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The Vu c.POD Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C2-C3 to C7-T1. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

The Vu c.POD implants are to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/ or corticocancellous bone and implanted via an open, anterior approach. The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Vu c.POD Intervertebral Body Fusion Device is intended for use with supplemental internal fixation systems.

The Complete Cervical Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

The Complete Cervical implants are to be used with autograft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an anterior approach. The cervical device is to be used in patients who have had six (6) weeks of non-operative treatment. The cervical device is to be used with two titanium alloy screws which accompany the implant.

Zuma-C is a stand-alone anterior cervical interbody fusion device intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Zuma-C is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an open, anterior approach. Zuma-C is intended to be used with the bone screw fixation provided and requires no additional fixation.

The SeaSpine Vu c-POD, Complete Cervical, and Zuma-C Systems are intervertebral fusion devices intended to act as a disc spacer and hold bone graft to promote fusion in the cervical spine. All three system spacers are manufactured from PEEK (ASTM F2026), with tantalum (ASTM F560) radiographic markers. The Complete Cervical spacers also include titanium alloy and screws (ASTM F136), while Zuma-C includes titanium screws, as well as plates and set screws (ASTM F136).

Each system spacer is generally box-shaped with a central canal for receiving autograft bone graft material and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The systems are implanted via an anterior approach.

The instruments included with each system facilitate the placement and adjustment of the interbody spacers, and removal if necessary. The instruments are placed in trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

The provided document is a 510(k) Premarket Notification from the FDA regarding intervertebral body fusion devices. It focuses on the substantial equivalence of the new devices (SeaSpine Vu cPOD, Zuma-C, Complete Cervical) to previously marketed predicate devices.

Crucially, this document explicitly states that "determination of substantial equivalence is not based on an assessment of clinical performance data" and that "no mechanical testing was performed for the Vu c Pod and Complete Cervical systems," with Zuma-C relying on prior testing.

Therefore, based on the information provided in this document, it is not possible to outline acceptance criteria and a study that proves the device meets those criteria in the context of clinical performance or AI/software-based device evaluation. The submission primarily relies on the physical and material equivalence to existing devices.

The questions you've asked (about acceptance criteria for performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training sets, etc.) are typical for the evaluation of medical devices that involve algorithms, AI, or clinical performance studies (e.g., diagnostic devices, imaging analysis software). This document does not describe such a study.

In summary, the document states:

• No clinical testing was performed for this submission.
• Substantial equivalence is not based on an assessment of clinical performance data.
• Mechanical testing was not performed for two of the devices, and for the third, previous testing was deemed sufficient.

Therefore, I cannot provide the requested information from this document. If you have a document that describes the clinical or performance study of an AI-powered or diagnostic medical device, I would be happy to analyze it for the details you've requested.

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Zuma-C™ is a stand-alone anterior cervical interbody fusion device intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Zuma-C™ is to be packed with autogenous bone graft and implanted via an open, anterior approach. Zuma-C™ is intended to be used with the bone screw fixation provided and requires no additional fixation.

Zuma-C is a stand-alone interbody fusion device composed of PEEK and titanium alloy with radiopaque markers, titanium screws and a locking cover. The screws are inserted through the device into adjacent vertebral bodies and the locking cover mates with the device, covering the screws. The device has an open central area for receiving bone graft material and is offered pre-assembled in a variety of heights and geometries to accommodate variations patient anatomy.

This document is a 510(k) summary for the Zuma-C™ interbody fusion device. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and pre-clinical testing for mechanical performance, rather than clinical efficacy or diagnostic accuracy. Therefore, many of the requested categories related to clinical studies, ground truth establishment, and expert involvement are not applicable or not detailed in this submission.

Here's the information extracted and categorized as requested:

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 applicable. The studies performed were pre-clinical (benchtop) tests on device constructs, not data from a patient test set.
• Data Provenance: The data provenance is pre-clinical testing conducted by the manufacturer, SeaSpine, Inc. No information on country of origin of data or retrospective/prospective nature is applicable as it's not a clinical study.

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

• Not applicable. Ground truth as typically defined for diagnostic or prognostic devices with expert review is not relevant for this type of pre-clinical mechanical performance assessment. The "ground truth" here is adherence to established ASTM standards.

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

• Not applicable. Adjudication is not relevant for pre-clinical mechanical performance 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. This is a medical device for spinal fusion, not an AI-powered diagnostic or decision support tool 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 not an algorithm or AI device.

