(148 days)
The Half Dome Posterior Lumbar Interbody System are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to LS-S1. DDD is defined as discogenic with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Half Dome implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
The Half Dome Posterior Lumbar Interbody TLIF and OTLIF are implants developed for the substitution of the classical autogenous bone graft blocks. They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis). X-ray markers allow the position to be determined post-op.
This document is a 510(k) Premarket Notification for the Half Dome Posterior Lumbar Interbody System. It describes the device, its intended use, and its equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity for a diagnostic algorithm.
The information provided is for a physical medical device (an intervertebral body fusion device), not a diagnostic algorithm or AI system. Therefore, the questions related to algorithmic performance metrics, sample sizes, ground truth, experts, and MRMC studies are not applicable to the content of this document.
Here's what can be extracted from the document regarding the "study" for this type of device and its equivalence:
The "study" in this context refers to non-clinical testing to demonstrate mechanical safety and performance, and the "acceptance criteria" are implied by showing the device performs similarly to or better than predicate devices according to established engineering standards.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent or superior mechanical performance to predicate devices | Results indicate equivalence to predicate devices for all tests |
| Specific Tests Conducted: | |
| Static and Dynamic Compression per ASTM F2077 | Passed, equivalent to predicate devices |
| Subsidence per ASTM F2267 | Passed, equivalent 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):
- Sample Size for Test Set: Not specified in the document. For mechanical testing, this would typically refer to the number of physical device samples tested.
- Data Provenance: Not applicable in the traditional sense for non-clinical mechanical testing. The tests are performed in a lab setting by the manufacturer (Astura Medical, located in Carlsbad, CA, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for mechanical testing is based on engineering standards (ASTM F2077, ASTM F2267) and direct measurement of physical properties, not expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Mechanical test results are objective measurements against established ASTM standards, not subject to adjudication by medical experts.
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:
- Not applicable. This is a physical medical device, not a diagnostic algorithm. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For non-clinical mechanical testing, the "ground truth" is defined by adherence to specific engineering standards (e.g., ASTM F2077 for static and dynamic compression, ASTM F2267 for subsidence) and objective measurements of device performance under controlled conditions.
8. The sample size for the training set:
- Not applicable. There is no training set as this is not an AI/ML algorithm.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set.
In summary: The provided document is a 510(k) submission for a physical intervertebral body fusion device. The "study" referenced refers to a series of non-clinical mechanical tests to demonstrate the device's safety and performance characteristics and its substantial equivalence to previously cleared predicate devices. It does not involve patient data, clinical outcomes, or AI algorithm performance metrics.
§ 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.