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The Byonyks X-1 APD Cycler is indicated for acute and chronic peritoneal dialysis.

The Byonyks X-1 APD Cycler System includes an Automated Peritoneal Dialysis Cycler and a disposable tubing set. The Byonyks X-1 APD Cycler is intended for acute and chronic peritoneal dialysis. Byonyks X-1 APD Cycler is an automated peritoneal dialysis system that uses a peristaltic pumping mechanism to infuse the dialysate (Dialyzing Solution) into the peritoneal cavity and drain it after the dialysate has dwelled within a patient's peritoneal cavity for a specified amount of time. Byonyks X-1 APD Cycler is a prescription-use-only device and the therapies administered using Byonyks X-1 APD Cycler are prescribed by a physician. The device operates according to a therapy prescription provided by the patient's physician. The device is designed to be used in dialysis clinics, outpatient care areas, and home treatment settings with dialyzing solutions approved for peritoneal dialysis. Dialysate is infused into the patient's peritoneal cavity from a dialysate bag through a surgically implanted catheter which provides a fluid connection to the device's disposable tubing set. The dialysate remains in the peritoneal cavity for the dwell time which is a programmed length of time prescribed by the patient's physician. After the dwell time has elapsed, the fluid is drained from the patient using the device's peristaltic pumping system to extract the fluid from the patient's peritoneal cavity. Peristaltic pumping mechanism of the Byonyks X-1 APD cycler assist the dialysate flow at pre- programmed flowrate up to the volume prescribed by the patient's physicians, device continuously monitors volume of dialysate exchanges along with the fluid pressure external to the cassette of disposable set, fluid pressure detects resistance in dialysate exchanges at which pumping regulates the overall flow.

The Byonyks X-1 APD Cycler System consists of the (i) main control unit (Cycler) and the (ii) disposable set.

The provided 510(k) clearance letter and summary for the Byonyks X-1 APD Cycler focuses on the substantial equivalence of the device to a predicate device, primarily through engineering and bench testing, and does not include an AI/ML component. Therefore, the information required to answer your prompt, such as acceptance criteria for AI/ML performance, study details for AI/ML models (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training data details), is not present in the provided document.

The document details performance testing for the physical cycler device and its disposable set, as well as general medical device requirements like biocompatibility, electrical safety, EMC, and human factors. However, these are evaluations of the hardware and overall system functionality, not specific to an AI/ML algorithm's performance on diagnostic tasks.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML acceptance criteria and performance study details based on the given text.

If this medical device were to incorporate AI/ML, the 510(k) summary would typically include a separate section outlining the AI/ML algorithm, its intended use, performance metrics, and the details of the validation study.

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stay•safe® catheter extension set with Safe-Lock, 12 inch:
The stay•safe catheter extension set with Safe-Lock is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe catheter extension set with Safe-Lock is used to connect a PD catheter with Safe-Lock compatible catheter adapter to PD systems that use stay•safe PIN technology.

stay•safe® catheter extension set with Luer-Lock, 6 inch;
stay•safe® catheter extension set with Luer-Lock, 12 inch;
and stay•safe® catheter extension set with Luer-Lock, 18 inch:
The stay•safe catheter extension set with Luer-Lock is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe catheter extension set with Luer-Lock is used to connect a PD catheter with Luer-Lock catheter adapter to PD systems that use stay•safe PIN technology.

stay•safe® to Luer-Lock Adapter, 4 inch:
The stay•safe to Luer-Lock adapter is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe to Luer-Lock adapter is used to connect a stay•safe catheter extension set to medical devices with a Luer-Lock connection.

The stay•safe® catheter extension set with Safe-Lock, 12 inch (Safe-Lock extension set) stay•safe® catheter extension set with Luer-Lock, 6 inch, stay•safe® catheter extension set with Luer-Lock, 12 inch, and stay•safe® catheter extension set with Luer-Lock, 18 inch (Luer-Lock extension sets), and stay•safe® to Luer-Lock adapter, 4 inch (Luer-Lock adapter), hereinafter collectively referred to as the "Catheter Extension Sets" are the subject devices of this 510(k).

