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The RITA Medical Systems UniBlate Electrosurgical Device is intended to coagulate tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.

The UniBlate Electrosurgical Device is a monopolar radiofrequency (RF) device that consists of a variably insulated electrode. The instrument has an attached electrical cable and infusion tubing set which connects the device directly to the RITA Medical 1500X RF generator and the IntelliFlow peristaltic pump respectively. The electrical cable provides RF energy and temperature feedback to the generator and the pump infuses normal saline through the infusion tubing set. The UniBlate Electrosurgical Device is a single use device.

The provided text describes a 510(k) summary for the UniBlate Electrosurgical Device. This regulatory submission primarily focuses on demonstrating substantial equivalence to predicate devices through performance testing, rather than establishing clinical efficacy through a detailed study with specific acceptance criteria as one might find for a novel therapeutic device.

Therefore, the requested information regarding "acceptance criteria" based on a study of clinical performance, "sample size for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "sample size for the training set" is not explicitly available within the provided text.

The document indicates that "Performance testing was done to ensure that the UniBlate Device functions as intended and meets design specifications." However, it does not detail these design specifications as specific quantitative acceptance criteria or report device performance against them in a table format. The primary goal of this 510(k) submission is to show that the device is "substantially equivalent to the predicate device, and meets safety and effectiveness criteria" through these performance tests, which are not described in detail.

Here's what can be extracted and inferred from the text:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided in the document. The text states: "Performance testing was done to ensure that the UniBlate Device functions as intended and meets design specifications. Sufficient data was obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria." This implies that internal acceptance criteria were met, but they are not listed, nor are specific performance metrics reported against them. The focus is on substantial equivalence to predicate devices (StarBurst XLi and Cool-Tip RF System) in terms of principles of operation, construction, and intended use.

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

Not explicitly provided in the document. The text mentions "Performance testing" but does not detail the nature, sample size, or provenance (country of origin, retrospective/prospective) of any clinical or technical test sets used for evaluating the device against its "design specifications."

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

Not applicable/provided. The document describes performance testing for device functionality and design specifications, not a study requiring expert-established ground truth for clinical outcomes or diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable/provided. No information on an adjudication method is discussed, as the document focuses on technical performance and substantial equivalence.

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

No. The document does not mention an MRMC comparative effectiveness study. The context is a device for tissue coagulation, not a diagnostic imaging device where such studies are common.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The UniBlate device is an electrosurgical device, not an algorithm. The concept of "standalone performance" in this context would relate to the device operating as designed, independent of human intervention in its function, which is implicitly what "Performance testing was done to ensure that the UniBlate Device functions as intended and meets design specifications" refers to. However, this is not detailed as a separate study.

7. Type of Ground Truth Used

Device-specific test parameters/design specifications, implicitly. For an electrosurgical device, "ground truth" for performance testing would typically refer to established engineering and safety standards, as well as the ability to achieve defined tissue coagulation parameters (e.g., lesion size, temperature profiles) in a controlled environment, demonstrating it functions "as intended." However, these specific "ground truths" (e.g., measurements of coagulation zone, power output, temperature feedback accuracy) are not detailed in the summary. The overarching "ground truth" for the 510(k) is substantial equivalence to legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable/provided. This device is hardware and does not involve AI or machine learning that would require a "training set."

9. How Ground Truth for the Training Set Was Established

Not applicable. As above, no training set is discussed or implied.

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The Vortex® CT Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and the sampling of blood.

When used with non Y site LifeGuard Safety infusion sets in 20 Ga or 19Ga sizes, the Vortex® CT Port Access System is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec.

The LifeGuard® Safety Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

When used with the Vortex® CT Port Access System, the LifeGuard® Safety Infusion Set is also indicated for power injection of contrast media into the central venous system. For power injection of contrast media, only models LG-19-75, LG-19-100, LG-20-75, LG-20-100, and LG-20-150 may be used at a maximum infusion rate of Sml/sec.

The Vortex® CT Port is a Titanium port with a self sealing silicone rubber septum designed to maintain integrity after punctures with a non-coring needle. The port has a hollow area, or reservoir, under the septum through which fluid passes during infusion or aspiration. The Vortex design features a proprietary reservoir with rounded walls giving it a toroidal shape. The outlet stem is located tangential to the reservoir wall allows fluid to pass between the reservoir and the catheter. The Vortex® Port Access systems offer models with single lumen 7.5 French to 9.6 French catheters made from either polyurethane or silicone. The catheters all contain radiopacifiers, and depth markings.

