(75 days)
The INDEPENDENCE® Spacer is a stand-alone interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-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 at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The INDEPENDENCE® Spacer is to be filled with autogenous bone graft material, and is to be used with three titanium alloy screws, which accompany the implant.
The INDEPENDENCE® Spacer is a stand-alone anterior lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacer is to be filled with autogenous bone graft material.
The INDEPENDENCE® Spacer is made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. The anterior portion of the implant and the mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295. The screws are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185.
Here's an analysis of the provided text regarding the acceptance criteria and study for the INDEPENDENCE® Spacer, structured as requested:
Acceptance Criteria and Study for INDEPENDENCE® Spacer
This 510(k) submission is for an enhancement to an existing device, the INDEPENDENCE® Spacer (K082252), specifically for the addition of hydroxyapatite (HA) coated screws. As such, the "acceptance criteria" and "study" are primarily focused on demonstrating substantial equivalence to the predicate device and ensuring the new component (HA coating) does not negatively impact performance.
Note: The provided document is a 510(k) summary and the FDA's clearance letter. It does not contain detailed study reports with raw data or comprehensive statistical analyses generally found in a full PMA (Premarket Approval) submission or a clinical trial report. Therefore, some information, particularly regarding specific performance metrics with numerical targets, sample sizes for specific tests, and details on expert ground truth, is limited or not explicitly stated in this summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Substantial equivalence in expulsion resistance to predicate device. | "Mechanical testing (expulsion) was conducted to demonstrate substantial equivalence to the predicate device in accordance with the 'Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Body Fusion Device', June 12, 2007." |
| Material Biocompatibility | Hydroxyapatite (HA) coating meets ASTM F1185. | Screws available with or without hydroxyapatite (HA) coating, "as specified in ASTM F1185." |
| Material Specification | Device components meet specific ASTM standards (F2026, F136, F1295, F560, F1185). | Spacer made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. Anterior portion and screws from titanium alloy, as specified in ASTM F136 and F1295. HA coating specified in ASTM F1185. |
| Intended Use | The device performs as intended for specified indications (DDD, L2-S1, 6 months non-op treatment, Grade 1 spondylolisthesis/retrolisthesis). | Indications for Use statement outlines the intended use, which is consistent with the predicate. |
| Structural Stability | Provides structural stability in skeletally mature individuals following discectomy. | Device description states it is "a stand-alone anterior lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy." |
| Sterilization & Packaging | (Implicit for all medical devices) Sterilizable and packaged appropriately. | Not explicitly detailed in this summary, but required for all medical devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "mechanical testing (expulsion)" but does not provide the number of devices or iterations tested.
- Data Provenance: The testing was conducted internally by the manufacturer (Globus Medical Inc.) to support the 510(k) submission. It's a retrospective analysis in the sense that the testing was performed, and the results were compiled for submission. The location of the testing is not specified, but it's presumed to be in a lab setting rather than a clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable / Not specified. This submission focuses on engineering bench testing (mechanical performance, material specifications). It does not involve a clinical test set requiring expert consensus for ground truth for diagnostic accuracy or similar evaluations. The "ground truth" for this device's performance is derived from established engineering test methods and material standards.
4. Adjudication Method for the Test Set
- Not applicable. As the "test set" primarily refers to mechanical testing results against engineering standards and a predicate device, there is no need for expert adjudication. The compliance with standards and equivalence to the predicate is determined by the results of the mechanical tests performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is typically performed for diagnostic imaging devices where human readers interpret medical images. This device is an intervertebral body fusion device, not a diagnostic device, and therefore such a study is not relevant or included.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- Yes, effectively. The primary form of "performance" described is standalone. The device's mechanical properties and material composition are assessed independently against established engineering standards and compared to a predicate device. There is no "human-in-the-loop" component in evaluating the expulsion resistance or material characteristics of the spacer itself.
7. Type of Ground Truth Used
- Engineering Standards and Predicate Device Performance: The ground truth for this submission is established by:
- Guidance Document: "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Body Fusion Device", June 12, 2007, which outlines the expectations for testing intervertebral fusion devices.
- ASTM Standards: Material specifications (e.g., F2026, F136, F1295, F560, F1185) serve as the ground truth for material properties.
- Predicate Device Data: The performance of the predicate device (InterContinental® Plate-Spacer, K103382) serves as the benchmark for substantial equivalence, particularly for mechanical properties like expulsion.
8. Sample Size for the Training Set
- Not applicable. This device is a physical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no "training set" for an AI/ML algorithm, this question is not relevant.
§ 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.