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The Ritus™ tunneling tool kit is used to both create a tunnel tract through subcutaneous tissue and seal the end of the catheter. This allows the external portion of the Covidien™ peritoneal dialysis catheter to be temporarily buried in advance of dialysis for patients that are candidates for delayed peritoneal dialysis treatment.

The Ritus™ tunneling tool kit comes with a separate tunneling device and plug. This kit is designed to create a subcutaneous tunnel to temporarily bury the external portion of the peritoneal dialysis catheter within the abdominal, subcutaneous tissue in advance of needing dialysis.

The tunneling device is made of stainless steel with a rigid plastic handle on the proximal end. There is an angled tip with a removable plastic cap. Functioning as a dilator, the tunneling device separates the tissue to create a tunnel tract, then is used to pull the catheter through the tunnel to desired exit site.

The titanium catheter plug is designed to seal the end of the catheter for the length of time that the catheter is buried within the subcutaneous tissue.

This is not an AI/ML device, therefore, the requested information is not applicable.

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Argyle(TM) Peritoneal Dialysis Catheter and Kits:
The peritoneal catheter is indicated for acute and chronic peritoneal dialysis.
The peritoneal dialysis catheter may be inserted using open, laparoscopic or percutaneous surgical techniques.

Argyle (TM) Presternal Peritoneal Catheter and Kits:
The presternal peritoneal catheter is indicated for acute and chronic peritoneal dialysis.
The Peritoneal Dialysis catheter may be inserted using open, laparoscopic or percutaneous surgical techniques.

Argyle(TM) Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter:
The Two Part Titanium Luer Adapter is indicated for acute and chronic peritoneal dialysis, to be used with the Argyle(TM) Peritoneal Dialysis Catheter and the Argyle(TM) Presternal Peritoneal Dialysis Catheter. The Two Part Titanium Luer Adapted to provide a permanent threaded closure when used with a standard continuous ambulatory peritoneal dialysis (CAPD) transfer set.

Argyle(TM) Adult Peritoneal Dialysis Accessory Titanium Catheter Extender
The Titanium Catheter Extender is indicated for acute and chronic peritoneal dialysis, to be used with the Argyle(TM) Peritoneal Dialysis Catheter and the Argyle(TM) Presternal Peritoneal Dialysis Catheter.
The adult catheter extender is used to extend a catheter by connecting two portions of the peritoneal catheter tubing.

The Argyle™ Peritoneal Dialysis Catheter products are single lumen catheters for acute and chronic peritoneal dialysis to allow consistent bi-directional flow of dialysate into and out of the abdominal cavity. One or more cuffs are bonded on to the catheter tubing, which allows for tissue ingrowth to maintain placement of the catheter. All catheters are made of translucent silicone rubber tubing containing a radiopaque stripe, with felt cuffs available to provide catheter stabilization by virtue of tissue in-growth.

The Argyle™ peritoneal dialysis catheter comes in a variety of lengths and cuff configurations including straight, curled, and Swan Neck catheter styles. The Argyle™ peritoneal dialysis catheter kit contains the basic items needed to insert a peritoneal catheter: a straight or Swan Neck Tenckhoff or Curl Cath catheter with single or double cuff (specified at time of order), a 16 Fr/Ch pull-apart introducer, an 18 G introducer needle, a 12 mL syringe, a J/straight guidewire, tunneling stylet, #11 scalpel, gauze sponges, Beta-Cap™ adapter, cap, clamp, and instructions.

The Argyle™ presternal peritoneal dialysis catheters include the curl catheter and Swan Neck catheter styles. The curl catheter segment contains a felt cuff. The Swan Neck Presternal catheter is a segment of catheter tubing with a Swan Neck bend and two cuffs. It is connected by a double-barbed connector to the intraperitoneal segment of the curl catheter. The Argyle™ presternal peritoneal dialysis catheter kit contains the basic items needed to insert a peritoneal catheter: a 16 Fr/Ch pull-apart introducer, an 18 G introducer needle, a 12 mL syringe, a J/straight guidewire, tunneling stylet, #11 scalpel, gauze sponges, Beta-CapTM adapter, cap, clamp, titanium connector, and instructions.

The titanium adapter is a two-piece luer-lock system with a barbed end and a threaded cover. The adapter is designed to provide a permanent threaded closure when used with a standard CAPD transfer set.

The adult catheter extender is double barbed and made of titanium. The adult catheter extender is used to extend a catheter by connecting two portions of the peritoneal catheter tubing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it indicates that "All performance testing met acceptance criteria." The performance evaluation is primarily focused on biocompatibility and design verification for the expanded indication of laparoscopic insertion.

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

• Sample Size for Test Set: Not explicitly stated for each test. The document refers to "the PD Catheter" for biocompatibility testing and "the proposed device" for design verification, implying a sufficient number of devices were tested to meet the respective standards, but no specific count is given.
• Data Provenance: The document does not specify the country of origin of the data. The studies appear to be retrospective in the sense that they were conducted for regulatory submission to demonstrate equivalence and safety (i.e., not a new clinical trial generating prospective data on patient outcomes).

