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The Innovasis Navigation Instruments are intended to be used in the preparation and placement of Innovasis pedicle screws during non-cervical spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures for skeletally mature patients. These instruments are designed for use with the Globus ExcelsiusGPS System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) are non-sterile, reusable instruments including taps and drivers that can be operated manually. These instruments are intended to be used with the Globus Medical ExcelsiusGPS® Robotic Navigation Platform to aid in implantation of the Innovasis pedicle screw system (Vector Pedicle Screw System and Excella Spinal System) implants. The instruments are manufactured from medical grade stainless steels and plastic.

The provided FDA clearance letter concerns the Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments). This letter primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and engineering analysis rather than a human reader study or AI performance evaluation.

Therefore, many of the requested details, such as those pertaining to AI model training, human reader studies (MRMC), or a comprehensive standalone algorithm performance, are not explicitly available within this document. The device in question is a set of surgical instruments, not an AI or imaging device requiring such detailed performance evaluation in the context of this 510(k) submission.

However, based on the provided text, we can extract information regarding the performance data used to demonstrate safety and effectiveness for these specific instruments.

Acceptance Criteria and Reported Device Performance

The letter states that the instruments were evaluated for their accuracy performance and their ability to register with the navigation system and fit within the guide tube of the end-effector.

Study Details (Based on available information)

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

   • Test Set Sample Size: Not explicitly stated as a numerical sample size of "cases" or "patients" in the context of a clinical study. The evaluation appears to be primarily an engineering analysis and verification testing on the instruments themselves.
   • Data Provenance: The study described is a technical evaluation of the instruments, not a clinical trial with patient data. It is an "engineering analysis and geometric comparison to predicate devices," and "pass/fail verification testing." The location of this engineering and testing work is not specified, but the applicant (Innovasis, Inc.) is based in Salt Lake City, Utah, and their regulatory consultant in Colorado Springs, Colorado, suggesting a U.S.-based context for the submission. The information implies a retrospective approach in terms of comparing to existing designs and prospective in terms of conducting new verification tests on the manufactured instruments.

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

   • Not Applicable. This submission does not describe a study involving expert readers or medical professionals establishing ground truth for diagnostic interpretation. The "ground truth" for this device relates to its physical and functional specifications (e.g., dimensions, fit, compatibility with the navigation system), established through engineering methods.

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

   • Not Applicable. Adjudication methods are typically used in studies where human experts are interpreting medical images or data and discrepancies need to be resolved. This study is an engineering and verification test.

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:

   • No. This device is a surgical instrument set and the submission does not mention an MRMC study or any AI component that would assist human readers in image interpretation or diagnosis.

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

   • No. This device is not an algorithm. The "performance data" refers to the instrument's mechanical and functional compatibility.

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

   • Engineering Specifications and Functional Compatibility. The ground truth for this device's performance is based on established engineering principles, design specifications, and the functional requirements for compatibility with the predicate navigation system (Globus ExcelsiusGPS). This includes geometric tolerances, material properties, and successful registration/fit with the navigation platform.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device requiring a training set.

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

   • Not Applicable. As above, this is not an AI/machine learning device. The "ground truth" for the device's design and function would be based on engineering design principles and specifications, tested through verification.

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The TACTIX Vector Syndesmosis System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the TACTIX Vector Syndesmosis System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.

The TACTIX Vector Syndesmosis System is intended to provide fixation during the healing process following syndesmotic trauma using a TACTIX Vector Suture Loop and Buttons.
The TACTIX Vector System features the following advantageous characteristics: a tensioner to apply suture tension for surgical repair, line lock suture technology without the need to tie a knot, removal of periosteum through a minimal medial skin nick, a larger medial button, and a small thru hole in the bone, only large enough to pass a 2.0 mm suture loop. The TACTIX Vector Syndesmosis System can be used in conjunction with Vilex fibular bone plates and screws, as deemed necessary by the surgeon.

