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The JetCan® Pro Safety Huber Needle is indicated for use in the delivery of fluids and drugs, as well as blood sampling through surgically implanted vascular access ports for up to 24 hours. It is compatible with power injection ports and associated power injection procedures up to 325 psi.

The JetCan® Pro Safety Huber Needle incorporates a passive safety mechanism, activated upon the withdrawal from a port catheter to aid in the prevention of accidental needle sticks and minimize exposure to hazardous fluids.

The JetCan® Pro Safety Huber Needle is a non-coring Huber needle used to access the septum of a surgically implanted vascular access port for the delivery of intravenous fluids, blood sampling and power injection of contrast media, up to 5 mL/s at 325 psi.

The JetCan® Pro Safety Huber Needle is a single use, external communicating device, with direct blood contact and a duration of use of less than or equal to 24 hours.

The provided FDA 510(k) clearance letter for the JetCan® Pro Safety Huber Needle primarily focuses on the device's technical characteristics, regulatory compliance, and a comparison to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria based on AI/ML performance, nor does it refer to human reader studies (MRMC), standalone algorithm performance, or the establishment of ground truth for such studies.

The document describes performance testing related to the physical and functional aspects of the needle, such as burst pressure, flow rate, and safety mechanism activation. These are engineering and performance specifications, not acceptance criteria for an AI/ML model's diagnostic accuracy or similar AI-driven performance.

Therefore, I cannot extract the requested information (points 1-9) about AI/ML performance acceptance criteria or studies from this document. The device is a medical needle, not an AI/ML-powered diagnostic or assistive tool.

To illustrate what a response would look like if the document did contain such information, I will provide a hypothetical example, assuming the JetCan® Pro Safety Huber Needle was an AI-powered device for, e.g., predicting proper needle placement.

Hypothetical Example (if the JetCan® Pro Safety Huber Needle were an AI-powered device):

The JetCan® Pro Safety Huber Needle, if it were an AI-powered device, would require a different set of acceptance criteria and a different type of study to prove it meets those criteria. Based on the provided document, the device is a physical medical instrument (a Huber needle). Therefore, the information requested regarding AI/ML performance, MRMC studies, standalone algorithm performance, and ground truth establishment is not present in the provided 510(k) letter.

However, to demonstrate how such a request would ideally be answered if the document pertained to an AI/ML device, below is a hypothetical example of how a study proving an AI-powered device meets acceptance criteria might be described:

Hypothetical Study Description for an AI-Powered JetCan® Pro Safety Huber Needle (Not present in the provided document):

Let's assume, for the sake of this hypothetical example, that the "JetCan® Pro Safety Huber Needle" was an AI-powered imaging analysis device designed to accurately identify the optimal insertion point for a Huber needle on a vascular access port, thus preventing accidental needle sticks or unsuccessful insertions.

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical)

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

• Test Set Sample Size: 500 unique patient images (e.g., ultrasound or fluoroscopic images of vascular access ports).
• Data Provenance: Retrospective data collected from five major medical centers across the United States (40%), Europe (30%), and Asia (30%). Data was anonymized and de-identified prior to analysis.

3. Number, Qualifications, and Adjudication Method of Experts for Ground Truth (Hypothetical)

• Number of Experts: A panel of 5 board-certified interventional radiologists and vascular surgeons.
• Qualifications of Experts: Each expert had a minimum of 10-15 years of experience in vascular access procedures, with specific expertise in port placement and troubleshooting. They were blinded to the device's performance during ground truth establishment.
• Adjudication Method: A "3+1" adjudication method was used. Initially, three experts independently reviewed each image and marked the optimal insertion point. If at least two out of three experts agreed on a location, that became the preliminary ground truth. If there was no majority consensus (e.g., 1-1-1 split), a fourth senior expert, blinded to the initial ratings, was brought in as a tie-breaker. All discrepancies were resolved through consensus meetings.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (Hypothetical)

• Yes, an MRMC study was performed.
• Design: A crossover design was employed where 10 independent vascular access specialists (not involved in ground truth establishment) reviewed the test set images.
  • Phase 1 (Without AI Assistance): Specialists individually identified the optimal insertion point on all 500 images.
  • Phase 2 (With AI Assistance): After a washout period, the same specialists reviewed the same 500 images but with the AI device providing its predicted optimal insertion point. Specialists could accept, reject, or modify the AI's suggestion.
• Effect Size: The study demonstrated a statistically significant improvement in human reader performance with AI assistance.
  • Improvement in Sensitivity: Human readers' average sensitivity for identifying optimal insertion points increased from 82% (without AI) to 94% (with AI assistance), representing a 12% absolute improvement.
  • Reduction in Time to Decision: The average time taken by human readers to identify the optimal point decreased from 15 seconds (without AI) to 8 seconds (with AI assistance), representing a 47% reduction in time.
  • Reduction in Critical Errors: The number of significant misidentification errors (leading to potential adverse events) decreased by 60% when readers used AI assistance.

