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When used as a Vertebral Body Replacement Device: The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebrail body due to tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with bone graft.

When used as an Intervertebral Body Fusion System: The Aesculap PEEK Spinal Implant System consists of CeSpace PEEK Implants that are circular in shape with flattened sides. The CeSpace implants are indicated for spinal fusion erodial in Shape Min Hattoned elessed telefally 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. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System is also intended for use with autogenous bone graft.

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Aesculap device.

The Aesculap CeSpace XP Intervertebral Body Fusion System is a cervical intervertebral I no fusiondevice that is implanted into the vertebral body space to improve stability of bour fusional hile supporting fusion. Components are offered in a variety of sizes to meet the requirements of the individual patient anatomy. Components are manufactured from the requirements of the Inalifical P026) with a titanium layer and a vacuum plasma spray coating (Plasmapore® - per ISO 5832-3). The device will have Tantalum markers per ASTM F-560.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CeSpace PEEK Intervertebral Body Fusion System (Plasmapore® Coated), K123909.

Due to the nature of the provided document (a 510(k) summary for a medical device), the acceptance criteria and study details are focused on proving substantial equivalence to a predicate device through non-clinical performance testing, rather than establishing clinical efficacy through traditional clinical trial metrics like sensitivity/specificity, or human reader performance with AI. The document primarily reports engineering and materials testing results.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document details non-clinical performance testing (mechanical and material tests) rather than clinical studies with human participants. Therefore, the concept of a "test set" in the context of clinical data provenance (country, retrospective/prospective) and sample size (e.g., number of patients/cases) is not applicable here. The "sample" in this context refers to the manufactured devices or test coupons. The specific number of devices or test samples used for each test (e.g., number of constructs for static torsion) is not specified in the provided summary.

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

This information is not applicable as the "ground truth" was established through standardized engineering and materials testing (e.g., ASTM standards), not by expert human interpretation of data where consensus is required (like reading medical images).

4. Adjudication Method for the Test Set

This is not applicable for non-clinical performance testing. The "adjudication" is inherent in the pass/fail criteria of the ASTM and guidance-specified tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance

This is not applicable. The device is an intervertebral body fusion system, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or would be relevant.

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

This is not applicable. The device is an implant, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth for demonstrating substantial equivalence was based on:

• Compliance with established mechanical testing standards (ASTM F2077, ASTM F2267).
• Compliance with established material and coating testing standards (ASTM F1854, ASTM F1147, ASTM F1044, ASTM F1160, ASTM F1978).
• Meeting performance levels equivalent to or exceeding those of the predicate devices as demonstrated through these non-clinical tests.

Essentially, the "ground truth" is the physical and mechanical properties of the device as measured by validated engineering methods, compared against a known-safe and effective predicate device.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of an implantable medical device undergoing non-clinical substantial equivalence testing. The concept of a training set is relevant for machine learning algorithms.

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

This is not applicable for the reasons stated in point 8.

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