(119 days)
The Reef TH 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 nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and supplemental fixation.
The SeaSpine Reef TH System is an intervertebral fusion device with large central graft windows which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous and/or corticocancellous bone prior to implantation. The implant is manufactured from PEEK (ASTM F2026) with tantalum (ASTM F560) and titanium alloy (ASTM F136) radiographic markers. The implants have a one-micron thick surface coat of commercially pure (CP) titanium (ASTM F67) and are sterile-packed. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary. The instruments are placed in system-specific trays for storage, protection, and organization prior to and during the steam sterilization process.
The provided text is a 510(k) summary for the SeaSpine Reef TH System, an intervertebral body fusion device. It details the device's characteristics and its substantial equivalence to predicate devices, but does not contain information about the acceptance criteria or a study proving the device meets those criteria, particularly for an AI/software as a medical device (SaMD).
Specifically, the document states:
- "Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."
This clearly indicates that clinical studies, which would typically involve performance metrics and acceptance criteria, were not performed or submitted for this specific device clearance. The document focuses on non-clinical mechanical performance testing and engineering analyses to demonstrate substantial equivalence to existing predicate devices.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone performance results.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This information is typically found in submissions for AI/SaMD devices where clinical performance and ground truth establishment are crucial for demonstrating safety and effectiveness. The SeaSpine Reef TH System is a physical medical device, and its clearance process, as described here, relied on demonstrating equivalence to predicate physical devices through non-clinical testing.
§ 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.