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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

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.

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The CoRoent® Small Interlock System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. The CoRoent Small Interlock System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to faciliate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

The NuVasive CoRoent Small Interlock System is a standalone anterior cervical interbody device consisting of a PEEK (polyetheretherkevtone) implant cage with titanium alloy and tantalum radiographic markers, titanium alloy washers, and three (3) titanium alloy bone fixation screws. The devices are manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, titanium alloy conforming to ASTM F136, and tantalum conforming to ASTM F560. The implants are available in a variety of sizes to accommodate anatomical conditions. The CoRoent Small Interlock System is a standalone system intended to be used with the bone screws provided, and when used as such requires no additional supplementary fixation systems.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter and summary for a medical device (NuVasive® CoRoent® Small Interlock™ System). It focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a clinical study with detailed acceptance criteria and performance data as you've outlined.

Specifically, the document states: "A systemic literature analysis of published clinical data for cervical interbody fusion devices similar to the CoRoent Small Interlock System was provided as performance data to support the expanded Indications for Use." and "Additionally, Finite Element Analysis and comparative methods were used to demonstrate that the subject CoRoent Small Interlock System is substantially equivalent to CoRoent Small Interlock System (K102547)."

This indicates that new clinical studies with defined acceptance criteria and performance metrics (as typically seen in AI/software device submissions) were not performed for this submission. The "performance data" referred to is a summary of existing literature and engineering analysis, not a de novo study with a test set, ground truth experts, or MRMC studies.

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