The Safe-Lock extension set is a single-use device designed to connect a PD catheter to PD systems that use the stay•safe PIN technology. The Safe-Lock extension set is provided sterile and non-pyrogenic. The Safe-Lock extension set is sterilized using ethylene oxide (EO).

The Luer-Lock extension sets are single-use devices designed to connect a PD catheter to PD systems that use the stay•safe PIN technology. The Luer-Lock extension sets are provided sterile and non-pyrogenic. The Luer-Lock extension sets are sterilized using EO.

The Luer-Lock adapter is a single-use device designed to connect a stay•safe catheter extension set to a medical device with a Luer lock connector. The Luer-Lock adapter is provided sterile and non-pyrogenic. The Luer-Lock adapter is sterilized using EO.

The provided FDA 510(k) clearance letter (K250404) for Fresenius Medical Care Renal Therapies Group's stay•safe® catheter extension sets and adapter pertains to a Class II medical device (Peritoneal Dialysis System and Accessories, Product Code KDJ).

Crucially, this document details the substantial equivalence of the new device to a legally marketed predicate device (K173593), based on non-clinical performance testing and biocompatibility. It explicitly states that "No clinical studies were performed for the Catheter Extension Sets." This means the type of study typically associated with assessing an AI/Software as a Medical Device (SaMD) to meet acceptance criteria through human reader performance (like MRMC studies) or standalone algorithmic performance was not conducted because this is a physical medical device, not AI/SaMD.

Therefore, I will describe the acceptance criteria and supporting studies based on the provided document, acknowledging that they are for a physical medical device and not an AI/SaMD.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

The acceptance criteria for the stay•safe® catheter extension sets and adapter are based on demonstrating substantial equivalence to a legally marketed predicate device (K173593) in terms of safety and efficacy. This is primarily achieved through non-clinical performance testing and biocompatibility assessments, rather than clinical efficacy studies involving human patient outcomes or AI performance metrics.

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

The document doesn't provide a direct "table of acceptance criteria" with specific numerical targets and performance results for each test. Instead, it lists the types of performance tests conducted to support the determination of substantial equivalence. The implication is that the new devices met the predefined specifications for each test, which would be deemed "acceptable" for equivalence.

Based on the provided text, the categories of performance testing serve as the basis for acceptance. The "Reported Device Performance" is implicitly that the device met the requirements of each test, demonstrating substantial equivalence.

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

• Sample Size: The document does not specify the exact sample sizes (number of units tested) for each of the performance or biocompatibility tests. This information is typically detailed in the engineering test reports or biocompatibility reports submitted as part of the 510(k) package, but not in the summary letter itself.
• Data Provenance: The data originates from non-clinical laboratory testing conducted by Fresenius Medical Care Renal Therapies Group, LLC, the device manufacturer. This is by nature prospective testing, as it is performed specifically to support the 510(k) submission for the new devices. The country of origin of the data is implied to be within the US, given the submission is to the US FDA.

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

• Not Applicable: For a physical medical device cleared via substantial equivalence based on non-clinical performance and biocompatibility testing, there are no "experts" in the sense of clinicians establishing a "ground truth" for a test set in the way one would for an AI/SaMD (e.g., radiologists annotating images). The "ground truth" for these tests is defined by engineering specifications, regulatory standards (e.g., ISO 10993-1 for biocompatibility), and established test methods. The "experts" involved are engineers and scientists responsible for designing, conducting, and interpreting these tests according to predefined protocols and standards. Their qualifications would be in relevant fields such as biomedical engineering, materials science, and toxicology.

4. Adjudication method for the test set:

• Not Applicable: As there are no human-read interpretations or clinical assessments requiring reconciliation, there is no "adjudication method" in the context of clinical expert consensus. Test results are objectively measured against predefined acceptance criteria (e.g., a leak test either passes or fails, a tensile strength measurement is or is not within specification). Any discrepancies in test results would be handled through standard quality control and engineering investigation procedures.

