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The SOVEREIGN™ Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a laparoscopic or an open anterior approach.

The SOVEREIGN™ interbody device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the SOVEREIGN™ interbody device is intended to be used with the three titanium alloy screws and the accompanying cover plate. If the physician chooses to use less than three or none of the provided screws, then additional supplemental fixation which has been cleared by the FDA for use in the lumbar spine must be used to augment stability. The accompanying cover plate MUST be used anytime the device is used with any number of screws.

The SOVEREIGN™ Spinal System is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The accompanying cover plate is designed to resist screw backout and must be used when screws are implanted. The implant is lens-shaped with three holes for placement of titanium screws. This device is intended to be radiolucent and the interior space of the product is to be used with bone graft.

The SOVEREIGNTM Spinal System interbody device is manufactured from PEEK Optima (polyetheretherketone) and contains tantalum radiopaque markers. The screws used with this device are manufactured from titanium alloy:

This document is a 510(k) premarket notification for the SOVEREIGN™ Spinal System. It asserts substantial equivalence to a previously cleared device (INTREPID™ Spinal System) and does not contain detailed acceptance criteria and performance study results as would be found in a clinical trial report.

Therefore, the requested information cannot be fully extracted or inferred from the provided text. Specifically, clinical study data, acceptance criteria tables, sample sizes for test and training sets, details on expert panels, adjudication methods, or MRMC study results are not present in this document.

The document focuses on:

• Device Description: The SOVEREIGN™ Spinal System is an intervertebral body fusion device with internal screw fixation, made from PEEK Optima with tantalum markers.
• Indications for Use: For degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, with autogenous bone graft, in skeletally mature patients who have had six months of non-operative treatment. Can be used stand-alone with three screws and a cover plate, or with supplemental fixation if fewer or no screws are used.
• Substantial Equivalence: The primary basis for clearance is substantial equivalence to the INTREPID™ Spinal System (K080083). Minor changes to labeling (indications, device description, contraindications).
• Regulatory Classification: Class II, regulated under 21 CFR 888.3080 (Intervertebral body fusion device).

No information regarding acceptance criteria or a specific study demonstrating performance against such criteria (as you would expect for a new, significant technological device) is provided in this 510(k) summary. This type of premarket notification for devices like the SOVEREIGN™ Spinal System often relies on demonstrating mechanical equivalence and biocompatibility, and substantial equivalence to a predicate device, rather than new clinical efficacy studies with predefined acceptance criteria.

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The INTREPID™ Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a laparoscopic or an open anterior approach. The INTREPID™ interbody device is intended to be used with the three titanium alloy screws which accompany the implant. If the physician chooses to use less than three, or none of the provided screws, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability.

The INTREPID™ Spinal System is a stand-alone intervertebral body fusion device, which consists of an anatomically shaped vertebral body spacer designed with a selfdistracting nose. The spacer is equipped with three holes which allow for the placement of internal fixation screws. The screws are inserted through the cage and help provide stabilization and back-out resistance. The INTREPID™ spacer is manufactured from medical grade polyetheretherketone (PEEK), while the screws are manufactured from titanium alloy.

This document, K080083, is a 510(k) summary for the INTREPID™ Spinal System. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed study that proves the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not present in this type of regulatory submission. 510(k)s primarily rely on showing that a new device is as safe and effective as a legally marketed predicate device, often through mechanical testing and comparison of design features and indications for use.

Here's a breakdown of what can be extracted based on the provided text, and where information is inherently missing for a 510(k) submission:

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

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics with specific thresholds in this submission. For 510(k) devices, acceptance criteria are generally met by demonstrating substantial equivalence to predicate devices, often through mechanical testing. The implied acceptance criteria are that the device meets the performance characteristics (e.g., strength, durability, biocompatibility) necessary to be considered equivalent to the predicate devices.
• Reported Device Performance: The document only states that "mechanical test results was provided which demonstrated that the subject INTREPID™ Spinal System is substantially equivalent to the SynFIX-LR Spacer (K072253...)." Specific numerical performance data from these mechanical tests are not included in this 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 specified in the summary. For mechanical tests, the "sample size" would refer to the number of devices tested, which is not provided.
• Data Provenance: Not specified. Mechanical testing data would typically be generated in a lab setting rather than from patient data.

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. For a 510(k) for a spinal implant, "ground truth" typically involves mechanical testing standards and comparison to predicate devices, not human expert interpretation of a clinical test set. No clinical experts or a "ground truth" derived from them were used in the context of this 510(k) summary.

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

• Not Applicable. There is no "test set" of clinical cases requiring adjudication by experts.

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 hardware implant (spinal system), not an AI/software device involving human readers or AI assistance.

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

• Not Applicable. This is a hardware implant, not an algorithm.

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

• The "ground truth" for this 510(k) is the established safety and efficacy profile of the predicate devices, as determined by their prior FDA clearance/approval. The INTREPID™ Spinal System aims to demonstrate equivalence to these established devices through mechanical testing and design comparison.

8. The sample size for the training set

• Not Applicable. This is a hardware implant, not a machine learning algorithm that requires a training set.

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

• Not Applicable. As above, no training set for a machine learning algorithm is involved.

In summary: K080083 is a 510(k) premarket notification for a new medical device. The primary method for gaining clearance is demonstrating "substantial equivalence" to previously cleared predicate devices. This typically involves:

• Performance Testing: Usually mechanical and material testing to show the new device performs comparably to predicates. Specific results are often summarized but not fully detailed in the public 510(k) summary.
• Comparison of Indications for Use and Design Features: Ensuring the new device's intended use and fundamental design are similar to predicates.
• Biocompatibility Assessment: Confirming materials are safe for human use, often by referring to existing data on similar materials in predicate devices.

The detailed "study" information (sample sizes, expert consensus, MRMC studies) you've requested is characteristic of clinical trials or AI/software evaluations, which are generally not part of a standard 510(k) submission for a non-active implant unless specific clinical data is deemed necessary by the FDA.

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