The provided text is a 510(k) premarket notification letter from the FDA regarding the TACTIX Vector Syndesmosis System. It clearly states:

"No clinical data was required in support of the subject device."

Therefore, the information requested for a clinical study proving the device meets acceptance criteria is not applicable in this case. The FDA's substantial equivalence determination for this device was based on non-clinical tests and analyses.

Here's a breakdown of the requested information based on the provided document, clarifying that clinical study details are absent:

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

   • Acceptance Criteria (as implied by the non-clinical tests):
     • Steam sterilization validation successful.
     • Mechanical performance equivalent to predicate device.
     • Biocompatibility (based on biological evaluation) acceptable.
   • Reported Device Performance: "All results met the acceptance criteria."
   • Note: Specific quantitative performance metrics are not provided in this document, only that the criteria were met.

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

   • Not applicable as this was a non-clinical evaluation (e.g., sterilization validation, mechanical testing, biological evaluation). The "test set" would refer to the physical devices/materials tested in these non-clinical studies. Data provenance would be from the studies themselves (e.g., in-house testing, or third-party lab testing). No details on the number of samples for these non-clinical tests are provided.

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

   • Not applicable for non-clinical testing. Ground truth for these tests is established by standardized testing protocols and analytical methods.

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

   • Not applicable for non-clinical testing.

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

   • No MRMC study was done. This device is not an AI/software device that would involve human readers.

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

   • Not applicable. This is a medical device (surgical system) and not an algorithm.

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

   • For the non-clinical tests, the "ground truth" is defined by the established scientific and engineering principles for sterilization, mechanical properties, and biocompatibility.

8. The sample size for the training set:

   • Not applicable. No training set was used as this was not an AI/machine learning device.

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

   • Not applicable. No training set was used.

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The TACTIX Vector Syndesmosis System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the TACTIC Vector Syndesmosis System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.

The TACTIX Vector Syndesmosis System is intended to provide fixation during the healing process following a syndesmotic trauma using a TACTIX Vector suture loop and buttons.

The TACTIX Vector System features the following advantageous characteristics: a tensioner to apply suture tension for surgical repair, line lock suture technology without the need to tie a knot, removal of periosteum through a minimal medial button, and a small thru hole in the bone, only large enough to pass a 2.0 mm suture loop. The TACTIX Vector Syndesmosis System can be used in conjunction with Vilex fibular bone plates and screws, as deemed necessary by the surgeon.

The TACTIX Vector Syndesmosis System is composed of two titanium alloy buttons and one UHMWPE suture.

The instruments of TACTIX System are composed of stainless steel, UHMWPE, and nylon material.

The TACTIX Vector Syndesmosis System is intended for single use and provided sterile to the end user via ethylene oxide sterilization.

This document is for a medical device called the "TACTIX Vector Syndesmosis System," which is a metallic bone fixation appliance. It is a 510(k) premarket notification to the FDA. The document focuses on establishing substantial equivalence to previously cleared predicate devices.

The information provided does not describe a study that proves the device meets acceptance criteria in the context of clinical performance or diagnostic accuracy, as would be relevant for an AI/ML-driven medical device. Instead, the document describes non-clinical (bench) testing to demonstrate the device's mechanical performance and safety characteristics.

Therefore, for aspects related to "acceptance criteria" for performance metrics like sensitivity, specificity, AUC, human reader improvement with AI, or ground truth establishment relevant to AI/ML, there is no information provided in this document.

However, I can extract the information relevant to the non-clinical testing performed:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not explicitly stated for each non-clinical test (e.g., number of devices tested for fatigue, pullout).
• Data Provenance: The tests are non-clinical (bench testing) performed by the manufacturer (Vilex LLC). The document does not specify the country of origin for these tests. The tests are "retrospective" in the sense that they are done in a lab setting to assess the final device design.

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

• Not applicable. This document describes non-clinical engineering bench testing, not clinical studies or AI/ML performance evaluations requiring expert ground truth for interpretation.

4. Adjudication method for the test set:

• Not applicable. This document describes non-clinical engineering bench testing.