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

• Number of Experts: Not specified.
• Qualifications of Experts: It mentions "validation testing by clinicians" for the laparoscopic insertion and "Good Laboratory Practice (GLP)" for biocompatibility, implying qualified professionals were involved, but specific qualifications (e.g., years of experience, specialty) are not detailed.

4. Adjudication Method for the Test Set

• No specific adjudication method (e.g., 2+1, 3+1) is mentioned or implied, as the studies are primarily about device performance against technical standards and benchmarks rather than diagnostic accuracy requiring expert consensus.

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

• No MRMC study was done. This submission is for a medical device (catheter and accessories), not a diagnostic imaging AI algorithm. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• No standalone performance study for an algorithm was done. This device is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI performance (e.g., expert consensus for image findings, pathology reports) is not directly applicable here. For this medical device, the "ground truth" or reference standards are:

• Biocompatibility: Established international standards (ISO 10993-1) and their associated testing protocols.
• Design Verification (Laparoscopic Insertion): Engineering specifications, validated insertion methods, and clinician feedback on feasibility and safety during simulated use.
• MR Status: Established testing procedures and standards for determining MR compatibility (e.g., ASTM F2503).

8. Sample Size for the Training Set

• Not applicable. This submission is for a physical medical device. There is no AI model involved that would require a training set.

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

• Not applicable. As there is no AI model, there is no training set or associated ground truth.

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The Faller stylet is a surgical tool used to create a 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.

Faller Stylet

This document is an FDA 510(k) clearance letter for the "Faller Stylet," a surgical tool used to create a subcutaneous tunnel for peritoneal dialysis catheters. As such, it does not contain the kind of detailed performance study information, acceptance criteria, or clinical trial data you are requesting for an AI/ML device.

The questions you've asked (about acceptance criteria, sample sizes, ground truth, expert adjudication, MRMC studies, and standalone performance) are highly relevant for the evaluation of AI/ML-based medical devices. These types of devices require rigorous testing against predefined performance metrics, typically involving clinical validation studies.

This document is for a mechanical surgical tool. Its clearance is based on substantial equivalence to predicate devices, which generally means demonstrating that it has the same intended use, technological characteristics, and safety and effectiveness profiles as legally marketed devices, without introducing new risks or questions of effectiveness. This usually involves:

• Bench testing: To confirm physical properties, strength, etc.
• Biocompatibility testing: To ensure materials are safe for human contact.
• Sterilization validation: To ensure the device can be properly sterilized.
• Performance testing: To confirm it performs its intended mechanical function (e.g., smoothly separates tissue).

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes for test/training, expert details, adjudication, MRMC, standalone performance, ground truth types) from this specific document because it pertains to a different type of medical device and regulatory pathway.

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The "X" Series PD Catheter is indicated for peritoneal dialysis in adults. It is intended for use in patients who are poor candidates for conventional peritoneal dialysis catheters and are candidates for presternal insertion.

The "X" Series Catheter is indicated for chronic peritoneal dialysis.

The extended length of the “X” Series Catheter makes it especially applicable for peritoneal dialysis patients when it is necessary to locate the skin exit site remote from the usual lower abdominal region. The catheter may be particularly indicated in patients with obesity, floppy abdominal skin folds, urinary or fecal incontinence, chronic yeast intertrigo, intestinal stomas, or in patients who desire to take deep tub baths.

The "X" Series PD Catheter is comprised of a silicone rubber, coiled tip, single polyester cuff abdominal catheter segment that is joined with a titanium double bared connector to a silicone rubber, double polyester cuff subcutaneous extension catheter possessing a preformed tubing arc bend between the two cuffs. The abdominal catheter segment is implanted into the peritoneal cavity. The attached subcutaneous extension piece allows remote location of the catheter skin exit site away from the lower abdominal region.

The catheter will be sold in two kit configurations, as the catheter only with a female luer, clamp, and male luer end cap and titanium connector. The catheter set will also include the addition of a dilator/sheath introducer, guidewire, scalpel, introducer needle, tunneling tool, gauze pads and syringe.

The provided text describes a medical device, the "X" Series PD Catheter, and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the context of AI/ML performance.

Instead, the document focuses on:

• Device Description: What the "X" Series PD Catheter is made of and how it's constructed.
• Intended Use and Indications for Use: For peritoneal dialysis, especially in patients with specific conditions like obesity or stomas, where a remote exit site is beneficial.
• Comparison to Predicate Devices: Asserting substantial equivalence in terms of intended use, materials, design, performance, etc.
• Performance Testing (Non-Clinical): A list of physical and material tests performed (e.g., Air Leakage, Gravity Flow, Biocompatibility).
• Regulatory Information: 510(k) summary, classification, product codes, and the FDA's substantial equivalence determination.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, human readers, ground truth establishment, or training/test set sizes because this information is not present in the provided text. The performance testing mentioned (Air Leakage, Liquid Leakage, etc.) are engineering/materials tests for the physical catheter, not a clinical study or AI/ML performance evaluation.

