(92 days)
The Sovereign™ Spinal System is indicated for use with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone marrow aspirate in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the Sovereign™ Spinal System is indicated for use in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions as an adjunct to fusion. These patients should be skeletally mature and have had 6 months of non-operative treatment. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions, additional supplemental fixation) must be used. These implants may be implanted via a variety of open or minimally invasive approaches include anterior and oblique.
The Sovereign™ Spinal System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Sovereign™ Spinal System is intended to be used with 3 titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable angle screws. If the physician chooses to use less than 3 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. Implants with lordosis angles greater than 18° are intended to be used with supplemental fixation (e.g. facet screws or posterior fixation).
The SOVEREIGN™ Spinal System is an intervertebral body fusion device with internal screw fixation. The subject devices in this submission add additional polyetheretherketone (PEEK) implant lordosis options with corresponding trials and PTC implant options with a Commercially Pure Titanium (CP Ti) coating, to the existing SOVEREIGN™ Spinal System.
The provided text describes a 510(k) summary for the Medtronic SOVEREIGN™ Spinal System, which is an intervertebral body fusion device. The submission focuses on adding new polyetheretherketone (PEEK) implant lordosis options and PTC implant options with a Commercially Pure Titanium (CP Ti) coating to the existing system. The document primarily discusses substantial equivalence to predicate devices based on mechanical testing and MRI compatibility. It does not describe an AI medical device or a study with clinical endpoints involving human readers or ground truth established by experts/pathology.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and AI performance metrics are not applicable to the information provided in the given text.
Based on the available information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the SOVEREIGN™ Spinal System are based on mechanical testing standards. The reported device performance indicates that the subject implants met these criteria.
| Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|
| Mechanical Testing: | |
| ASTM F2077, Test Methods For Intervertebral Body Fusion Devices | Subject implants met pre-determined acceptance criteria. |
| ASTM F2267, Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression | Subject implants met pre-determined acceptance criteria. |
| ASTM Draft Standard F-04.25.02.02, Static Push-out Test Method for Intervertebral Body Fusion Devices | Subject implants met pre-determined acceptance criteria. |
| Specific Tests Performed: | |
| Static Compression | Subject implants met pre-determined acceptance criteria. |
| Compression Fatigue | Subject implants met pre-determined acceptance criteria. |
| Static Compression Shear | Subject implants met pre-determined acceptance criteria. |
| Compression Shear Fatigue | Subject implants met pre-determined acceptance criteria. |
| Subsidence | Subject implants met pre-determined acceptance criteria. |
| Expulsion | Subject implants met pre-determined acceptance criteria. |
| MRI Testing: | |
| Guidance for Industry and FDA Staff – Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment | Subject devices were evaluated and can be classified as MR-Conditional. |
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 as the document describes mechanical and MRI compatibility testing of a physical medical device (intervertebral body fusion device), not a software or AI device with a test set of data.
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 the document describes mechanical and MRI compatibility testing of a physical medical device. Ground truth by experts is not established for this type of testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document describes mechanical and MRI compatibility testing of a physical medical device. Adjudication methods are not used for this type of testing.
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
This information is not applicable. The document does not describe an AI medical device or any study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The document does not describe an AI medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" is defined by the performance requirements set forth in the referenced ASTM standards. For MRI testing, it's about meeting safety and compatibility guidelines outlined by the FDA for the MR environment. These are objective engineering and regulatory standards, not clinical ground truth like pathology or expert consensus.
8. The sample size for the training set
This information is not applicable as the document describes mechanical and MRI compatibility testing of a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as the document describes mechanical and MRI compatibility testing of a physical medical device, not an AI model requiring a training set.
§ 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.