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

• No, not applicable. This document describes a medical device (physical implant), not an AI/ML diagnostic or assistive tool. No MRMC study was mentioned or performed.

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

• No, not applicable. This document is for a physical medical device.

7. The type of ground truth used:

• Not applicable in the AI/ML context. For the non-clinical tests, the "ground truth" is established by standard engineering test methods and their defined pass/fail criteria (e.g., meeting a certain force threshold, cycles to failure, absence of toxins). Comparison to a predicate device serves as the benchmark for "truth."

8. The sample size for the training set:

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

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

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

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When used for posterior pedicle screw or posterior non-pedicle fixation, the Innovasis Vector™ Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (DDD - defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture, dislocation, failed previous fusion (pseudoarthrosis), and/or tumor resection.

When used for posterior non-cervical screw fixation in pediatric patients, the Innovasis Vector Pedicle Screw System is indicated as an adjunct to freat adolescent idiopathic scoliosis (AIS). Additionally, the Innovasis Vector Pedicle Screw System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

The Vector" Pedicle Screw System is a thoracolumbar system composed of polyaxial pedicle screws, rods, hooks, rod connectors, locking caps, lateral connectors, and transverse cross links. The system is designed with multiple options to address complex, multi-level deformity cases and accommodate various patient anatomies. The Vector Pedicle Screw System is also designed to facilitate percutaneous screw and rod placement via Minimally Invasive Surgery (MIS). The cannulated pedicle screws and extended reduction tabs allow for rod placement and minimal tissue disruption. The system was designed to minimize the number and complexity of procedural steps. Implants are manufactured from Titanium (Ti-6Al-4V ELI) per ASTM F136 or Cobalt Crome (CoCr) per ASTM F562.

This is a 510(k) summary for the Vector™ Pedicle Screw System. The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical performance. It does NOT describe a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. Therefore, most of the requested information cannot be extracted directly from this document.

Here's a breakdown of what can be extracted and a clear statement of what cannot:

Information that can be extracted:

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

   • Acceptance Criteria (Mechanical Performance): The document states that "All testing performed demonstrated substantially equivalent mechanical performance to legally marketed predicate devices." This implies the acceptance criteria were to be substantially equivalent to the predicates in the tested mechanical properties.
   • Reported Device Performance:
     • Static and Dynamic Compression Bending per ASTM F1717
     • Static Torsion per ASTM F1717
     • Static Axial and Torsional Grip per ASTM F1798
     • The performance for these tests was deemed "substantially equivalent" to predicate devices. Specific quantitative values are not provided in this summary.

2. Sample sized for the test set and the data provenance: Not applicable. This document refers to mechanical testing of components, not clinical data from a test set of patients. The provenance would be the test labs where the mechanical tests were performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This pertains to clinical or diagnostic accuracy studies, which were not conducted or reported here.

4. Adjudication method 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. This device is a pedicle screw system, not an AI diagnostic device.

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: For the mechanical tests, the ground truth was the established standards and performance of the predicate devices.

8. The sample size for the training set: Not applicable. This refers to mechanical testing, not a training set for an AI model.

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

Summary of what the document addresses vs. what it does not:

This FDA 510(k) summary is for a physical medical device (pedicle screw system), not an AI/software device. The "study" referenced is a series of non-clinical (mechanical) tests to establish substantial equivalence with predicate devices, as opposed to a clinical study demonstrating diagnostic accuracy or clinical effectiveness in patients.

Therefore, the detailed questions about ground truth, expert adjudication, test set/training set sizes, and MRMC studies related to human reader performance with or without AI are not applicable to this document. The document explicitly states: "N/A - no clinical data were necessary."

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The LimFlow Vector is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves.

