Search Results

Ask a specific question about this device

Vista OS is an accessory to 1.5T and 3.0T whole-body magnetic resonance diagnostic devices (MRDD). It is intended to operate alongside, and in parallel with, the existing MR console to acquire traditional, real-time and accelerated images.

Vista OS software controls the MR scanner to acquire, reconstruct and display static and dynamic transverse, coronal, sagittal, and oblique cross-sectional images that display the internal structures and/or functions of the entire body. The images produced reflect the spatial distribution of nuclei exhibiting magnetic resonance. The magnetic resonance properties that determine image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that may assist in the determination of a diagnosis.

Vista OS is intended for use as an accessory to the following MRI systems:

Manufacturers: GE Healthcare (GEHC), Siemens Healthineers
Field Strength: 1.5T and 3.0T
GE Software Versions: 12, 15, 16, 23, 24, 25, 26, 30
Siemens Software Versions: N4/VE; NX/VA

The Vista AI "Vista OS" product provides a seamless user experience for performing MRI studies on GE and Siemens scanners. The underlying software platform that we use to accomplish this task is called "RTHawk".

RTHawk is a software platform designed from the ground up to provide efficient MRI data acquisition, data transfer, image reconstruction, and interactive scan control and display of static and dynamic MR imaging data. It can control MR pulse sequences provided by Vista AI and, on scanners that support it, it can equally control MR pulse sequences provided by the scanner vendor. Scan protocols can be created by the user that mix and match among all available sequences.

RTHawk is an accessory to clinical 1.5T and 3.0T MR systems, operating alongside, and in parallel with, the MR scanner console with no permanent physical modifications to the MRI system required.

The software runs on a stand-alone Linux-based computer workstation with color monitor, keyboard and mouse. It is designed to operate alongside, and in parallel with, the existing MR console with no hardware modifications required to be made to the MR system or console. This workstation (the "Vista Workstation") is sourced by the Customer in conformance with specifications provided by Vista AI, and is verified prior to installation.

A private Ethernet network connects the Vista Workstation to the MR scanner computer. When not in use, the Vista Workstation may be detached from the MR scanner with no detrimental, residual impact upon MR scanner function, operation, or throughput.

RTHawk is an easy-to-use, yet fully functional, MR Operating System environment. RTHawk has been designed to provide a platform for the efficient acquisition, control, reconstruction, display, and storage of high-quality static and dynamic MRI images and data.

Data is continuously acquired and displayed. By user interaction or data feedback, fundamental scan parameters can be modified. Real-time and high-resolution image acquisition methods are used throughout RTHawk for scan plane localization, for tracking of patient motion, for detection of transient events, for on-the-fly, sub-second latency adjustment of image acquisition parameters (e.g., scan plane, flip angle, field-of-view, etc.) and for image visualization.

RTHawk implements the conventional MRI concept of anatomy- and indication-specific Protocols (e.g., ischemia evaluation, valvular evaluation, routine brain, etc.). Protocols are pre-set by Vista AI, but new protocols can be created and modified by the end user.

RTHawk Apps (Applications) are composed of a pulse sequence, predefined fixed and adjustable parameters, reconstruction pipeline(s), and a tailored graphical user interface containing image visualization and scan control tools. RTHawk Apps may provide real-time interactive scanning, conventional (traditional) batch-mode scanning, accelerated scanning, or calibration functions, in which data acquired may be used to tune or optimize other Apps.

When vendor-supplied pulse sequences are used in Vista OS, parameters and scan planes are prescribed in the Vista interface and images reconstructed by the scanner appear on the Vista Workstation. RTHawk Apps and vendor-supplied sequences can be mixed within a single protocol with a unified user experience for both.

Here's a breakdown of the acceptance criteria and study information for Vista OS, Vista AI Scan, and RTHawk, based on the provided FDA 510(k) clearance letter:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several clinical verification studies for new AI-powered features. Each feature has specific acceptance criteria.

2. Diagnostic quality of denoised data judged superior to paired non-denoised series in > 80% of test cases. | Meets or exceeds |
   | Automatic Brain Localizer Prescriptions | Mean error in plane angulation

Ask a specific question about this device

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, fentanyl citrate, xylazine, gastric acid, fentanyl in gastric acid and xylazine in gastric acid in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical gloves to Permeation by Chemotherapy Drugs.

