(231 days)
The Sypher Spacer System is an intervertebral body fusion system indicated for intervertebral body fusion procedures in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use with autogenous bone graft at one or two contiguous levels of 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 radiographic studies. The device system is designed for use with supplemental fixation to facilitate fusion.
The Sypher Spacer System implants are cylinder shaped blocks made of PEEK Optima® LT1 (Polyether ether ketone per ASTM F2026), with tantalum alloy radiological position markers (per ASTM F560), titanium alloy self-drilling and self-tapping bone screws (per ASTM F136), and titanium alloy cage lock assemblies (per ASTM F136).
The implants are available in a variety of footprints, heights and lordotic angles. The shape of the Sypher product allows for a larger implant (height and width) to be used allowing for more surface area contact. The Sypher Spacer System is offered in a closed graft space design. The implants incorporate integrated anterior screw holes to allow for medial placement of screws, as well as a titanium alloy cage lock assembly for securing the screws once in place. Additional or other supplemental fixation may be used, as patient needs dictate. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and to prevent movement of the implants. The Sypher Spacer System is intended to be used with autologous bone graft.
The provided text describes the 510(k) premarket notification for the Sypher Spacer System, an intervertebral body fusion device. While it mentions performance testing, it does not include detailed acceptance criteria or a study that specifically proves the device meets those criteria in the way you've outlined.
Here's what can be extracted based on the provided text, and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific quantitative criteria for intervertebral fusion devices related to clinical outcomes or device durability (e.g., fusion rates, subsidence limits, stability thresholds) | Not explicitly stated in the provided document. The document refers to "sufficient strength for its intended use" without quantifiable acceptance criteria. |
| Material conformance to standards | PEEK Optima® LT1 conforms to ASTM F2026. Tantalum conforms to ASTM F560. Titanium alloy conforms to ASTM F136. |
| Mechanical Test Standards | Device was tested according to: |
- Static axial compression bending per ASTM F2077-11
- Static compressive shear per ASTM F2077-11
- Static subsidence per ASTM F2267-04 and ASTM F2077-11
- Dynamic axial compression per ASTM F2077-11
- Dynamic compressive shear per ASTM F2077-11
- Expulsion per ASTM Draft Standard F-04.25.02.02 |
| Comparative Strength | The device's strength is considered "substantially equivalent to legally marketed predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only mentions that the device "has been tested" in various modes. It refers to "non-clinical testing," which typically means bench testing or cadaver studies, not human clinical trials.
- Data Provenance: The testing is "non-clinical," implying it was conducted in a laboratory setting, likely in the US where the company and consultants are located. It is not clinical data (retrospective or prospective from patients).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. This document describes non-clinical, mechanical performance testing of an implantable medical device, not a diagnostic device or a study requiring expert interpretation of results to establish ground truth. The "ground truth" for mechanical testing is typically the adherence of the device's physical properties to engineering standards and comparison to predicate devices, measured by instruments.
4. Adjudication Method for the Test Set
- Not applicable. As this is mechanical testing, there is no "adjudication method" in the sense of expert consensus on clinical or imaging readings. The results are quantitative measurements against established engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study (MRMC) is typically done for diagnostic devices where human readers interpret images or other data, and the goal is to assess the impact of an AI tool on reader performance. The Sypher Spacer System is an implantable surgical device, not a diagnostic one, and the reported tests are mechanical performance tests.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
- Not applicable. The Sypher Spacer System is a physical intervertebral fusion device, not a software algorithm. Its "performance" is its mechanical integrity and ability to facilitate fusion when implanted, which is assessed through bench testing and, eventually, clinical outcomes (though clinical trial data is not presented here, as this is a 510(k) submission based on substantial equivalence to predicates).
7. Type of Ground Truth Used
- For the non-clinical mechanical testing, the "ground truth" is defined by established ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices, and comparison to the mechanical properties of legally marketed predicate devices. The goal is to demonstrate that the Sypher Spacer System's mechanical characteristics are equivalent or superior to these benchmarks.
8. Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of mechanical performance testing of a physical medical device. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set.
In summary: The provided document is a 510(k) clearance letter and summary for a physical medical device. It focuses on demonstrating substantial equivalence to predicate devices primarily through mechanical (bench) testing, adherence to material standards, and similar indications for use. It does not contain information about clinical trials, diagnostic performance, or AI algorithms, which are the contexts in which many of your questions would typically apply.
§ 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.