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The Vista@-S Device is intended for use in skeletally mature patients with degenerative disc disease (DDD) with/without radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Vista®-S Device is intended for use with supplemental spinal fixation systems and with autogenous bone graft. The Vista S Device is implanted via an anterior approach.

The purpose of this submission is a line extension to the Vista®-S Device adding additional height and footprint options. The Vista -S Device is a box-shaped device for interbody fusion fabricated from polyetheretherketone (PEEK). The device is available in a variety of cross sections and heights to accommodate variations in the individual pathology and anatomic condition of the superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. Radiopaque markers are press fit into the device to aid in determining the location of the implant postoperatively.

The provided 510(k) summary for the Vista®-S Device describes a line extension to an intervertebral body fusion device and relies on showing substantial equivalence to previously cleared predicate devices. Therefore, the "acceptance criteria" and "device performance" are established by demonstrating that the new line extension does not negatively impact the safety and efficacy compared to the predicate devices, and that it satisfies relevant ASTM standards and FDA guidance. This is primarily done through performance testing in the form of Finite Element Analysis (FEA).

Here’s a breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study conducted to prove the device meets the acceptance criteria was a Finite Element Analysis (FEA) testing study.

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

• Sample Size: Not applicable in the traditional sense of patient data. FEA is a computational simulation. The "samples" would be the specific FEA models created for the various device configurations. The document implies that multiple FEA simulations were conducted for axial compression, torsion, and compression shear, but does not specify the exact number of models or iterations.
• Data Provenance: Not applicable as it's an engineering simulation, not human data.

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

This is not applicable for an FEA study. Ground truth, in this context, would be the established engineering principles, material properties, and the ASTM F2077-03 standard itself, which are developed by experts in the field through consensus. The "experts" reviewing the FEA results would be the internal engineering and regulatory teams at Zimmer and the FDA reviewers.

4. Adjudication Method for the Test Set:

Not applicable in the context of clinical adjudication. The FEA results were likely reviewed and accepted by internal engineering and regulatory teams at Zimmer and subsequently by the FDA for the 510(k) submission.

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

No, an MRMC study was not done. This device is an intervertebral body fusion device, and the submission is for a line extension based on mechanical equivalence, not on image interpretation or diagnostic accuracy where MRMC studies are typically employed.

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

Yes, the Finite Element Analysis (FEA) testing can be considered a standalone performance assessment of the device's mechanical properties, without human interaction during the test itself. The FEA simulates the device's behavior under specific loads.

7. The Type of Ground Truth Used:

The ground truth used for the FEA study is based on:

• Established engineering principles and biomechanical models.
• Material properties of PEEK.
• The specifications outlined in the ASTM F2077-03 Test Methods for Intervertebral Body Fusion Devices.
• Recommendations from the FDA Class II Special Controls Guidance Document: Intervertebral Fusion Device.

8. The Sample Size for the Training Set:

Not applicable. FEA is a simulation technology and does not involve "training sets" in the machine learning sense.

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

Not applicable, as there is no "training set" for FEA.

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The Vista S Device is intended for use in skeletally mature patients with degenerative disc disease (DDD) with/without radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Vista® S Device is intended for use with supplemental spinal fixation systems and with autogenous bone graft. The Vista -S Device is implanted via an anterior approach.

The Vista -S Device is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vista -S Device is intended for use with supplemental internal spinal fixation systems. The Vista -S Device may be used with bone graft.

The Vista -- S Device is a box-shaped device for interbody fusion and vertebral body replacement fabricated from polyetheretherketone (PEEK). The Vista -S currently cleared to accommodate the replacement of a vertebral body in the thoracic and lumbar region of the spine. Use of this device is expanded to include use as a cervical interbody fusion device at one level from C2-T1. The device is available in a variety of cross sections and heights to accommodate variations in the individual pathology and anatomic condition of the patient. The superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. Radiopaque markers are press fit into the device to aid in determining the location of the implant postoperatively.

The provided text describes a 510(k) premarket notification for a medical device called the Vista®-S Device. This submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of diagnostic performance against acceptance criteria in the way one might for an AI/ML medical device.

Based on the information provided, here's a breakdown of the requested points:

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

   Acceptance Criterion Topic	Acceptance Criteria	Reported Device Performance
   Substantial Equivalence	Device is substantially equivalent to legally marketed predicate devices.	The Vista®-S Device was shown to be substantially equivalent. No significant differences that would adversely affect use. No new issues of safety or efficacy.
   Material	Identical or similar material to previously cleared predicate devices.	Identical material to previously cleared predicate devices.
   Intended Use/Indications	Similar to predicate devices.	Similar to its predicate devices. Expanded indications for cervical interbody fusion (C2-T1) in addition to existing thoracolumbar vertebral body replacement (T1-L5).
   Design Features/Geometry	Similar to cleared predicate devices.	Similar to cleared predicate devices.
   Mechanical Performance	Adequately meets predetermined requirements established for its mechanical performance as per FDA guidance.	Mechanical testing results and analyses demonstrate that the proposed system adequately meets predetermined requirements.

