(154 days)
The DIANA™ Fusion Cage is intended for interbody fusion procedures and is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the device is intended to be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
The DIANA™ Fusion Cage is comprised of a variety of implant sizes to accommodate various patient anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).
Here's an analysis of the provided text regarding the acceptance criteria and study for the DIANA™ Fusion Cage.
Unfortunately, the provided document does not contain the detailed clinical study data or acceptance criteria that would typically be found in a performance study report for a medical device submitted for 510(k) clearance. The information provided is a 510(k) summary and the FDA's clearance letter.
A 510(k) relies on demonstrating "substantial equivalence" to a predicate device, rather than requiring new clinical trials that establish specific performance metrics against pre-defined acceptance criteria. Therefore, the information you're asking for regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is generally not present in a 510(k) submission of this nature.
Based on the provided text, here's what can be inferred and what is missing:
Acceptance Criteria and Device Performance (Inferred/Missing)
| Acceptance Criteria Category | Specific Metric/Description (Expected/Inferred) | Reported Device Performance (Inferred from Substantial Equivalence Claim) |
|---|---|---|
| Mechanical Performance | - Static Compression Strength: Ability to withstand axial loads without failure. |
- Dynamic/Fatigue Compression: Ability to withstand cyclic loading over time without failure or significant deformation.
- Subsidence Resistance: Ability to resist sinking into the vertebral endplates. | "The pre-clinical testing performed indicated that the DIANA™ Fusion Cage is substantially equivalent to the predicate devices and is adequate for the intended use."
This implies that mechanical testing results met or exceeded the performance of the predicate devices based on established ASTM/ISO standards for interbody fusion devices. |
| Material Biocompatibility | - Cytotoxicity: Non-toxic to cells. - Sensitization/Irritation: No adverse skin reactions.
- Systemic Toxicity: No harmful systemic effects. | Implied to be equivalent due to using "medical grade titanium alloy (Ti6Al4V-ELI)," which is a well-established and biocompatible material for implants. |
| Anatomical Fit/Design | - Range of sizes to accommodate various anatomies. - Design features for stability and insertion. | "comprised of a variety of implant sizes to accommodate various patient anatomy and pathology, and associated instrumentation."
Implied to be comparable to predicate devices in terms of its design for anatomical fit and surgical technique. |
Study Details (Based on Provided Text)
-
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. The document states "pre-clinical testing." This typically refers to benchtop mechanical and material testing, not clinical studies with patient test sets. Therefore, there's no patient sample size, data provenance, or retrospective/prospective information mentioned.
-
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):
- N/A. For pre-clinical, benchtop testing, ground truth is established by engineering standards and validated testing protocols, not typically by medical experts in this context.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. This concept is relevant for clinical studies involving expert reviews or assessments, which were not conducted or reported in this 510(k) summary.
-
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:
- No. This device is an interbody fusion cage, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is completely irrelevant and was not performed.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. As above, this is not an AI device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For pre-clinical mechanical testing, the "ground truth" would be established by validated engineering standards (e.g., ASTM F2077 for intervertebral body fusion devices) and material specifications. The performance is judged against these quantifiable structural integrity and material properties.
-
The sample size for the training set:
- N/A. There is no "training set" in the context of an interbody fusion cage's pre-clinical testing. This term applies to machine learning or AI models.
-
How the ground truth for the training set was established:
- N/A. As there is no training set, this question is not applicable.
Summary of Device Performance Claim:
The core of the K091122 submission relies on demonstrating substantial equivalence to four previously cleared predicate devices:
- BAK Interbody Fusion Device (P950002)
- Inter Fix Threaded Fusion Device (P970015)
- Ray Threaded Fusion Cage (P950019)
- Brantigan Cage (P960025)
The document explicitly states: "The DIANA™ Fusion Cage was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used." It further mentions: "The pre-clinical testing performed indicated that the DIANA™ Fusion Cage is substantially equivalent to the predicate devices and is adequate for the intended use."
This means that the testing performed (primarily mechanical and material characterization) indicated that the DIANA™ Fusion Cage performs similarly to or better than the predicate devices, meeting the necessary safety and performance requirements for its intended use, without requiring new clinical efficacy data.
§ 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.