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Vortex Surgical Laser Probes and Illuminated Laser Probes are indicated for use in laser endophotocoagulation procedures in the posterior segment of the eye during vitreoretinal surgery at 500nm. Vortex Surgical Illuminated Laser Probes, Endoilluminator, and Chandelier are indicated for illumination during vitreoretinal surgery with visible light.

Vortex Surgical Illuminated Laser Probe is a sterile, single used for delivering laser endophotocoagulation with illumination into the posterior segment of the eye.

Vortex Surgical Laser Probe is a sterile, single use medical device used for delivery laser endophotocoagulation into the posterior segment of the eye.

The laser probe is a cable made fiberoptic, one laser connector, one handle for surgeon manipulation, nitinol, PEEK, or stainless steel tubing extending from the handle which penetrates the surgical site, and protective sheath over the fiber. The MAXReach model device also contains a slide button allowing the surgeon to bend the nitinol, PEEK, or stainless steel tubing once inside the eye to direct output into the periphery of the eye. On the proximal end the fiberoptic is terminated by a connector that attaches to the distal side, the fiberoptic is terminated by nitinol, PEEK, or stainless steel tubing which penetrates the eye. The probe can be either 23ga, 25ga, or 27ga. The fiber for laser transmission is made from silica glass and is restricted for use with the wavelength of 500nm to 1100mm. In illuminated laser probes, the illumination fiber is made of PMMA. The total length of the device is 90 ± 6 inches.

Vortex Surgical Endoilluminator and Chandelier are sterile, single use medical devices used for delivering illumination into the posterior segment of the eye.

The endoilluminator is an illuminators made from one fiber optic cable, one handle for surgeon manipulation, stainless steel tubing extending from the handle which penetrates the surgical site, and the protective sheath over the fiber. On the proximal side the fiberoptic is terminated by a connector that attaches to the illumination console. The endoilluminator utilizes a needle. The illumination fiber is made of PMMA. The total length of the devices is 90 ± 6 inches.

The chandelier is an illuminator made from one fiber optic cable and the protective sheath over the fiber. The illumination fiber is made of PMMA. The total length of the devices is 90 ± 6 inches.

The provided text describes a 510(k) premarket notification for Vortex Surgical's Laser Probes, Illuminated Laser Probes, Endoilluminators, and Chandeliers. As a medical device submission, it focuses on demonstrating substantial equivalence to existing predicate devices rather than proving novel clinical efficacy or conducting a multi-reader multi-case (MRMC) study. Therefore, the details requested in points 5, 8, and 9 (related to AI-assisted human reader improvement, training set size, and training set ground truth establishment) are not applicable in this context, as the device is not an AI/ML software or diagnostic tool that requires such studies.

Here's an analysis based on the information provided for the other points:

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

The document does not present explicit "acceptance criteria" in a table format with specific quantitative thresholds. Instead, the performance evaluation focuses on demonstrating that the subject devices are substantially equivalent to their predicates across various non-clinical bench tests and material assessments. The criteria are implicitly met if the test results show equivalence and do not raise new safety or effectiveness concerns.

The document concludes: "The performance of the Vortex Surgical Laser Probes, Illuminated Laser Probes, Endoilluminators, and Chandeliers show that the instruments are substantially equivalent to their predicates. Vortex Surgical had demonstrated through Ethylene Oxide (EO) sterilization EU residual testing, endotoxin testing, biocompatibility testing, shelf-life testing, and nonclinical bench test results that the Vortex Surgical instruments are safe and effective as their predicate devices and any difference between the two raise of safety or effectiveness."

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

The document does not specify a "sample size" in terms of number of patients or cases. The tests described are primarily non-clinical bench tests (e.g., laser output, mechanical actuation, biocompatibility assessments) and material characterization. Therefore, the data provenance is from laboratory testing of the devices themselves, not from patient data. There is no indication of country of origin for such non-clinical test data, nor is it classified as retrospective or prospective in the clinical sense.

