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SeaSpine® Spacer System - Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, and Ventura NanoMetalene®:

When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft (autograft) and supplemental fixation.

Cambria is intended to be used as an adjunct to spinal fusion procedures at one level (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 prior to treatment with the device. Devices are intended to be implanted via an open, and used with autogenous bone and supplemental fixation, such as an anterior plating system.

The SeaSpine® Spacer System (Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, Ventura NanoMetalene®), and the Cambria NanoMetalene® are intervertebral fusion devices manufactured from polyetheretherketone (PEEK OPTIMA LT1 per ASTM F2026) with markers (tantalum per ASTM F560 or Ti-6AI-4V ELI per ASTM F136) for radiographic visualization. The implants have a one-micron thick surface coat of commercially pure (CP) titanium. The devices have a central canal for receiving autogenous bone graft and are offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy. The purpose of this 510(k) is to receive clearance to offer the interbody devices of the noted systems gamma sterilized in individual packaging.

The provided text does not describe acceptance criteria for a medical device's performance, nor does it detail a study proving specific performance metrics. Instead, it is an FDA 510(k) clearance letter for the SeaSpine® Spacer System, which focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving new performance criteria.

Here's an analysis based on the information provided, specifically addressing the points in your request:

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

This information is not provided in the document. The document focuses on demonstrating substantial equivalence to predicate devices, not on setting or meeting specific performance acceptance criteria for a new device's functionality. The "Performance Testing" section under "Summary of Technological Characteristics" states "No new testing required," indicating that performance was largely inferred from the predicate devices.

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. The document explicitly states "Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This means there was no clinical test set in the traditional sense for assessing device performance.

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)

This information is not provided. As no clinical testing was performed for the device's efficacy or safety to establish a ground truth, there were no experts used for this purpose in the context of a performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. There was no test set or clinical study requiring an adjudication method.

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 information is not provided. The device is an intervertebral body fusion device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is not applicable.

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

This information is not provided. The device is a physical implant, not an algorithm. The concept of "standalone performance" for an algorithm is not relevant here.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not explicitly stated as no clinical performance data was assessed for the subject device to establish a "ground truth." The determination of safety and effectiveness for substantial equivalence relies on the established performance characteristics and indications for use of the predicate devices, not on new ground truth established for the subject device itself.

8. The sample size for the training set

This information is not provided. As no AI/algorithm is involved, the concept of a "training set" is not applicable.

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

This information is not provided. As no AI/algorithm is involved, the concept of a "training set" and its ground truth is not applicable.

Summary of Device and Approval Process (based on the document):

The document is an FDA 510(k) clearance for the SeaSpine® Spacer System - Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, Ventura NanoMetalene®, and SeaSpine® Cambria NanoMetalene®.

• Type of Device: Intervertebral Body Fusion Device
• Purpose of 510(k): To receive clearance to offer the interbody devices gamma sterilized in individual packaging, rather than being sterilized by the end-user as with the predicate devices.
• Key Argument for Clearance: Substantial equivalence to legally marketed predicate devices (K102026 and K142488).
• Evidence for Substantial Equivalence:
  • Intended Use/Indications for Use: The subject devices have substantially equivalent indications and intended use as the cited predicates.
  • Technological Characteristics: Similar operating principle, design, materials (PEEK-OPTIMA with titanium alloy/tantalum markers and CP titanium surface), manufacturing.
  • Performance (Mechanical Safety): No new mechanical testing was required because the design and materials are essentially the same as the predicate devices, which underwent analysis and static & dynamic testing (ASTM F2027), wear evaluation (ASTM F1877), and subsidence (ASTM F2267).
  • New Element Justified: The change to pre-sterilized packaging required non-clinical testing, including packaging, shipping, sterility validation (SAL 10⁻⁶), and bacterial endotoxin testing (BET) in accordance with ANSI/AAMI ST-72:2011.
• Clinical Testing: Not applicable; the determination of substantial equivalence was not based on an assessment of clinical performance data.

In essence, the "study that proves the device meets the acceptance criteria" in this context is the 510(k) submission itself, which demonstrated substantial equivalence to predicate devices, thereby implying that existing acceptance criteria for similar devices are met without requiring new primary performance studies. The "acceptance criteria" here are aligned with the FDA's requirements for substantial equivalence to a predicate device, as opposed to specific clinical performance metrics for a novel technology.

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