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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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If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, the Flex-Neck™ PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the Flex-Neck™ PD Catheter is if the patient is not a candidate for peritoneal dialysis. Numerous prior surgeries or suspected or documented intraperitoneal adhesions may be relative contraindications to PD. However, since the Y-TEC® System of peritoneoscopic implantation enables inspection of the peritoneum to confirm the presence of adhesions and to avoid them, all patients who are suitable for PD can receive this catheter.

The current Tenckhoff peritoneal catheter is generally successful in providing peritoneal access for fluid infusion and drainage. The Flex-Neck™ PD Catheter is extruded of medical long-term implantable silicone basically identical to the existing Tenckhoff peritoneal catheters. All these peritoneal catheters include one or two Dacron® cuffs, the "deep" cuff in the abdominal musculature and the "superficial" cuff near the skin exit site of the catheter. Ingrowth of fibrous tissue over a few weeks period results in a thick fibrous plug preventing passage of bacteria around the Dacron® cuff. The coiled or straight intraperitoneal portion of the catheters contains multiple holes: 0.75mm in the Flex-Neck™ and 1.0mm in the Tenckhoff. Generally, the smaller the hole, the less likely omentum is to become trapped within the holes. During infusion of PD fluid, most of the flow is through the tip of the catheter. During outflow of the fluid, the soft surfaces of the peritoneum over bowel loops and omentum may be drawn to the tip, however, outflow continues through the multiple side holes.

The provided text, K970159, describes a 510(k) premarket notification for the Flex-Neck™ PD Catheter. This document asserts the substantial equivalence of the new device to legally marketed predicate devices rather than proving the device meets specific acceptance criteria through a study.

Therefore, the information required to populate the fields regarding acceptance criteria and a study demonstrating performance is not present in the provided text. The document is generally focused on comparing the new device's characteristics to existing devices to establish substantial equivalence for regulatory approval.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on comparing physical characteristics (material, dimensions, number of cuffs, hole diameter) to predicate devices, not performance against acceptance criteria.
2. Sample size used for the test set and the data provenance: Not mentioned, as no study demonstrating performance against acceptance criteria is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no study with a test set requiring ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
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 medical device (catheter), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (catheter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no study with a test set requiring ground truth is described.
8. The sample size for the training set: Not applicable. This is a medical device, and the concept of a "training set" is not relevant here.
9. How the ground truth for the training set was established: Not applicable.

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