The LifeGuard safety infusion set is a port access needle set with an integrated proprietary safety feature to prevent re-bound injury. The safety infusion set includes a huber needle, a winged housing, non-DEHP PVC extension legs, and a luer standard connector.

This document describes the non-clinical performance data for the Vortex® CT Port Access System and LifeGuard® Safety Infusion Set, which is a medical device for vascular access and power injection of contrast media.

Here's the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific "reported device performance" values for each test, but rather indicates that the tests were performed to establish substantial equivalence, safety, and effectiveness. The "Required Results" column from the provided table serves as the acceptance criteria.

The study concludes that "The non-clinical tests demonstrate that the device is as safe, as effective for the modified intended use." This statement implies that the device met all the required results set as acceptance criteria for the non-clinical tests.

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

• Test Set Sample Sizes:
  • Sterilization exposure: All
  • Physiological exposure: All
  • Power injection Performance Test: 18
  • Simulated Power Injection: 30
  • Dynamic Failure Test: 18
  • Static Burst Test: 18
  • Life Cycle Power Injection Test: 10
  • Cyclic testing: 30, 10 cycles per port
  • Port Patency Verification: 5
  • Port Occlusion Test: 10
  • Puncture Life: 2
• Data Provenance: The data is from non-clinical testing. There is no mention of country of origin for the data (as it's laboratory-based testing, not human patient data) and it is inherently prospective as it involves conducting specific tests on the devices.

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

Not applicable. This is a submission for a physical medical device (Vortex® CT Port Access System and LifeGuard® Safety Infusion Set) and the testing performed is non-clinical/pre-clinical (laboratory-based physical and performance testing), not involving human interpretative tasks or diagnostic assessment. Therefore, no experts were used to establish ground truth in the context of diagnostic accuracy, and no qualifications of such experts are relevant.

4. Adjudication Method for the Test Set

Not applicable, for the same reasons as point 3. The tests are objective physical and performance measurements with defined pass/fail criteria, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical port and infusion set, not an AI or imaging diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant to its evaluation.

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

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

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

The "ground truth" for the non-clinical tests is based on pre-defined engineering specifications and performance requirements. These are objective, measurable outcomes (e.g., "no bursts, leaks, / plastic deformations allowed," "meet expected flow rate and pressure withstand requirements," "withstand 10 cycles").

8. The sample size for the training set

Not applicable. Since this is a physical medical device and not an AI/machine learning model, there is no "training set."

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

Not applicable, for the same reason as point 8.

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The OmniPICCPI Peripherally Inserted Central Catheter is indicated for use in attaining short and long term vascular access for administration of medications, parenteral nutrition, IV fluids, blood products or blood withdrawal. The OmniPICCPI is indicated for power injection of contrast media at a maximum recommended infusion rate of 3ml/sec and maximum pressure or pounds per square inch (psi) of 300 psi.

The Peripherally Inserted Central Catheter (OmmiPICC P.I.) kit includes a catheter and introduction components. The catheter is a percutaneous central venous catheter inserted peripherally. The catheter is comprised of radiopaque polyurethane tubing. The catheter is attached to an injection molded polyurethane hub with extension leg(s) for access via a luer lock device. Each product is packaged in a sterile tray with appropriately sized introducer components. This PICC product line includes externally communicating central venous catheters of 60 cm that is trimmable from the distal end with a single 4 Fr single and 5 Fr dual lumen configurations. These are tested to withstand power injection of 3ml/sec (4 Fr Single) to 5 ml/sec at a maximum power injection setting of 300 psi.

The provided document is a 510(k) premarket notification for the OmniPICC P.I. (Peripherally Inserted Central Catheter). This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical trial to prove safety and effectiveness from scratch. Therefore, the information typically requested in your prompt regarding acceptance criteria, specific study designs (like MRMC), and detailed ground truth establishment for AI/algorithm-based devices is not present in this document because it pertains to a different type of device (a physical medical catheter) and regulatory pathway.