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

This question is not applicable as the device is not a diagnostic tool requiring expert interpretation of medical images or data for ground truth establishment. The "ground truth" for the non-clinical tests would be defined by engineering specifications, recognized standards (e.g., IEC 60601-2-22, ANSI Z80.36-2016, ISO 10993-1, ISO 11135), and the performance characteristics of the predicate device.

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

This point is not applicable as there is no human interpretation or subjective assessment of data that would require an adjudication method. The testing involves objective, measurable physical and chemical properties and performance characteristics against established standards or predicate device performance.

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

This is not applicable. The device is not an AI-assisted diagnostic tool. It is a surgical instrument (laser probes, illuminators). MRMC studies are typically performed for diagnostic devices, especially those incorporating AI, to evaluate human reader performance with and without AI assistance. This document describes a submission for a substantially equivalent predicate device, not an AI-powered one.

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

This is not applicable. The device is a physical surgical instrument, not an algorithm. Standalone performance evaluation (without human-in-the-loop) would refer to the performance of a software algorithm on its own, which is not relevant here.

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

As explained in point 3, the "ground truth" for this type of device and submission is based on engineering specifications, recognized international standards (e.g., ISO, IEC, ANSI), and the established performance characteristics of the predicate device. For biocompatibility, it's about meeting the safety thresholds defined by ISO 10993-1. For performance, it's about meeting the requirements of electro-optical and mechanical standards and demonstrating equivalence to a legally marketed predicate. There is no clinical "ground truth" derived from patient outcomes, pathology, or expert consensus on interpretations.

8. The sample size for the training set

This question is not applicable. The device is not an AI/ML model, so there is no "training set."

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

This question is not applicable. The device is not an AI/ML model, so there is no "training set" or ground truth establishment for such a set.

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Intended Use: The truFreeze® System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -196°C, requiring either active or passive venting during surgical procedures.

Indications for Use. VortexTM Radial Spray catheter: The Vortex™ Radial Spray catheter is indicated for use as a cryosurgical tool to ablate benign (e.g., Barrett's Esophagus with high grade and/or low grade dysplasia) in the upper gastrointestinal tract using active venting.

The CSA Medical (CSA) truFreeze® System consists of a truFreeze Console and a truFreeze Spray Catheter Kit. The truFreeze Console is to be used only with a truFreeze Spray Kit. This document specifically applies to the Vortex Radial Spray Kit (20-00360) for use with the truFreeze® System. Vortex Radial delivers liquid nitrogen in a 3-cm long, 360° spray pattern to ablate circumferential, epithelium such as Barrett's Esophagus.

The Vortex Radial Spray Kit (20-00360) consists of one (1) truFreeze Vortex Radial Spray Catheter (20-00187), one (1) 4-inch Suction Canister Connector, and one (1) Patient Tube.

The catheter is connected to the console and transports cryogen from the console to the targeted ablation area. The Suction Cannector and Patient Tube provide the connection from the suction source in the console to the Cryo-Decompression Tube (CDT) at the end of the catheter, to provide active evacuation (suction) of nitrogen gas at the ablation site. The spray head is surrounded by the Mesh that expands to dilate the lumen to a diameter of 20 mm and center the device during the delivery of cryogen spray.

The provided text is a 510(k) Premarket Notification for the CSA Medical, Inc. truFreeze® System, specifically the Vortex™ Radial Spray Catheter. This document primarily focuses on establishing substantial equivalence to a predicate device (K171626) by comparing technological characteristics and presenting performance testing results.

Crucially, this document does not contain a typical "acceptance criteria and study that proves the device meets the acceptance criteria" in the format of a clinical trial designed with defined endpoints (like sensitivity, specificity, accuracy) for a diagnostic AI device.

Instead, this submission is for a cryosurgical treatment device, not an AI/ML diagnostic tool. Therefore, the "acceptance criteria" and "study" are geared towards demonstrating the device's safety and effectiveness compared to a predicate device that performs a similar function.