The LimFlow Vector is a single-use medical device designed to cut venous valves during vascular in-situ bypass procedures. The LimFlow Vector consists of a 4Fr intravascular catheter that has a working length of 120cm. It utilizes a deployment mechanism to deploy the self-expanding nitinol cutting basket mounted at distal tip which self-centers in the vessel to prevent the cutting blades from damaging the vessel wall. The size of the cutting basket and cutting blades adjust to the internal diameter of the vein as the LimFlow Vector is being drawn through the vessel. The LimFlow Vector is compatible with 0.018" standard guide wires. The LimFlow Vector is used in a healthcare facility, such as a catheter lab or hospital. It is in contact with patient tissue for less than 24 hours. The LimFlow Vector is supplied sterile.

The provided text is a 510(k) summary for the LimFlow Vector device. It outlines the device description, intended use, comparison to a predicate device, and performance data. However, it does not include the specific details required to answer your questions thoroughly, particularly regarding acceptance criteria, the statistical design of a study proving the device meets those criteria (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies).

The document focuses on engineering performance tests and biocompatibility, as commonly required for a 510(k) submission for certain device types. It does not describe a clinical study in the format typical for AI/ML device evaluations where performance is measured against human experts or a gold standard on a medical imaging dataset.

Therefore, I cannot extract the information you've requested from the provided text because it is not present. The document lists performance tests such as:

• Dimensional verification
• Simulated Use
• Tensile Strength testing
• Flexibility and Kink resistance
• Torque Strength
• Radiopacity
• Corrosion resistance
• Particulate Evaluation
• Luer and Leak Testing
• Shelf-life Testing
• Sterilization Validation
• Packaging Validation
• Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis, PTT, Complement Activation, Thrombogenicity)
• Pre-clinical studies in swine and cadaveric models.

These are primarily engineering and bench-testing parameters, not the clinical performance metrics (like sensitivity, specificity, AUC) typically associated with AI/ML systems evaluated against image-based ground truth established by experts.

There is no mention of:

• A table of acceptance criteria with reported device performance in the context of AI/ML metrics.
• Specific sample sizes for a 'test set' or 'training set' for an AI model.
• Data provenance (country of origin, retrospective/prospective) for a clinical dataset.
• Number/qualifications of experts for ground truth or adjudication methods.
• MRMC studies to evaluate human reader improvement with AI assistance.
• Standalone algorithm performance.
• Type of ground truth used as pathology or outcomes data for clinical performance.

In summary, the provided FDA 510(k) summary is for a physical medical device (valvulotome) and details its engineering and biocompatibility testing, not the evaluation of an AI/ML component.

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The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

The Vector Hammertoe Correction System is comprised of a sterile PEEK (polyetheretherketone) HA (hydroxyapatite) fixation device. The implants are offered in Ø3.00mm, Ø3.50mm and Ø4.00mm and in 0° angle. The system has K-wires, drill, taps, implant inserters, and sizers manufactured from medical grade stainless steel.

The provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria, as it relates to performance metrics of a device, particularly an AI/imaging device. The document is an FDA 510(k) clearance letter for a medical device called the "Vector® Hammertoe Correction System," which is a bone fixation system, not an imaging or AI-driven diagnostic device.

Therefore, I cannot provide the requested information from the given text.

The document discusses:

• Device Name: Vector® Hammertoe Correction System
• Regulation Number: 21 CFR 888.3040 (Smooth Or Threaded Metallic Bone Fixation Fastener)
• Regulatory Class: Class II
• Indications for Use: Fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
• Device Description: Sterile PEEK (polyetheretherketone) HA (hydroxyapatite) fixation device, K-wires, drill, taps, implant inserters, and sizers manufactured from medical grade stainless steel.
• Predicate Devices: K201850 (Nvision Biomedical's Vector Hammertoe Correction System), K183055 (Nvision Biomedical's Vector Hammertoe Correction System), and K193645 (Nvision Biomedical's nva, nvt).
• Non-Clinical Testing: Primarily engineering analysis comparing device characteristics (materials, intended use, cleaning, sterilization) to predicate devices. It states no FDA performance standards have been established for this device and that the results indicate substantial equivalence. The key modification mentioned is the addition of steam sterilization as an alternative method.

None of the information required for explaining acceptance criteria for an AI/imaging device, such as sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, is present in this regulatory document.

