(163 days)
The STALIF C® and STALIF C-Ti™ devices are intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion.
The cervical cage is to be used in a skeletally mature patient who has had six weeks of nonoperative treatment prior to implantation of the cage.
STALIF C® is a radiolucent intervertebral body fusion cage with unicortical cancellous bone screws. It is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIF C® is similar to that of the vertebral body endplate with central cavity that can be packed with autograft or allograft. STALIF C® is manufactured from either PEEK-OPTIMA® LT1 supplied by Invibio or Zeniva ZA PEEK supplied by Solvay per ASTM F2026 with titanium alloy screws (Ti6A14V, ASTM F136) and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F560). The STALIF C-Ti™ is identical to this design with a titanium plasma spray coating (CPT) per ASTM F1580) on the device endplates.
The provided text is a 510(k) summary for a medical device (STALIF C® and STALIF C-Ti™ intervertebral body fusion cages). This document details a regulatory submission for expanding the indications for use of an already cleared device, not the initial approval or a study explicitly proving acceptance criteria for a new device's performance.
Therefore, the information typically requested in your prompt regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance, is not present in this type of regulatory document.
Here's what can be inferred and what is explicitly stated:
- Device Type: The STALIF C® and STALIF C-Ti™ are intervertebral body fusion cages, which are physical implants. The "performance" in this context mainly refers to biomechanical properties, materials, and clinical safety/efficacy when used in the human body, not an AI algorithm's diagnostic performance.
- Purpose of Submission: The current 510(k) (K150053) is to expand the indications of the device to allow its use in multilevel cervical procedures (one or two contiguous levels). The original device (K142079) was already cleared for single-level use.
- "Study that proves the device meets the acceptance criteria": For this specific submission, the "study" primarily consists of:
- Clinical literature review: To assess additional safety concerns for multilevel use.
- PearlDiver reimbursement data: To investigate risks and benefits.
- Cadaveric biomechanical testing: Conducted to support substantial equivalence.
Given this context, I cannot fill out the requested table or answer most of your detailed questions because they pertain to diagnostic AI performance studies, which are not applicable to this physical implant's regulatory submission.
However, I can extract the following relevant information based on the provided text:
Acceptance Criteria and Device Performance (Not applicable in the AI sense for this implant)
This document does not present acceptance criteria for an AI algorithm's performance or a device performance table for diagnostic metrics. Instead, the "performance" discussed relates to the biomechanical and safety aspects of the physical implant for its expanded indication. The device is deemed "substantially equivalent" to its predicate based on design, material, and performance, which implies meeting established safety and effectiveness standards for such devices.
1. A table of acceptance criteria and the reported device performance
- Not applicable / Not explicitly stated for AI diagnostic performance. The document focuses on demonstrating substantial equivalence for an expanded indication (multilevel use) of a physical implant. The "acceptance criteria" for a 510(k) submission are met by showing the device is as safe and effective as a legally marketed predicate. Performance is demonstrated through biomechanical testing and clinical literature review, not in terms of AI metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: "Cadaveric biomechanical testing was conducted." The specific number of cadavers or samples is not provided.
- Data Provenance: Not specified for the cadaveric testing. The clinical literature review and PearlDiver reimbursement data are mentioned, but details on provenance (country, retrospective/prospective) are not provided.
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. This pertains to a physical implant, not an AI diagnostic device. Ground truth in this context would implicitly relate to established biomechanical standards and clinical outcomes for spinal fusion, which are assessed by relevant specialists (e.g., orthopedic surgeons, biomechanical engineers), but specific numbers and qualifications of experts for a "ground truth" establishment are not mentioned for this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically for expert interpretation of diagnostic data, which is not the focus here.
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
- No. An MRMC study is not mentioned as this is a physical medical implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the cadaveric biomechanical testing, the "ground truth" would be established biomechanical principles and measurements related to spinal stability and fusion construct integrity.
- For the clinical literature review and PearlDiver data, the "ground truth" would be derived from a synthesis of published clinical outcomes data and real-world reimbursement trends related to spinal fusion procedures.
- Specific, explicit statements on "ground truth" definition are not in the document.
8. The sample size for the training set
- Not applicable. No AI algorithm is being trained here.
9. How the ground truth for the training set was established
- Not applicable. No AI algorithm is being trained here.
§ 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.