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, an MRMC study was not done. This type of study is specifically relevant for software/AI devices that assist human readers in diagnosing or interpreting medical images/data. The device in question is a physical catheter extension set and adapter, not an AI or imaging device. The document explicitly states: "No clinical studies were performed for the Catheter Extension Sets."

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

• No, a standalone performance study was not done. This is also relevant for AI/SaMD devices. The Catheter Extension Sets do not contain any software or algorithms. The document explicitly states: "Not applicable. The Catheter Extension Sets do not contain software."

7. The type of ground truth used:

• Engineering Specifications and Standardized Test Methods: The "ground truth" for the performance tests relies on established engineering specifications, mechanical properties of materials, and successful adherence to recognized industry standards (e.g., ISO for biocompatibility testing). For instance, a "leak test" has an objective pass/fail criterion based on absence of fluid leakage under defined pressure, not a clinical interpretation. Biocompatibility results are compared against toxicological limits and biological responses as defined by ISO 10993-1.

8. The sample size for the training set:

• Not Applicable: This pertains to machine learning models. As this is a physical medical device, there is no "training set."

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

• Not Applicable: There is no training set for this type of device.

In summary, the FDA's clearance for the stay•safe® catheter extension sets and adapter is based on a demonstration of substantial equivalence to an existing predicate device, supported by a comprehensive battery of non-clinical performance tests and biocompatibility assessments, validating its physical and material properties for its intended use, rather than clinical efficacy studies or AI/SaMD specific evaluations.

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The ASEPT Glide Peritoneal Drainage System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites.

The use of the ASEPT Glide Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for trans-juqular intrahepatic portosystemic shunt or LVP. The ASEPT Glide Peritoneal Catheter is indicated for adults only.

The ASEPT Glide Peritoneal Drainage System provides patients with a method to drain accumulated fluid from the abdomen. The primary components of the system are the indwelling ASEPT Glide Peritoneal Catheter and the ASEPT Drainage Kit. The catheter is placed in the patient's peritoneal cavity enabling the patient to perform periodic peritoneal drainage at home or in the hospital. The device is provided sterile.

The ASEPT Glide Peritoneal Drainage Catheter has a surface modification applied from the distal tip to the polyester cuff.

The provided text is a 510(k) summary for the ASEPT® Glide Peritoneal Drainage System, a medical device for draining ascites. It focuses on demonstrating substantial equivalence to a predicate device through bench testing and technical comparisons.

Crucially, this document does not describe a study involving an AI/software device that generates performance metrics (like accuracy, sensitivity, specificity) against acceptance criteria established with expert consensus or ground truth.

Therefore, I cannot extract the information required to answer your request regarding acceptance criteria and performance data for an AI/software device. The document explicitly states:

• "No clinical tests were required to confirm the safety and effectiveness of the subject device." (Page 7, Section IX)
• The performance data section (Page 7, Section VIII) refers to "Bench testing" for the catheter and valve, and "Biocompatibility" and "sterilization process" validation, not AI model performance.

The device is a physical medical device (Peritoneal Drainage System), not an AI/software as a medical device (SaMD).

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The PeritX™ Drainage Kits are indicated for use only with the PeritX™ Peritoneal Catheter for intermittent drainage.

The PeritX™ Peritoneal Catheter System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and nonmalignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms relate to recurrent ascites. The use of the PeritX™ Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-jugular intra hepatic portosystemic shunt or LVP. The PeritX™ Peritoneal Catheter is indicated for adults only.

The Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.

For Pleural Use: The PleurX™ LP Catheter Mini Kit is indicated for intermittent, long-term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for the palliation of dyspnea due to pleural effusion and providing pleurodesis (resolution of the pleural effusion). The PleurX™ Low Profile Catheter is indicated for adults only.

For Peritoneal Use: The PleurX™ LP Catheter Mini Kit is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites. The use of the PleurX™ Low Profile Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-jugular intrahepatic portosystemic shunt or LVP. The PleurX™ Low Profile Catheter is indicated for adults only.

The Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.

The PeritX™ Valve Kit is indicated for use in adults only. The PeritX™ Valve Kit is designed for health care facility use only. There is no change to the PeritX™ Valve Kit within this submission.

For Pleural Use: The Catheter Access Kit is intended to provide access to the PleurX™ Catheter to inject and withdraw fluids.

For Peritoneal Use: The Catheter Access Kit is intended to provide access to the PeritX™ Catheter for aspiration and catheter maintenance.

The Lockable Drainage Line is indicated for use only with the PleurX™ Pleural Catheter and PeritX™ Peritoneal Catheter for intermittent drainage.

The Lockable Drainage Line Kit is indicated for use only with the PleurX™ Catheter and PeritX™ Catheter for intermittent drainage. The Lockable Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, or other appropriate method (portable suction).

The PleurX™ Supplemental Insertion Kit intended to aid in the percutaneous insertion of a PleurX™ Catheter into the pleural space and PeritX™ Catheter into the peritoneal space.

The Procedure Pack is indicated for dressing of the PleurX™ Pleural Catheter and PeritX™ Peritoneal Catheter and exit site.

The PleurX™ Drainage Kits are indicated for use only with the PleurX™ Catheter and PeritX™ Catheter for intermittent drainage.

The PeritX™ Drainage Bag is indicated for use only with the PeritX™ Peritoneal Catheter for intermittent drainage.

The subject device, the PeritX™ Peritoneal Catheter System, includes the PeritX™ Peritoneal Catheter and PleurX™ Low Profile Catheter, sterile, single use indwelling peritoneal catheters, the PeritX™ Valve Kit, Catheter Access Kit, Lockable Drainage Line, Lockable Drainage Line Kit, PleurX™ Supplemental Insertion Kit, Procedure Pack, PleurX™ Drainage Kits, and the PeritX™ Drainage Bag that allow for the management of ascites at home.

The PeritX™ Drainage Kit (for vacuum-initiated drainage) is a sterile, single use fluid collection device used with the Peritoneal Catheter to drain fluid from the peritoneal cavity to relieve symptoms associated with malignant and non-malignant ascites. The PeritX™ Drainage Kit includes the PeritX™ Drainage Bag and Procedure Pack. The PeritX™ Drainage Kit is offered in two sizes (1L and 2L).

This document is a 510(k) summary for the PeritX™ Peritoneal Catheter System. It describes a medical device, which is a peritoneal dialysis system and accessories. This is a Class II device. The document states that performance testing was conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided text in the context of device acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria for the performance tests conducted. Instead, it lists the types of non-clinical tests performed to evaluate "technological characteristics and performance criteria". The conclusion states that the device's performance is "comparable to the predicate device and that it performs as safely and as effectively as the legally marketed predicate device."

Table of Acceptance Criteria and Reported Device Performance:

The study primarily focuses on demonstrating equivalence through various engineering and functional tests rather than clinical efficacy, given it's a 510(k) submission for a device system with a new accessory.

Details of the Study:

• 1. Table of Acceptance Criteria and the Reported Device Performance:
  As noted above, specific quantitative acceptance criteria are not presented in the provided text. The reported device performance is a general statement of comparability and equivalent safety and effectiveness to the predicate device.

• 2. Sample Size Used for the Test Set and Data Provenance:
  The document lists various non-clinical tests (e.g., Visual Inspection, Tensile Strength, Volume Capacity, Drop Test, Resistance to Leakage). However, it does not specify the sample size used for any of these tests. The data provenance is implied to be from internal testing conducted by Bard Peripheral Vascular, Inc. within the USA. The data is non-clinical, likely from laboratory testing.

• 3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
  This information is not provided in the document, as the testing described is non-clinical (engineering and functional tests), not involving expert-established ground truth in the typical clinical sense.

• 4. Adjudication Method for the Test Set:
  This information is not provided as the tests are non-clinical and do not involve human interpretation or adjudication in the context of clinical studies.