Based on the provided text, here's an attempt to extract relevant information, adapting to the nature of the device:

1. Table of "Acceptance Criteria" (interpreted as performance specifications/comparisons to predicate) and Reported Device Performance:

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

• Bench Tests: "A number of bench tests were conducted to verify the product design met the predetermined product performance specifications." No specific sample sizes for these tests are mentioned.
• Pre-clinical (GLP Studies): "Three preclinical GLP studies were completed utilizing the Vortex™ Radial Spray catheter in swine." The exact number of swine used is not specified, only the number of studies.
• Clinical Data (Literature/RWD for Predicate Device):
  • Literature: "Three scientific, peer-reviewed literature articles have been published demonstrating the ability of the predicate device (i.e. linear spray) to achieve circumferential freezing of diseased tissue in the esophagus."
  • Patient Count from Literature: "73 patients have been treated with spray LN2 circumferentially since 2012 to ablate BE lesions."
  • Real-World Data (RWD) from Registry: "Real-World Data (RWD) has been extracted from an ongoing prospective, multi-center patient registry."
  • Patient Count from RWD: "Of the 112 patients identified in the registry as having Barrett's Esophagus, 49 of those patients received circumferential ablation."
  • Provenance: No specific country of origin is mentioned for the literature or RWD, but it can be inferred to be from regions where such studies are conducted (likely US/Europe). The RWD is "prospective, multi-center."

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

Not applicable in the context of this submission. This is not an AI diagnostic device requiring expert reading for ground truth establishment. The "ground truth" for this device's performance would be direct measurements (e.g., cooling power, depth of freeze in hydrogel) and histological assessment in animal models. Clinical outcomes cited from literature/RWD would be physician-documented.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study requiring adjudication of expert readings from a test set.

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

No. This type of study (MRMC) is typically performed for diagnostic imaging devices to assess human reader performance with and without AI assistance. This submission is for a medical device that performs a physical ablation.

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. Bench and preclinical data are provided for the device's standalone physical performance.

7. The Type of Ground Truth Used:

• Bench Testing: Engineering specifications and direct physical measurements (e.g., temperature, power density, dimensional measurements).
• Pre-clinical (Swine Studies): Histopathology data (e.g., assessment of lesion size, depth of injury) and survival/adverse event data.
• Clinical Data (from Literature/RWD for predicate): Clinical outcomes (ablation endpoint, adverse events like stricture), and physician observations.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device with a distinct training set. The "training" in this context refers to the development and iterative testing of the device throughout its design process.

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

Not applicable for the reasons stated above.

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Indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.

The Vortex Medical AngioVac Cardiopulmonary Bypass Circuit and Accessories consists of: Tuohy Borst Adapter, Non-Vented Spike, Vented Cap, PVC tubing .375"ID, PVC tubing .500" ID, PVC tubing .250" ID, Y Connectors, Colder MPX Series Coupling Body (In-Line Hose Barb with Lock - Male), Colder MPX Series Coupling Insert (In-Line Hose Barb - Female), Reducers, Adhesive backed tubing holder, Pinch Clamps ("Roberts").

The provided text [K092486](https://510k.innolitics.com/search/K092486) describes a device for "Cardiopulmonary Bypass Tubing and Accessories." This is a mechanical device, not an AI/ML-driven software device. Therefore, the questions about acceptance criteria for AI models, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, ground truth definitions, and training set information are not applicable.

The document indicates that substantial equivalence was determined based on non-clinical performance data and no clinical tests were performed. The non-clinical tests focused on connection strength and system integrity to verify the integrity of the fittings and the assembled system.

Here's the information that can be extracted relevant to acceptance criteria and performance for this type of medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only broadly states "Connection strength and system integrity testing was performed to verify the integrity of the fittings and the assembled system." It does not specify quantitative acceptance thresholds (e.g., minimum burst pressure, tensile strength limits) or detailed reported values, only that the tests were performed and the integrity verified.