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

• The "ground truth" for these pre-clinical studies is defined by the performance requirements and testing methodologies outlined in the referenced ASTM standards (ASTM F2077, ASTM F2267, ASTM F1714, ASTM F1877). The goal was to show "substantial equivalence" to legally marketed predicate devices under these conditions.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set. The "samples" would be the physical device constructs tested in the pre-clinical studies, but the concept of a "training set" doesn't apply.

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

• Not applicable. No training set for an AI/ML model was used.

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When used as an intervertebral body fusion device, the Zuma System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autograft. Zuma is a stand alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.

When used as a Vertebral Body Replacement Device, the Zuma System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Zuma System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period. Additionally, Zuma is intended for use with bone graft.

Zuma is an implantable spinal device made from polyetheretherketone (PEEK) and titanium with markers for radiographic visualization; it is secured to vertebral bodies with bone screws. The device has an open central area for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy.

The provided text describes the 510(k) summary for the Zuma™ Interbody Fusion Device/Vertebral Body Replacement Device. It indicates that the device was deemed substantially equivalent to predicate devices based on comparisons in intended use, design, materials, and function. The only performance data mentioned is related to mechanical testing.

Here's a breakdown of the requested 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

• Sample Size for Test Set: Not mentioned.
• Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The performance data mentioned is mechanical testing.

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

• Not Applicable. The submission states "Clinical data was not required for this device," and the performance data provided is mechanical testing, which typically does not involve expert ground truth for a test set in the same way clinical studies do.

4. Adjudication Method for the Test Set

• Not Applicable. As no clinical test set requiring expert adjudication is described.

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

• No. A MRMC comparative effectiveness study was not done. The submission explicitly states, "Clinical data was not required for this device."

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

• Not Applicable. This device is a physical medical implant, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance mentioned is related to its mechanical properties.

7. The Type of Ground Truth Used

• The ground truth for the mechanical performance testing would be established by engineering standards and specifications for interbody fusion devices and vertebral body replacement devices. These standards define the acceptable mechanical properties (e.g., strength, stiffness, fatigue life) that the device must meet for its intended use.

8. The Sample Size for the Training Set

• Not Applicable/Not provided. This information is typically relevant for AI/ML models. For a physical medical device, there isn't a "training set" in the same sense. The device design and materials are developed based on engineering principles and preclinical testing, but a "training set" is not a concept explicitly applied here.

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

• Not Applicable/Not provided. Similar to point 8, this concept does not directly apply to the development of a physical medical device. The "ground truth" for the device's design and materials would be founded on established biomechanical and materials science principles, industry standards, and requirements for spinal implants.

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The Zuma System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

The Zuma System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period. Additionally, The Zuma System is intended for use with bone graft.

Zuma is a vertebral body replacement device fabricated from PEEK OPTIMA® and titanium. Zuma is designed to restore the biomechanical integrity of the spinal column following full or partial vertebrectomy. The interior of the device is open to provide space for placement of grafting material. Bone screws are inserted through the device into adjacent vertebral bodies. Zuma is available in varying depths, widths, and heights to accommodate variations in patient anatomy.

The provided document is a 510(k) summary for the Zuma™ Vertebral Body Replacement Device. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on design, operating principle, materials, intended use, and sterilization methods.

However, the document does not contain the detailed performance data, acceptance criteria, or study results that would typically be associated with a comprehensive evaluation of a medical device's performance against specific metrics. It primarily focuses on demonstrating substantial equivalence to existing devices rather than presenting a standalone performance study with quantifiable acceptance criteria.

Based on the provided text, I can only extract limited information regarding performance and no specific details about the study methodology you requested.

Here's a breakdown of what can and cannot be answered from the provided text:

What can be answered:

• 1. A table of acceptance criteria and the reported device performance:
  • Acceptance Criteria: The document implies that the acceptance criteria are related to "sufficient strength" and performing "as well as or better than the predicate devices" in terms of safety and effectiveness. However, no specific numerical or qualitative criteria are provided.
  • Reported Device Performance:
    • "Zuma demonstrated sufficient strength in series of mechanical tests."
    • "Analysis indicated that Zuma is as safe, as effective and performs as well as or better than the predicate devices."
  • Table: A table cannot be generated with specific numerical values for acceptance criteria or performance from the provided text.

