(89 days)
The Phantom™ Plus Cages- Lumbar are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six (6) months of nonoperative therapy. The Phantom™ Plus Cage System- Lumbar is to be filled with autogenous bone graft material. The Phantom™ Plus Cages- Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System.
Phantom™ Plus Cages-Cervical are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Phantom™ Plus Cages-Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Phantom™ Plus Cages-Cervical are to used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The Phantom™ Plus Cage System consists of a variety of hollow vertebral body spacers featuring convex, bullet nose design and an axial void designed to hold bone graft material. The subject device is made of various lengths. The subject devices are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices range from 6mm to 22mm in height and 11mm to 45mm in length. Materials: The devices are manufactured from Medical Grade PEEK (Polyetheretherketone) OPTIMA® LT1 (Invibio™) per ISO 10993-1 USP Class VI and ASTM F2026. Tantalum rods to be Grade UNS R05200 according to ASTM F560.
This 510(k) summary for the Phantom™ Plus Cage System describes a medical device, an intervertebral body fusion cage. For such devices, acceptance criteria and performance studies generally focus on mechanical properties, biocompatibility, and substantial equivalence to predicate devices, rather than AI/software performance metrics like sensitivity or specificity.
Based on the provided text, there is no information regarding:
- Acceptance Criteria and Reported Device Performance (as a table): The document doesn't provide specific quantitative acceptance criteria (e.g., minimum compression strength, fatigue life) or corresponding reported performance values for these metrics.
- Sample size and data provenance for a test set: This is not relevant for this type of device submission, as there's no "test set" in the context of AI or diagnostic performance.
- Number of experts and qualifications for ground truth: Not applicable.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm-only) performance: Not applicable, as this is not an AI/software device.
- Type of ground truth used: Not applicable in the AI/diagnostic sense.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What the document does describe is a regulatory submission demonstrating substantial equivalence to predicate devices, which is the primary "proof" for this type of medical device.
The relevant sections of the document indicate:
- Description of the device: The Phantom™ Plus Cage System consists of hollow vertebral body spacers made of PEEK featuring a convex, bullet nose design and angular teeth for expulsion resistance. They range from 6mm to 22mm in height and 11mm to 45mm in length. Materials are Medical Grade PEEK (OPTIMA® LT1) and Tantalum rods.
- Intended Use:
- Lumbar: For use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, with or without up to Grade I spondylolisthesis, who are skeletally mature and have undergone six months of non-operative therapy. To be used with supplemental spinal fixation systems.
- Cervical: For use in skeletally mature patients with DDD of the cervical spine with accompanying radicular symptoms at one disc level (C3 to C7), using autograft bone and supplemental fixation, after at least six months of non-operative treatment.
- Comparison to predicate devices: "There are no significant differences between the Phantom™ Plus Cage System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use."
In summary, for K082801, the "study that proves the device meets the acceptance criteria" is the demonstration of substantial equivalence to legally marketed predicate devices. This involves showing that the design, materials, function, and intended use of the Phantom™ Plus Cage System are equivalent to previously approved devices, therefore implying it meets the safety and effectiveness standards established for those predicates. The 510(k) clearance letter (pages 2-3) confirms the FDA's agreement with this assessment.
If this were an AI or diagnostic device, the requested information would be crucial. However, for a physical implant like an intervertebral cage, the regulatory pathway and "proof" focus on mechanical integrity, biocompatibility, and comparison to existing, safe, and effective devices.
§ 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.