(130 days)
Keos Lumbar IBFD is indicated for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The Keos Lumbar IBFD is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e., posterior pedicle screws and rod systems, anterior plate systems, and anterior screw and rod systems). The device(s) is intended to be used with autogenous bone graft.
Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The Keos Lumbar IBFD can be used in one of two methods:
Transforaminal Lumbar Interbody Fusion (TLIF)
Used as a TLIF, a single device is implanted in the appropriate location (L2-S1) to provide support for a transforaminal approached surgery.
Posterior Lumbar Interbody Fusion (PLIF)
Used as a PLIF, two devices are implanted in the appropriate locations (L2-S1) to provided support to the spine for a posterior surgery.
The series of intervertebral body fusion devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various fixed heights and shapes for placement in the spine. There are different cages designed for specific regions of the spine and approaches to the spine. Each cage has a hollow center to allow placement of graft material inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.
The series of intervertebral body fusion devices are made from the PEEK radiolucent material and HA enhanced PEEK with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.
The provided text details a 510(k) premarket notification for the "Keos Lumbar IBFD," an intervertebral body fusion device. While it describes the device's indications for use and a summary of nonclinical tests, it does not contain information about studies involving human readers, AI assistance, training sets, or expert ground truths as requested in the prompt. The submission primarily focuses on demonstrating substantial equivalence to predicate devices through material and mechanical testing.
Therefore, many of the requested elements about acceptance criteria and studies cannot be extracted from this document, as they are not present.
Here's a breakdown of the information that can be extracted or inferred from the document regarding acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance | |
| Static Compression per ASTM F2077 | Met acceptance criteria |
| Dynamic Compression per ASTM F2077 | Met acceptance criteria |
| Static Compression Shear per ASTM F2077 | Met acceptance criteria |
| Dynamic Compression Shear per ASTM F2077 | Met acceptance criteria |
| Subsidence Test per ASTM F2267 | Met acceptance criteria |
| Static Expulsion Test | Met acceptance criteria |
| Sterilization Assurance Level (SAL) | |
| 10^-6 per ISO 17665 (for implants and instruments/case) | Met acceptance criteria |
Note: The document explicitly states "The results of these studies showed that the Keos Lumbar IBFD met the acceptance criteria." However, it does not provide the specific numerical acceptance criteria or detailed numerical results for each test. It only confirms that the device passed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify the sample size for the testing performed (e.g., number of devices tested for mechanical properties).
- The data provenance (country of origin, retrospective/prospective) is not mentioned, as these are non-clinical (mechanical) tests, not clinical studies.
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 present. The studies performed were non-clinical mechanical tests, not studies requiring expert interpretation of medical data or images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable and not present, as the studies performed were non-clinical mechanical tests.
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 MRMC or comparative effectiveness study involving human readers or AI assistance was performed or reported. The document explicitly states: "No clinical tests were performed."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone algorithm performance study was done. This device is a physical intervertebral body fusion device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the mechanical tests would be the established scientific and engineering principles outlined in the referenced ASTM standards (e.g., F2077, F2267) and ISO standards (e.g., 17665). The tests measure physical properties against these predefined parameters. There is no biological or expert-derived "ground truth" in this context.
8. The sample size for the training set
- This information is not applicable and not present. The device is a physical implant, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- This information is not applicable and not present, as there is no training set for this type of device.
§ 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.