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The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

The VECTOR Hammertoe Correction System is comprised of a sterile PEEK (polyetheretherketone) HA (hydroxyapatite) fixation device. The implants are offered in Ø3.0mm (cannulated), Ø3.50mm (cannulated and non-cannulated) and Ø4.00mm (cannulated and non-cannulated) and in 0° angle. The system has K-wires, drill, taps, implant inserters, and sizers manufactured from medical grade stainless steel.

The provided text is a 510(k) summary for the VECTOR™ Hammertoe Correction System. It describes the device, its indications for use, and its equivalence to predicate devices, primarily through engineering analysis. This document does not contain information about an AI/ML powered device, nor does it present acceptance criteria or a study proving device performance in the context of AI/ML.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone (algorithm only) performance data
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document explicitly states: "No FDA performance standards have been established for the Vector Hammertoe Correction System. The following was performed to demonstrate safety per methods of the previous submission: Engineering Analysis comparison of mechanical performance characteristics." This indicates that the safety and effectiveness were demonstrated through mechanical performance characteristics engineering analysis and comparison to predicates, not through clinical or AI/ML performance studies with human readers or AI algorithms.

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The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

The VECTOR Hammertoe Correction System is comprised of a sterile PEEK (polyetheretherketone) HA (hydroxyapatite) fixation device. The implants are offered in Ø3.50mm and Ø4.00mm and in 0° angle. The system has K-wires, drill, taps, implant inserters, and sizers manufactured from medical grade stainless steel.

The VECTOR Hammertoe Correction System is a medical device designed for the fixation of osteotomies and reconstruction of lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. The provided text describes the regulatory filing for this device, not a study evaluating its performance against specific acceptance criteria. Therefore, most of the requested information cannot be extracted directly from this document.

However, based on the "SUMMARY OF NON-CLINICAL TESTING" section, we can infer the types of tests performed to demonstrate safety and equivalence to predicate devices, which serve as the implicit acceptance criteria for this type of regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not specify the sample size for individual tests (e.g., number of implants tested for torsion, pullout, etc.). It describes non-clinical laboratory testing. The data provenance is from laboratory testing conducted by the manufacturer, Nvision Biomedical Technologies, LLC. Since these are non-clinical (mechanical and biological) tests, "country of origin of the data" and "retrospective or prospective" are not directly applicable in the same way they would be for clinical studies with human subjects.

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 non-clinical study involving mechanical and biocompatibility testing, not human expert evaluation of clinical images or diagnoses. The "ground truth" here is established by the specifications of the ASTM standards and regulatory limits (e.g., endotoxin levels).

4. Adjudication method for the test set
Not applicable. There was no expert adjudication process as this was non-clinical laboratory testing.

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 document describes the regulatory filing for a medical fixation device, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic or AI-based device.

7. The type of ground truth used
The "ground truth" for the non-clinical tests is based on:

• Engineering specifications and recognized consensus standards: Specifically ASTM F543, which outlines standard test methods for metallic medical bone screws.
• Regulatory limits for biocompatibility: Recommended Bacterial Endotoxins limits (20 EU/device).
• Comparison to predicate devices: The "substantially equivalent" determination implies that the test results met or exceeded the performance characteristics of the predicate devices.

8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this type of device.

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The Vector™ PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arterio-venous dialysis fistulae.

The Vector" Catheter is not indicated for use in the coronary arteries or for placement of or post dilatation of stents.

The Vector™ PTA Balloon Dilatation Catheter is a high pressure, non-compliant balloon catheter. It is a coaxial dual lumen over-the-wire balloon dilatation catheter. The central lumen accommodates guide wires up to the 0.035 inches in diameter while the outer lumen is the inflation lumen for the balloon.

The balloon is a high pressure composite balloon with radio-opaque marker bands to help visualize the balloon placement within the vasculature during both placement and inflation. The balloon's rated burst pressure is 30 atm.

