(77 days)
PATRIOT® Spacers (including Constitution®, Constitution® TPS, Signature®, Signature® TPS, Continental®, Continental® TPS, TransContinental®, TransContinental® TPS, TransContinental® M and TransContinental® M TPS) are interbody fusion devices 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 as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
InterContinental® Plate-Spacers (including InterContinental® TPS) are lateral lumbar interbody fusion devices 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). InterContinental® Plate-Spacers are to be filled with autogenous bone graft material, and are to be used with two titanium alloy screws which accompany the implant. These devices are intended to be used with supplemental fixation (e.g. pedicle or facet screw systems) in addition to the integrated screws.
PATRIOT® Spacers (including Constitution®, Constitution® TPS, Signature®, Signature® TPS, Continental®, Continental® TPS, TransContinental®, TransContinental® TPS, TransContinental® M and TransContinental® M TPS) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. Each of the PATRIOT® spacers provides a different shape to accommodate various surgical approaches to the lumbar spine. Constitution® PLIF Spacers are inserted using a posterior approach. Signature® TLIF Spacers are inserted using a transforaminal approach. Continental® ALIF Spacers are inserted using an anterior approach. Transcontinental® and TransContinental® M Spacers are inserted using an anterior or lateral approach. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
PATRIOT® Spacers are made from PEEK radiolucent polymer (ASTM F2026) with titanium alloy or tantalum markers (ASTM F560). Signature® R Spacers also include an internal titanium alloy or commercially pure titanium (ASTM F67) component, and TransContinental® M Spacers also include an integrated titanium alloy nut. The Signature® Ti Spacer is made from titanium alloy or commercially pure titanium. The titanium alloy is TAV (ASTM F136) or TAN (ASTM F1295). PATRIOT® TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.
InterContinental® Plate-Spacers (including InterContinental® TPS) are lateral lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. InterContinental® Plate-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 grip the endplates of the adjacent vertebrae to aid in expulsion resistance. InterContinental® Plate-Spacers are to be filled with autogenous bone graft material, and are to be used with two titanium alloy bone screws, with or without hydroxyapatite coating. Bone screws are used to attach to the lateral portion of the adjacent vertebral bodies for bony fixation.
The spacers in the InterContinental® Plate-Spacers are manufactured from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F136, F560, F1295, and F2026. The plates in the InterContinental® Plate-Spacers are manufactured from titanium alloy, as specified in ASTM F136 and F1295. The screws in the InterContinental® Plate-Spacers are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185. InterContinental® TPS Plate-Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Globus Medical Incorporated TransContinental® M Spacers and InterContinental® Plate-Spacers.
Important Note: The provided document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing entirely new performance criteria through clinical trials. Therefore, the information regarding "acceptance criteria" and "study results" will be framed within the context of comparability to already approved devices and established consensus standards for medical devices, particularly regarding mechanical performance. This document does not describe a clinical study in the typical sense (e.g., patient outcomes, diagnostic accuracy, etc.).
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for substantial equivalence based on mechanical testing to predicate devices and recognized consensus standards, the "acceptance criteria" are implicitly meeting those standards and demonstrating equivalent or superior performance to the predicates. The document does not specify exact numerical acceptance criteria separate from the standards themselves, nor does it provide a table of precise quantitative performance values.
However, based on the text, the following can be inferred:
| Acceptance Criteria (Inferred from Standards & Predicate Equivalence) | Reported Device Performance (Summary from Document) |
|---|---|
| Mechanical Performance: | Mechanical Performance: |
| Conformity to ASTM F2077 (Static and Dynamic | "Mechanical testing (static and dynamic compression and compression-shear, subsidence, and expulsion) was conducted in accordance with... ASTM F2077, and ASTM F2267." |
| Compression and Compression-Shear) | Performance was sufficient to demonstrate substantial equivalence to predicate devices. |
| Conformity to ASTM F2267 (Subsidence) | |
| Conformity to "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device" (Expulsion) | "Additional expulsion testing and cadaver studies were performed to demonstrate equivalence of the subject devices." |
| Equivalent or superior mechanical properties to predicate devices | "TransContinental® M and InterContinental® Additional Implants are as safe, as effective, and perform as well as or better than the predicate devices." |
| Material Biocompatibility: | Material Biocompatibility: (Inferred from material specifications) |
| Use of biocompatible materials | PEEK radiolucent polymer (ASTM F2026), titanium alloy or tantalum markers (ASTM F560), titanium alloy (ASTM F136 or F1295), commercially pure titanium (ASTM F67) |
| Conformity to relevant ASTM material standards | Materials used conform to specified ASTM standards. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of the number of devices tested for each mechanical test. The document mentions "Additional expulsion testing and cadaver studies" but does not give specific numbers for devices or cadavers. For typical mechanical testing, a predetermined number of samples are tested according to the ASTM standards.
- Data Provenance: The studies were conducted by Globus Medical Incorporated for regulatory submission in the United States (FDA). The nature of the mechanical and cadaver studies implies they are prospective tests performed specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Ground Truth Establishment: For mechanical testing, the "ground truth" is established by the specified ASTM standards and FDA guidance documents for intervertebral fusion devices. These standards define the test methods, conditions, and how to interpret the results. There isn't a direct "expert consensus" in the sense of clinical diagnosis for this type of submission.
- Qualifications of Experts: The experts involved would be the engineers and technicians performing the mechanical tests, who are qualified to conduct such tests according to the specified ASTM and ISO standards. The FDA reviewers (e.g., Mark N. Melkerson, Director, Division of Orthopedic Devices) are experts in medical device regulation and orthopedic devices.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable in the context of mechanical testing against predefined standards. The results of mechanical tests are objective measurements, and the determination of "passing" or "failing" is based on adherence to the parameters defined in the ASTM standards and the demonstrated equivalence to predicate devices. There isn't a human adjudication process for interpreting these raw mechanical test results in the same way there would be for diagnostic imaging.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No MRMC study was done. This document pertains to the mechanical and material properties of an intervertebral fusion device, not a diagnostic imaging algorithm. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant (intervertebral body fusion device), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used
- Ground Truth Type:
- Consensus Standards: Primary ground truth is established by the ASTM standards (F2077, F2267) and the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device", which specify methods for evaluating mechanical performance.
- Predicate Device Performance: Performance of the predicate devices (NuVasive CoRoent, previously cleared TransContinental® M Spacers, InterContinental® Plate-Spacer, TPS Spacers) serves as a comparative "ground truth" for demonstrating substantial equivalence.
8. The Sample Size for the Training Set
- Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no "training set." The development of the device would involve engineering design and material selection, informed by biomechanical principles and clinical needs, rather than machine learning training.
9. How the Ground Truth for the Training Set was Established
- Not applicable. See 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.