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Cambria NanoMetalene is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and supplemental fixation, such as an anterior plating system.

Cambria is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and supplemental fixation, such as an anterior plating system.

The Cambria System device is an intervertebral fusion device intended to act as a disc spacer and hold bone graft to promote fusion in the cervical spine. The cervical spacers are manufactured from PEEK (ASTM F2026), with tantalum (ASTM F560) radiographic markers, and are generally box-shaped with 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 Cambria System device is offered in a variety of heights and footprints to accommodate variations in patient anatomy. The cervical spacers are offered in all PEEK or with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene (NM).

The Cambria NanoMetalene cervical spacers are provided in gamma sterilized packaging; the Cambria PEEK implants are provided non-sterile for subsequent sterilization at the healthcare facility.

The instruments included with the Cambria System facilitate the placement and adjustment 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 510(k) summary for the SeaSpine Cambria System does not include acceptance criteria or a study demonstrating the device meets such criteria in the way typically found for AI/software-as-a-medical-device (SaMD) products. This document describes a medical device (an intervertebral fusion device) and its substantial equivalence to a predicate device, focusing on mechanical performance, materials, and sterility, rather than diagnostic accuracy or algorithmic performance.

Therefore, many of the requested sections (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the information provided in this regulatory submission for a physical implantable device.

However, I can extract the relevant information regarding the non-clinical and clinical testing performed to support the device's substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a physical medical device (intervertebral fusion device), the "acceptance criteria" and "device performance" are primarily related to its mechanical properties, material safety, and sterility, rather than diagnostic metrics like sensitivity or specificity. No explicit acceptance criteria values (e.g., "must withstand X force") are provided in this summary, but the types of tests performed imply compliance with relevant standards.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set (Non-Clinical): Not explicitly stated, but mechanical testing typically uses a specific number of samples per test type as proscribed by the ASTM standards (e.g., ASTM F2077, F2267). The summary indicates "engineering analysis" and states that "conclusions from previously performed" tests remained valid, suggesting that a formal re-testing of a full set of samples might not have been performed if the modifications were deemed minor structurally.
• Data Provenance (Clinical Literature): The summary mentions an "assessment of clinical literature data." This implies retrospective data collection from existing studies, but the specific country of origin or the nature of these studies is not detailed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the document describes a physical medical device, not an AI/SaMD product requiring expert-derived ground truth for diagnostic or interpretative tasks. The "ground truth" for mechanical testing is compliance with physical standards. For clinical equivalence, it relies on literature established via clinical trials for similar predicate devices.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated above.

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

This section is not applicable as the device is not an AI product.

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

This section is not applicable as the device is not an AI product.

7. The Type of Ground Truth Used

• Non-Clinical (Mechanical): Ground truth is based on established engineering and materials science principles, and adherence to recognized standards such as ASTM F2077, ASTM F2267, and ANSI/AAMI ST-72:2011.
• Clinical: For supporting the expanded indications, the ground truth was derived from "clinical literature data," implying established clinical outcomes and efficacy data for similar devices from published studies or historical clinical trials.

8. The Sample Size for the Training Set

This section is not applicable as the device is not an AI product and therefore does not have a "training set" in the machine learning sense. Its design and manufacturing are based on established engineering principles and materials.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the reasons stated above.

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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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