(51 days)
The Opticage Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior or transforaminal approach.
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had a six month course of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.
The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).
The Opticage Interbody Fusion Device is a lumbar intervertebral body fusion device manufactured from implant grade titanium alloy. The Opticage Interbody Fusion Device consists of an upper and lower titanium plate and two titanium wedges that interact to change the height of the device. The device is available in a single configuration that ranges in length from 29mm (closed) to 21mm (expanded) and ranges in nominal height from 9mm (closed) to 14mm (expanded). The top and bottom of the device are fenestrated and contain openings to enhance bony in growth. The Opticage Interbody Fusion Device is provided non-sterile, for single use only.
Here's an analysis of the provided text regarding the Opticage™ Interbody Fusion Device, focusing on acceptance criteria and study details:
This document is a 510(k) summary and the FDA's clearance letter for a medical device. It does not describe a study involving device performance related to diagnostic accuracy, AI, or human-in-the-loop scenarios. Instead, it focuses on demonstrating substantial equivalence to previously cleared predicate devices through engineering performance testing. Therefore, many of the requested categories (like AI assistance, reader study details, ground truth for training/test sets) are not applicable to this type of submission.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Opticage™ Interbody Fusion Device primarily revolve around meeting established mechanical and biological performance standards for intervertebral body fusion devices, demonstrating substantial equivalence to its predicate devices.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance (per ASTM F2077) | Met: "All necessary performance testing, has been completed for the Opticage Interbody Fusion Device including those identified in ASTM F2077 (static and dynamic compression, static compression shear, static and torsional loading paradigms)." |
| Subsidence (per ASTM F2267) | Met: "All necessary performance testing... including... subsidence per ASTM F2267." |
| Expulsion | Met: "All necessary performance testing... including... expulsion." |
| Wear Debris/Particulates Evaluation | Met: "All necessary performance testing... including... evaluation of wear debris/particulates." |
| Material Biocompatibility | Met: "The Opticage Interbody Fusion device and the referenced predicates are all intended for use as intervertebral body fusion devices. The Opticage Interbody Fusion Device and the predicates are fabricated from well-known osteo-compatible materials with a long history of biocompatibility." |
| Intended Use, Design, Materials, Principle of Operation, and Overall Technological Characteristics (vs. Predicates) | Substantially Equivalent: "Upon reviewing the performance data provided in this submission and comparing intended use, design, materials, principle of operation and overall technological characteristics, the Opticage Interbody Fusion Device is determined by Interventional Spine, Inc., to be substantially equivalent to existing legally marketed devices." (Confirmed by FDA clearance). |
Study Details (Based on available information)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This submission describes engineering performance testing, not a clinical study with patient data or a diagnostic test set. Therefore, "sample size for the test set" typically refers to the number of devices or test samples fabricated and subjected to mechanical testing. The document does not specify the exact number of devices tested for each mechanical parameter (e.g., how many devices underwent static compression).
- Data Provenance: The mechanical and material testing would have been conducted in a laboratory setting, likely in the country of manufacture or a qualified testing facility, but the specific origin is not stated in the provided text. This is not "retrospective" or "prospective" in the clinical sense.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. For mechanical testing of an implant, "ground truth" is typically defined by the specified engineering standards (e.g., ASTM F2077, F2267) and the physical properties of the materials and device design. The "experts" in this context would be the engineers and technicians conducting the tests and interpreting the results against established mechanical criteria, rather than medical specialists establishing diagnostic truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This concept primarily applies to clinical studies or diagnostic performance evaluations where human assessors or multiple methods establish a truth. For mechanical testing, the results are typically objectively measured against pre-defined engineering thresholds.
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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:
- Not Applicable. This device is a physical surgical implant, not a diagnostic imaging device or AI software. Therefore, no MRMC study, AI assistance evaluation, or human reader improvement analysis was performed or is relevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical interbody fusion device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance, as demonstrated in the submission, is based on engineering standards and specifications (e.g., ASTM F2077, ASTM F2267) for mechanical properties, material composition, and biocompatibility.
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The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device. The concept of a "training set" is irrelevant here.
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How the ground truth for the training set was established:
- Not Applicable. As above, no training set or associated ground truth establishment is relevant to this device submission.
§ 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.