(187 days)
The STALIF X™ is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. These DDD patients may also have up to Grade I 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open lateral approach.
The STALIF X™ is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine.
The STALIF X™ system should be used with bone grafting material (autograft only).
The STALIF XTM is a radiolucent intervertebral body fusion device and unicortical cancellous bone screws intended to be used with supplemental fixation. The device is manufactured from PEEK Optima LT-1 or Zeniva ZA PEEK per ASTM F2026 and titanium alloy (Ti6Al4V) per ASTM F136.
The provided text describes a 510(k) premarket notification for a medical device called STALIF XTM. This submission focuses on demonstrating substantial equivalence to predicate devices based on mechanical performance and does not involve a study to evaluate AI algorithm performance or establish acceptance criteria related to such algorithms.
Therefore, most of the requested information regarding acceptance criteria for a device's performance (especially AI/software performance), sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone algorithm performance cannot be extracted from the given text.
The document is a regulatory submission for a physical intervertebral body fusion device and outlines its indications for use, device description, and mechanical performance testing against predicate devices.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (from predicate device standards) | Reported Device Performance (STALIF X™) |
|---|---|---|
| Mechanical Soundness | Static Compression (per ASTM F2077) | As mechanically sound as predicate devices (K073109, K101301, K112986, K121733, K103729) |
| Static Compression-Shear (per ASTM F2077) | As mechanically sound as predicate devices | |
| Dynamic Compression (per ASTM F2077) | As mechanically sound as predicate devices | |
| Dynamic Torsion (per ASTM F2077) | As mechanically sound as predicate devices | |
| Dynamic Compression-Shear (per ASTM F2077) | As mechanically sound as predicate devices | |
| Expulsion (per ASTM F2267) | As mechanically sound as predicate devices | |
| Subsidence (per ASTM F-04.25.02.02) | As mechanically sound as predicate devices |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not available in the provided text. The text refers to "testing performed" but does not specify sample sizes for mechanical tests or data provenance.
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)
- This information is not applicable and not available. This is a submission for a physical medical device, not an AI or software device that requires expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable and not available.
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
- This information is not applicable and not available. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable and not available. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance demonstration is based on established mechanical testing standards (ASTM F2077, F2267, and F-04.25.02.02) and comparison to the performance of legally marketed predicate devices.
8. The sample size for the training set
- This information is not applicable and not available. This is not an AI/machine learning device that uses a training set.
9. How the ground truth for the training set was established
- This information is not applicable and not available.
§ 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.