• 5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
  No MRMC comparative effectiveness study was done. The document focuses on non-clinical performance testing for substantial equivalence.

• 6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
  This question is not applicable as the device is a physical medical device (catheter system and accessories), not a software algorithm with standalone performance metrics.

• 7. Type of Ground Truth Used:
  The "ground truth" for the non-clinical tests performed would be defined by engineering specifications, material properties, and functional requirements. For example, a tensile strength test would have a specified minimum strength that the device must meet. This is derived from design requirements and industry standards, not from expert consensus, pathology, or outcomes data in the clinical sense.

• 8. Sample Size for the Training Set:
  This information is not applicable as the device is a physical medical device and does not involve AI or machine learning models that require a "training set."

• 9. How the Ground Truth for the Training Set Was Established:
  This information is not applicable for the same reason as point 8.

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These sets are used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient catheter from the source solution container.

The MiniCap Extended Life PD Transfer Set with Twist Clamp – Code 5C4482A and MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 are single use, sterile, non-pyrogenic devices for use with Baxter peritoneal dialysis systems. A Transfer Set is connected to a Titanium Adapter that is at the end of an implanted peritoneal catheter. The Transfer Sets stay connected to the patient and allow for the exchange of peritoneal dialysis solution into and out of the peritoneal cavity as prescribed.

This document is a 510(k) Premarket Notification from the FDA regarding Baxter Healthcare Corporation's MiniCap Extended Life PD Transfer Sets. It focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on proving that a device meets specific acceptance criteria through a study as one might conduct for a new AI/software-as-a-medical-device (SaMD) product.

Therefore, the requested information (acceptance criteria, details of a study proving device performance, sample sizes, ground truth establishment, MRMC studies, etc.) is not applicable to this type of FDA submission (510(k) for a physical medical device, specifically a transfer set for peritoneal dialysis).

Here's why and what information is provided:

Why the requested information is not applicable:

• Device Type: The "device" in question is a physical medical device (Peritoneal Dialysis Transfer Set), not an AI/software product. The typical acceptance criteria and study designs for SaMD (which would involve accuracy, sensitivity, specificity, human reader performance, etc.) do not apply here.
• Submission Type (510(k)): A 510(k) submission aims to demonstrate "substantial equivalence" to a predicate device already on the market. It does not require a full clinical trial or a study proving independent performance against specific clinical acceptance criteria in the same way a PMA (Premarket Approval) or a SaMD submission might. The focus is on showing the new device is as safe and effective as a previously cleared device, not necessarily proving new clinical benefit or performance from scratch.
• Nature of Changes: The document explicitly states the primary change is a "material change" from Dichlorobenzoyl peroxide cured silicone to platinum cured silicone for the tubing. This triggers a need to demonstrate that this material change does not negatively impact the device's fundamental function, safety, or biocompatibility.

What information is provided in the document and how it relates to device proving safety and effectiveness for a 510(k):

Instead of a "study proving the device meets acceptance criteria" in the AI/SaMD sense, the document details "non-clinical tests" and "performance data" that support the device's safety and functional equivalence after a material change.

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

   • Acceptance Criteria: While not presented in a formal table with specific numerical targets like for an AI model's operating characteristics, the document implies acceptance criteria by stating "All results meet their acceptance criteria." These criteria would be tied to the functional tests described, ensuring the device performs as intended (e.g., no leaks, proper flow rate, withstands pressure, biocompatibility).
   • Reported Device Performance: Instead of performance metrics like accuracy, the "performance data" section lists the types of tests conducted:
     • Visual Inspection
     • Initial Pressure Test (clamp in closed position)
     • Cycling (conditioning step prior to pressure tests)
     • 8 psi Pressure Test Post Cycling (clamp in both open and closed position)
     • 5 lb Pull of Tubing to Barb Connection
     • Functionality after Iodine Exposure (over 48 hours continuous and 6 months simulated use)
     • Flow Rate (after iodine exposure)
     • Shelf Life
   • Biocompatibility Testing: Per ISO 10993-1 and FDA Guidance: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Sub-chronic Toxicity, Genotoxicity, Implantation, Hemolysis, Extractables and Leachables (per ISO 9003-18:2020), Toxicological Evaluation (per ISO 10993-17:2002).
   • No specific numerical results are provided in this summary document, only the types of tests performed and the general conclusion that "The non-clinical data supports the safety of the proposed devices and demonstrates that the proposed devices perform comparably to the predicate device that is currently marketed for the same intended use."

