(90 days)
The Helena System is indicated for intervertebral body fusion of the lumbar spine, from L2 to Sl, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
The Helena System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of: Lumbar interbody fusion device(s), which may be implanted bi-laterally via a posterior (PLIF) approach; as a single device via a transforaminal (TLIF) approach - as a single device via an anterior (ALIF) approach; or The Helena System implant components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device. The Helena System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
The Helena System is an intervertebral body fusion device made of PEEK Optima LT1 with tantalum markers, designed for lumbar spine fusion from L2 to S1.
1. Acceptance Criteria and Device Performance
The acceptance criteria for the Helena System are based on non-clinical mechanical testing standards, demonstrating substantial equivalence to predicate devices. The device performance, as reported, met these criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static and Dynamic Compression Testing (per ASTM F2077-03) | Substantially equivalent results compared to predicate devices, indicating acceptable mechanical integrity under physiological loads. |
| Subsidence Testing (per ASTM F2267-04) | Substantially equivalent results compared to predicate devices, demonstrating acceptable resistance to subsidence into vertebral endplates. |
| Expulsion Testing (per ASTM Draft Standard F-04.25.02.02) | Substantially equivalent results compared to predicate devices, indicating acceptable resistance to unintentional expulsion from the intervertebral space. |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated in the provided documents. The testing was non-clinical, involving mechanical tests of the device itself rather than patient data.
- Data Provenance: The data is based on laboratory non-clinical testing of the Helena System implants, following specified ASTM standards. No human or animal data provenance (e.g., country of origin, retrospective/prospective) is applicable to this type of testing.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. The ground truth for the non-clinical mechanical tests is based on the performance standards defined by ASTM (American Society for Testing and Materials) specifications, not expert interpretation of medical images or patient data.
4. Adjudication Method for the Test Set
Not applicable. As the testing involved mechanical measurements against predefined standards, there was no need for expert adjudication. The results are quantitative and objective.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or mentioned. This type of study is relevant for imaging-based diagnostic or prognostic AI tools that involve human interpretation, not for mechanical orthopedic implants.
6. Standalone Performance Study
A standalone performance study was done in the sense that the device's mechanical properties were tested independently against established standards (ASTM F2077-03, ASTM F2267-04, and ASTM Draft Standard F-04.25.02.02). The "algorithm only" concept is not applicable here as it's a physical medical device. The tests evaluated the device's ability to withstand various forces encountered in the body.
7. Type of Ground Truth Used
The ground truth used was objective engineering standards and performance criteria as defined by the ASTM standards (ASTM F2077-03 for static and dynamic compression, ASTM F2267-04 for subsidence, and ASTM Draft Standard F-04.25.02.02 for expulsion).
8. Sample Size for the Training Set
Not applicable. There is no "training set" in the context of mechanical testing for a physical medical device like this. Machine learning algorithms require training sets, but this regulatory submission concerns a physical implant.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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.