Warning: do not use with Carmustine and Thiotepa.

The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time:

• Carmustine (BCNU) 3.3 mg/ml 21.5 minutes
• Thiotepa 10.0 mg/ml 13.6 minutes

"Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid" is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of this medical device is to provide single use barrier protection for the wearer and the device meets the specifications for Barrier Protection and tensile properties as defined in ASTM D6319-19, Standard specification for Nitrile Examination Gloves.

The provided document is an FDA 510(k) clearance letter for a medical device: "Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid."

This is a physical medical device (a glove), not a software device or an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML model validation (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of FDA submission.

The document assesses the device's physical properties and its resistance to permeation by various hazardous substances. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to bench testing against established ASTM and CFR standards for medical gloves.

Here's the breakdown of the relevant information from the document, tailored to the nature of this device:

Acceptance Criteria and Device Performance for Disposable Nitrile Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance

The device (Disposable Powder Free Nitrile Examination Glove, Blue Color) was tested against several physical and chemical permeation standards. The acceptance criteria and results are outlined in the "Assessment of Non-Clinical Performance Data" section (Page 17-19) and the "Indications for Use" section (Page 4-5) and summarized within the "510(k) Summary" (Page 7-11).

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

• Sample Size: The document does not explicitly state numerical sample sizes for each specific test (e.g., how many gloves were tested for a burst, tensile, or permeation). However, it implies that testing was conducted according to the specified ASTM and FDA methodologies, which inherently define minimum sample sizes for material testing (e.g., AQL levels for freedom from holes).
• Data Provenance: The tests are "bench testing" conducted on physical glove samples. The manufacturer is "Ever Global (Vietnam) Enterprise Corporation" from Vietnam, so the testing was likely conducted in accordance with international standards at a facility associated with the manufacturer or a certified testing lab. The data is non-clinical performance data from laboratory experiments, not patient data.

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

• Not Applicable. As this is a physical device subject to material property and permeation testing, "ground truth" is established by adherence to physical measurement standards and chemical analysis protocols (e.g., ASTM D6319-19 for physical properties, ASTM D6978-05 for permeation). No human expert interpretation or consensus is required to establish the "truth" of a chemical breakthrough time or tensile strength value.

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

• Not Applicable. Adjudication methods are relevant in subjective human interpretation tasks (e.g., radiology image reading). For objective bench testing of physical properties, results are determined by instrumentation and adherence to standardized protocols, not human 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. MRMC studies are used for evaluating the impact of AI on human reader performance, typically in medical imaging. This is a physical glove, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a physical device, not an algorithm.

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

• The "ground truth" is established through objective, standardized laboratory measurement methods as defined by the referenced ASTM (American Society for Testing and Materials) and CFR (Code of Federal Regulations) standards.
  • For physical properties (Dimensions, Tensile Strength, Elongation, Powder Residual, Freedom from Holes), the ground truth is the measured physical values against the defined thresholds in ASTM D6319-19 and 21 CFR 800.20 & ASTM D5151-19.
  • For chemical permeation (Resistance to Hazardous Drugs), the ground truth is the measured breakthrough time determined by chemical analysis according to ASTM D6978-05.
  • For Biocompatibility, the ground truth is the biological response (cytotoxicity, dermal reactions) as measured per AAMI/ANSI/ISO 10993-5 and 10993-10 standards.

8. The sample size for the training set:

• Not Applicable. This is a physical product, not a machine learning model; therefore, there is no "training set." The product's design and manufacturing process are developed through engineering and material science, not data training.

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

• Not Applicable. As there is no training set for this physical device.

Ask a specific question about this device

The Venclose System (Venclose digiRF Generator with EVSRF Catheter) is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

The Venclose™ digiRF Generator is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter to be used with the generator (time, temperature, etc.), which is connected via a triaxial catheter connector port. The Venclose™ digiRF Generator is intended to be used with Venclose™ RF Catheter(s) (either the Venclose™ EVSRF Catheter or the Venclose™ Maven Catheter) as a system. The Venclose™ RF System uses resistive radiofrequency ablation via energy delivery to heat the wall of an incompetent vein with temperature-controlled RF energy to cause irreversible luminal occlusion, followed by fibrosis and ultimately resorption of the vein.