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

   • Sample Size: Not explicitly stated for each test in this summary. For physical device testing, sample sizes are typically determined by statistical methods for device reliability, manufacturing process validation, and regulatory standards (e.g., ISO, ASTM standards for material testing, biocompatibility). These are generally much smaller than data sets for AI models.
   • Data Provenance: Not applicable. These are laboratory/bench tests, not clinical data from patients or specific countries.

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

   • Not Applicable. Ground truth, in the context of AI models, refers to verified labels (e.g., disease presence/absence in an image). For a physical medical device like this, "ground truth" would be the engineering specifications and performance standards established by the manufacturer and relevant regulatory bodies. Experts involved would be engineers, material scientists, toxicologists, and quality control professionals.

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

   • Not Applicable. This is a concept used in medical image annotation or clinical trial data interpretation by multiple readers. For physical device testing, results are typically objective (e.g., pass/fail a pressure test) and follow standardized protocols.

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. This is a physical medical device, not an AI or imaging diagnostic device. MRMC studies are not relevant.

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

   • Not Applicable. This is a physical medical device.

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

   • Ground Truth: For this device, the "ground truth" is defined by established engineering specifications, material properties, and performance standards expected for a product of this type. It's based on objective measurements from laboratory tests and compliance with recognized standards (e.g., ISO 10993 for biocompatibility).

8. The sample size for the training set:

   • Not Applicable. This is not an AI/ML model.

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

   • Not Applicable. This is not an AI/ML model.

In summary: The provided document is a regulatory letter for a 510(k) submission of a physical medical device undergoing a material change. The information required for your query predominantly applies to software/AI medical devices, particularly those involving image analysis or diagnostic support. The "study" mentioned in the document refers to a series of non-clinical functional and biocompatibility tests designed to ensure the modified physical device maintains safety and performance comparable to its predicate.

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The Passio Pump Drainage System is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, or any studies involving AI or ground truth. The document is an FDA 510(k) clearance letter for the "Passio Pump Drainage System," which is a medical device for draining malignant ascites, not an AI or software-based device. It confirms that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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The ASEPT Peritoneal Drainage System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites.

The use of the ASEPT Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-jugular intrahepatic portosystemic shunt or LVP. The ASEPT Peritoneal Catheter is indicated for adults only.

The ASEPT Peritoneal Drainage System provides patients with a method to drain accumulated fluid from the abdomen. The primary components of the system are the indwelling ASEPT Peritoneal Catheter and the ASEPT Drainage Kit. The catheter is placed in the patient's peritoneal cavity enabling the patient to perform periodic peritoneal drainage at home or in the hospital.

Based on the provided text, the device in question is the ASEPT® Peritoneal Drainage System, which is a medical device and not an AI or imaging diagnostic tool. Therefore, the questions related to AI performance, ground truth establishment for AI training/testing, expert adjudication, and MRMC studies are not applicable to this submission.

The document describes the acceptance criteria and study for demonstrating substantial equivalence of a medical device, primarily through bench testing and a clinical literature review, not through AI performance metrics or clinical trials with human subjects for efficacy.

Here's a breakdown of the information that can be extracted from the provided text, addressing the relevant parts of your request:

Acceptance Criteria and Device Performance:

Since this is a 510(k) submission for a non-AI medical device (a catheter system), the "acceptance criteria" are related to demonstrating substantial equivalence to a predicate device, focusing on functional performance, materials, and safety, primarily through bench testing. Clinical efficacy is supported by existing literature rather than a new clinical study.

