(150 days)
The ROCCIA PLIF System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the ROCCIA PLIF System is indicated in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis. These implants may be implanted via an open posterior approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
The ROCCIA PLIF cage is manufactured from polyetheretherketone (PEEK) according ASTM F2026. The cage is equipped with a chamber system that can be filled with autogenous bone graft. The integrated x-ray markers which are made of tantalum according ASTM F560 enable a presentation of the implant during insertion and postoperative control examinations.
The ROCCIA PLIF cage is available in different sizes and angles. The implants are single use devices. 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 PLIF, 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 the multiple implantation procedure. The ROCCIA instrumentation is manufactured from stainless steels conforming to ISO 16061 and ASTM F899.
This document is a 510(k) premarket notification for the ROCCIA® PLIF intervertebral body fusion device. The focus of the document is to demonstrate "substantial equivalence" to legally marketed predicate devices, rather than establishing acceptance criteria or proving device performance through specific studies with reported metrics in the way a clinical trial for an AI/ML device would.
Therefore, many of the requested categories related to acceptance criteria, study design, and performance metrics are not applicable in this context. The document relies on non-clinical performance data and the established safety and efficacy of the predicate devices.
Here's a breakdown of the information as it relates to your request:
1. Table of Acceptance Criteria and Reported Device Performance
This type of information (specific performance metrics with acceptance criteria) is not present in the provided document. The submission is focused on demonstrating that the new device is "substantially equivalent" to existing predicate devices based on non-clinical testing and shared characteristics, rather than meeting novel performance thresholds in a clinical study.
The closest to "acceptance criteria" are the standards the device passed:
| Acceptance Criteria Category | Standard / Requirement Met |
|---|---|
| Mechanical Performance | ASTM F2077 (for Intervertebral Body Fusion Devices) |
| Mechanical Performance | ASTM F2267 (for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression) |
| Performance | Static expulsion testing (Passed) |
| Performance | Subsidence testing (Passed) |
| Biocompatibility | ISO 10993-1 (Met) |
| Cleaning and Sterilization | ISO 11137 (Met) |
| Shelf Life | 5 years (Testing passed) |
| Storage and Transport | Testing passed |
The document does not provide specific numerical performance values for these tests (e.g., specific load resistance in Newtons, or subsidence displacement in mm), only that the device "passed all the testing in accordance with internal requirements, national and international standards."
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. This submission relies on non-clinical ( benchtop/laboratory) testing, not a clinical test set of patient data.
- Data Provenance: Not applicable. The "data" are from mechanical, material, and sterilization tests performed on the device itself, not patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. Ground truth, in the sense of clinical annotations by experts, is not established for this type of submission.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set requiring adjudication was used.
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
- MRMC Study: No. This device is a physical intervertebral body fusion device, not an AI/ML-driven diagnostic or assistive tool. Therefore, an MRMC study and effects on human reader improvement are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: No. This is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the non-clinical performance data, the "ground truth" is defined by the specifications within the relevant ASTM and ISO standards (e.g., ASTM F2077, ASTM F2267, ISO 10993-1, ISO 11137). The device components and materials are also specified to conform to relevant ASTM standards (e.g., PEEK according to ASTM F2026, tantalum according to ASTM F560, stainless steels conforming to ISO 16061 and ASTM F899).
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is not an AI/ML device that requires training data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. This is not an AI/ML device.
Summary of the K181899 Submission:
The K181899 submission for the ROCCIA® PLIF device is a traditional 510(k) pathway to market. It demonstrates substantial equivalence by:
- Comparing the device's indications for use, principles of operation, technological characteristics, and materials to legally marketed predicate devices.
- Providing non-clinical performance data (mechanical, biocompatibility, sterilization, shelf life, storage, transport testing) showing that the ROCCIA PLIF meets established design input specifications and relevant national and international standards (e.g., ASTM F2077, ASTM F2267, ISO 10993-1, ISO 11137).
- Stating that no human clinical testing was required due to the equivalence to predicate devices with proven safety and efficacy.
This regulatory pathway does not involve the types of clinical studies, expert-based ground truth, or AI/ML performance metrics that your request primarily focuses on.
§ 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.