The scope of this 510(k) is only the Venclose™ digiRF Generator as the generator software has been modified. The Venclose™ Maven Catheter is not in the scope of this submission as the changes discussed within this submission are only applicable to the Venclose™ digiRF Generator as used with the Venclose™ EVSRF Catheter. There is no change to the Venclose™ EVSRF Catheter, as previously cleared via K160754.

Based on the provided 510(k) Clearance Letter, the device in question is the "Venclose digiRF Generator" and the modifications are related to its software when used with the "Venclose EVSRF Catheter." The clearance letter states that the scope of this 510(k) is only the Venclose digiRF Generator as the generator software has been modified, and there is no change to the Venclose EVSRF Catheter.

The document explicitly states that the device is an "Electrosurgical Cutting And Coagulation Device And Accessories" and the testing performed was "Software Verification and Validation." There is no mention of a study involving human subjects, interpretation of medical images by experts, or any kind of diagnostic performance evaluation typically seen with AI/ML-based diagnostic devices.

Therefore, many of the requested criteria regarding acceptance criteria for diagnostic performance, ground truth establishment, expert adjudication, MRMC studies, and training/test set details for AI/ML models are not applicable to this submission. This is a clearance for a software modification to an electrosurgical generator, not a medical imaging AI/ML diagnostic aid.

Here's the breakdown of what can be gathered from the provided text, addressing the points where information is available and indicating where it is not applicable or not provided.

Device: Venclose digiRF Generator (VCRFG1) with Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)
Type of Modification: Software Modification to the Venclose digiRF Generator.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a software modification to an electrosurgical generator, the acceptance criteria are not related to diagnostic performance metrics like sensitivity, specificity, or AUC, but rather to software functionality, safety, and effectiveness. The document states that internal risk assessments procedures were used.

Note: Specific numerical acceptance values are not detailed in this public 510(k) summary, as they are typically proprietary and part of detailed engineering and software validation reports submitted to the FDA.

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

This is not applicable in the context of an AI/ML diagnostic performance test set. The "test set" here refers to the software verification and validation activities. The document does not specify exact "sample sizes" (e.g., number of test cases or iterations) for the software testing. Data provenance is also not applicable in the context of clinical data for AI/ML, as the testing relates to engineering and software validation.

• Software Verification and Validation: This typically involves rigorous testing against defined requirements, including unit testing, integration testing, system testing, and perhaps regression testing. The "sample size" would relate to the number of test cases executed, input parameters varied, and error conditions simulated. Specific numbers are not provided in this summary.
• Data Provenance: Not applicable as no clinical data for diagnostic performance was used in this clearance for a software modification to an electrosurgical device.

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

Not applicable. Ground truth, in the sense of expert annotation of medical data, is not established for an electrosurgical generator's software modification. The "ground truth" for this device's performance would be its adherence to engineering specifications and its ability to safely and effectively deliver RF energy for its intended purpose, as measured by calibrated equipment and functional tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for consensus building among human experts for ground truth label generation in diagnostic studies. This process is not part of software verification and validation for an electrosurgical device.

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

No. An MRMC study is relevant for evaluating the impact of an AI/ML diagnostic device on human reader performance. This 510(k) is for a software modification to an electrosurgical generator, not a diagnostic AI/ML device. Therefore, no MRMC study was performed or reported.

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

No. "Standalone performance" refers to the diagnostic accuracy of an AI/ML algorithm by itself. This device is an electrosurgical generator. Its performance is measured by its ability to generate and deliver RF energy according to specifications, not by its diagnostic capabilities. The software's "performance" was evaluated through verification and validation activities.

7. The Type of Ground Truth Used

Not applicable in the AI/ML diagnostic sense. For this device, the "ground truth" for software validation would be derived from:

• Design Specifications: The documented requirements and expected behavior of the software and the device.
• Predicate Device Performance: The existing performance characteristics of the previously cleared predicate devices, to which the modified device is being compared for substantial equivalence.
• Engineering Standards and Measurements: Data from calibrated test equipment, electrical measurements, temperature readings, and time controls.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The software was likely developed using traditional software engineering methodologies.

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

Not applicable. As there is no AI/ML training set, there is no ground truth to establish for such a set.

