(174 days)
The MAGNIFY™ 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 non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MAGNIFY™ Spacer is to be filled with autogenous bone graft material, and is to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems.
The MAGNIFY™-S 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 non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MAGNIFY™-S Spacer is to be filled with autogenous bone graft material, and is to be used with three titanium alloy screws that accompany each implant.
MAGNIFY™ Spacers are expandable anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The devices are available in various height expansion ranges 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. These devices are to be filled with autogenous bone graft material.
The MAGNIFY™ Spacer is to be used with supplemental fixation. The MAGNIFY™-S Spacer is to be used with three titanium alloy screws that accompany the implant.
MAGNIFY™ Spacers are manufactured from titanium alloy, as specified in ASTM F136, and include an internal component manufactured from radiolucent PEEK polymer, as specified in ASTM F2026. The screws used with MAGNIFY™-S are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and are available with hydroxyapatite (HA) coating, as specified in ASTM F1185.
The provided text describes a medical device called MAGNIFY™ and MAGNIFY™-S Spacers and its 510(k) clearance. It is a submission for a spinal interbody fusion device, not an AI/ML powered device. Therefore, the information required to answer the prompt for acceptance criteria and study proving device meets acceptance criteria for an AI/ML device (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) is not applicable or available in the provided text.
The closest relevant information is contained within the "Performance Data" section, which outlines mechanical testing performed for this physical medical device. This is not about software or AI/ML performance.
Here's an attempt to answer based on the provided text, acknowledging the limitations due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical "acceptance criteria" for the mechanical tests, nor does it provide specific numerical "reported device performance" values. It only states that testing was conducted and demonstrated "substantial equivalence."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets standards of "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, ASTM F2077, and ASTM F2267 for: | Substantially equivalent to predicate devices for mechanical performance |
| - Static compression strength/performance | (Not specified numerically, but met equivalence) |
| - Dynamic compression strength/performance | (Not specified numerically, but met equivalence) |
| - Static compression-shear strength/performance | (Not specified numerically, but met equivalence) |
| - Dynamic compression-shear strength/performance | (Not specified numerically, but met equivalence) |
| - Subsidence resistance | (Not specified numerically, but met equivalence) |
| - Expulsion resistance | (Not specified numerically, but met equivalence) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to a physical device undergoing mechanical testing, and therefore, not present in the document. Mechanical tests typically use a defined number of test articles (e.g., several units of each device type) rather than "test sets" in the clinical or AI/ML sense. Data provenance regarding country of origin or retrospective/prospective is not relevant for this type of testing.
3. 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)
This information is not applicable, as this is a physical medical device undergoing mechanical testing, not a diagnostic or AI/ML device requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there is no "test set" requiring adjudication in the context of an AI/ML device. Mechanical testing follows standardized protocols, not adjudication by human experts.
5. 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
No such study was done as the device is an interbody fusion spacer, not an AI-assisted diagnostic or analysis tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as the device is an implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For mechanical testing, the "ground truth" is defined by the objective physical measurements and engineering specifications outlined in the ASTM standards (F2077, F2267) and the specific FDA guidance document for intervertebral fusion devices. It's not based on expert consensus, pathology, or outcomes data in the traditional sense for diagnostic tools, but rather on material science and biomechanical principles.
8. The sample size for the training set
This information is not applicable. There is no "training set" for an interbody fusion device undergoing mechanical testing.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" for this type of device.
§ 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.