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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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