(183 days)
The InterContinental™ Plate-Spacer is an 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 InterContinental™ Plate-Spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant. These devices are intended to be used with supplemental fixation in addition to the integrated screws.
The InterContinental™ Plate-Spacer is a lateral lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectorny. InterContinental™ is 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™ is to be filled with autogenous bone graft material, and is to be used with 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 spacer in the InterContinental™ Plate-Spacer is 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-Spacer are manufactured from titanium alloy, as specified in ASTM F136, and F1295. The screws in the InterContinental™ Plate-Spacer 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.
Here's an analysis of the provided information regarding the InterContinental™ Plate-Spacer's acceptance criteria and studies:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Test | Device Performance (as reported) |
|---|---|---|
| Mechanical Performance | Static Compression | Conducted to demonstrate substantial equivalence to predicate devices (INDEPENDENCE® Spacer (K082252), PATRIOT® TransContinental™ LLIF Spacer (K093242), CoRoent® XL-F (K071795)). |
| Dynamic Compression | Conducted to demonstrate substantial equivalence to predicate devices. | |
| Static Compression-Shear | Conducted to demonstrate substantial equivalence to predicate devices. | |
| Dynamic Compression-Shear | Conducted to demonstrate substantial equivalence to predicate devices. | |
| Subsidence | Conducted to demonstrate substantial equivalence to predicate devices. | |
| Expulsion | Conducted to demonstrate substantial equivalence to predicate devices. (The device description also notes "Protrusions on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to aid in expulsion resistance.") | |
| Fatigue Bending | Conducted to demonstrate substantial equivalence to predicate devices. | |
| Biocompatibility | Not explicitly mentioned in the provided text | The device is manufactured from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F136, F560, F1295, and F2026. The plates and screws are titanium alloy, as specified in ASTM F136 and F1295, with optional HA coating per ASTM F1185. These ASTM standards generally cover biocompatible materials. However, explicit biocompatibility testing results or criteria are not detailed in the provided excerpt. |
| Material Specifications | Radiographic Markers | Titanium alloy or tantalum markers, as specified in ASTM F136, F560, F1295, and F2026. |
| Plates | Titanium alloy, as specified in ASTM F136, and F1295. | |
| Screws | Titanium alloy, as specified in ASTM F136 and F1295, and available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185. |
Study Information
Based on the provided text, the submission is about the InterContinental™ Plate-Spacer being a modification of a previously cleared device. The primary study conducted for this submission is a mechanical testing study to demonstrate substantial equivalence to predicate devices.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. Mechanical testing typically involves a specific number of samples (e.g., n=5, n=10) for each test type, but these numbers are not detailed in the summary.
- Data Provenance: The study was conducted in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007. This suggests standard laboratory testing, not data derived from human patients or a specific geographic region. It's a prospective test in a controlled lab environment.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was a mechanical engineering study, not a clinical study involving expert interpretation of data. The "ground truth" would be the measured physical properties of the device under specific loads, as compared to established standards and predicate device performance.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used in clinical studies when interpreting ambiguous patient data, not for direct mechanical test results.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This submission is for a medical implant (interbody fusion device), not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
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The type of ground truth used:
- The "ground truth" for this device's performance is established by validated mechanical testing standards (e.g., ASTM standards indirectly referenced by the guidance document) and the performance characteristics of the predicate devices. The device is deemed acceptable if its mechanical performance falls within acceptable ranges relative to these standards and predicates, demonstrating "substantial equivalence."
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The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set.
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How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device submission.
§ 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.