The document describes the device, its intended use, and its indications for use, highlighting its capability for power injection. The primary "study" involved is a comparison to a predicate device (Bard PowerPICC™ Catheter) to demonstrate substantial equivalence, rather than a clinical trial assessing performance against specific acceptance criteria in the way an AI diagnostic device would.

However, I can extract the relevant information that is present in the document. The "device performance" in this context refers to its physical capabilities for power injection, which are stated parameters rather than measured outcomes from a clinical study with a test set.

Here's the closest representation of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

The document describes the physical capabilities and new features of the OmniPICC P.I. to justify its substantial equivalence to predicate devices, particularly for power injection. The "acceptance criteria" for the device, in this context, are the specified physical performance limits it is designed to meet for safe and effective use during power injection procedures.

Study Details (Based on Substantial Equivalence Justification)

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

• Sample Size: Not applicable in the context of a clinical test set for AI. The "test" for this device involved comparing its physical and material characteristics, intended use, and indications for use against predicate devices. The document does not describe a clinical trial with a "test set" of patients or data.
• Data Provenance: Not applicable. The justification is based on design specifications and material properties, rather than patient data.

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. Ground truth as typically understood for AI algorithms (e.g., expert consensus on an image) is not relevant for this medical device submission. The "ground truth" for a substantial equivalence determination is the performance and safety profile of the predicate device and the engineering specifications of the new device.

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

• Not applicable. No clinical test set requiring adjudication of findings is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is not an AI/software device, therefore MRMC studies are irrelevant to this submission.

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 (expert consensus, pathology, outcomes data, etc.):

• For the purpose of a 510(k) for a physical medical catheter, the "ground truth" is established by a combination of:
  • Predicate Device Performance: The safety and effectiveness data and established performance of legally marketed predicate devices (OmniPICC PI™ Catheter, PowerPICC™ Catheter).
  • Engineering Specifications and Material Testing: The inherent physical properties, design, and manufacturing standards of the OmniPICC P.I. catheter, including its ability to withstand specified pressures and flow rates for power injection.
  • Regulatory Standards: Compliance with relevant FDA regulations (e.g., 21 CFR 880.5970).

8. The sample size for the training set:

• Not applicable. No training set for an algorithm is described.

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

• Not applicable. No training set for an algorithm is described.

Summary of the "Study" (510(k) Substantial Equivalence):

The document serves as a premarket notification (510(k)) to the FDA. The "study" described is a demonstration of substantial equivalence to previously cleared predicate devices (K051102 for OmniPICC PITM Catheter and K033389, K050931, K051672, & K051991 for PowerPICCTM Catheter by Bard Access Systems, Inc.).

Key points of this "study" are:

• Intended Use and Fundamental Scientific Technology: The OmniPICC P.I. is stated to be identical to its predicate device (Bard PowerPICC™) in these aspects.
• Configuration, Dimensions, and Materials: The two devices are stated to be substantially similar in these aspects. The 510(k) specifically aims to add new product codes in 4 French single and 5 French dual lumen sizes, which are within the scope of predicate devices' capabilities.
• Performance Claim: The device has been tested (implicitly, through engineering and design validation) to withstand power injection of 3ml/sec (4 Fr Single) to 5 ml/sec (5 Fr dual lumen) at a maximum power injection setting of 300 psi. This is a design specification intended to demonstrate equivalency or improvement upon predicate devices for similar power injection capabilities.

This type of submission does not involve clinical trials with human subjects or a statistical analysis of diagnostic accuracy that would be typical for an AI-powered device. Instead, it relies on a comparison of technical specifications, intended use, and materials to establish that the new device is as safe and effective as a device already on the market.

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The OmniPICC P.I. is intended to be used by medical professionals in patients who require either acute or long-term (chronic) peripheral central venous access for the infusion of medications, nutritional or other parenteral solutions, or blood products, and for the withdrawal of blood samples.

The OmniPICCPI Peripherally Inserted Central Catheter is indicated for use in attaining short and long term vascular access for administrations, parenteral nutrition, IV fluids, blood products or blood withdrawal. The catheter may be inserted via the basilic, cephalic and medial veins of the upper extremity. The catheter is intended for implantation dwell time of shorter or greater than 30 days. The maximum recommended infusion rate is 5ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.

