(117 days)
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
| Acceptance Criteria Category | Specific Acceptance Criteria (Performance Measure) | Reported Device Performance (as stated in document) |
|---|---|---|
| Mechanical Performance (per ASTM F2077) | Static Torsion | Meets or exceeds performance of predicate devices |
| Dynamic Torsion | Meets or exceeds performance of predicate devices | |
| Static Axial Compression | Meets or exceeds performance of predicate devices | |
| Dynamic Axial Compression | Meets or exceeds performance of predicate devices | |
| Biomechanical Performance | Shear Resistance | Evaluation performed, results indicate substantial equivalence to predicate devices |
| Subsidence (per ASTM F2267) | Meets or exceeds performance of predicate devices | |
| Coating Performance (per "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings") | Microstructure of the coating (per ASTM F1854) | Tests performed, results indicate substantial equivalence to predicate devices |
| Static Tensile Strength (per ASTM F1147) | Tests performed, results indicate substantial equivalence to predicate devices | |
| Static Shear Strength (per ASTM F1044) | Tests performed, results indicate substantial equivalence to predicate devices | |
| Shear Fatigue Test (per ASTM F1160) | Tests performed, results indicate substantial equivalence to predicate devices | |
| Abrasion Resistance (per ASTM F1978) | Tests performed, results indicate substantial equivalence to predicate devices | |
| Material Equivalence | Components offered in same range of shapes and sizes as predicate. Material used for CeSpace XP Intervertebral Body Fusion System is same as predicate devices (PEEK with titanium layer and Plasmapore® coating). | Confirmed. The only difference is the addition of the titanium layer and vacuum plasma spray coating to the CeSpace XP, which was then subjected to additional testing outlined above. |
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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.