What cannot be answered from the provided text:

• 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 mentions "series of mechanical tests" but does not specify sample sizes or data provenance.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
  • No information on expert involvement or ground truth establishment is provided. The tests described are "mechanical tests," which typically don't involve expert readers in the same way as imaging or clinical studies.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
  • Not applicable/Not provided.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
  • Not applicable. This is a spinal implant device, not an AI-powered diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
  • Not applicable. This is a spinal implant device, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
  • For mechanical tests, the "ground truth" would typically be defined by engineering standards, material properties, and biomechanical specifications. However, the document does not elaborate on these specifics.
• 8. The sample size for the training set
  • Not applicable. This refers to an AI training set, and this device is not an AI algorithm.
• 9. How the ground truth for the training set was established
  • Not applicable.

Conclusion:

The provided 510(k) summary serves as a regulatory filing to demonstrate substantial equivalence to predicate devices, focusing on design, materials, and intended use for a spinal implant. It includes a general statement about "sufficient strength in series of mechanical tests" but lacks the detailed performance data, acceptance criteria, and study methodology typically found in clinical trials or comprehensive performance studies for AI/diagnostic devices. The questions you posed are largely geared towards software/AI performance evaluations, which are not relevant to this hardware medical device described.

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The Medtronic® Zuma™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Zuma™ catheter is intended to be used in the coronary or peripheral vascular system.

The Medtronic® Zuma™ Guiding Catheters will be available in 5F 9F outer diameters. The 6F and 9F (non-segmented) catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The 5F, 7F, 8F and 9F(segmented) Zuma catheters are manufactured with a braided proximal shaft and segments, an inner liner and a soft distal tip. The inner lumen of the Zuma™ catheter has a thin lubricious coating. The Zuma™ Guiding Catheter (6F - 9F) has a larger inner lumen diameter than its predicate devices. The 5F Zuma is comparable in stiffness to a 6F predicate device.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, structured according to your request:

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

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

The provided text does not specify the sample size used for the test set or the data provenance. The document indicates that tests were performed ("Test results verified"), but there are no details on the number of catheters or samples tested, nor where the testing was conducted or if it was retrospective or prospective.

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 information is not provided in the document. The document refers generally to "Test results" and "specifications" for a medical device (guiding catheter), which typically involve engineering and material science testing, rather than human expert interpretation of data like images. Therefore, the concept of "experts" establishing ground truth in this context (for mechanical and material properties) is not directly applicable in the same way it would be for AI-powered diagnostic devices.

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

This information is not provided and is not typically relevant for the type of device (guiding catheter) or the nature of the testing described (biocompatibility, performance specifications of physical attributes). Adjudication methods are more commonly associated with human interpretation tasks or clinical endpoints requiring consensus.

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

There is no indication of an MRMC comparative effectiveness study being conducted. This device is a guiding catheter, a physical medical instrument, not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI" is not applicable here.

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

This question is not applicable as the device is a physical guiding catheter, not an algorithm or AI system.

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

For the performance criteria mentioned (biocompatibility, inner lumen diameter, stiffness), the "ground truth" would be established by standardized laboratory testing procedures, physical measurements, and adherence to predefined material science and engineering specifications. For example, biocompatibility testing would follow ISO standards, diameter measurements would use precision instruments, and stiffness testing would involve specific mechanical test setups.

8. The sample size for the training set

This information is not applicable. This document describes the 510(k) submission for a physical medical device (guiding catheter), not a machine learning model. There is no concept of a "training set" in this context.

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

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

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The Medtronice ZumaTM Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Zuma™ catheter is intended to be used in the coronary or peripheral vascular system

The Medtronic® Zuma™ Guiding Catheters will be available in 6F, 7F and 8F outer diameters. The 6F catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The 7F and 8F catheters are manufactured with a braided proximal and segmented shaft with an inner liner and a soft distal tip. The inner lumen of the 22ma™ catheter (6F-8F) has a thin lubricious coating. The Zuma™ Guiding Catheter has a larger inner lumen diameter and a stiffer shaft than its predicate devices.

The provided text refers to a 510(k) summary for a medical device called the Medtronic® Zuma™ Guiding Catheter, not a study evaluating an AI-powered device. Therefore, information regarding AI-specific acceptance criteria, test sets, expert ground truth, MRMC studies, or training sets is not available in the provided document.

However, I can extract the general acceptance criteria for this medical device and how it was shown to meet them based on the provided text.