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

   This document describes mechanical testing and comparison to predicate devices for a physical implant, not a study involving a "test set" of patient data or images in the way an AI/ML diagnostic device would. There is no mention of a clinical test set, patient data, or provenance (country of origin, retrospective/prospective). The "test set" here refers to the actual device units subjected to mechanical tests.

   • Sample Size: Not specified for mechanical testing, but typically involves a certain number of devices per test.
   • Data Provenance: Not applicable in the context of device mechanical testing.

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

   Not applicable. This is not a diagnostic device involving expert ground truth for interpretation. Ground truth for mechanical testing would be defined by engineering specifications and standards.

4. Adjudication method for the test set

   Not applicable. This is not a study requiring adjudication of expert interpretations. Mechanical testing results are objective measurements against predefined engineering standards.

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, an MRMC study was not done. This device is a physical implant (interbody fusion device/vertebral body replacement), not an AI-assisted diagnostic tool.

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

   No, a standalone algorithm performance study was not done. This is a physical medical device.

7. The type of ground truth used

   For the mechanical performance testing, the ground truth would be established by engineering standards and specifications based on recommendations from the FDA Class II Special Controls Guidance Document: Intervertebral Fusion Device. For the substantial equivalence argument, the "ground truth" is the established safety and efficacy of the predicate devices.

8. The sample size for the training set

   Not applicable. This device is not an AI/ML algorithm 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 medical device submission.

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The Vista -S Device is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vista -S Device is intended for use with supplemental internal spinal fixation systems. The Vista -S Device may be used with bone graft.

The Vista -S Device is a box-shaped vertebral body replacement fabricated from polyetheretherketone (PEEK) that is designed to accommodate the partial replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to accommodate variations in the individual pathology and anatomic condition of the patient. The superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. Radiopaque markers are press fit into the device to aid in determining the location of the implant postoperatively.

The provided text is a 510(k) summary for the Vista®-S Device, a vertebral body replacement device. This type of regulatory submission in the medical device industry does not typically involve the kind of "acceptance criteria" and "device performance study" as would be found in an AI/software device submission.

Instead, a 510(k) demonstrates "substantial equivalence" to a legally marketed predicate device. This means the new device is as safe and effective as a device already on the market. The studies conducted for such devices are typically focused on bench testing (e.g., mechanical strength, fatigue), biocompatibility, and sometimes limited animal studies, rather than clinical performance metrics like sensitivity, specificity, or reader improvement.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable to this type of medical device and the information provided in the 510(k) summary.

Here's an analysis based on the provided text, highlighting what is and isn't available:

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

• Not Applicable in the traditional sense for this device type.
• For a spinal implant like the Vista®-S Device, "acceptance criteria" would typically relate to mechanical properties (e.g., compressive strength, fatigue life, subsidence resistance), biocompatibility, and sterilization effectiveness. The 510(k) summary does not detail specific acceptance criteria or quantitative performance data from such tests.
• Instead, the submission focuses on substantial equivalence to predicate devices in terms of materials, technological characteristics, and basic principles of operation. The "performance" is implicitly deemed acceptable if it meets the safety and effectiveness standards of the predicate.

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

• Not Applicable.
• No clinical "test set" in the context of diagnostic accuracy or AI performance is mentioned. The studies conducted would be non-clinical (mechanical, biological). The document does not specify sample sizes for these non-clinical tests.

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

• Not Applicable.
• There is no "ground truth" to establish for a test set in this context. The evaluation is on the device's physical properties and comparison to existing technology, not on interpretations by experts.

4. Adjudication method for the test set

• Not Applicable.
• No clinical test set requiring adjudication 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.
• This device is a physical implant, not an AI or diagnostic tool. Therefore, MRMC studies are not relevant.

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

• Not Applicable in the traditional sense.
• For this type of device, "ground truth" would be established by validated engineering standards, material specifications, and regulatory guidelines for mechanical testing and biocompatibility. The summary does not elaborate on these details.

8. The sample size for the training set

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

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

• Not Applicable.
• No training set is involved.

Summary of what is known from the provided text:

• Device Name: Vista®-S Device
• Device Type: Vertebral Body Replacement Device (spinal implant)
• Intended Use: Partial replacement of a collapsed, damaged, or unstable vertebral body in the thoracolumbar spine (T1-L5) due to tumor or trauma (e.g., fracture). Intended for use with supplemental internal spinal fixation systems and may be used with bone graft.
• Regulatory Pathway: 510(k) Premarket Notification, demonstrating "substantial equivalence" to predicate devices.
• Basis for Acceptance: The FDA determined the device is substantially equivalent to legally marketed predicate devices with respect to intended use/indications for use, materials, technological characteristics, and basic principles of operation. This means the device is deemed as safe and effective as existing devices without requiring new clinical performance studies of the type typical for AI or diagnostic devices.
• Classification: Class II, product code MQP (Spinal intervertebral body fixation orthosis).

The provided text focuses on the regulatory submission process and the classification of the device rather than detailed performance studies or AI validation.

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