaluation" seems to be a direct assessment of the device's function by the users/medical staff at the dialysis center.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. The device's function is mechanical and procedural, not diagnostic or interpretive by multiple readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

6. Standalone Performance Study (Algorithm Only)

• This is not an AI-powered device, and therefore, no standalone algorithm-only performance study was conducted. The device is a physical tool.

7. Type of Ground Truth Used

• For "Functional testing": The ground truth would have been established through engineering specifications, material properties, and mechanical test standards (e.g., assessing strength, durability, fit, and operation as designed).
• For "Clinical evaluation": The ground truth was the direct observation of the device functioning "as intended" during actual clinical use in patients undergoing peritoneal dialysis catheter implantation. This would likely involve physician assessment of successful embedding, ease of use, and absence of immediate complications related to the device.

8. Sample Size for the Training Set

• There is no training set mentioned, as this is a physical medical device, not an AI/machine learning algorithm. Therefore, "sample size for the training set" is not applicable.

9. How Ground Truth for the Training Set Was Established

• Not applicable, as there is no training set.

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If the patient is a suitable candidate for peritoneal dialysis (PD) therapy and is too small for the current Flex-Neck™ catheters, the Flex-Neck™ Catheter, Infant, can be implanted either surgically, peritoneoscopically or percutaneously. The only contraindication to implantation of the Flex-Neck™ PD Catheter, Infant, is if the patient is not a candidate for peritoneal dialysis.

This device consists of the following components:
a. 1-Flex-Neck™ Catheter, Infant, made of long-term, implantable grade silicone tubing with radiopaque strip and 1 or 2 polyester cuffs. All components are made of the same materials as the Flex-Neck™ Catheter, Adult and Pediatric. The Infant catheter also has 4 rows of side holes punched into the tubing at the distal end to facilitate inflow and outflow of dialysate.
b. 1-Right hand and 1-left hand tunnel marking stencils to mark and guide and thereby assist the implanting doctor to make a sound subcutaneous tunnel for the catheter.
c. 1-Surgical grade marking pen
d. 1-Catheter connector, plastic
e. 1-Catheter cap, plastic
f. 1-Tube (20 cc) of water-soluble lubricating gel

This document describes a 510(k) submission for the Flex-Neck™ PD Catheter, Infant. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria for device performance. Therefore, many of the requested elements (like MRMC study, separate training/test sets, expert qualifications, etc.) are not applicable to the information provided.

However, based on the available text, here's an analysis of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "Functional testing has been performed," but does not specify the sample size used for these tests.
The data provenance is not explicitly stated, but given this is a 510(k) submission for a medical device in the US, the testing would generally be conducted by the manufacturer, MEDIGROUP, Inc. It is implicitly internal company testing rather than external clinical data. It is retrospective in the sense that the testing was completed prior to the submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The submission relies on functional testing for mechanical integrity and retention, not on expert-adjudicated ground truth like in image analysis or diagnostic studies.

4. Adjudication Method for the Test Set

Not applicable. See point 3.

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

No. This type of study is not mentioned as it's not relevant for demonstrating substantial equivalence of a physical medical device based on mechanical properties. The focus is on the device's physical and functional attributes.

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

Not applicable. This device is a physical medical catheter, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the functional testing would be the physical measurement and observation of the device's mechanical integrity and retention properties under defined test conditions, evaluated against engineering specifications. This is not "expert consensus" or "pathology" in the typical sense, but rather objective physical testing results.

8. The Sample Size for the Training Set

Not applicable. This submission describes a medical device, not a machine learning model, so there is no "training set."

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

Not applicable. See point 8.

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Peritoneal dialysis connectors are used to connect the peritoneal dialysis catheter to the dialysate line.

Peritoneal dialysis connectors are used to connect the peritoneal dialysis catherer to the dialysate line. Medigroup intends to market titanium connectors for use with their large diameter, low duromoter (Flex Neck™) cathere only. Those connectors have the same intended use, general configuration, and materials as titanium connectors marketed by Accurate Surgical Instruments.

The provided text describes a Premarket Notification (510(k)) for a Peritoneal Dialysis Catheter Connector. This is a medical device submission seeking a determination of "substantial equivalence" to a legally marketed predicate device, rather than a study proving the device meets acceptance criteria in the same way a new, novel device might. Therefore, many of the requested elements for a typical study (like sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone performance evaluation of an AI algorithm) are not applicable in this context.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission like this, "acceptance criteria" are generally tied to demonstrating substantial equivalence to the predicate device. The performance is shown through functional testing.

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

The document does not specify the sample size for the functional testing. It only states "Functional testing has been performed". Data provenance is not applicable as this concerns mechanical device testing, not data generated from patients or populations.

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

Not applicable. Ground truth as typically defined for AI/diagnostic studies (e.g., expert labels on images) is not relevant for this type of mechanical device testing. The performance is assessed against engineering specifications and functional requirements.

4. Adjudication method for the test set

Not applicable. There's no indication of multiple human readers or adjudication processes in a medical image/diagnostic context.

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 mechanical device, not an AI or diagnostic tool where a MRMC study would be relevant.

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

Not applicable. This is a mechanical medical device, not an algorithm. The "standalone" performance refers to the device's functional testing as described.

7. The type of ground truth used

For this device, the "ground truth" or reference standard for testing would be engineering specifications, functional requirements, and performance characteristics established for similar predicate devices. The testing verifies if the new device meets these pre-defined physical and mechanical criteria.

8. The sample size for the training set

Not applicable. This is a physical device being tested functionally; there is no "training set" in the machine learning sense.

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

Not applicable. As there's no training set, there's no ground truth for it. The standards for device performance are derived from industry standards and the predicate device's established performance.

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