(145 days)
LATIS™ Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
LATIS™ Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.
LATIS™ Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. LATIS™ Spacers are provided in a shape that accommodates a posterior, transforaminal, or lateral approach to the lumbar spine; after insertion the implant can be transformed to the desired footprint. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
LATIS™ Spacers are manufactured from titanium alloy per ASTM F136 and F1295.
The provided text is a 510(k) summary for the LATIS™ Spacers, an intervertebral body fusion device. This document describes the device, its intended use, and the basis for its substantial equivalence to predicate devices. It does not contain information relevant to AI/ML device performance or clinical study details as requested. It specifically states that mechanical testing was performed in accordance with ASTM standards to demonstrate substantial equivalence, rather than clinical studies or evaluations of diagnostic performance.
Therefore, most of the requested information regarding acceptance criteria for an AI device, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document.
However, I can extract the information provided regarding the type of study and general acceptance criteria for this specific medical device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Stability: To demonstrate substantial equivalence to predicate systems. | Mechanical testing consisting of static and dynamic compression, static and dynamic compression-shear, and subsidence was conducted in accordance with: |
- "Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007
- ASTM F2077
- ASTM F2267
The results supported substantial equivalence to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the study described is mechanical testing of a medical implant, not a clinical study involving a test set of data.
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 as the study described is mechanical testing, not a study requiring expert clinical review or ground truth establishment in a diagnostic context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the study described is mechanical testing, not a study requiring adjudication of clinical data.
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, a multi-reader, multi-case comparative effectiveness study was not done. The submission focuses on mechanical testing for a spinal implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device, regarding its mechanical performance, was established through adherence to recognized industry standards (ASTM F2077, ASTM F2267) and the FDA's "Class II Special Controls Guidance Document: Intervertebral Fusion Device." This means performance was compared against established mechanical load and stability requirements for intervertebral fusion devices.
8. The sample size for the training set
This information is not applicable as the study described is mechanical testing of a physical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the study described is mechanical testing of a physical device, not an AI/ML algorithm.
§ 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.