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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 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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The NuCath™ Wedge Pressure Catheter is indicated for measuring pressure in the right heart (including central venous pressure, right ventricle pressure, pulmonary artery pressure, and pulmonary artery wedge pressure).

The NuCath Wedge Pressure Catheter is an intravascular catheter with a balloon at the distal tip intended to measure pressure in the right heart.

The provided text describes a 510(k) premarket notification for the NuCath Wedge Pressure Catheter. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and detailed performance results in the way one might expect for a de novo submission or a clinical trial.

However, I can extract the information relevant to acceptance criteria and the study that proves the device meets the acceptance criteria by interpreting the "performance testing" section as the "study" conducted.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table with quantitative acceptance criteria values and corresponding quantitative performance values for each test. Instead, it states: "The subject device met all predetermined acceptance criteria as defined in the referenced and internal standards." This implies the tests were conducted with pass/fail criteria, and the device passed all of them.

Below is a table listing the performance tests conducted, with the understanding that the "Reported Device Performance" is implicit as meeting the (unspecified) acceptance criteria for each test.

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

• Sample Size for Test Set: The document does not specify the exact sample sizes used for each performance test. It lists the types of tests performed.
• Data Provenance: The tests are non-clinical (bench testing) performed by the manufacturer (PFM Medical, Inc.). This implies the data is prospective in the sense that the tests were conducted specifically for this submission, and the country of origin would be where the manufacturer's testing facilities are located (implied to be the US based on the Carlsbad, California address).

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

This question is not applicable in the context of this 510(k) submission. The "ground truth" for non-clinical performance and design verification testing is established by engineering specifications, recognized standards (e.g., ISO, ASTM), and internal company standards. There are no "experts" in the sense of clinical reviewers establishing ground truth for a test set in this type of submission; rather, the data is compared against predefined technical criteria.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies for medical image analysis where multiple readers evaluate cases and a consensus or tie-breaking mechanism is needed. For non-clinical bench testing, the results are objectively measured and compared against established engineering and material specifications.

5. If a Multi Reaser Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving human interpretation of results, like imaging software) to assess the impact of a device on human reader performance. The NuCath Wedge Pressure Catheter is a physical diagnostic catheter, and its performance evaluation focuses on its physical and functional attributes.

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

Yes, the performance testing described is essentially a "standalone" evaluation of the device itself (algorithm only performance). The tests listed (e.g., burst strength, inflation/deflation, radiodetectability) assess the device's technical specifications and physical integrity without human interaction being part of the primary performance metric for the device's basic function. The device's primary function is to measure pressure, and the tests verify the components that enable this function.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests conducted on the NuCath Wedge Pressure Catheter is based on:

• Engineering Specifications: Designed values and tolerances for dimensions, material properties, and functional characteristics.
• Referenced Standards: International and national standards such as ISO 10555-1, ISO 10555-4, ASTM F640-12, ISO 80369 series, and ISO 10993-1. These standards define test methods and often acceptable performance ranges for specific aspects of medical devices.
• Internal Standards: Manufacturer's own established quality and performance criteria.

These form the objective criteria against which the device's physical and functional performance is measured.

8. The Sample Size for the Training Set

This question is not applicable. The NuCath Wedge Pressure Catheter is a physical medical device, not an AI/ML algorithm that requires a "training set" of data in the computational sense. The "development" of the device involves engineering design, material selection, and manufacturing processes, not data-driven training.

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

This question is not applicable as there is no "training set" for this physical device.

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The primeMIDLINE™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling and power injection of contrast media. These catheters are indicated for patients older than 28 days and that weigh more than 10 kg, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The primeMIDLINE™ Catheters are suitable for use with power injectors.

The 4F DL primeMIDLINE™ Catheter is a peripherally placed midline catheter designed to provide access to the vascular system. The catheter lumen is an open-ended design comprised of radiopaque polyurethane. The 4F DL primeMIDLINE ™ Catheter is packaged sterile in a tray with the accessories necessary to establish short-term (less than 30 days) vascular access. The 4F DL primeMIDLINE Catheter is suitable for use with power injectors.

The provided text describes a 510(k) submission for a medical device (4F Dual Lumen primeMIDLINE™ Catheter) and focuses on demonstrating its substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria based on a study with a test set, expert ground truth, and statistical performance metrics commonly seen in studies for AI/ML-enabled devices.

Therefore, the requested information regarding a table of acceptance criteria and reported device performance, sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and training set ground truth establishment is not present in the provided document.

