(56 days)
PathLoc-TA Expandable Lumbar Cage System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. PathLoc-TA Expandable Lumbar Cage System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. Patients should have at least six months of non-operative treatment with a lumbar intervertebral fusion device. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems).
Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
The PathLoc-TA Expandable Lumbar Cage System is interbody fusion devices. This cage system is made of Titanium 6AL-4V Alloy (ASTM F136). And cages are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies.
The cage can be expanded in height using the system instrument after being inserted in the unexpanded state. The cages have serrations on the superior endplate and inferior endplate surfaces area to contact vertebrae bone endplate. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g., posterior pedicle screw and rod systems, anterior or lateral plate systems, and anterior screw and rod systems). All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances.
Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria. Instead, it relies on comparison to predicate devices and established ASTM standards. The reported performance is generally qualitative, stating the device performance is "higher or similar" to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical properties meet or exceed predicate devices. | Bench testing showed "higher or similar mechanical value" than predicate devices. |
| Compliance with ASTM F2077 for static and dynamic compression. | Testing was "presented to demonstrate the substantial equivalency". |
| Compliance with ASTM F2077 for static and dynamic shear. | Testing was "presented to demonstrate the substantial equivalency". |
| Compliance with ASTM draft F-04.25.02.02 for static expulsion. | Testing was "presented to demonstrate the substantial equivalency". |
| Compliance with ASTM F2267 for static subsidence. | Testing was "presented to demonstrate the substantial equivalency". |
| Identical technological characteristics to predicate devices. | "The subject and predicate devices have identical technological characteristics". |
| No new issues of safety and effectiveness compared to predicates. | "there is not any new issues of safety and effectiveness". |
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 provide details about the sample size for the mechanical tests, nor does it specify the provenance of the data (country of origin, retrospective/prospective). It only mentions "bench testing."
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. The study described is a benchtop mechanical testing study, not a clinical study involving experts establishing ground truth from patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable, as it was a benchtop mechanical testing study.
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 such study was done. The document describes a 510(k) submission for a physical medical device (intervertebral cage), not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this study is derived from established ASTM standards for mechanical testing of intervertebral body fusion devices, and the comparative performance of legally marketed predicate devices. The "truth" is whether the device's mechanical properties meet the standards and are equivalent or superior to existing devices.
8. The sample size for the training set
This information is not applicable, as this is a mechanical testing study for a physical device, not a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable, as this is a mechanical testing study for a physical device, not a machine learning model.
§ 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.