(46 days)
The SeaSpine® Shoreline™ ACS is a stand-alone device indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease of the cervical spine at a single level (C2-T1). 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 (6) weeks of non-operative treatment. The cervical device is to be used with bone screw fixation and a locking cover.
The SeaSpine® Shoreline™ ACS - Anterior Cervical Standalone System consists of the implant assembly composed of a single use 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. Both Low-Profile and No-Profile spacers are available with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene® (NM), bonded to PEEK. The Low-Profile version consists of a NanoMetalene bonded PEEK interbody and two-, three-, and four-hole titanium alloy plates. The No-Profile version consists of an interbody spacer with a two-hole anterior titanium alloy face section with a NanoMetalene bonded PEEK posterior section.
The No-Profile versions of the spacers are available in a standard lordotic angle, while the Low-Profile Spacer is offered in multiple lordotic versions. The 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 No-Profile and Low-Profile NanoMetalene cervical spacers will be provided in gamma sterilized packaging; the bone screws, plate, and locking cover will be provided non-sterile for subsequent sterilization at the healthcare facility.
The instruments included with the Shoreline™ ACS System facilitate the placement, adjustment, and final locking of the interbody spacers, and removal if necessary. The instruments also include the travs and caddies for storage, protection, and organization prior to and during the steam sterilization process.
The provided FDA 510(k) summary for the SeaSpine® Shoreline™ ACS - Anterior Cervical Standalone System does not contain any information about acceptance criteria or a study proving the device meets said criteria in the context of device performance related to diagnostic or treatment efficacy.
This document pertains to a medical device being cleared for market based on "substantial equivalence" to existing predicate devices. The focus is on mechanical and material safety, and similarity in intended use and technological characteristics, rather than clinical performance outcomes or diagnostic accuracy.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and the reported device performance: This type of data is typically associated with studies demonstrating clinical efficacy or diagnostic accuracy, which are not present in this 510(k) summary.
- Sample size used for the test set and the data provenance: No clinical test set involving patient data is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no clinical test set for ground truth evaluation.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not a diagnostic device involving AI.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What the document does state regarding testing:
- Non-Clinical Testing: "Non-clinical mechanical testing was not performed on the subject devices. The subject implants are the same as the predicate devices in terms of materials, sizes, and intended use. The subject (modified) devices do not introduce a new worst-case. Engineering analyses of the modifications to the SeaSpine® Shoreline™ ACS System determined that no additional mechanical testing is necessary." This indicates reliance on previous testing of predicate devices and engineering analysis for mechanical safety, rather than new performance testing.
- Clinical Testing: "There was no clinical testing performed for this submission." This explicitly states that no clinical studies were conducted to prove the device's performance in patients for this submission.
In summary, the FDA 510(k) process for this device relies on demonstrating substantial equivalence to existing, legally marketed predicate devices through comparison of design, materials, manufacturing, intended use, and existing performance data (primarily mechanical for similar devices), rather than new clinical trials or performance studies against specific acceptance criteria.
§ 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.