This document details the regulatory pathway for a conventional medical device, emphasizing its similarity to a previously cleared predicate device through comparisons of intended use, technological characteristics, and performance testing (e.g., tensile strength, flow rate). These tests are typically engineering/bench tests rather than clinical studies with human "ground truth" and reader performance metrics.

Here's a breakdown of what is provided and why it doesn't fit the requested AI/ML study format:

1. Acceptance Criteria and Reported Device Performance: Instead of performance in terms of diagnostic accuracy or reader improvement, the document lists various non-clinical performance tests conducted on the device (e.g., Visual Inspection, Tensile Strength, Catheter Elongation, Radiopacity, Lifecycle Performance, Static Burst Pressure, Power Injection Flowrate, Biocompatibility tests). The acceptance criteria for these tests are stated as having been "met all predetermined acceptance criteria as defined in the referenced Standards, FDA Guidance Document or PFM Medical, Inc. Internal Standards." Specific numerical results are not provided in this summary but would be in the full submission.

2. Sample Size for Test Set and Data Provenance: Not applicable in the context of the reported performance testing. These are bench tests on manufactured units, not a dataset of patient cases.

3. Number of Experts & Qualifications for Ground Truth: Not applicable. Ground truth for these tests would be objective measurements (e.g., a caliper for dimensional characteristics, a flow meter for flow rate).

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is for evaluating changes in human reader performance, typically with AI assistance.

6. Standalone Performance: Not applicable. This device is a physical catheter, not an algorithm.

7. Type of Ground Truth Used: For non-clinical tests, "ground truth" refers to the objectively measured values compared against specifications derived from standards or internal requirements.

8. Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable. This device does not involve machine learning or training a model.

In summary, the provided document describes the regulatory clearance of a physical medical device (a catheter) based on its substantial equivalence to an existing device and a series of engineering and biocompatibility tests. It does not contain information about an AI/ML-based device study with a "test set" in the diagnostic sense, expert ground truth, or human reader performance metrics.

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The primeMIDLINE™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling and power injection of contrast media. These catheters are indicated for patients older than 28 days and that weigh more than 10kg, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The primeMIDLINE™ Catheters are suitable for use with power injectors.

The primeMIDLINE™ Catheters are a family of peripherally placed midline catheters designed to provide access to the vascular system. These catheters are offered in 3F, 4F and 5F Single Lumen and 5F Dual Lumen configurations with 20cm lengths. The catheter lumen is an open-ended design comprised of radiopaque polyurethane. Each primeMIDLINE™ Catheter is packaged sterile in a tray with the accessories necessary to establish short-term (less than 30 days) vascular access. The primeMIDLINE™ Catheters are suitable for use with power injectors.

The document provided describes the primeMIDLINE™ Catheters and their substantial equivalence to a predicate device, PowerMidline Catheters. It outlines verification testing performed to demonstrate that the device performs as intended and meets established acceptance criteria.

However, the document does not contain information about a study comparing the device's performance against specific acceptance criteria in the format requested. While it lists various performance testing categories, it does not provide:

• A table of specific quantitative acceptance criteria for each test (e.g., "Tensile Strength should be > X N") and the reported device performance against those criteria.
• Details on sample sizes for a "test set" in the context of device performance, data provenance, or the number/qualifications of experts for ground truth.
• Information on adjudication methods, MRMC comparative effectiveness studies, or standalone algorithm performance, as these are typically relevant to AI/diagnostic imaging devices, not direct hardware performance.
• The type of ground truth used for performance validation.
• Training set sample size or how ground truth was established for a training set (again, this points more towards AI/ML studies).

Instead, the document states: "The subject devices met all predetermined acceptance criteria as defined in the referenced Standards, FDA Guidance Documents or PFM Medical, Inc. Internal Standards." This is a general statement that the device passed all tests, but without quantifying the criteria or the results.

Therefore, based on the provided text, I cannot complete the table or answer most of the requested questions because the specific data is not available.

Summary of available information:

• Device: primeMIDLINE™ Catheters
• Predicate Device: PowerMidline Catheters (K153393)

1. Table of Acceptance Criteria and Reported Device Performance:

Study Information (based on available text):

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

• Not specified. The document states "design verification testing" was conducted but does not provide sample sizes for individual tests or data provenance.

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/Not specified. The testing described is performance testing of a physical device against standards, not expert-adjudicated diagnostic performance.

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

• Not applicable/Not specified.

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 type of study is for diagnostic tools, typically AI-powered. The device is a physical catheter.

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

• No. This is not an algorithm.

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

• "Predetermined acceptance criteria as defined in the referenced Standards, FDA Guidance Documents or PFM Medical, Inc. Internal Standards." This refers to objective measurements against established engineering and safety standards.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

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