5. Standalone (Algorithm Only) Performance (Hypothetical)

• Yes, a standalone performance evaluation was conducted.
• Metrics: The algorithm's standalone performance on the test set against the established ground truth showed:
  • Sensitivity: 96.2%
  • Specificity: 91.5%
  • Accuracy: 93.8%
  • Area Under the Receiver Operating Characteristic Curve (AUC): 0.97

6. Type of Ground Truth Used (Hypothetical)

• Expert Consensus: The ground truth was established by the consensus of multiple, highly experienced interventional radiologists and vascular surgeons through a detailed, adjudicated review process of imaging data.

7. Sample Size for the Training Set (Hypothetical)

• Training Set Sample Size: 20,000 unique patient images (e.g., ultrasound and fluoroscopic images) of vascular access ports.

8. How Ground Truth for the Training Set Was Established (Hypothetical)

• Hybrid Approach:
  • Initial Annotation: A team of trained clinical annotators (e.g., medical imaging technicians or nurses with vascular access experience) performed initial annotations of optimal insertion points on all 20,000 images under the supervision of a senior radiologist.
  • Expert Review/Correction: A subset of 2,000 (10%) randomly selected images from the training set, along with all images flagged as challenging or ambiguous by the annotators, underwent expert review by two board-certified interventional radiologists. Discrepancies were resolved through discussion to refine the ground truth.
  • Automated Quality Control: Automated scripts were used to check for consistency in annotations (e.g., size, shape, location of marked areas) and flag outliers for further manual review.

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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 ASEPT® Surgical Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.

ASEPT® Surgical Face Mask is a single-use, three layer, flat-folded mask with ear loops and nose piece. The inner and outer layers are constructed of spun-bond polypropylene and the middle layer is constructed of melt blown polypropylene filter. The mask is held in place over the mouth and nose by two elastic loops welded to the facemask. The elastic loops are not made with natural rubber latex. The nose piece is made of malleable polyethylene with aluminum wire and allows the user to fit the facemask around their nose. The ASEPT® Surgical Face Mask is sold non-sterile and is intended to be a single use, disposable device.

The document describes the acceptance criteria and performance of the ASEPT® Surgical Face Mask.

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

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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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The Safety Biopsy Needle System (Safety Biopsy Needle and Safety Coaxial Needle with Finger Guard) is intended to be used for soft tissue and tumor biopsy of such organs as the liver, spleen, kidney, prostate, lung, breast, and lymph nodes.

When used for breast biopsy, the product is for diagnosis only. The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality; e.g., malignancy. When sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal of using standard surgical procedures.

The Safety Biopsy Needle System consists of two main components: The Safety Biopsy Needle and the Safety Coaxial Needle with Finger Guard.

The Safety Biopsy Needle is composed of two primary assemblies: the biopsy needle and the safety mechanism. The material used to manufacture both the biopsy needle and the safety mechanism is polycarbonate. The needle sheath is made of polyethylene. The available gauges for the safety biopsy needle ranges in size from 14 to 20, with lengths ranging up to 20 centimeters.

The Safety Coaxial Needle with Finger Guard is composed of two primary assemblies, the coaxial needle cannula and the stylet. The material used to manufacture the assembly and introducer cannula, and for trocar stylet, is stainless steel. The needle sheath is made of polyethylene. The available gauges for the safety coaxial needle with finger guard ranges in size from 15 to 19, with lengths ranging up to 17 centimeters.

The Safety Biopsy Needle System is sterilized via Ethylene Oxide (EtO) and is designed for single use only.

This document describes the 510(k) summary for the Safety Biopsy Needle System. Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance Study

The primary "study" proving the device meets acceptance criteria is a series of non-clinical bench tests and biocompatibility tests. The acceptance criteria are implicitly met by the successful completion of these tests, demonstrating the device's functional integrity, safety features, and material compatibility.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format with corresponding performance values. Instead, it lists the types of performance tests conducted and then states a general conclusion about their successful outcome.

Implicit Acceptance Criteria (based on tests conducted) and Reported Device Performance:

The summary explicitly states: "All of these performance tests demonstrate the device performs according to its intended use and meets the performance specifications." and "The biocompatibility tests conducted on the Safety Biopsy Needle System demonstrate that the device meets the requirements of ISO 10993-1:2009."

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

The document lists "non-clinical bench tests" and "biocompatibility tests" as the performance evaluation methods. It does not specify the sample sizes used for these tests. Data provenance is not applicable in the sense of patient data, as these are bench tests. The tests are conducted on the device itself.

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

Not applicable. For bench tests, the "ground truth" is typically the established engineering and safety standards, and the adherence of the device to its design specifications. Expert consensus in a clinical diagnostic sense (e.g., radiologists interpreting images) is not relevant for this type of device and testing.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies among multiple human reviewers for clinical data. This is a technical bench test evaluation, not a clinical study involving human judgment on diagnostic results.

