(267 days)
The SOVEREIGN™ Spinal System is indicated for use with autogenous bone graft 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. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a laparoscopic or an open anterior approach.
The SOVEREIGN™ Interbody System may be used as a stand-alone device or in conjunction with supplemental fixation.
When used as a stand-alone device, the SOVEREIGN™ interbody device is intended to be used with the three 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 three or none of the provided screws, then additional supplemental fixation for use in the lumbar spine must be used to augment stability.
The SOVEREIGN™ Spinal System is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant is lens-shaped with three holes for placement of titanium screws. The SOVEREIGN™ Spinal System contains both a fixed and a variable angle screw option. The fixed angle screw option provides an interference fit with the PEEK interbody implant. The variable angle screw option provides a slight clearance between the PEEK interbody implant and the screw which allows for a small amount of variable screw angulation. This system is intended to be radiolucent and the interior space of the product is to be used with autogenous bone graft. The accompanying cover plate is designed to resist screw backout and must be used when the variable angle screws are implanted.
The SOVEREIGN™ Spinal System interbody device is manufactured from PEEK Optima® (polyetheretherketone) and contains tantalum radiopaque markers. The screws used with this device are manufactured from titanium alloy.
The provided document is a 510(k) summary for the SOVEREIGN™ Spinal System, specifically addressing an update to include modified screws. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical mechanical testing.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a quantitative table format alongside performance data. Instead, it states that the testing was performed "in accordance with ASTM Standard F2077-03 'Test Methods for Intervertebral Body Fusion Devices'" and "ASTM Standard F2267-04 'Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device under Static Axial Compression'." The acceptance criterion can be inferred to be meeting the performance requirements or demonstrating comparable performance to the predicate device as outlined by these ASTM standards.
The reported device performance is summarized as: "Based on the non-clinical testing conducted in accordance with ASTM F2077 and ASTM F2267 and additional supporting documentation provided in this premarket notification, the subject device demonstrated substantial equivalence to the predicate SOVEREIGN™ Spinal System (K091813 - S.E. 11/17/2009) in terms of design, intended use, indications for use and fundamental technology."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Static Screw Push-out Testing: Conformity with relevant test methods (ASTM F2077-03) and performance comparable to predicate device. | Demonstrated substantial equivalence to predicate device based on non-clinical testing. |
| Static Compression Testing: Conformity with relevant test methods (ASTM F2077-03) and performance comparable to predicate device. | Demonstrated substantial equivalence to predicate device based on non-clinical testing. |
| Compression Fatigue Testing: Conformity with relevant test methods (ASTM F2077-03) and performance comparable to predicate device. | Demonstrated substantial equivalence to predicate device based on non-clinical testing. |
| Static Compression-Shear Testing: Conformity with relevant test methods (ASTM F2267-04) and performance comparable to predicate device. | Demonstrated substantial equivalence to predicate device based on non-clinical testing. |
| Compression-Shear Fatigue: Conformity with relevant test methods (ASTM F2267-04, inferred) and performance comparable to predicate device. | Demonstrated substantial equivalence to predicate device based on non-clinical testing. |
| Static Subsidence Testing: Conformity with relevant test methods (ASTM F2267-04) and performance comparable to predicate device. | Demonstrated substantial equivalence to predicate device based on non-clinical testing. |
| Analysis of Particulate from Fatigue Testing: Conformity with relevant test methods (ASTM Standard Practice for Characterization of Particles) and performance comparable to predicate device. | Demonstrated substantial equivalence to predicate device based on non-clinical testing. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes used for each non-clinical test (e.g., number of implants, screws tested). It simply lists the types of tests performed.
Regarding data provenance, this is a pre-market notification (510(k)) for a medical device, which involves bench testing (non-clinical) of the physical device. Therefore, the data provenance is from laboratory testing, not human subjects. There is no information on country of origin for the data as it pertains to clinical studies, nor is it retrospective or prospective in a clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to the provided document. The "ground truth" for these types of mechanical tests is established by adherence to specified ASTM standard test methods and the resulting physical measurements (e.g., load, displacement). There are no human experts "establishing ground truth" in the way one would for diagnostic imaging.
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
This question is not applicable. Adjudication methods are typically used in clinical studies or studies involving expert interpretation (e.g., radiology reads). For mechanical bench testing, results are objective measurements.
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 question is not applicable. The SOVEREIGN™ Spinal System is a physical intervertebral fusion device, not an AI or imaging diagnostic tool. Therefore, MRMC studies are not relevant to its regulatory submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This question is not applicable. The device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
As mentioned, for this type of submission, the "ground truth" is defined by the objective physical measurements obtained during controlled laboratory testing following established ASTM standards. The goal is to demonstrate that the device performs mechanically as intended and is comparable to a predicate device.
8. The Sample Size for the Training Set
This question is not applicable. The SOVEREIGN™ Spinal System is not an AI algorithm, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for a physical medical implant.
§ 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.