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that "Bench testing was performed on the ASEPT® Peritoneal Catheter and replacement valve to demonstrate substantial equivalence." The performance testing requirements were determined by the predicate and reference devices and assessment of risk. However, the specific quantitative acceptance criteria and the detailed reported numerical performance data from these bench tests are not provided in this summary.

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

• Test Set (Bench Testing): The specific sample sizes for the bench tests are not mentioned in the document.
• Data Provenance (Clinical Literature Review): The clinical literature review "demonstrates that peritoneal drainage catheters have a history of safety and efficacy in non-malignant refractory ascites and that the incidence of device related complications is more closely related to patient specific health status and preferences than the underlying cause (malignant vs non-malignant) of ascites." The provenance of this literature (e.g., countries of origin, retrospective/prospective nature of studies reviewed) is not specified.

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

• Not Applicable. As this is not an AI/imaging diagnostic device requiring expert interpretation for ground truth, this question is not relevant. The substantial equivalence is based on engineering design, materials, and a review of existing clinical literature.

4. Adjudication Method for the Test Set:

• Not Applicable. There is no "adjudication method" in the context of human expert review of AI output or images for this type of device.

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

• No. An MRMC study is relevant for imaging diagnostic devices assessing reader performance with and without AI. This device is a peritoneal drainage system. The document explicitly states: "No clinical tests were conducted for this submission."

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

• Not Applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used:

• For Bench Testing: The "ground truth" for bench testing would be established by the engineering specifications and performance standards determined from the predicate and reference devices.
• For Clinical Support: The "ground truth" for clinical support is derived from a clinical literature review summarizing existing evidence on the safety and efficacy of peritoneal drainage catheters in general, as well as specific data related to the predicate device. This literature effectively serves as the "outcomes data" or "expert consensus" from prior studies.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/machine learning device that requires a training set.

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

• Not Applicable. See point 8.

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Intelligent Dialysis Assistant (IDA) is intended for automatic single exchange of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis.

All therapies using the Intelligent Dialysis Assistant (IDA) must be prescribed and performed under the responsibility of a physician who is familiar and well informed about peritoneal dialysis. The patient prescription may include single or multiple exchanges, depending on the patient's need.

The IDA Cartridge is a single-use, sterile cartridge exclusively for use with the IDA. It is intended to interface the IDA with the Twin Bag Set (patient dialysis prescription) and the patient's peritoneal catheter.

The Medical Supervision Portal is intended for use by healthcare professionals to remotely communicate new or modified treatment parameters with compatible dialysis instruments and transfer completed treatment database to aid in the review, analysis, and evaluation of patients' historical treatment results. This Medical Supervision Portal is not intended to be a substitute for good clinical management practices, nor does its operation creatment pathways.

The IDA Smartphone App is a software medical application intended for patients to review their treatment and review and approve their dialysis prescription provided by the healthcare professional through the Medical Supervision Portal. The user is not intended to take clinical action based on the application of a qualified healthcare professional.

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The provided FDA 510(k) clearance letter for the "Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) & IDA Cartridge with Medical Supervision Portal and IDA Smartphone App" primarily focuses on the substantial equivalence determination for regulatory clearance. It does not contain specific details about the acceptance criteria or a detailed study proving the device meets those criteria, as typically found in clinical study reports or more comprehensive device descriptions.

The letter confirms the device's classification, intended use, and substantial equivalence to predicate devices, but lacks the in-depth technical and clinical performance data required to answer your specific questions about acceptance criteria, detailed study methodology, ground truth establishment, or human-AI interaction effects.

Therefore, I cannot provide the requested information from the given text. To answer your questions, you would typically need to consult a detailed clinical study report, a regulatory submission, or technical documentation for the device, which are not included in this FDA clearance letter.

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The Fresenius Liberty Select Cycler is indicated for acute and chronic peritoneal dialysis.

The Liberty Select Cycler is a software-controlled electro-mechanical medical device designed to deliver Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD). The Cycler is designed as a table-top unit that can be used to perform peritoneal dialysis (PD) in hospitals, dialysis clinics, and at home. The software has been updated from version 2.9.2 to introduce the Remote Therapy Programming feature. This feature allows the Cycler to securely receive prescription settings remotely from a Fresenius server.

