(48 days)
The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
These patients should be skeletally mature and have had six months of nonoperative treatment. The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology is intended to be used with autograft bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate or a bone void filler cleared for use in intervertebral body fusion to facilitate fusion. These implants may be implanted via an open or a minimally invasive posterior approach and/or transforaminal approach.
The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology consists of Additively Manufactured (AM) titanium spacers of various lengths, and heights to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The open geometry of the implants allows them to be packed with autograft bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate or a bone void filler cleared for use in intervertebral body fusion to facilitate fusion. The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology in intended for use with supplemental fixation systems cleared for use in the lumbar spine.
The subject Adaptix™ Interbody System Fusion devices are available in a variety of lengths and heights for treatment in lumbar interbody fusion procedures. The subject device is designed with a large hollow region in the center to house autograft or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate or a bone void filler cleared for use in intervertebral body fusion to facilitate fusion. The design incorporates "honeycomb windows" through the interbody device to permit bone growth through the implant. The new bone formation through the Interbody Device is intended to provide long-term structural support and fusion at the implanted disc space. The Interbody Device incorporates Titan Surface Technologies™ including a macro-rough surface on the superior and inferior surfaces of the device along with the entire device being treated with nanoLOCK™ Surface Technology (MMN™) to improve fixation to the adjacent bone. The nanoLOCK™ Surface Technology (MMN™) provides a microscopic roughened surface with nano-scale features.
The subject device is manufactured from Titanium-6 Aluminum-4 Vanadium Extra Low Interstitial (Ti-6Al-4V ELI) powder in accordance with ASTM F3001: Standard specification for additive manufacturing titanium-6 aluminum-4 vanadium ELI (Extra Low Interstitial) with powder bed fusion.
This 510(k) clearance letter is for the Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology, which is an intervertebral body fusion device. This type of device is a physical implant designed to facilitate spinal fusion in patients with Degenerative Disc Disease (DDD).
Crucially, this document describes a medical device (an implant), not a software or AI-driven diagnostic/therapeutic device.
Therefore, most of the requested information regarding acceptance criteria and study design for AI/software devices (such as sample sizes for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for AI models) is not applicable to this 510(k) submission.
The "performance data" section in this document refers to the data demonstrating the safety and effectiveness of the physical implant, which typically involves mechanical testing, biocompatibility testing, material characterization, and comparison to predicate devices, rather than clinical performance data from a diagnostic algorithm.
Here's how to interpret the provided document in the context of your request:
Key Takeaway from the Document:
The current 510(k) submission (K250669) is not for a new device design or new technology assessment, but rather to expand the indications for use of an already cleared physical implant (Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology, K201267) to include the use of bone void fillers as an additional graft option.
The core argument for clearance is substantial equivalence to existing predicate devices, arguing that the expanded use does not introduce new safety or effectiveness concerns, as bone void fillers are widely used and the primary predicate device is already cleared.
Given this understanding, here's an attempt to answer your questions based on the provided text, highlighting where the information is not applicable due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
Acceptance Criteria (Implicit for this type of device and submission):
For an interbody fusion device, the acceptance criteria typically revolve around:
- Biocompatibility: The material (Ti-6Al-4V ELI) must be biocompatible and safe for long-term implantation.
- Mechanical Strength/Durability: Ability to withstand physiological loads, prevent subsidence, and maintain stability. This is typically demonstrated through static and fatigue testing.
- Pore Size/Osteoconductivity: The design (e.g., "honeycomb windows," macro-rough and nanoLOCK™ surfaces) should facilitate bone ingrowth and fusion.
- Substantial Equivalence: The device must be demonstrated to be as safe and effective as predicate devices. For this specific submission, the crucial acceptance criterion is that adding bone void fillers does not negatively impact the safety or effectiveness of the pre-existing device.
Reported Device Performance (as described in the 510(k) Summary):
The document explicitly states:
"The subject Adaptix™ Interbody System devices do not require any additional data to support their expanded use with bone void fillers to facilitate intervertebral body fusion. This submission does not contain any new or modified implants since the original 510(k) clearance (K201267, S.E. 08-26-2020)."
"The overall design and dimensions of the subject devices are within the established size range of the predicate devices, ensuring compatibility and consistency in performance."
"The inclusion of bone void fillers as an additional graft option does not introduce new safety or effectiveness concerns. Bone void fillers are widely used in spinal fusion procedures and have been demonstrated to be safe and effective promoting bone growth and fusion."
Therefore, the "performance" demonstrated for this specific submission is that the device, when used with bone void fillers, maintains its established safety and effectiveness profile, relying on the prior clearance of the device itself and the known safety/effectiveness of bone void fillers.
2. Sample size used for the test set and the data provenance
- Not Applicable: This is a physical implant device seeking expanded indications based on substantial equivalence, not an AI/software device requiring a clinical test set from patient data. The "test set" would have referred to mechanical testing and material characterization, which are not detailed here beyond stating the device is made from Ti-6Al-4V ELI in accordance with ASTM F3001.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: No "ground truth" in the AI/ML sense (e.g., labeling of medical images) is established for an implant device. Clinical efficacy is ultimately determined by fusion rates and patient outcomes in clinical trials, but this 510(k) relies on substantial equivalence and previous data.
4. Adjudication method for the test set
- Not Applicable: No diagnostic interpretations requiring adjudication are involved.
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 refers to AI-assisted diagnostic studies, which are not relevant to this physical interbody fusion device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This refers to the performance of an AI algorithm, not relevant to this physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable in the AI/ML sense. For a physical implant, "ground truth" relates to successful fusion (bone growth) and clinical outcomes (pain reduction, functional improvement). This is typically established through radiographic evidence (CT scans, X-rays to confirm fusion), clinical examinations, and patient-reported outcomes from clinical studies, often comparing to a control or predicate. However, in this specific 510(k), the "ground truth" for the expanded use with bone void fillers is the established safety and effectiveness of bone void fillers themselves, and the prior data supporting the device's original clearance.
8. The sample size for the training set
- Not Applicable: No AI/ML training set is involved.
9. How the ground truth for the training set was established
- Not Applicable: No AI/ML training set is involved.
Summary for this specific 510(k) (K250669):
The submission is for an expanded indication for use of an already cleared spinal interbody fusion device (Adaptix™ Interbody System). The "acceptance criteria" and "study" are implicitly tied to demonstrating that the addition of bone void fillers as a graft option does not compromise the device's established safety and effectiveness.
The "study" that proves the device meets the "acceptance criteria" for this specific submission is a demonstration of substantial equivalence by:
- Asserting that no new or modified implants are introduced.
- Confirming the overall design and dimensions are consistent with predicate devices.
- Citing the widespread use and established safety/effectiveness of bone void fillers in spinal fusion.
- Pointing out that the language for bone void fillers mirrors that of other cleared predicate devices.
This 510(k) is a regulatory update based on existing knowledge and established practices, rather than the presentation of novel clinical study data for a new device or an AI algorithm.
§ 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.