(78 days)
The CONDUIT™ Cervical Cages with a microscopic roughened surface and micro and nano-scale features are intervertebral body fusion devices intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The CONDUIT™ Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. CONDUIT™ Cervical Cages are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.
The CONDUIT™ ALIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
The CONDUIT™ TLIF Cages with a microscopic roughened surface and micro and nanoscale features in combination with supplemental fixation are indicated for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
The CONDUIT™ LLIF Cages with a microscopic roughened surface and micro and nano- scale features is indicated for intervertebral body fusion procedures 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. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. CONDUIT™ LLIF Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The CONDUIT™ T/PLIF Cages with a microscopic roughened surface and micro and nanoscale features in combination with supplemental fixation are indicated for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
FIBERGRAFT™ BG Putty - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT BG Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT BG Putty must be used with autograft in the posterolateral spine. When used in intervertebral body fusion procedures, FIBERGRAFT BG Putty must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler. FIBERGRAFT BG Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
FIBERGRAFTIM BG Putty GPS - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT BG Putty GPS is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT BG Putty GPS must be used with autograft in the posterolateral spine. When used in intervertebral body fusion procedures, FIBERGRAFT BG Putty GPS must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler. FIBERGRAFT BG Putty GPS is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be obtain rigid stabilization.
The GPS Cannula is intended for use only with FIBERGRAFT™ BG Putty GPS and no other products.
The CONDUIT™ Technology platform is a comprehensive portfolio of 3D-printed porous titanium interbody devices intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1). Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Lateral (LLIF), Anterior (ALIF) and Transforaminal/Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes, footprints, heights and angles. The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system). The CONDUIT™ Cages are made from Ti-6A1-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous, or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion. The 3D Printed CONDUIT™ Cages have a microscopic roughened surface with micro and nanoscale features. The micro and nano features are on all surfaces of the cage, including the superior, inferior, and peripheral surfaces, as well as each member of the internal cell structure. The FIBERGRAFT™ BG Putty is an osteoconductive, resorbable, biocompatible bone graft substitute to be gently packed into defect sites and to be used as non-structural scaffolds. The FIBERGRAFT™ BG putty is made from 45S5 bioactive glass, where the bioactive glass components are mixed with an absorbable/polymeric carrier to form a cohesive material.
The provided text does not contain typical acceptance criteria and device performance metrics, as it is a 510(k) summary for medical devices (intervertebral body fusion devices and bone graft substitutes). These summaries typically demonstrate substantial equivalence to predicate devices rather than proving specific performance against defined acceptance criteria in the same way a diagnostic AI/ML device would.
However, I can extract information related to the clinical data used to support the expanded indications, which functions as the nearest equivalent to "device performance" in this context.
Here's an analysis of the provided text, structured to address your questions. Please note that several of your requested fields (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not explicitly detailed in this type of regulatory document for these specific medical devices.
1. Table of Acceptance Criteria and Reported Device Performance
As noted, this document does not present quantitative "acceptance criteria" and "reported device performance" in the typical sense for an AI/ML diagnostic device with discrete metrics like sensitivity, specificity, or AUC. Instead, the "performance" is demonstrated through clinical data showing fusion rates and adverse event rates to support the safety and effectiveness of the device for its expanded indications. The "acceptance criteria" in this context are implicitly met if the clinical data demonstrates reasonable safety and effectiveness comparable to predicate devices for the expanded use.
| Acceptance Criteria (Implicit) | Reported Device Performance (from Clinical Data) |
|---|---|
| Demonstrated performance in intervertebral body fusion, specifically with CONDUIT™ Cages used with FIBERGRAFT™ BG Putty, for expanded indications. | Fusion rates and adverse event rates are reported. The results of the data support the performance of the subject devices in intervertebral body fusion based on these rates. (Specific numerical rates are not provided in this 510(k) summary). |
| Safety of the expanded use. | Adverse event rates are considered within acceptable limits, supporting the safety of the devices. (Specific numerical rates are not provided in this 510(k) summary). |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): 178 subjects. (This is the total number of subjects in the clinical data used to support the expanded indications.)
- Data Provenance:
- Country of Origin: United States (specifically, multiple sites across CA, TX, FL).
- Retrospective or Prospective: The text mentions "a retrospective study and two investigator-initiated studies." This indicates a mix of retrospective and potentially prospective (investigator-initiated studies often have a prospective component, though not exclusively de novo prospective trials for this type of submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For intervertebral fusion devices, "ground truth" would typically relate to clinical outcomes assessed by treating physicians (e.g., fusion status determined radiographically and clinically by surgeons/radiologists) rather than consensus among independent experts for a diagnostic algorithm.
4. Adjudication method for the test set
This information is not provided in the document.
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
This is not applicable. The devices (intervertebral fusion cages and bone graft putty) are physical implants, not AI/ML diagnostic software that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The devices are physical implants, not an algorithm.
7. The type of ground truth used
The "ground truth" is implicitly clinical outcomes data, including:
- Fusion status: Assessed radiographically and clinically (though details of how this assessment was performed for the studies are not provided).
- Adverse events: Clinical documentation of complications.
8. The sample size for the training set
This is not applicable. The clinical data mentioned is for demonstrating the performance of the physical device for expanded indications, not for training a machine learning model.
9. How the ground truth for the training set was established
This is not applicable.
§ 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.