(180 days)
INDEPENDENCE® (including INDEPENCE® MIS) Spacers 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 have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). INDEPENDENCE® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
The INDEPENDENCE® Spacer is a stand-alone interbody fusion device intended to be used with three titanium alloy screws which accompany the implant.
The INDEPENDENCE® MIS Spacer is an interbody fusion device to be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, the INDEPENDENCE® MIS Spacer is a stand-alone interbody fusion device. When used with anchors, the INDEPENDENCE® MIS Spacer is intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (≥25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).
INDEPENDENCE® MIS Spacers are anterior lumbar interbody fusion devices 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 the device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws and/or anchors are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation.
INDEPENDENCE® MIS Spacers are made from titanium alloy, or titanium alloy and radiolucent polymer with titanium alloy or tantalum markers, as specified in ASTM F136, F560, F1295, and F2026. All PEEK implants are additionally available with a commercially pure titanium plasma spray coating, as specified in ASTM F1580. The mating screws and anchors are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and the screws and anchors are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185.
This document is a 510(k) Pre-Market Notification from the FDA regarding Globus Medical, Incorporated's INDEPENDENCE® MIS Spacers. It describes the device, its intended use, and the basis for its substantial equivalence to previously cleared devices.
Acceptance Criteria and Device Performance:
The document doesn't explicitly state "acceptance criteria" in terms of specific numerical thresholds for performance. Instead, it relies on demonstrating substantial equivalence to predicate devices through mechanical testing. The implication is that if the new device performs comparably to the legally marketed predicate devices under standard testing, it meets the "acceptance criteria" for market clearance.
Here's a table summarizing the performance data presented and the implied criteria:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Demonstrated substantial equivalence in mechanical performance to predicate devices. | "Mechanical testing (static and dynamic compression and compression-shear, subsidence, and expulsion) was conducted in accordance with the 'Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device,' June 12, 2007, ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate spacers." The document concludes: "INDEPENDENCE® MIS Spacers have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use." |
| Compliance with relevant ASTM standards for interbody fusion devices. | Mechanical testing was conducted in accordance with "ASTM F2077" and "ASTM F2267." |
| Materials meet specified standards. | "INDEPENDENCE® MIS Spacers are made from titanium alloy, or titanium alloy and radiolucent polymer with titanium alloy or tantalum markers, as specified in ASTM F136, F560, F1295, and F2026. All PEEK implants are additionally available with a commercially pure titanium plasma spray coating, as specified in ASTM F1580. The mating screws and anchors are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and the screws and anchors are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185." |
Study Information (Based on the provided text):
The document describes a regulatory submission to demonstrate substantial equivalence for a medical device, not a typical clinical study with patient outcomes or a multi-reader, multi-case study for AI performance. Therefore, many of the requested points are not applicable.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not specified in terms of clinical patient numbers. The "test set" for this submission was the INDEPENDENCE® MIS Spacers themselves, subjected to various mechanical tests. The number of physical units tested is not provided, but typically this involves multiple samples to ensure reproducibility and statistical validity within engineering testing.
- Data Provenance: The mechanical testing was conducted according to US FDA guidance documents and ASTM standards. The location where the testing was performed, or details about the specific test articles' origin, are not specified, but it's presumed to be from the manufacturer (Globus Medical Inc. in Audubon, Pennsylvania, USA) or a certified testing facility. This is a pre-market performance evaluation, not clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. This is a mechanical device performance evaluation, not an analysis requiring expert interpretation of diagnostic images or patient physiology. The "ground truth" for mechanical testing is established by the defined test methodologies in the ASTM standards and FDA guidance, measured by engineering instruments.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies involving human readers to resolve discrepancies in diagnoses or interpretations. This document describes mechanical engineering tests.
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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. The device in question is an intervertebral body fusion device (a physical implant), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness was assessed or is relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. As above, this is a physical medical implant, not an algorithm or software device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" in this context is the established mechanical performance parameters as defined by the relevant ASTM standards (F2077, F2267) and FDA guidance for intervertebral fusion devices. The device's performance (e.g., load-to-failure, subsidence, expulsion resistance) is objectively measured against the requirements of these standards and compared to the predicate devices.
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The sample size for the training set:
- Not Applicable. This is a physical device, not an AI model, so there is no "training set."
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How the ground truth for the training set was established:
- Not Applicable. There is no training set.
In summary, this FDA 510(k) clearance document focuses on demonstrating that a new intervertebral fusion device is substantially equivalent to existing, legally marketed devices primarily through mechanical testing that adheres to established engineering standards and FDA guidance. It is not an evaluation of an AI-driven device or a clinical outcome study.
§ 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.