The OmniPICCPI is indicated for power injection of contrast media at a maximum recommended infusion rate of 5ml/sec and maximum pressure or pounds per square inch (psi) of 300 psi.

The Peripherally Inserted Central Catheter (OmniPICC P.I.) kit includes a catheter and introduction components. The catheter is a percutaneous catheter inserted peripherally. The catheter is comprised of radiopaque polyurethane tubing. The catheter is attached to an injection molded polyurethane hub with extension leg(s) for access via a luer lock device. Each product is packaged in a sterile tray with appropriately sized introducer components. This PICC product line includes externally communicating central venous catheters of 60 cm that is trimmable from the distal end with a single 5 Fr lumen configuration. These are tested to withstand power injection of 5 cc/sec at a maximum power injection setting of 300 psi.

The provided text is a 510(k) summary for the OmniPICC P.I. (Peripherally Inserted Central Catheter). It focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through an AI/Machine Learning lens.

Therefore, I cannot fulfill your request for information regarding:

• A table of acceptance criteria and reported device performance (in the context of AI/ML).
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study, including effect size.
• Standalone algorithm performance.
• Type of ground truth used (beyond general clinical indications).
• Sample size for the training set.
• How ground truth for the training set was established.

This document is a regulatory submission for a medical device (a catheter), not an AI/ML product. The "acceptance criteria" discussed in such a document would typically refer to engineering specifications, biocompatibility, sterilization, and mechanical testing, not the performance metrics of an AI model against a ground truth.

If you have a document describing the validation of an AI/ML medical device, I would be happy to analyze it against your specified criteria.

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The Vortex® EZ Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood.

The Vortex® EZ Port Access System is a device comprised of a vascular access port, a catheter, locking mechanism and introduction components. The Vortex® EZ Port is available in a Delrin port body configuration with a self sealing silicone septum designed to maintain integrity after repeated punctures with a non-coring needle. The port base is crafted of silicone so that the port can be sutured to the underlying tissue anywhere around this base. A pre-attached or a detached/attachable catheter is offered in either polyurethane or silicone models with or without a highly radiopaque tip molded on. The products are packaged in sterile trays with introduction components.

The provided text is a 510(k) summary for the Vortex® EZ Port Access System. This type of document focuses on establishing substantial equivalence to a legally marketed predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for novel device performance.

Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes for test/training sets, number and qualifications of experts for ground truth, adjudication methods, MRMC study, standalone performance, type of ground truth used, how ground truth for training set was established) are not applicable or not present in the provided document.

Here's a breakdown of what can be extracted or inferred based on the provided text, and what cannot:

1. Table of acceptance criteria and the reported device performance:

• Not applicable/Not present. The document states, "The Vortex® EZ Port Access System design was evaluated through risk analysis and qualified through design verification testing following established Design Control procedures." However, it does not provide specific acceptance criteria or the reported performance data against those criteria. It relies on substantial equivalence to predicate devices (LifePort® VTX® Access System (K010767) and LifePort® LPS 7013 (K905852)).

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

• Not applicable/Not present. As this is a 510(k) for a device modification, clinical studies with test sets in the context of AI/imaging are not required or detailed here. The premarket notification focuses on design verification testing, which would involve engineering tests rather than patient data.

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

• Not applicable/Not present. No ground truth established by experts is mentioned, as this is not an AI/imaging device.

4. Adjudication method for the test set:

• Not applicable/Not present. No adjudication method is mentioned.

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/Not present. This device is a vascular access system, not an AI-assisted diagnostic tool. Therefore, an MRMC study is irrelevant.

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

• Not applicable/Not present. This is not an algorithm-based device.

7. The type of ground truth used:

• Not applicable/Not present. No ground truth in the context of clinical outcomes or pathology is used for this type of device submission. The "ground truth" for a medical device in a 510(k) context often relates to demonstrating that the device performs as intended and is safe and effective when compared to existing legally marketed devices, usually through engineering testing, biocompatibility testing, and sometimes bench or animal studies, not typically through clinical "ground truth" in the AI/diagnostics sense.

8. The sample size for the training set:

• Not applicable/Not present. This device is a physical medical device, not an AI model requiring a "training set."

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

• Not applicable/Not present. As above, no training set or ground truth in this context.

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