(100 days)
The Shoreline Cervical Interbody RT System are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone graft and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.
When used as a standalone system, the Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at a single level of the cervical spine (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 Interbody Spacer Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels of the cervical spine (C3-C7).
When the system is used at two contiguous levels, the Shoreline Cervical Interbody RT System must be used with supplemental fixation.
The SeaSpine Shoreline Anterior Cervical Standalone (ACS) System consists of the implant assembly 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.
The Shoreline ACS System offers spacers in low profile (TruProfile) and no profile versions. Both TruProfile and no profile spacers are available with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene (NM).
The subject Shoreline Cervical Interbody RT System is a NanoMetalene titanium bonded device offered in a variety of footprints and heights to accommodate variations in patient anatomy. The low-profile spacer is box-shaped with a central canal for receiving autograft bone and/or allogenic bone graft composed of cancellous, cortical and/or corticocancellous bone material.
The Shoreline Cervical Interbody RT System can be used with supplemental fixation, such as an anterior plate or as a standalone construct to be used with the Shoreline ACS bone screw fixation and locking cover.
This document is a 510(k) Premarket Notification for the Shoreline Cervical Interbody RT System. It focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than a study proving the device meets specific acceptance criteria based on its performance in a clinical or standalone study.
Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not applicable or not provided in this specific regulatory submission.
Here's an breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Not explicitly stated in terms of performance metrics for the device itself, but rather engineering standards) | Reported Device Performance (Demonstrated Equivalence) |
|---|---|
| Mechanical Performance: | The Shoreline Cervical Interbody RT System demonstrated equivalent performance to the predicate Shoreline ACS system through: |
| * Static compression (per ASTM F2077) | * Equivalent performance to predicate |
| * Dynamic compression (per ASTM F2077) | * Equivalent performance to predicate |
| * Compression shear (per ASTM F2077) | * Equivalent performance to predicate |
| * Torsion (per ASTM F2077) | * Equivalent performance to predicate |
| * Subsidence (per ASTM F2267) | * Equivalent performance to predicate |
| Sterility & Packaging: | |
| * Sterility Assurance Level (SAL) of 10-6 | Validated at SAL of 10-6 through packaging, shipping, and sterilization tests. |
| * Maintenance of a sterile barrier | Ensured through packaging, shipping, and sterilization tests. |
| * Bacterial Endotoxin testing (BET) in accordance with ANSI/AAMI ST-72:2011 | Conducted in accordance with ANSI/AAMI ST-72:2011. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This submission relies on substantial equivalence through non-clinical (bench) testing, not on clinical performance data or a test set of patient data.
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. See point 2.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 2.
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 not an AI/software device and no MRMC study was performed or required for this type of medical device (intervertebral body fusion device).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant, not a standalone algorithm. The "standalone" mentioned in the "Indications for Use" refers to the device being used without supplemental fixation, but still as part of a surgical procedure involving a human surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of clinical "ground truth". The "ground truth" for this submission are the established mechanical testing standards (ASTM F2077, ASTM F2267) and sterility standards (ANSI/AAMI ST-72:2011). The "ground truth" for substantial equivalence is the performance of the legally marketed predicate devices.
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning. The "training" here would refer to the design and development process based on established engineering principles and prior device knowledge, and validation against relevant standards.
9. How the ground truth for the training set was established:
- Not applicable. See point 8. The "ground truth" for device development for this type of product is based on established biomechanical property requirements, material standards, and the performance characteristics of predicate devices.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.