Ask a specific question about this device

Nerveblox assists qualified healthcare professionals in identifying anatomical structures in the following ultrasound-guided peripheral nerve block regions for use prior to any needle intervention and is used for adult patients 18 years of age or older. It is not used in combination with needles or during needle insertion.

Nerveblox supports users in the following block regions:

• Interscalene Brachial Plexus
• Supraclavicular Brachial Plexus
• Infraclavicular Brachial Plexus
• Cervical Plexus
• Axillary Brachial Plexus
• PECS I & II
• Transversus Abdominis Plane (TAP)
• Rectus Sheath
• Femoral Nerve
• Adductor Canal
• Popliteal Sciatic
• Erector Spinae Plane (ESP)

Nerveblox is a software as a medical device, designed to assist clinicians in identifying anatomy for ultrasound-guided peripheral nerve blocks.

Integrated into commercially available Venue (Venue K240111, Venue Go K240053, Venue Fit K234106 and Venue Sprint K240206) ultrasound systems (GE HealthCare, Chicago, IL), Nerveblox utilizes non-adaptive AI/ML functionalities to highlight anatomical structures by applying color overlays, adding name labels, and providing a quality score that informs the user about the overall image's suitability for anatomical assessment and the completeness level of detected anatomy regarding the key anatomical structures.

While Nerveblox enhances visualization, it does not replace the clinician's expertise but supports anatomical identification prior to the procedure.

Here's a breakdown of the acceptance criteria and the study proving Nerveblox meets them, based on the provided FDA 510(k) clearance letter:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document presents two main areas for acceptance criteria: Analytical Validation and Clinical Safety and Accuracy Validation.

Ask a specific question about this device

The Viction Disposable Irrigation and Suction system is intended to provide irrigation and suction functions during general surgery and laparoscopic surgery.It is designed to deliver irrigation fluids to surgical sites and to remove fluid waste and tissue debris.

The Viction disposable Irrigation and suction system are constitutes with Irrigation & suction device and a double tubes(optional accessories).The Irrigation & suction device including an inner/outer stainless steel tubes,On-off Control Button,Conical connectors and Hand-piece. Double tubes constitutes with Irrigation tube、suction tube, and it connects with Yankee joint、Insert needle and Robert Clip.The Viction Disposable Suction Irrigation system is used to deliver sterile irrigation fluids to surgical sites during laparoscopic and endoscopic procedures.

The Irrigation & suction device including an inner/outer stainless steel tubes,On-off Control Button,Conical connectors and Hand-piece. On-off control button on handle-piece can control fluid circuit on and off. It is designed to deliver-sterile irrigation fluids to surgical sites during surgery procedures.

Double tubes constitutes with Irrigation tube,suction tube, and it connects with Yankee joint,Insert needle and Robert Clip.The suction tube is connected to the negative pressure device of the hospital through the Yankee joint, The waste liquid is discharged through a suction tube under the negative pressure environment.Which to improve the surgeon's visibility.

There are 12 models of the product, models VC-FLA0514;VC-FLA0523;VC-FLA0532;VC-FLB0514;VC-FLB0523;VC-FLB0532;VC-FLC0514;VC-FLC0523;VC-FLC0532;VC-FLD0514;VC-FLD0523;VC-FLD0532. All product's Structure are the same, the length of the irrigation suction tubes is the main difference. It is a single use, disposable device and is sold sterile.

The provided FDA 510(k) clearance letter and summary for the "Viction Disposable Irrigation and Suction System" addresses acceptance criteria and the studies performed to meet them. However, it focuses heavily on non-clinical bench testing and comparisons to a predicate device, as is common for medical devices of this classification. It does not present information related to clinical performance metrics involving human readers or AI algorithms, as the device is a physical surgical tool and not an AI-powered diagnostic or assistive system. Therefore, sections related to multi-reader multi-case studies, standalone algorithm performance, and training set details for AI are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists several performance characteristics and implies that the device met these criteria through bench testing. The specific acceptance criteria values are directly stated for some tests.

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

The document describes non-clinical bench testing. Therefore, the concept of a "test set" and "data provenance" in the context of human or patient data does not apply. The tests described were performed on physical units of the Viction Disposable Irrigation and Suction System. The origin of the device manufacturer is China.

