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The NuVasive CoRoent Ti-C System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion.

The CoRoent Ti-C System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The NuVasive® CoRoent Ti-C System is manufactured from PEEK-OPTIMA® (Polyetherether-ketone) conforming to ASTM F2026, commercially pure titanium conforming to ASTM F1580, Ti-6Al-4V ELI conforming to ASTM F136/1472 or Tantalum (Ta) conforming to ASTM F560 or ISO 13782. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The provided document is a 510(k) premarket notification for a medical device (CoRoent Ti-C System), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical or performance study results for achieving specific acceptance criteria.

Therefore, the document does not contain the information requested for acceptance criteria and the study proving the device meets those criteria, specifically:

• A table of acceptance criteria and the reported device performance: This information is not provided. The document states "no new worst-case for performance testing" but does not detail specific performance thresholds or results against them.
• Sample sized used for the test set and the data provenance: No test set is described in the context of clinical performance.
• Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable as no clinical test set/ground truth is discussed.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: The document explicitly states, "No non-clinical or clinical studies were conducted."
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical implant, not a software/algorithm device.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable, as no training set for an algorithm is described.
• How the ground truth for the training set was established: Not applicable.

The performance data mentioned in the document (Section G, Page 4) is limited to nonclinical testing primarily for demonstrating equivalence to predicate devices:

• Static and dynamic axial compression and compression shear per ASTM F2077
• Wear debris testing per ASTM F2077, ASTM F1714 and ASTM F1877

The conclusion drawn from this testing is that "the subject CoRoent Ti-C System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate." However, specific acceptance criteria values and the device's numerical performance against those values are not detailed in this submission.

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The SynCage Evolution spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the SynCage Evolution spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin 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.

The Synthes SynCage Evolution spacer is a radiolucent device for use in interbody fusion. It is to be used in conjunction with supplemental fixation to provide structural stability in skeletaly mature individuals. The Synthes SynCage Evolution spacer is fabricated from Invibio® PEEK-OPTIMA® LT-1 (ASTM F2026-10) with four anterior and one posterior tantalum (ASTM F560-08) radiopaque markers. The markers allow intra-operative radiographic assessment of the position of the implant. Implantation is through an anterior or anterolateral approach. The Synthes SynCage Evolution spacer is provided sterile. The Synthes SynCage Evolution spacer is available in three footprints (Small: 32x25mm; Medium, 36x28mm; Large, 40x31mm), four lordotic angles (6°, 10°, 14°, 18°), and a range of heights (9-19mm) to suit individual pathology and anatomical conditions. Pyramidal teeth that assist in stabilization of the construct are located on the inferior and superior surfaces of the spacers. The open architecture of the device allows it to be packed with autogenous bone graft material (i.e., autograft).

The provided text describes a 510(k) summary for the Synthes SynCage Evolution Spacer, an intervertebral body fusion device. It details the device's description, intended use, and a comparison to predicate devices, focusing on non-clinical performance data.

Here's an analysis based on your request:

1. Acceptance Criteria and Reported Device Performance

The document does not specify explicit acceptance criteria in terms of numerical thresholds or performance targets for a device meeting clinical or diagnostic accuracy. Instead, it states that the device's performance was evaluated through non-clinical bench testing and compared to predicate devices for substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

2. Sample Size for the Test Set and Data Provenance

The document explicitly states: "Clinical data and conclusions were not needed for this device."
Therefore, there was no test set of clinical data used to evaluate the device's performance in humans. The evaluation was based solely on non-clinical bench testing.

• Sample Size for Test Set: Not applicable (no clinical test set).
• Data Provenance: Not applicable (no clinical data).

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

As no clinical data was used for evaluation, there was no ground truth established by experts for a test set. The evaluation relied on engineering principles and bench testing standards.

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Since no clinical test set was used, there was no adjudication method employed.

• Adjudication Method: Not applicable.

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

No MRMC study was conducted. The document states: "Clinical data and conclusions were not needed for this device."

• MRMC Study: No.
• Effect Size of Human Readers with vs. without AI: Not applicable.

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

This device is an intervertebral fusion spacer, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The device's performance was evaluated through bench testing.

• Standalone Study: Not applicable (device is not an algorithm).

7. The Type of Ground Truth Used

For the non-clinical performance evaluation, the "ground truth" was established by standardized engineering testing protocols as defined by ASTM F2077-11 and ASTM F2267-04. The performance was then compared to that of legally marketed predicate devices, implying that their established performance under these tests served as a reference for "substantial equivalence."

• Type of Ground Truth: Bench testing standards (ASTM F2077-11 and ASTM F2267-04) and performance of predicate devices.

8. The Sample Size for the Training Set

This document describes a physical medical device, not an AI or machine learning model. Therefore, the concept of a "training set" is not applicable.

• Sample Size for Training Set: Not applicable.

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

As there is no training set mentioned or implied for this physical device, this question is not applicable.

• How Ground Truth for Training Set Was Established: Not applicable.

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