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The Shoreline ACS (Anterior Cervical System) are interbody fusion devices intended for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The Shoreline ACS implants are to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/ or corticocancellous bone and implanted via an anterior approach. The device is to be used in patients who have had at least six (6) weeks of non-operative treatment.

When used as a standalone system, Shoreline ACS is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) and must be used with the Shoreline ACS bone screw fixation and locking cover.

When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical low profile (TruProfile) Interbody Spacer is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C2-T1).

The Shoreline Anterior Cervical System (ACS) 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, cortical, and/or corticocancellous bone. The system is implanted via an anterior approach.

The system offers spacers in low profile (TruProfile) and no profile versions. Both are available with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene® (NM), bonded to PEEK. The 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 trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

This document, a 510(k) Premarket Notification from the FDA, describes the Shoreline ACS (Anterior Cervical System), an intervertebral body fusion device. While it details the device and its intended use, it explicitly states that no clinical testing was performed or required for its substantial equivalence determination.

Therefore, I cannot provide information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number of experts or their qualifications for ground truth.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone (algorithm-only) performance.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

The "Non-Clinical Testing" section on page 5 states: "The subject implants are the same as the predicate devices in terms of materials, sizes, and intended use. The subject device does not introduce a new worst-case. Engineering analyses of the modifications to Shoreline ACS determined that no additional mechanical testing was necessary."

And the "Clinical Testing" section on page 5 explicitly says: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

This FDA clearance is based on the device being substantially equivalent to existing predicate devices, meaning its safety and effectiveness are considered comparable based on non-clinical data and technological similarity, rather than new clinical trials demonstrating performance against specific acceptance criteria.

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