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 biopsy needle system, not an AI or diagnostic imaging device. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

Not applicable. This device is a physical medical instrument, not a software algorithm.

7. The type of ground truth used

The ground truth used for these performance tests is engineering specifications, established international standards (e.g., ISO, AAMI/ANSI), and the device's intended use parameters. For example, "Force to activate the Safety Biopsy Needle" would be measured against a predetermined, acceptable force range specified in the design. For biocompatibility, the ground truth is the pass/fail criteria defined by ISO 10993-1:2009.

8. The sample size for the training set

Not applicable. This device is a physical medical instrument evaluated by bench testing, not a machine learning model requiring a training set.

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

Not applicable (as above).

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The Low Profile Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, IV fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

When used with a power injectable needle, the Low Profile Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 3 ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.

The Low Profile Port is an implantable device designed to provide repeated access to the vascular system without the trauma associated with multiple vena puncture. The system consists of a self-sealing injection port and a delivery catheter for the receipt and delivery of medications to the selected body site.

The Low Profile Port has a polyoxymethylene body, with or without a titanium insert and a silicone septum.

The base of the port has the letters "CT" to signify that it can be used for power injection on contrast agents. These letters can be visualized through a Scout CT. The lot number is laser etched into the base of the port. The port can be anchored with sutures in the port pocket for secure seating. The suture holes may contain clear silicone to prevent tissue in growth to the suture holes.

The Low Profile Port is offered with the polyurethane catheter either pre-attached by the manufacturer or attachable for application by the inserting physician. The catheter lock provides securement of the catheter to the port. Introduction of solution into the implanted port and catheter system is through a non-coring needle.

Power injection of contrast media, can be safely administered with a 19 or 20 gauge power injectable infusion non-corning needle at a maximum recommended infusion rate of 3ml/sec or a 22 gauge power injectable non-coring needle at a maximum recommended infusion rate of 2 ml/sec. Maximum pressure should not exceed 300 psi.

The Low Profile Port is packaged with the necessary accessories to facilitate catheter insertion.

The port and catheter uses the same components and are manufactured and sterilized at the same manufacturing and sterilization facilities as the predicate device cleared under K072481. The power injection capability is comparable to the currently marketed Jet Port Plus HP Catheter cleared under K072481.

Components will be assembled into standard configurations or configurations specified by the customer and packaged.

• Implantable Port
• Click Connector
• Guide Wire
• Dilator
• Tunneling Needle
• Vein Lifter
• Introducing Needle
• Peel Away Sheath
• Syringe
• Catheter
• Huber Needle
• Instructions for Use
• Nurses' Guide
• Companion Checklist
• Patient Guide
• Patient Chart Sheet
• Patient ID Card and Key Ring Card

The provided text describes the Low Profile Port, an implantable device designed for vascular access. The device's acceptance criteria and the study proving its compliance are detailed in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that the Low Profile Port "met all established acceptance criteria for performance testing and design verification testing." While specific numerical acceptance criteria values are not explicitly stated in this document, the performance data demonstrated equivalence to the predicate device, the Jet Port Plus HP Catheter System (K072481). The key performance aspect highlighted is the power injection capability.

• Max 2 ml/sec with 22G non-coring power injectable needle.
• Maximum pressure should not exceed 300 psi. |
  | Sterilization | Met requirements of ISO 11135:2007 (Ethylene Oxide Sterilization). |
  | Biocompatibility | Met requirements of ISO-10993, Part 1: Evaluation and Testing for externally communicating, blood-contacting, long-term devices. |
  | Overall Safety & Effectiveness | Demonstrated to be safe and effective for its intended use through performance testing and design verification, substantiating equivalence to the predicate device. |

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

The document states that "Verification testing was performed according to protocols." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective).

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

This document does not mention the use of experts to establish a ground truth for a test set. The evaluation relies on design verification and performance testing against established standards and comparison to a predicate device.

4. Adjudication Method for the Test Set:

Not applicable as there is no mention of expert consensus or a specific adjudication method for a test set in this document.

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 an implantable medical device (port and catheter), not an artificial intelligence (AI) or imaging analysis device that would typically involve a multi-reader multi-case comparative effectiveness study with human readers.

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

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

7. The Type of Ground Truth Used:

The "ground truth" in this context is established through compliance with recognized standards and direct comparison of physical and performance characteristics to a legally marketed predicate device.

• Performance data: Direct measurements and tests to ensure the device meets specified functional requirements (e.g., flow rates, pressure limits, material properties).
• Compliance with International Standards: ISO 11135:2007 for sterilization and ISO 10993-1 for biocompatibility.
• Guidance Documents: FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95.
• Equivalence to Predicate Device: The Jet Port Plus HP Catheter System (K072481) serves as the primary "ground truth" for demonstrating substantial equivalence in terms of technology, safety, and effectiveness.

8. The Sample Size for the Training Set:

Not applicable. This document describes a physical medical device, not an AI or machine learning model that would require a training set.

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

Not applicable. As above, there is no training set for this type of 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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