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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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The Veta Peritoneal Dialysis Catheter is indicated for acute and chronic access to the peritoneal cavity. The Veta Peritoneal Dialysis Catheters will be used to drain and infuse fluid during peritoneal dialysis procedures.

Veta™ Peritoneal Dialysis Catheters are side-ported silicone catheters with a single and double retention cuff, available in a range of lengths and French sizes and in either a straight or spiral tip configuration.

The provided document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically seen for AI/ML-driven medical devices. This document refers to a conventional medical device (Veta™ Peritoneal Dialysis Catheter), and its clearance is based on in vitro testing and substantial equivalence to predicate devices, rather than performance metrics from clinical or AI-specific studies.

Therefore, most of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. The "test set" in this context refers to physical samples of the catheter used for in vitro engineering tests, not a dataset of patient cases. The specific number of catheters tested is not provided, but it would have been sufficient to meet the standards.
• Data Provenance: Not applicable. This was in vitro testing, not clinical data from patients.

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

• Not applicable. Ground truth for in vitro engineering tests is established by adhering to published performance standards (e.g., BS EN 1618-1997) and verified by standard laboratory test methods, not by expert consensus on medical images or diagnoses.

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

• Not applicable. This is not a study requiring adjudication of clinical findings.

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

• No MRMC study was done (or is relevant) as this is not an AI-driven device.

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

• No standalone algorithm performance was done (or is relevant) as this is not an AI-driven device.

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

• The "ground truth" for the in vitro tests was defined by compliance with established engineering and biocompatibility standards (BS EN 1618-1997 and ISO 10993).

8. The sample size for the training set

• Not applicable. This device did not involve machine learning; therefore, there was no training set.

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

• Not applicable. There was no training set.

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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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The PD Cath is indicated for use in attaining long term peritoneal access for peritoneal dialysis via the peritoneum. The catheter is intended for implantation dwell time of greater than 30 days.

The PD Cath is a radiopaque silicone, single lumen catheter used to insert and remove peritoneal fluid. The fixed Dacron cuff allows for tissue ingrowth for long-term placement. A flexible silicone overtube is permanently bonded to the lumen passages and the cuff to insulate the cuff from forces applied to the external or internal lumens.

The provided text is for a 510(k) premarket notification for a medical device called "PD Cath." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to establish safety and efficacy from scratch.

Therefore, the information typically requested in your prompt (such as acceptance criteria tables, sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and extensive training set details) is generally not applicable to a 510(k) submission for a device like the PD Cath, which is a relatively low-risk device without complex diagnostic algorithms or image analysis components.

Here's a breakdown based on the provided document:

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

• Acceptance Criteria: The document directly states that "Clinical data was not deemed necessary since in vitro testing was sufficient to demonstrate safety and efficacy by way of comparison to legally marketed predicate device intended for peritoneal dialysis." The acceptance criteria are implicitly tied to demonstrating substantial equivalence in performance characteristics to the predicate devices, specifically in terms of flow rate and tensile strength. The exact numerical acceptance criteria are not specified in the public summary.
• Reported Device Performance:

  Performance Metric	Reported Device Performance (PD Cath)	Predicate Device (Dermaport™ Access Device - K894131, Missouri Catheter - K874650)
  Flow Rate	Substantially equivalent	Data not provided, but inferred to be similar to legally marketed devices
  Tensile Strength	Substantially equivalent	Data not provided, but inferred to be similar to legally marketed devices

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

• Sample Size: Not applicable. No clinical test set data was used. The performance testing was in vitro.
• Data Provenance: Not applicable. In vitro testing was conducted, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No clinical test set requiring expert ground truth was performed for this 510(k) submission.

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

• Not applicable. No clinical test set requiring adjudication was performed.

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 device is a physical catheter, not an AI-powered diagnostic tool. MRMC studies or AI assistance are not relevant.

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

• Not applicable. This is not an algorithmic device.

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

• Not applicable for the reasons mentioned above. The "ground truth" for this submission was the established performance characteristics of the legally marketed predicate devices, against which the in vitro performance of the PD Cath was compared.

8. The sample size for the training set

• Not applicable. No AI/machine learning training set was used.

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

• Not applicable. No AI/machine learning training set was used.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria was an in vitro performance test demonstrating that the PD Cath's flow rate and tensile strength were "substantially equivalent" to legally marketed predicate devices (Dermaport™ Access Device -- K894131 and Missouri Catheter-K874650). The FDA determined that clinical data was not necessary for this substantial equivalence determination. The specific details of the in vitro testing methodology, raw data, and precise quantitative equivalence metrics are not provided in this public summary, as is typical for 510(k) summaries. The acceptance criteria were met by showing that the physical characteristics (flow rate, tensile strength) of the PD Cath were comparable to established, safe, and effective peritoneal dialysis catheters already on the market.

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