(50 days)
When used as an intervertebral fusion device, the MOBIS® II devices are intended for use at one 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. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. Patients with previous nonfusion spinal surgery at the involved level may be treated with the device. The devices are intended for use with a supplemental internal fixation system and with autograft to facilitate fusion.
The basic shape of the MOBIS® II devices is a hollow structural frame having a rounded, tapered leading face. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is available in a variety of sizes and two angulations thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, focusing on what's available and noting what's not explicitly stated:
Based on the provided 510(k) summary for the MOBIS® II intervertebral fusion device, the acceptance criteria and study details are primarily focused on mechanical performance testing to demonstrate substantial equivalence to predicate devices, rather than clinical efficacy or AI performance.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for MOBIS® II (Implicit from substantial equivalence claim):
The device's mechanical performance, specifically for static and dynamic compression and subsidence properties, must be equivalent to or better than previously cleared predicate devices (MOBIS®, PEEK TETRIS™, and Python) when tested according to relevant ASTM standards.
| Test Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Static Compression | Performance substantially equivalent to predicate devices | Meets or exceeds predicate device performance in ASTM F2077 |
| Dynamic Compression | Performance substantially equivalent to predicate devices | Meets or exceeds predicate device performance in ASTM F2077 |
| Subsidence Properties | Performance substantially equivalent to predicate devices | Meets or exceeds predicate device performance in ASTM F2267 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each mechanical test. The text mentions "worst case MOBIS® II" was tested, implying a representative sample but not a specific number of units tested.
- Data Provenance: The study was conducted by the device manufacturer, SIGNUS Medizintechnik GmbH, based in Alzenau, Germany. The testing was likely performed in a lab setting, not using patient data.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable: This device is an intervertebral fusion device, not an AI or diagnostic imaging device. The "ground truth" for its performance is established through objective mechanical testing against engineering standards. Experts were not involved in establishing a "ground truth" in the way they would be for evaluating diagnostic accuracy or clinical outcomes.
4. Adjudication Method
- Not Applicable: As this is a mechanical performance study, there's no "adjudication method" in the context of human expert review of cases. The results are quantitative measurements against predefined standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No: This is not an MRMC study. MRMC studies are typically performed for diagnostic imaging devices to assess how AI assistance impacts human reader performance.
6. Standalone (Algorithm Only) Performance Study
- No: This device is a physical implant, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant. The performance study focused on the mechanical integrity of the implant itself.
7. Type of Ground Truth Used
- Mechanical Engineering Standards: The "ground truth" for the device's performance is objective mechanical measurements validated against established ASTM standards (ASTM F2077 for static and dynamic compression; ASTM F2267 for subsidence properties). The performance is then compared to accepted limits or to the performance of predicate devices that have already met regulatory requirements.
8. Sample Size for the Training Set
- Not Applicable: There is no "training set" as this is a physical medical device undergoing mechanical validation, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: (See point 8).
§ 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.