(149 days)
The Shoreline ACS device is a stand-alone device interior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease of the cervical spine at a single level (C2-T ). The Shoreline ACS implants are to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and implanted via an anterior approach. The cervical device is to be used in patients who have had at least six (0) weeks of nonoperative treatment. The cervical device is to be used with Shoreline bone screw fixation and the Shoreline locking cover.
The SeaSpine Shoreline™ ACS (Anterior Cervical Standalone) System consists of the implant assembly, associated instrumentation as well as caddies and trays that may be used for storage and organization. The implant assembly is composed of a PEEK cervical spacer (ASTM F2026) and a titanium alloy (ASTM F136) plate with titanium alloy variable angle or fixed bone screws and a titanium alloy locking cover. Shoreline ACS is offered in a variety of footprints and heights to accommodate variations in patient anatomy and is generally box-shaped with surface teeth and a central canal for receiving autograft bone graft material and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The system is implanted via an anterior approach.
The system offers spacers in low profile and no profile versions. Low profile versions have minimal profile anterior to the disc space (1.6mm), while no profile versions have zero profile. Both low profile and no profile spacers are available with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene® (NM). Alternatively, the no profile spacer is available without a NanoMetalene® coating. Both low profile and no profile versions of the spacers are available in a standard lordotic angle. The Low Profile spacer will also be offered in multiple lordosis versions. The SeaSpine Shoreline™ ACS spacers include radiographic markers manufactured from either titanium alloy (ASTM F136) or tantalum (ASTM F560).
No profile implant versions are offered in a two-screw construct and the low profile versions in two. three, and four-screw constructs to accommodate a range of surgeon preference. For all spacer, plate and screw variations, the locking cover attaches to the device and physically blocks the screw heads to prevent screw back out from the construct.
The provided text refers to a 510(k) premarket notification for the SeaSpine Shoreline™ ACS - Anterior Cervical Standalone System, an intervertebral body fusion device. The focus of this document is to demonstrate "substantial equivalence" to legally marketed predicate devices, rather than presenting a study proving that the device meets specific acceptance criteria as you might find for a novel AI/software device.
Therefore, many of the requested sections related to acceptance criteria, ground truth, expert opinions, and AI performance studies are not applicable to this particular document. This is a medical device approval based primarily on mechanical testing and material equivalence to existing devices.
Here's an analysis based on the information provided and what is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical performance equivalent to predicate device per ASTM standards | Demonstrated equivalent performance to the Globus predicate through static and dynamic compression shear, and torsion testing per ASTM F2077, subsidence testing per ASTM F2267, and wear particle analysis per ASTM F1877. |
| Intended Use | Single level cervical spinal fusion via anterior approach for skeletally mature patients with Degenerative Disc Disease (DDD) (Matches predicate) |
| Materials | Equivalent or similar materials: PEEK-OPTIMA per ASTM 2026, Titanium alloy (ASTM F136), Tantalum, (ASTM F560), CP Titanium Surface (ASTM F67) (Matches or similar to predicate) |
| Design | Equivalent or similar spacer height, footprint, lordotic angle, and screw/plate dimensions (Matches or similar to predicate) |
Notes:
- The document explicitly states that the device demonstrated equivalent performance to the predicate device in specific mechanical tests. The "acceptance criteria" here are implicitly that the device performs at least as well as the predicate device in these tests, adhering to the specified ASTM standards. Specific numerical thresholds for acceptance are not detailed in this summary but would be part of the underlying test reports.
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 provided in the document. Mechanical testing typically involves a set number of samples of the device components, but the specific quantity is not mentioned here. Data provenance (country, retrospective/prospective) is not relevant for this type of mechanical comparison 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)
- Not applicable. This study is not evaluating expert interpretation or diagnostic performance. It's focused on the physical and mechanical properties of the device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no "test set" requiring adjudication in the context of expert review or diagnostic outcomes.
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
- Not applicable. This is a medical device, not an AI/software product that assists human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical 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 ASTM standards (e.g., F2077, F2267, F1877) themselves, which specify the methodology and expected performance characteristics against which the device is measured. There is no expert consensus or pathology involved in establishing this ground truth for a mechanical test.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 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.