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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 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).

The no profile versions of the spacers are available in a standard lordotic angle, while the low profile spacer is offered in multiple lordosis 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 trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

The provided text describes a 510(k) premarket notification for a medical device called the "SeaSpine® Shoreline™ ACS – Anterior Cervical Standalone System." This document is a regulatory submission to the FDA, asserting that the new device is substantially equivalent to legally marketed predicate devices.

Crucially, this document does not describe a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to existing devices, primarily through non-clinical (mechanical) testing.

Therefore, many of the requested points regarding acceptance criteria for performance, sample sizes for test/training sets in clinical studies, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for a diagnostic or AI device cannot be directly answered from the provided text. This document is for a traditional medical device (an implant), not a diagnostic or AI-driven system that would typically undergo such rigorous performance evaluation.

However, I can extract information related to the non-clinical testing performed to demonstrate equivalence to a predicate device, which serves as a form of "acceptance criteria" in the context of a 510(k) submission for this type of device.

Here's an interpretation based on the provided text, focusing on what is present and noting what is absent:

Device: SeaSpine® Shoreline™ ACS – Anterior Cervical Standalone System (an intervertebral body fusion device)

Purpose of Submission: Premarket Notification (510(k)) to demonstrate substantial equivalence to legally marketed predicate devices.

1. A table of acceptance criteria and the reported device performance

The "acceptance criteria" here are based on meeting the performance of predicate devices or relevant ASTM standards for mechanical properties. There isn't a table of specific numerical criteria and reported values in the provided summary, but rather a statement of successful demonstration of equivalence.

2. Sample sizes used for the test set and the data provenance

• Test Set Sample Size: Not specified for the non-clinical mechanical tests. These tests typically involve a defined number of samples per test type according to the ASTM standards, but specific numerical sample sizes are not provided in this summary.
• Data Provenance: The tests are "Non-Clinical Testing" and "engineering analysis," implying laboratory testing of the device itself, not human subject data. Therefore, notions of country of origin or retrospective/prospective data do not apply in the context of this 510(k) submission for an implantable device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable: This type of information is relevant for diagnostic devices or AI systems that interpret medical images/data, where human expert consensus often forms the ground truth. For this mechanical implant device, the "ground truth" is established by adherence to engineering standards and comparison to a predicate device's measured mechanical properties. There's no mention of experts establishing a "ground truth" in the diagnostic sense.

4. Adjudication method for the test set

• Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are for reconciling differences in expert interpretations, typically in diagnostic studies. This is not pertinent to the mechanical testing described.

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 PEEK/titanium implant, not an AI software or a diagnostic reading device. No MRMC study was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable: As above, this is a physical implant, not an algorithm. Standalone performance as an algorithm is not relevant.

7. The type of ground truth used

• For the non-clinical mechanical testing, the "ground truth" is defined by the established mechanical properties of the predicate device and the requirements of the specified ASTM standards (e.g., F2077, F2267, F1877). The goal was to show that the new device's mechanical behavior was "equivalent" to the predicate.

8. The sample size for the training set

• Not Applicable: As this is a physical medical device and its performance was assessed through non-clinical mechanical testing and comparison to a predicate, there is no "training set" in the context of machine learning. There was "No clinical testing required to demonstrate equivalence."

9. How the ground truth for the training set was established

• Not Applicable: See point 8. No training set was used.

Summary of what was reported in the 510(k) in relation to proving the device meets criteria:

The primary method for demonstrating the device meets the necessary criteria for FDA clearance via 510(k) was to show substantial equivalence to a legally marketed predicate device (SeaSpine® Shoreline™ ACS - K161081) through:

• Non-Clinical Mechanical Testing: This involved engineering analyses of static and dynamic compression, compression shear, torsion (per ASTM F2077), subsidence (per ASTM F2267), and wear particle analysis (per ASTM F1877), as well as screw push out testing. The results of these tests demonstrated "equivalent performance" to the predicate.
• Performance Testing for Sterility and Packaging: This included packaging, shipping, and sterilization tests to validate a Sterility Assurance Level (SAL) of 10⁻⁶ and ensure maintenance of a sterile barrier. Bacterial Endotoxin Testing (BET) was also conducted per ANSI/AAMI ST-72:2011.
• Comparison of Technological Characteristics: The submission highlighted that the device shared similar technological elements with predicate devices, such as implant spacer heights, footprints, lordotic angles, screw sizes and lengths, and anterior plates.

Crucially, the document explicitly states: "No clinical testing was required to demonstrate equivalence." This means that the "acceptance criteria" and "proof" were entirely based on non-clinical, laboratory-based demonstrations of mechanical and material equivalence to a device already deemed safe and effective by the FDA.

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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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