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

Not applicable. The ground truth for the bench tests was established by objective measurements against predefined engineering and safety standards, not by expert interpretation of clinical data.

4. Adjudication Method for the Test Set:

Not applicable, as no expert adjudication was involved in the non-clinical bench testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No. This is a physical device, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.

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

Not applicable. The device is a physical surgical instrument and does not involve any algorithms.

7. The Type of Ground Truth Used:

For the performance tests (flow rates, pressure, sterility, coating adhesion, etc.), the ground truth was based on objective engineering specifications and recognized international standards (e.g., ISO 11135 for sterilization, ASTM D3359-23 for coating adhesion). For biocompatibility, the ground truth was established by adherence to FDA Blue Book Memorandum #G95-1 and ISO10993-1, which define acceptable biological responses.

8. The Sample Size for the Training Set:

Not applicable. The Viction Disposable Irrigation and Suction System is a physical medical device. It does not utilize a training set in the context of machine learning or AI.

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The Viction Disposable Irrigation and Suction Catheter is indicated for use in conjunction with the handpiece , dual tubing, and probes to provide controlled powered irrigation during Laparoscopic surgery.

The Viction Disposable Irrigation and suction Catheter is constitutes with Suction/irrigation handpiece , dual tubing, Irrigation device that is a battery-powered mechanical pumping system connect with dual tubing(suction tubing and irrigation tubing) to deliver sterile fluids to surgical sites. Control of the irrigation flow is generated by depressing the on-off Control Button on the handpiece. The mechanical pumping system is powered with nine(9) standard AAlkaline Battery.
Hand piece equipped with pistol style attach to Suction irrigation probes and suction tubing . And it should be used with negative pressure device of the hospital.
There are 8 models of the product, models VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532,VC-IRC0523,VC-IRD0532, VC-IRD0532. All product's Structure are the same, the length of the irrigation suction tubes is the main difference. It is a single use, disposable device and is sold sterile.

The provided FDA 510(k) clearance letter and summary for the "Viction Disposable Irrigation and Suction Catheter" (K250124) concerns a medical device, specifically an endoscope accessory. It does not involve an AI/ML component for diagnosis or analysis, but rather outlines the substantial equivalence of a physical medical device to a predicate device.

Therefore, many of the requested elements typically relevant to AI/ML software (such as ground truth establishment by experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details, etc.) are not applicable to this submission.

The "acceptance criteria" for this device are demonstrated through bench testing, electrical safety, electromagnetic compatibility, biocompatibility, and sterilization performance against predefined criteria and relevant industry standards, establishing substantial equivalence to a legally marketed predicate device.

Here's the information that can be extracted and presented based on the provided document:

Device Acceptance Criteria and Performance (Based on provided 510(k) Summary)

The device, "Viction Disposable Irrigation and Suction Catheter," demonstrates substantial equivalence to its predicate device, CORE E3 Suction/Irrigator (K202303), primarily through non-clinical performance data and design comparisons.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a numerical "sample size" for the performance tests (e.g., number of devices tested for flow rate, pressure, etc.). It states "All the test results meets the predefined acceptance criteria..." implying that a sufficient number were tested to demonstrate compliance.
• Data Provenance: Not explicitly stated (e.g., in terms of country of origin of testing facilities), but implies internal testing performed by the manufacturer or a contracted lab. The studies were non-clinical bench and lab tests, not human subject data.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This is a physical medical device, not an AI/ML diagnostic tool. "Ground truth" in this context refers to established technical standards (e.g., IEC, ISO) and comparison to a predicate device's established performance specifications. There were no human expert readers establishing "ground truth" labels from medical images or clinical data.

4. Adjudication Method for the Test Set

• Not Applicable. There was no human "adjudication" of test results in the sense of resolving disagreements among experts for a diagnostic task. Performance was measured against technical specifications and standards.

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

• Not Applicable. No MRMC study was conducted or is relevant for this device type. This device is a tool for surgery, not an imaging analysis or diagnostic aid requiring human reader performance evaluation.

6. Standalone (Algorithm Only) Performance

• Not Applicable. There is no standalone algorithm. This is a physical device.

7. Type of Ground Truth Used

• The "ground truth" for this device's performance is established by engineering specifications, international consensus standards (IEC, ISO), and the performance characteristics of the legally marketed predicate device. For example, the "truth" for biocompatibility is conformance to ISO 10993, and the "truth" for electrical safety is conformance to IEC 60601-1.

8. Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI/ML system. There is no "training set."

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

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

Summary of the Study Proving Device Acceptance:

The "study" proving the device meets acceptance criteria is a comprehensive set of non-clinical performance tests and analyses. These include:

• Electrical Safety & EMC Testing: Following IEC 60601-1 and IEC 60601-1-2 standards to ensure the device is electrically safe and compatible within its intended electromagnetic environment.
• Biocompatibility Testing: Following ISO 10993-1 guidelines, including tests for acute systemic toxicity, skin sensitization, intracutaneous reactivity, pyrogenicity, and in vitro cytotoxicity. This demonstrates the materials used are safe for patient contact.
• Bench Testing: Evaluation of critical functional parameters such as fluid flow rate of the irrigation tube, negative pressure resistance of the suction, and sealing integrity of the irrigation tube. These tests confirm the device performs its intended functions effectively.
• Sterilization Validation: Performance qualification for ethylene oxide sterilization to ensure the device achieves a required Sterility Assurance Level (SAL) of 10⁻⁶, rendering it safe for single use in surgical environments.
• Comparative Analysis: A detailed comparison of technological characteristics (intended use, design, materials, specifications) against the predicate device (CORE E3 Suction/Irrigator, K202303) demonstrated substantial equivalence.

The document states, "All the test results meets the predefined acceptance criteria and complied with the design specification of the subject device throughout the use life. The results of the non-clinical testing demonstrate that the viction disposable irrigation and suction catheter is as safe and effective as the predicate device." This statement serves as the conclusion that the device successfully met its acceptance criteria through these documented non-clinical studies. No clinical testing was deemed applicable or necessary for this submission.

Ask a specific question about this device

HydroPICC Single Lumen: Indicated for short-or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 5.0 ml/s

HydroPICC Dual Lumen: Indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for a maximum power injection flow rate of 5.0 ml/s

HydroMID Single Lumen: Indicated for short term access(

The HydroMID catheters are a family of midline catheters comprised of a radiopaque, hydrophilic catheter with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in the manufacture of catheters. Catheters are provided packaged in kit configurations with the appropriate accessories for placement in the respective clinical environments. The maximum power injection flow rate for the lumen is indicated on the extension tube clamp. HydroMID has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. Reduction of thrombus accumulation and thrombotic occlusions were evaluated using an in vitro model. Pre-clinical in vitro evaluations do not necessarily predict clinical performance with respect to thrombus formation.

The HydroPICC catheters are a family of peripherally inserted central catheter (PICC) comprised of a radiopaque hydrophilic catheter material with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in the manufacture of catheters. Catheters are provided packaged in kit configurations with the appropriate accessories for placement in the respective clinical environments. The maximum power injection flow rate for the lumen is indicated on the extension tube clamp. HydroPICC has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. Reduction of thrombus accumulation and thrombotic occlusions were evaluated using an in vitro model. Pre-clinical in vitro evaluations do not necessarily predict clinical performance with respect to thrombus formation.

The purpose of this 510(k) is to add an additional statement to the indications for use.

The provided FDA 510(k) clearance letter (K243458) details the HydroPICC and HydroMID catheters. The focus of this submission is to add a statement to the indications for use regarding the anti-thrombogenic properties of the MIMIX® Technology incorporated into these catheters. The acceptance criteria and supporting studies are described below:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this 510(k) submission is to demonstrate that the expanded Indications for Use statement, specifically concerning the anti-thrombogenic properties of the MIMIX® Technology, does not introduce new questions of safety or effectiveness and is supported by non-clinical data. The reported device performance is based on in vitro studies.

Note: The FDA letter explicitly states: "The clinical impact has not been evaluated in human clinical trials. This device is not intended for the treatment of existing vein thrombosis." This indicates that the acceptance criteria are based solely on in vitro performance for the anti-thrombogenic claims, not on in vivo clinical outcomes.

Study Details for Acceptance Criteria

The provided document does not fully delineate separate "test sets" for the in vitro studies in the way one might for an AI/algorithm-based device. Instead, the "studies" themselves are the performance evaluations for the stated acceptance criteria.

