(147 days)
The BoneBac™ T-PLIF Intervertebral Body Fusion Device System is indicated for use in skeletally mature patients who have had six months of non-operative treatment. The in biololially maters patte treatment of degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s).
The BoneBac™ T-PLIF Intervertebral Body Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine and autogenous bone graft to facilitate fusion.
Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies.
The BoneBac™ T-PLIF Intervertebral Body Fusion Device is a spinal intervertebral body fusion device system comprised of implants with a variety of lengths, widths, and heights to accommodate patient anatomy. The implants are made of Solvay Zeniva ZA-500 PEEK (ASTM F2026). The devices have raised contours on the superior and inferior surfaces that will resist device movement following implant. The devices contain radiographic markers to enable fluoroscopic visualization.
This is a 510(k) summary for a spinal intervertebral body fusion device, not an AI/ML device. Therefore, the requested information regarding AI/ML acceptance criteria, study details, and expert evaluation is not applicable.
The submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of intended use, technological characteristics, operating principles, materials, and mechanical testing, rather than performance against specific AI/ML metrics.
Here's a breakdown of the relevant information provided, adapted to the context of a medical device submission:
1. Acceptance Criteria and Reported Device Performance (Non-AI/ML):
The acceptance criteria for this device are based on demonstrating substantial equivalence to predicate devices and meeting established mechanical testing standards. The "device performance" in this context refers to its mechanical properties.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance/Conclusion |
|---|---|---|
| Substantial Equivalence | Comparison of Intended Use | Shares same intended use as predicates |
| Comparison of Technological Characteristics | Shares same characteristics as predicates | |
| Comparison of Operating Principles | Shares same operating principles as predicates | |
| Comparison of Materials | Shares same materials (Solvay Zeniva ZA-500 PEEK) as predicates | |
| Mechanical Testing | ASTM F2077-03 (Static and Dynamic Axial Compression, Static Torsion, Static and Dynamic Shear Compression) | Demonstrated substantially equivalent performance |
| ASTM F2267-04 (Subsidence Under Static Axial Compression) | Demonstrated substantially equivalent performance | |
| ASTM Draft Standard F-04.25.02.02 (Static Expulsion) | Demonstrated substantially equivalent performance | |
| ASTM F1877 (Wear Debris Characterization) | Demonstrated substantially equivalent performance | |
| Regulatory Guidance | FDA Document, Class II Special Controls, Guidance Document: Intervertebral Fusion Device, June 12, 2007 | Found to meet criteria defined in the guidance document |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of mechanical testing. Mechanical tests typically involve a defined number of device units or test articles run according to the specific ASTM standard. The document does not specify the exact number of units tested for each standard, but it refers to the standard methods which dictate such details.
- Data Provenance: Not applicable in the context of mechanical testing. The data provenance would be from the laboratory conducting the ASTM standard tests.
- Retrospective/Prospective: Not applicable. These terms relate to clinical study design, which was not required for this device type.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. "Ground truth" in this context refers to the outcome of mechanical testing against established standards, not expert labels of clinical data. The standards themselves (e.g., ASTM F2077-03) define the "truth" for performance.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discrepancies in expert opinions on clinical data. For mechanical testing, the results are quantitative measurements against defined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is specifically for evaluating the impact of an AI system on human reader performance. This submission is for a physical medical device (spinal implant), not an AI/ML diagnostic or assistive tool. Clinical data, including MRMC studies, was explicitly "not required for this device."
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
- No. This concept applies to AI algorithms. This device is a physical implant.
7. Type of Ground Truth Used:
- Mechanical Test Standards and Predicate Device Performance: The "ground truth" for this submission is established through adherence to recognized ASTM mechanical testing standards and by demonstrating comparable performance to legally marketed predicate devices.
8. Sample Size for the Training Set:
- Not applicable. There is no "training set" in the context of a physical medical device. This term is specific to AI/ML model development.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set, there is no ground truth to establish for it.
§ 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.