(220 days)
The ROCCIA® MultiLIF is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
The ROCCIA® MultiLIF implants are intended for use in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).
The ROCCIA® MultiLIF implants are intended for use at one or two contiguous levels in the lumbar spine, from L1 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 ROCCIA® MultiLIF implants can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
The ROCCIA MultiLIF cage is manufactured from Ti6Al4V ELI alloy. The cage has a large cylindrical hollow in the middle which can be filled with bone material. The cage has numerous threaded holes that allow for correct placement of the cage.
The ROCCIA MultiLIF cage is available in a range of sizes to accommodate individual patient pathology and anatomical conditions.
The ROCCIA instrumentation is ergonomically appropriate and designed as modular components. The ROCCIA insertion device enables the user to perform various instrumentation steps with just a single instrument. The instruments are designed to be used with the ROCCIA MultiLlF, and are made of materials common for medical devices used in implantable device instrumentation tools. The instruments are intended to be cleaned, sterilized, and reused for the purposes of future implantation procedures.
The ROCCIA MultiLIF cage is manufactured from Ti6Al4V ELI alloy conforming to ASTM F136. The ROCCIA instrumentation is manufactured from stainless steels conforming to ISO 16061 and ASTM F899.
The provided text describes a 510(k) premarket notification for the ROCCIA® MultiLIF intervertebral body fusion device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials for effectiveness in the same way a PMA would require. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of substantial equivalence to a predicate device, primarily through non-clinical performance testing.
Here's the information extracted and organized based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, "acceptance criteria" are typically met by demonstrating that the device performs equivalently to the predicate device in relevant non-clinical tests. The reported device performance is that it met these equivalence standards.
| Acceptance Criteria (Demonstrated Equivalence to Predicate Device) | Reported Device Performance (ROCCIA® MultiLIF) |
|---|---|
| Mechanical Load Testing (according to ASTM F2077) | Demonstrated comparable results to the predicate device. |
| Subsidence Behavior Testing (according to ASTM F2267) | Demonstrated comparable results to the predicate device. |
| Static Expulsion Testing | Demonstrated comparable results to the predicate device. |
| Materials (Ti6Al4V ELI alloy conforming to ASTM F136 for cage) | Conforms to the specified standard, which is typically considered equivalent to or an acceptable alternative to the predicate's material if it meets performance. Explicit comparison to predicate material not detailed but implied by overall substantial equivalence claim. |
| Indications for Use | Substantially equivalent to the predicate device (NuVasive® CoRoent® Thoracolumbar System). The text explicitly states "the indications for use are equivalent to the predicate device." Replication of the predicate's intended use in skeletally mature patients for intervertebral body fusion. |
| Principles of Operation | Substantially equivalent to the predicate device. |
| Technological Characteristics | Substantially equivalent to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of clinical trials with human subjects for this specific submission. The "test set" for performance evaluation involved in vitro mechanical testing of the device and a predicate. The specific number of physical device samples tested for each non-clinical test (mechanical load, subsidence, static expulsion) is not specified in the provided document.
- Data Provenance: The data comes from non-clinical performance tests conducted by Silony Medical GmbH, presumably in a laboratory setting. There is no mention of country of origin for this testing, nor is it a retrospective or prospective human clinical data set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. The "ground truth" for the non-clinical tests is established by adherence to recognized international and national standards (e.g., ASTM F2077, ASTM F2267) and internal requirements. There isn't a human expert "ground truthing" process for these engineering performance tests in the same way there would be for an AI diagnostic device.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert interpretations of cases in clinical studies or for AI ground truth labeling. The "test set" here refers to physical device testing against engineering standards, not human-interpreted data.
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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is a physical intervertebral body fusion device, not a diagnostic AI or imaging device that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No standalone (algorithm only) performance study was done. This device is a physical medical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
- For non-clinical performance evaluation, the "ground truth" is defined by established engineering standards and pre-defined acceptable performance ranges for the physical device, typically benchmarked against the predicate device's performance in the same tests. For the overall submission, the primary ground truth is the substantial equivalence of the device to its predicate, as determined by the FDA based on the provided non-clinical data and comparison of intended use, technological characteristics, and materials.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. No training set was used.
§ 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.