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

   • The document lists several in vitro tests.
   • Sample Size: The specific number of devices or experimental replicates used in each in vitro test is not explicitly stated in the provided text.
   • Data Provenance: All studies are indicated as "in vitro" (meaning conducted in a test tube, culture dish, or other controlled environment outside of a living organism). The country of origin is not specified but is presumably where Access Vascular Inc. conducts its research and development or contracts with testing facilities.

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

   • For in vitro studies of this nature (evaluating properties like thrombus accumulation), the "ground truth" is typically established by the experimental setup, validated measurement techniques, and potentially statistical analysis.
   • No specific number of experts or their qualifications are mentioned as having established "ground truth" for these in vitro tests in the context of expert consensus, as might be the case for image-based diagnostic devices. The results are based on objective physical or biological measurements.

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

   • Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving subjective expert review (e.g., radiology image interpretation) to resolve discrepancies in independent assessments. As these are in vitro physical/biological tests, such adjudication methods are not relevant or mentioned.

4. 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 medical catheter, not an AI software/algorithm requiring human reader interpretation. No MRMC study was conducted or is relevant for this device.

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

   • Not applicable. This device is a physical medical device (catheter) with a material technology, not an AI algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this submission.

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

   • The ground truth for the in vitro studies described (e.g., "Assessment of PICC Catheter Thrombosis," "Thrombosis Accumulation Report") is based on objective measurements of physical and biological phenomena (e.g., quantification of thrombus accumulation, pressure required to remove occlusions) within controlled laboratory environments. This is a form of empirical scientific measurement, rather than expert consensus, pathology, or outcomes data.

7. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" because this is a physical medical device, not an AI/machine learning model that requires training data.

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

   • Not applicable. As no training set is mentioned, the method for establishing ground truth for it is also not applicable.

Ask a specific question about this device

The Baxter AK 98 dialysis machine is intended to be used for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload upon prescription by a physician. The AK 98 dialysis machine is indicated to be used on patients with a body weight of 25 kg or more. The AK 98 dialysis machine is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis or hospital care environment. The Baxter AK 98 dialysis machine is not intended for Selfcare or home use.

The AK 98 Dialysis Machine is a standalone hemodialysis machine intended for use as a single patient dialysis machine to perform HD treatments of patients with renal failure or fluid overload. The Vantive AK 98 Dialysis Machine is intended to be used in a chronic dialysis or hospitale care environment for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload upon prescription by a physician. The AK 98 Dialysis Machine is intended to be used on patients with a body weight of 25 kg or more.

To perform hemodialysis therapy, the AK 98 system needs a high purity water source and the appropriate consumables for treatment, including but not limited to: cleaning products, ultrafilters, acid and base dialysate concentrates, bloodlines, and dialyzers.

In hemodialysis therapies, the AK 98 is used to pump the blood through the extracorporeal circuit and to monitor the arterial and venous pressure, but the blood directly contacts only the disposable bloodline and dialyzer, not the monitor itself.

The fluid unit of the AK 98 Dialysis Machine is used to produce the dialysis fluid (with the correct temperature, flow, and composition) from reverse osmosis water and concentrates (dry or liquid) and to transport the dialysis fluid through the dialyzer. The fluid unit offers Profiling of Ultrafiltration and/or conductivity, it also offers isolated Ultrafiltration. The fluid unit also includes "Clearance Measurement" (Diascan). The fluid unit maintains the dialysis fluid flow through the dialyzer and controls ultrafiltration. If a fault occurs, the machine enters a patient safe state, which, depending upon the fault, can include actions such as bypassing the dialyzer.

The fluid path of the AK 98 is composed of a variety of different materials, including silicone tubing.

The provided FDA 510(k) clearance letter and summary for the AK 98 Dialysis Machine (K250508) do not contain the details typically associated with Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for AI/ML-driven medical devices.

The document describes a submission for a dialysis machine, and the key changes and testing detailed focus on physical components and performance attributes of a medical device (e.g., changes in silicone tubing curing process, ultrafiltration accuracy, blood flow rate accuracy). It specifically highlights non-clinical tests rather than clinical studies with human subjects or AI-specific validation.

Therefore, many of the requested categories in the prompt (e.g., sample sizes for test and training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance) are not applicable to this type of device and submission as described in the provided text.

