(108 days)
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.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance (demonstrate equivalent performance to predicate Shoreline system) | Demonstrated equivalent performance to the predicate Shoreline™ ACS system through engineering analysis. This included: |
| - Static Compression (per ASTM F2077) | Performed, equivalence demonstrated. |
| - Dynamic Compression (per ASTM F2077) | Performed, equivalence demonstrated. |
| - Compression Shear (per ASTM F2077) | Performed, equivalence demonstrated. |
| - Torsion (per ASTM F2077) | Performed, equivalence demonstrated. |
| - Subsidence (per ASTM F2267) | Performed, equivalence demonstrated. |
| - Wear Particle Analysis (per ASTM F1877) | Performed, equivalence demonstrated. |
| - Screw Push Out Testing | Performed, equivalence demonstrated. |
| Sterility Assurance | Validated a Sterility Assurance Level (SAL) of 10⁻⁶. |
| Packaging & Shipping Integrity | Ensured maintenance of a sterile barrier. |
| Bacterial Endotoxin Testing | Conducted in accordance with ANSI/AAMI ST-72:2011. |
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.
§ 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.