(26 days)
The FUSE Cage is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
The FUSE™ Cage is a titanium interbody cage of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The implants may be implanted via a posterior or transforaminal approach and the procedure may be open or minimally invasive. The implants can be implanted unilaterally. FUSE™ implants consist of pure titanium according to the standard ISO 5832-2 or ASTM F67. It is not allowed to use FUSE™ cages in direct connection with components of other manufacturers. FUSE™ cages are for single use only.
This document, a 510(k) Premarket Notification for the FUSE™ Spinal System, describes the process for demonstrating substantial equivalence to a previously cleared device, not the rigorous performance testing typically associated with an AI/ML device where the criteria listed in your prompt would be highly relevant.
Therefore, the information provided does not contain the details necessary to fill out many parts of your requested output table and descriptions. This is because a 510(k) for a hardware device like an intervertebral body fusion device focuses on:
- Comparison to a predicate device: Showing that the new device is as safe and effective as a device already on the market.
- Biocompatibility: Ensuring materials are safe for biological contact.
- Mechanical Testing: Demonstrating the physical strength and integrity of the device.
- Non-Pyrogenicity Endotoxin Testing: Confirming the absence of bacterial toxins.
There is no AI/ML component mentioned in this document, no diagnostic/interpretive function, and consequently, no need for the type of clinical performance study with human readers, ground truth establishment, or multi-reader multi-case studies you've inquired about.
Therefore, I will provide the information that is available from the document and explicitly state where the information requested is not applicable (N/A) or not provided (NP) based on the nature of this submission.
Device Name: FUSE™ Spinal System
Device Type: Intervertebral Body Fusion Device (Hardware)
FDA Submission Type: 510(k) Premarket Notification for Substantial Equivalence
1. Acceptance Criteria and Reported Device Performance
Given that this is a hardware device undergoing a 510(k) for substantial equivalence, the "acceptance criteria" are primarily related to mechanical performance, biocompatibility, and non-pyrogenicity, demonstrated through testing and engineering rationale, rather than diagnostic accuracy metrics.
| Acceptance Criterion (Hardware) | Reported Device Performance (Reference) |
|---|---|
| Mechanical Strength | Documented in a "confirmatory engineering rationale" to demonstrate substantial equivalence to the predicate, particularly concerning ASTM F2077. |
| Expulsion Resistance | Documented in a "confirmatory engineering rationale" to demonstrate substantial equivalence to the predicate. |
| Biocompatibility | Materials (pure titanium, stainless steel) are "identical to the primary predicate devices" and have "a long clinical history of safe and effective use." No additional testing required. |
| Non-Pyrogenicity (Endotoxin) | Worst-case subject implants met the 20 endotoxin units (EU)/device pyrogen limit specification as per ANSI/AAMI ST72 and USP . |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. For hardware testing, "samples" refer to units tested mechanically or for material properties, not patient data sets. The document mentions "worst case subject implants" for endotoxin testing but does not specify a number. Mechanical testing usually involves a defined number of physical units.
- Data Provenance: Not applicable in the context of clinical data for AI/ML validation. This submission relies on engineering analyses, material science data, and existing clinical history of predicate devices/materials.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. There is no "ground truth" to establish in the context of patient data, as this is a hardware device submission. The "ground truth" for its safety and effectiveness is established through engineering principles, material standards, and comparison to existing, cleared devices.
4. Adjudication Method for the Test Set
- Not applicable. There is no test set of clinical cases requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not an AI/ML diagnostic device; therefore, an MRMC study is not relevant or performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- Not applicable. The device is a surgical implant, not a software algorithm.
7. The Type of Ground Truth Used
- Not applicable in the AI/ML sense. The "ground truth" for this device's safety and effectiveness relies on:
- Compliance with industry standards (e.g., ASTM F2077, ANSI/AAMI ST72, USP ).
- Engineering rationale and risk analysis.
- Long clinical history of the materials (pure titanium, stainless steel) and the predicate devices.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
Summary of Device and Acceptance:
The FUSE™ Spinal System, an intervertebral body fusion device, gained 510(k) clearance by demonstrating substantial equivalence to a previously cleared predicate device (FUSE Spinal System K121288) and Capstone Control™ Spinal System (K120368). The acceptance criteria for this hardware device focused on:
- Mechanical strength and expulsion resistance: Verified via a "confirmatory engineering rationale" against ASTM F2077 standards, claiming the new lengths (28mm and 31.5mm) do not introduce a "new worst case scenario" compared to the 24.5mm predicate.
- Biocompatibility: Demonstrated by using materials (pure titanium and stainless steel) identical to the predicate devices, benefiting from their established "long clinical history of safe and effective use."
- Non-pyrogenicity: Verified through bacterial endotoxin testing (LAL test) on "worst case subject implants," successfully meeting the 20 EU/device pyrogen limit, adhering to ANSI/AAMI ST72 and USP standards.
The study presented is a technical justification and comparison to a predicate, not a clinical performance study involving patient data, human readers, or AI/ML algorithms.
§ 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.