Here's the information parsed from the provided text:

Acceptance Criteria and Device Performance for Medtronic® Zuma™ Guiding Catheter

Study Details (as inferable from a 510(k) submission for a non-AI device):

• Sample size for the test set and the data provenance: Not applicable in the context of an AI device. For this traditional medical device, testing would involve in-vitro (bench) testing, and potentially animal studies, to demonstrate performance and safety, but not human "test set" data in the AI sense. The provenance would be the laboratory where testing was conducted.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a guiding catheter, "ground truth" relates to physical and performance specifications verified through engineering and biocompatibility testing, not expert interpretation of data.
• Adjudication method for the test set: Not applicable. Performance is based on objective, quantifiable measurements against pre-defined specifications for physical properties, functionality, and biocompatibility.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-powered device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-powered device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this type of device, the "ground truth" would be established by engineering specifications, material science standards (for biocompatibility), and established medical device performance criteria.
• The sample size for the training set: Not applicable. This is not an AI-powered device and therefore does not have a training set.
• How the ground truth for the training set was established: Not applicable. This is not an AI-powered device.

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The Medtronic® Zuma™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.

The Medtronic® Zuma™ Guiding Catheters will be available in a 6F outer diameter size. The catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The inner lumen of the catheter has a thin lubricious coating. The Zuma™ Guiding Catheter has a larger inner lumen diameter and a stiffer shaft.

The provided text is a 510(k) summary for the Medtronic® Zuma™ Guiding Catheter. It outlines the device's intended use, construction, and provides a statement of substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria, detailed study results, or the comprehensive information required to fill in all aspects of your request.

Here's a breakdown of what can be extracted and what is missing:

The document states:
"Test results verified that the Medtronic® Zuma™ Guiding Catheters meets all of the applicable specifications and is deemed adequate for the intended use."

This confirms that some testing was done to meet specifications, but it doesn't provide the specifications themselves (the acceptance criteria) or the detailed results.

Assuming a hypothetical scenario for a medical device cleared via 510(k) and drawing common practices from such submissions, the following table and explanations are constructed. Please note these are inferred or placeholders where the original text lacks details.

1. Table of Acceptance Criteria and Reported Device Performance

(The following sections will contain "Not mentioned in the provided text" for most points, as the 510(k) summary does not include this level of detail. Such information is typically found in the full 510(k) submission, not the public summary.)

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

• Sample Size: Not mentioned in the provided text. For physical properties, this would typically be a statistical sample of manufactured units (e.g., n=30 per test). For biocompatibility, it refers to the material samples tested.
• Data Provenance: Not mentioned in the provided text. Most likely laboratory testing (in-vitro) and animal studies (if required for certain biocompatibility or preclinical performance aspects), generally conducted in the country of manufacture or a certified lab. The summary implies the data is prospective, generated specifically for this submission.

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

• Not applicable/Not mentioned. This device is a guiding catheter, a physical medical device, not an AI diagnostic tool. Ground truth in this context refers to established engineering specifications and performance benchmarks, not expert consensus on interpretations. Physical tests are carried out by engineers and technicians according to established protocols.

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

• Not applicable/Not mentioned. Adjudication methods are relevant for subjective diagnostic tasks, not for objective physical performance testing of a catheter. Testing follows pre-defined pass/fail criteria.

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

• Not applicable. This is a physical medical device (guiding catheter), not an AI diagnostic system. Therefore, MRMC studies and "human readers improving with AI" are irrelevant to this submission.

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

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

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

• The ground truth for this type of device is established engineering specifications, mechanical test standards (e.g., ISO, ASTM), and clinical performance criteria derived from predicate devices and intended use. For biocompatibility, the ground truth is the pass/fail criteria of ISO 10993 tests.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/machine learning model, so there is no "training set."

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

• Not applicable. As there is no training set for a physical device, this question is not relevant.

Summary of Device Clearance:

The Medtronic® Zuma™ Guiding Catheter was cleared through the 510(k) pathway by demonstrating substantial equivalence to existing legally marketed predicate devices (Medtronic® Vector™ X Guiding Catheter and Cordis® Brite Tip® Guiding Catheter). This means the FDA determined that the new device is as safe and effective as the predicate devices, based on its technological characteristics, intended use, and performance data. The review focuses on demonstrating that the new device does not raise different questions of safety and effectiveness compared to the predicate. The document confirms that "Test results verified that the Medtronic® Zuma™ Guiding Catheters meets all of the applicable specifications and is deemed adequate for the intended use." indicating successful performance testing, though the specifics of those tests and their acceptance criteria are not detailed in this public summary.

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