2. Sample sized used for the test set and the data provenance: Not applicable. This is a non-clinical evaluation of a physical device.

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 physical device testing typically involves engineering specifications and direct measurement, not expert clinical consensus in the way an AI model would be evaluated.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For this physical medical device, the "ground truth" for the non-clinical tests would be established engineering specifications and performance benchmarks for connection strength and system integrity of similar predicate devices.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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The Vortex Cannula is intended for use as a venous drainage cannula during extracorporeal bypass for up to 6 hours.

The Vortex Cannula is a wire reinforced, ranging from 22 to 26 French, device that is of appropriate stiffness and flexibility so that it can be manipulated throughout the vascular svstem. The cannula is rigid enough to resist kinking, collapse and deformation that may compromise the lumen and inhibit flow through the cannula. The cannula has a proprietary distal end with a balloon activated, expandable, funnel-shaped tip that willenhance flow when the balloon is activated and will prevent clogging of the cannula with commonly encountered undesirable intravascular material that occurs with the predicate devices and facilitate en-bloc removal of such material from the vascular system. The cannula has a proximal end that can attach to a standard off the shelf extracorporeal circuit. The cannula will be shipped to the user in a sterile package and ready for use.

The provided text describes a 510(k) summary for the Vortex Cannula. This is a premarket notification for a medical device seeking substantial equivalence to a predicate device. The information provided focuses primarily on non-clinical bench testing and adherence to design control and risk analysis standards, rather than clinical studies involving human patients or complex AI algorithms. Therefore, many of the requested categories related to clinical trials, ground truth, and AI-specific metrics will not be applicable or available in this document.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states "Non-clinical Testing: Bench top testing was conducted and comparisons were made to the predicated device." This indicates the use of in vitro or mechanical testing, not a clinical test set from human subjects. Therefore, the concept of data provenance (e.g., country of origin, retrospective/prospective) and sample size for a "test set" in the context of patient data is not applicable here. The "test set" would refer to the specific units of the device and predicate device used in the bench testing. No specific number of devices tested is provided.

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

Not applicable. Ground truth, in the context of clinical studies, typically refers to expert diagnoses or pathological findings. The testing described is non-clinical bench testing, not involving human expert assessment of clinical data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert consensus on clinical data. Since this was non-clinical bench testing, such methods are not relevant.

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. An MRMC study involves human readers interpreting cases, often with and without AI assistance, to assess AI's impact on their performance. The Vortex Cannula is a physical medical device, not an AI diagnostic tool, and the provided document describes non-clinical testing.

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

Not applicable. The Vortex Cannula is a physical device, not an algorithm. Standalone performance refers to the accuracy of an AI model independently.

7. The Type of Ground Truth Used

The ground truth for the non-clinical testing would be the objective measurements obtained during the bench testing (e.g., flow rates, resistance to kinking, visual assessment of clogging, observation of material removal, successful attachment). The performance of the predicate device would also serve as a benchmark for comparison.

8. The Sample Size for the Training Set

Not applicable. A "training set" refers to data used to train machine learning models. This document describes a physical medical device and its non-clinical testing, not an AI product.

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

Not applicable, as there is no training set for an AI model.

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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 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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The Vortex® MP Peripheral Access System is indicated for peripheral placement in the mid-arm, above the antecubital space and well below the subaxillary area, when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

The Vortex® MP Peripheral Access System is a device comprised of a vascular access port, a catheter, locking mechanism and introduction components. The Vortex MP® Port is available in a titanium configuration with a self sealing silicone septum designed to maintain integrity after repeated punctures with an non-coring needle. The catheter is offered in polyurethance and silicone models. The products are packaged in sterile trays with introduction components.

This 510(k) summary (K032754) is for a medical device, the Vortex® MP Peripheral Access System, not a software or AI-powered diagnostic device. Therefore, many of the requested criteria, such as "acceptance criteria," "reported device performance," "sample sizes for test and training sets," "ground truth establishment," "MRMC studies," or "standalone performance," are not applicable in the context of AI/software validation.