The provided text describes a 510(k) premarket notification for the Fresenius Liberty Select Cycler, focusing on a software modification (Remote Therapy Programming feature). The document emphasizes that there are no changes to the fundamental device characteristics or performance specifications compared to the predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the Liberty Select Cycler has the same essential performance characteristics as the predicate device (K181108). The acceptance criteria are presented as "Specifications" for key features:

Note: The document doesn't provide specific "reported device performance" values for these characteristics for the modified device. Instead, it states that the modified device has the "same essential performance characteristics" as the predicate and that "test results demonstrate that the differences between the proposed and the predicate devices do not raise any new concerns with regard to safety or effectiveness." This implies that the modified device performs within these established specifications.

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "Unit, software, regression (system verification), and validation testing" and "Human Factors Validation Testing" but does not detail the specifics of these test sets.

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications. The testing mentioned (software verification, human factors) would typically involve engineering and possibly human factors specialists, but no details are given.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

No MRMC comparative effectiveness study is mentioned in the document. The submission focuses on substantial equivalence based on a software modification, not a comparison of human reader performance with and without AI assistance.

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

The device is a medical cycler, not an AI algorithm for diagnostic purposes. The "Remote Therapy Programming feature" is a software update that allows the device to receive prescription settings remotely. This is a functional update to the device's operational capabilities, not a standalone diagnostic algorithm. Therefore, "standalone" algorithm performance in the typical sense (e.g., for image analysis) is not applicable or discussed. The testing done covers software verification and validation, as well as human factors for the new feature.

7. Type of Ground Truth Used

For the specific performance characteristics listed (inflow, outflow, temperature, volume accuracy), the ground truth would be established by physical measurements and engineering standards against the device's design specifications. The document implies these were the basis for demonstrating equivalence to the predicate device.

For the software verification and validation testing, the "ground truth" would be the expected functional behavior and security requirements of the software, as defined in design documents and specifications, and adherence to relevant standards (e.g., ANSI/AAMI/IEC 62304 for medical device software lifecycle).

For the human factors validation testing, the "ground truth" would be safe and effective use of the device, particularly with the new remote programming feature, as measured against usability metrics and error rates.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning. The software modification described involves a new feature for remote programming, not a machine learning algorithm that requires training data.

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

As no training set for machine learning is mentioned, this information is not applicable.

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The Lilliput™ APD System is indicated for adult chronic peritoneal dialysis in home and clinical settings.

The Lilliput APD System is available in one (1) configuration that includes an electromechanical cycler (hereinafter referred to as "Cycler"), disposable set (hereinafter referred to as "Disposable Set''), USB key, and Kinexus Gateway. The Disposable Sets are available in three (3) configurations:

• . Lilliput Disposable Set, One Patient Connector (Low feature)
• Lilliput Disposable Set, One Patient Connector with Extended Drain and Patient Lines (Medium Feature)
• . Lilliput Disposable Set, Two Patient Connectors with Extended Drain and Patient Lines (High Feature)

The Cycler is a software-controlled electromechanical device. The Disposable Sets are single-use Class II devices designed to operate with the Cycler to perform Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD). The Disposable Sets are provided sterile and non-pyrogenic and are sterilized using ethylene oxide (EO).

The provided text describes the acceptance criteria and performance data for the Lilliput™ APD System, but it does not detail a study proving the device meets acceptance criteria in the context of diagnostic performance involving human readers or ground truth established by experts/pathology. Instead, the document focuses on engineering and safety performance criteria typical for a medical device.

Therefore, many of the requested fields cannot be filled as the information is not present in the provided text, particularly for AI/diagnostic performance studies.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document lists "Essential Performance Specifications/Characteristic" in Table 4 and also describes various performance tests. The reported device performance is generally stated as "verified," "determined," or "acceptable results obtained," without specific numerical outcomes in all cases.

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