The provided document is a 510(k) summary for a medical device called the Vector™ PTA Balloon Dilatation Catheter (K143652). It outlines the device's technical characteristics, intended use, and a summary of performance testing to establish substantial equivalence to a predicate device.

Here's an analysis to extract the requested information:

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

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

The document does not explicitly state the specific sample sizes used for each individual test. It mentions "All devices met the performance specifications" implying that a sufficient number of devices were tested for each performance characteristic. The data provenance is not specified, but the testing would typically be internal bench testing conducted by the manufacturer. It is not a clinical study, so concepts like country of origin or retrospective/prospective don't apply in the same way.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This document describes bench testing of a device's physical and functional properties, not a diagnostic or AI device that relies on expert interpretation to establish "ground truth." Therefore, this question is not applicable. The "ground truth" for these tests are the engineering specifications and established test methods.

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

This question is not applicable as the document describes bench testing of a physical device, not an assessment requiring expert adjudication of clinical outcomes or diagnostic interpretations.

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 question is not applicable. This is a 510(k) submission for a physical medical device (balloon catheter), not an AI/CAD diagnostic device.

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

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

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

For the performance tests described (Rated Burst Pressure, Balloon Compliance, etc.), the "ground truth" is defined by the engineering specifications, industry standards, and established test methodologies. For example, the rated burst pressure is a design specification that the device must meet or exceed. There is no expert consensus, pathology, or outcomes data involved in establishing "ground truth" for these types of bench tests.

8. The sample size for the training set

This question is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

This question is not applicable. As there is no training set, there is no ground truth for it.

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The Arrow VectorFlow Antegrade Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow VectorFlow Antegrade Chronic Hemodialysis Catheter is inserted percutaneously and is preferentially placed into the internal jugular (II) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Arrow VectorFlow Antegrade Chronic Hemodialysis Catheter is intended for use in adult patients.

The Arrow VectorFlow Retrograde Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow VectorFlow Retrograde Chronic Hemodialysis Catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Arrow VectorFlow Retrograde Chronic Hemodialysis Catheter is intended for use in adult patients.

The Arrow VectorFlow Retrograde Replacement Hub Set is indicated for use in the replacement of a Arrow VectorFlow Retrograde hub connection assembly that has been damaged.

The Arrow VectorFlow Antegrade Chronic Hemodialysis Catheter (herein referred to as the proposed VFA catheter) and the Arrow VectorFlow Retrograde Chronic Hemodialysis Catheter (herein referred to as the proposed VFR catheter) are long-term, single use catheters designed to provide access to the central venous system in a healthcare facility environment. The VFA catheter is a one piece catheter, two lumen, 15 French symmetrical-tipped catheter designed for antegrade placement. The VFR catheter is two-piece, two-lumen, 15 Fr, symmetrical tipped catheter designed for retrograde placement. The VFA and VFR catheters are available in multiple lengths. The Arrow VectorFlow Retrograde Replacement Hub Set (herein referred to as the proposed Hub Set) is sold separately to perform a repair of the VFR, replacing cracked or broken luer connectors, clamps, and/or damaged extension lines.

The VFA and VFR catheters and Hub Set will be packaged sterile with various components to facilitate insertion.

The provided text describes a 510(k) summary for Arrow VectorFlow catheters and a replacement hub set. This document is a premarket notification for a medical device seeking substantial equivalence to existing predicate devices, not a study describing the performance of an AI/ML-driven device with acceptance criteria.

Therefore, I cannot extract the information required to populate the fields you specified (e.g., acceptance criteria for an AI/ML device, sample size for test sets, number of experts for ground truth, MRMC study, training set details) because this document is for a physical medical device (hemodialysis catheters) and does not involve AI/ML.

The "Nonclinical Testing" section mentions "Bench testing" and compliance with ISO standards, which are typical for physical medical devices to demonstrate safety and performance. The "Clinical Data" section explicitly states, "Clinical performance data was not used to determine substantial equivalence."

Key takeaway: This document does not describe an AI/ML device or its performance evaluation in the context of your request.

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