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The Phantom Plus Ceramic 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 Ceramic Cage System-Lumbar is to be filled with autogenous bone graft material. The Phantom Plus Ceramic Cages-Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System.

The Phantom Plus Ceramic 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 Ceramic 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.

The Phantom Plus Ceramic Cages-Cervical are to used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Phantom Plus Ceramic 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 offered in 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 14mm to 45mm in length.

The provided text describes a 510(k) premarket notification for the Phantom Plus® Ceramic Cage System, which is an intervertebral body fusion device. The focus of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove the device meets those criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, as well as details about sample sizes, expert involvement, and ground truth establishment, cannot be directly extracted from the provided text because such a study was not presented.

Instead, the submission relies on demonstrating compliance with recognized performance standards and substantial equivalence to predicate devices.

Here's a summary of what can be gathered, addressing the spirit of the request as much as possible given the available information:

1. Table of acceptance criteria and the reported device performance

Since this is a 510(k) submission focused on substantial equivalence to predicate devices and compliance with existing standards, explicit acceptance criteria for a novel performance study are not defined or reported in the text. Instead, the device's performance is demonstrated by meeting the requirements of recognized ASTM and AAMI standards.

• Adherence to ASTM F2077 (for lumbar intervertebral body fusion devices)
• Adherence to ASTM F1839 (for ceramic materials for surgical implants)
• Adherence to ASTM F1877 (for intervertebral body fusion devices with integrated plate fixation) | "Testing and engineering analyses on this device indicate that the Phantom Plus Cage System is substantially equivalent to predicate devices... all applicable requirements were met." |
  | Material/Biocompatibility:
• Adherence to AAMI TIR 33 (Guidance for biocompatibility risk management)
• Same or equivalent materials as predicate devices (ceramic) | "Testing and engineering analyses on this device indicate that the Phantom Plus Cage System is substantially equivalent to predicate devices... all applicable requirements were met." |
  | Design and Function:
• Same or equivalent design and function as predicate devices (e.g., hollow vertebral body spacers, convex, bullet nose design, axial void for bone graft, angular teeth for expulsion resistance) | "The Phantom Plus Ceramic Cage System was shown to be substantially equivalent to previously cleared devices, including itself (K082801) and the Valeo® Spacer System (K091278), and has the same or equivalent indications for use, design, function, and materials used." |
  | Indications for Use:
• Equivalent indications for use as predicate devices (e.g., DDD patients with specific conditions, autogenous bone graft, supplemental fixation) | "The Phantom Plus Ceramic Cage System was shown to be substantially equivalent to previously cleared devices... and has the same or equivalent indications for use..." |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a clinical "test set" in the context of a prospective clinical trial. The "testing and engineering analyses" mentioned likely refer to bench testing and mechanical studies conducted in a laboratory setting, not human clinical trials. Therefore, information about sample size (patients), data provenance, or retrospective/prospective nature is not provided.

3. 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, as a clinical test set with human subject data requiring expert ground truth establishment is not discussed in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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

Not applicable. This device is an implant, not an AI-assisted diagnostic tool, and therefore MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable, as a clinical study requiring ground truth is not presented. The "ground truth" for this submission is adherence to recognized performance standards and demonstrated mechanical equivalence to predicates.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device requiring a training set. The "engineering analyses" would involve material samples and device prototypes.

9. How the ground truth for the training set was established

Not applicable.

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