The information that can be extracted relates to the device's functional performance and how it maintains equivalence to its predicate.

Here's an attempt to address the prompt based only on the provided text, while noting the limitations:

Acceptance Criteria and Device Performance for AK 98 Dialysis Machine

Based on the provided 510(k) summary for the AK 98 Dialysis Machine (K250508), the device is demonstrated to be substantially equivalent to its predicate device (AK 98 Dialysis Machine, K232467). The assessment of differences focuses on ensuring the proposed device maintains similar performance and safety characteristics despite a material change in its silicone tubing.

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this context refers to maintaining the performance specifications of the predicate device. The "reported device performance" is implicitly that the proposed device performs identically to the predicate device for all listed features, having passed non-clinical functional testing. The key change evaluated was the transition from peroxide-cured and platinum-cured tubing to solely platinum-cured tubing.

Note on Silicone Tubing Difference: The crucial "acceptance criteria" here for the tubing change was that "Performance, biocompatibility, and extractables testing demonstrates that the difference in the curing process does not impact the performance or safety of the AK 98 Hemodialysis System." The reported performance is that this testing was successfully conducted, confirming no impact.

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

The provided document describes non-clinical functional performance testing, biocompatibility testing, and extractables and leachables assessment. It does not mention a "test set" in the context of patient data or clinical trials. Therefore, sample sizes for such data are not applicable here. The data provenance would be laboratory testing results from the manufacturer.

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

This submission pertains to a physical medical device and primarily relies on engineering and laboratory testing for equivalence, not AI/ML-driven analysis of medical images or patient data requiring expert adjudication. Thus, this information is not applicable.

4. Adjudication Method for the Test Set

As there is no mention of a clinical test set requiring human interpretation or AI output evaluation, an adjudication method is not applicable.

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

No, an MRMC study was not done, as this device is a physical hemodialysis machine, not an AI/ML diagnostic or assistive tool for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

No, a standalone algorithm performance study was not done, as this device does not contain a discrete AI/ML algorithm whose performance is being evaluated in isolation. Its "performance" refers to the mechanical and fluid dynamic functions of the dialysis machine itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation lies in established engineering standards, device specifications, and the performance characteristics of the legally marketed predicate device. The change in the silicone tubing's curing process required "Performance, biocompatibility, and extractables testing" to demonstrate continued safety and effectiveness. This testing serves as the "ground truth" method for verifying that the new component does not negatively impact the device's adherence to its established specifications.

8. The Sample Size for the Training Set

This concept is not applicable to the submission of this physical medical device. There is no AI/ML model being trained with a dataset.

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

This concept is not applicable as there is no training set for an AI/ML model.

Ask a specific question about this device

The Micro Catheter is intended for the delivery of interventional devices or contrast media into the vasculature of the peripheral and neuro anatomy.

The Micro Catheter is a sterile, single-use, single lumen, variable stiffness, composite catheter. The Micro Catheter is available in three inner diameters (0.017″, 0.021″ and 0.027″), and two working lengths (150cm and 155cm). All models are designed with a straight tip, and are steam shapeable by the user. Single or dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of Micro Catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter body has a semi-rigid proximal end which transitions into the flexible distal end to facilitate the advancement of the catheter in the tortuous vasculature. The Micro Catheter is compatible with ≤ 0.014″ guidewires and 5F or larger guide catheters.

The provided 510(k) clearance letter pertains to a Micro Catheter and describes its performance and testing to demonstrate substantial equivalence to a predicate device. This document does not discuss an AI/ML powered device, nor does it present data from a study involving human readers or the establishment of ground truth for AI model training or testing. Therefore, I cannot address most of your specific questions related to AI device evaluation.

However, I can extract the acceptance criteria and performance data for the Micro Catheter based on the provided text.

Acceptance Criteria and Device Performance for Micro Catheter

The document describes the testing performed on the Micro Catheter to demonstrate its substantial equivalence to a predicate device. The "acceptance criteria" are implied by the "Results" column in the tables, indicating whether the device met the required performance standards for each test.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA 510(k) summary for a medical device like a micro catheter focuses on engineering and biocompatibility performance rather than AI-specific metrics. The "acceptance criteria" are implicitly met if the "Results" indicate compliance, comparability to a predicate, or "met the acceptance criteria."

Ask a specific question about this device