The document describes a traditional substantial equivalence determination for a physical medical device. The manufacturer is demonstrating that their new device is as safe and effective as a legally marketed predicate device, not validating a new algorithm or diagnostic tool.

Here's a breakdown of what can be extracted from the provided text, and where the information relevant to AI/software validation is missing or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide explicit quantitative acceptance criteria or reported performance metrics in the way one would expect for an AI diagnostic study (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device through design evaluation and verification testing.

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

• Sample Size for Test Set: Not applicable/not reported in the context of an AI/software validation. The "design verification testing" would involve engineering tests on device prototypes, the specific "sample size" of which is not detailed here.
• Data Provenance: Not applicable. This refers to the testing of a physical device, not patient data in terms of its origin (country, etc.). The testing would have been conducted by the manufacturer (Horizon Medical Products, Inc.).
• Retrospective or Prospective: Not applicable. This refers to experimental design for data collection, not the physical testing of a medical device's components.

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

• Number of Experts: Not applicable. Ground truth in this context would relate to the performance of the physical device components during engineering testing, typically assessed against design specifications and industry standards by engineers, not medical experts establishing a diagnostic "ground truth."
• Qualifications of Experts: Not applicable for establishing ground truth in this type of submission.

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

• Adjudication Method: Not applicable. This pertains to resolving disagreements among multiple human readers for diagnostic image interpretation, which is not relevant here.

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:

• MRMC Study: No, an MRMC study was not done. This is exclusively a physical medical device.
• Effect Size of AI Improvement: Not applicable. The device does not incorporate AI for diagnostic or interpretative tasks.

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

• Standalone Performance: Not applicable. There is no algorithm to evaluate in a standalone manner.

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

• Type of Ground Truth: For a physical device, "ground truth" would refer to established engineering and material science principles, performance specifications (e.g., septum resealability, material biocompatibility, structural integrity), and comparisons against the predicate device's known characteristics. It's not clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This device is not an AI/ML model that undergoes a "training" phase.

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

• How Ground Truth for Training Set was Established: Not applicable.

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Vortex is indicated for use as a spacer/valved holding chamber for use in delivery of aerosol medication with metered dose inhalers.

Vortex is a new spacer/holding chamber designed to assist patients using metered dose inhalers (MDI) for aerosolized drug delivery. Vortex may provide enhanced drug delivery, ease of use and ability to clean/disinfect the device.

Vortex is a reusable device consisting of an aluminum cylinder with an elastomeric fitting on one end to accept metered dose inhalers and a valved mouthpiece on the other end to interface with the patient. The elastomeric fitting may be removed for cleaning and/or replacement.

Vortex will be available as a stand-alone item and will also be available packaged with a mask.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes for the "test set" (i.e., the number of devices or experimental replicates used in the non-clinical testing). It only states that "Testing to compare Vortex to Aerochamber was conducted."

The data provenance is retrospective, as the testing was conducted for the purpose of a 510(k) submission to demonstrate substantial equivalence to an already legally marketed device. The country of origin of the data is not explicitly stated.

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

This information is not applicable as the provided document describes non-clinical performance testing of a medical device (a valved holding chamber/spacer), not a diagnostic or AI-driven system that requires expert-established ground truth. The "ground truth" here is objective physical measurements (e.g., drug delivery, resistance).

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. Adjudication methods are typically relevant for subjective assessments or when multiple experts review the same data, which is not the case for this non-clinical performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not completed/is not required to show substantial equivalence." MRMC studies typically involve human readers and clinical outcomes.

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

This question is not applicable as the device (Vortex valved holding chamber) is a physical medical device, not an algorithm or AI system. Its performance is measured directly, not through an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this device's performance assessment was based on objective physical measurements and established testing methodologies. For example:

• Drug delivery: Measured quantitatively according to FDA guidance.
• Fit with MDI elbows: An objective assessment of physical compatibility.
• Inhalation and exhalation resistance: Measured quantitatively using instruments (e.g., in pascal at a specific flow rate).

