(172 days)
The FOCUS Interbody System is intended to be used as a lumbar intervertebral fusion device at one or two adjacent levels from L2 to S1. This system should be limited to skeletally mature patients who have had six months of non-operative care for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. In addition, the FOCUS Interbody System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The FOCUS Interbody System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate. These implants are intended for use with supplemental fixation indicated for lumbar spinal fusion procedures such as the OrthoCircle Spine Pedicle Screw System.
The FOCUS Interbody System includes interbody fusion devices for lumbar implantation. The FOCUS-T and FOCUS-TO implants are designed as structural columns to provide surgical stabilization of the lumbar spine. Each interbody has a central cavity to be packed with bone graft material and inferior/superior teeth to resist expulsion. Lateral windows provide for radiographic visualization on most implant sizes. The implants are available with and without the XCELLerate surface coating and in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances. The implants are supplied sterile.
The provided text describes the 510(k) premarket notification for the "FOCUS Interbody System," a lumbar intervertebral fusion device. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through mechanical testing rather than performance in a study involving human subjects or AI-assisted interpretation of medical images. As such, many of the requested elements for an AI/device study (such as MRMC studies, ground truth establishment for image data, or AI-specific acceptance criteria) are not applicable to this specific device submission.
The "study" in this context refers to the performance data obtained from mechanical testing of the device itself, proving its structural integrity and functional characteristics are substantially equivalent to predicates.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from ASTM Standards) | Reported Device Performance |
|---|---|
| Static Axial Compression (ASTM F2077) | Met established criteria |
| Dynamic Axial Compression (ASTM F2077) | Met established criteria |
| Subsidence (ASTM F2267) | Met established criteria |
Note: The document states that "The mechanical test results demonstrate that the FOCUS Interbody System performance is substantially equivalent to the predicate devices." Specific numerical thresholds for acceptance criteria and the exact numerical results for the device are not provided in this summary, but are implicitly deemed acceptable by the FDA's clearance.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document refers to "worst case FOCUS Interbody System implant" undergoing testing. This implies a limited, focused sample size for mechanical testing. The exact number of units tested is not specified but is typical for benchtop mechanical validation rather than clinical study sample sizes.
- Data Provenance: The data is generated from laboratory mechanical testing of the device prototypes. This is not patient data; therefore, concepts like country of origin or retrospective/prospective do not apply.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
- Not Applicable. For mechanical testing, the "ground truth" is defined by established engineering standards (ASTM F2077, ASTM F2267) and the physical properties of the materials and design. There are no "experts" establishing ground truth in the sense of medical image interpretation. Engineers and test technicians perform the testing and interpret results against the standards.
4. Adjudication Method for the Test Set:
- Not Applicable. This is mechanical engineering testing against defined standards, not an observational study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This device is a physical medical implant. MRMC studies are relevant for devices that assist in diagnostic interpretation (e.g., AI for radiology). This is not such a device.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used:
- Engineering Standards and Material Properties: The "ground truth" for the performance of the FOCUS Interbody System is established by recognized ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices (F2077 for static/dynamic axial compression and F2267 for subsidence), as well as the known properties of the materials used (Ti6Al4V ELI titanium alloy, titanium powder, calcium phosphate).
8. The Sample Size for the Training Set:
- Not Applicable. This device did not involve machine learning or a "training set."
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As there was no training set, this question is irrelevant to this device.
In summary, the provided document details the regulatory clearance of a physical medical device based on its mechanical performance demonstrating substantial equivalence to existing devices, adhering to established engineering standards. It does not involve AI, image analysis, or clinical performance studies with human subjects in the contexts typically associated with the acceptance criteria questions.
§ 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.