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI/ML algorithm that requires a training set. The performance testing was conducted on the physical device itself.

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

This information is not applicable for the same reason as point 8.

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The system is designed to provide image storage, display, and workflow integration. The image display architecture provides capabilities for near-realtime capabilities for radiologists as well as image reviewing workgroup members and other clinicians. In addition to traditional 2D image viewing functionality, the image display system provides advanced 3D features including volume rendering and multi-planar reconstruction designed to function in web-enabled viewers over both local and wide area networks.

UltraVisual Vortex™ is an integrated client-server software package, which may be marketed as software only, that is used in conjunction with standard PC hardware. UltraVisual Vortex™ is a PC-based, DICOM-compliant PACS device that is able to receive, transmit and display DICOM images over both local and wide area network. Images sent to the UltraVisual Vortex™ server are converted into formats suitable for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by UltraVisual Vortex™ to create JPEG and wavelet images follow known and accepted protocols.

Vortex™ can be used within a hospital, a managed care facility or an isolated imaging center. It can also be used for image distribution over the network for teleradiology/review purpose.

UltraVisual Vortex™ uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack.

Here's an analysis of the provided text regarding the acceptance criteria and study for the UltraVisual Vortex™ software, structured according to your request:

Acceptance Criteria and Study for UltraVisual Vortex™ Software

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the "acceptance criteria" for the UltraVisual Vortex™ software are primarily focused on substantial equivalence to predicate devices and functional parity in terms of image handling and display capabilities. The document doesn't explicitly state quantitative performance metrics or acceptance criteria in the typical sense (e.g., minimum accuracy percentages). Instead, it demonstrates effectiveness by comparing its features and intended use to already cleared devices.

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

The provided text does not specify a sample size for a test set in terms of patient cases or images. It states: "Extensive testing of the software package has been performed by programmers, by non-programmers, quality control staff, and by potential customers." This suggests internal testing and perhaps user acceptance testing, but no formal, documented clinical test set of specific size is mentioned.

Therefore, the data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied that the testing involved internally generated data or data readily available to the development team.

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

The document does not mention the use of experts to establish ground truth for any specific test set. The validation focuses on functional equivalence and internal testing by various staff members, not on clinical performance or diagnostic accuracy validated against expert consensus.

4. Adjudication Method for the Test Set

Since no formal test set with ground truth established by experts is described, there is no adjudication method mentioned.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The document does not describe any study comparing human readers with and without AI assistance.

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

The validation described is primarily a standalone functional validation of the software. It verifies that the algorithm can perform its stated functions (receive, convert, display images, perform 3D rendering, etc.) and that these functions are comparable to predicate devices. However, this is not a study of diagnostic performance or clinical effectiveness, but rather a verification of its technical capabilities. There is no mention of measuring the algorithm's diagnostic performance without human interaction.

7. The Type of Ground Truth Used

Given the nature of the device (an image processing, communication, and visualization workstation) and the described validation, the "ground truth" used would primarily be functional correctness and adherence to standards. For example:

• DICOM compliance: Verified by successfully processing DICOM 3.0 images.
• Image integrity: Verified that images are displayed correctly after conversion (e.g., JPEG and wavelet conversion following "known and accepted protocols").
• Feature functionality: Verified that tools like volume rendering, MPR, and MIP operate as designed and produce expected outputs for various inputs.
• Substantial equivalence: Verified by feature-by-feature comparison with predicate devices.

There is no mention of pathology, outcomes data, or expert consensus being used as ground truth for diagnostic accuracy, as this device primarily handles image viewing and manipulation, not automated diagnosis.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. The Vortex™ software is described as using "known and accepted protocols" for image conversion and processing. This suggests that the algorithms are based on established methods rather than a machine learning model that would require a distinct training set.

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

Since there is no mention of a training set or machine learning algorithms in the context of a training phase, there is no information provided on how ground truth for a training set was established.

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