(278 days)
When used as a cervical intervertebral body fusion device, the Zavation IBF implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.
The Zavation IBF implants offers a variety of heights, widths and lengths. There are six main configurations: ALIF, LLIF, TLIF, T-PLIF and CIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade PEEK (Polyetheretherketone).
The Zavation IBF implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the implants as an option to help allow for radiographic visualization. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. This modification seeks clearance for the addition of PEEK devices coated with a plasma-spray Titanium coating. The Titanium coated implants will be provided non-sterile.
The provided text is a 510(k) summary for the Zavation IBF System, which is an intervertebral body fusion device.
Crucially, this document is a premarket notification for a medical device (an implant) and not for an AI/ML-based medical device. Therefore, the information requested in the prompt, such as acceptance criteria for AI model performance, sample sizes for test sets, ground truth establishment, MRMC studies, and training set details, is not applicable to this document.
The "Performance Data" section in the document refers to mechanical and material testing of the implant itself, specifically related to the addition of a titanium coating, and not to the performance of an AI algorithm.
To answer your request, if this were an AI device, here's what would be expected based on the prompt's structure:
Based on the provided document, it is not possible to answer the detailed questions regarding acceptance criteria for an AI/ML-based medical device, as this 510(k) pertains to a physical intervertebral body fusion implant, not an AI algorithm.
The "Performance Data" section in the document refers to the mechanical and material performance testing of the implant and its coating, not the performance of an AI algorithm.
If this document were for an AI/ML medical device, the information would typically include:
1. Table of Acceptance Criteria and Reported Device Performance:
This would typically list metrics like sensitivity, specificity, AUC, recall, precision, F1-score, etc., along with the pre-defined target values (acceptance criteria) and the actual achieved performance of the AI model. Since this is a physical device, these metrics are irrelevant.
2. Sample Size and Data Provenance:
For an AI device, this would detail the number of cases (e.g., images, patient records) in the test set, their country of origin, and whether the data was collected retrospectively or prospectively. The current document makes no mention of AI test data.
3. Number of Experts and Qualifications for Ground Truth:
For an AI device, this would specify how many experts (e.g., board-certified radiologists, pathologists) annotated the test data to establish the "ground truth" (the correct diagnosis or finding). It would also detail their experience level. This is not applicable to a physical implant.
4. Adjudication Method for the Test Set:
This would describe how disagreements among experts were resolved (e.g., 2+1 means two experts agree, or a third expert adjudicates if they disagree). This is for AI model validation, not implant testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
If performed for an AI device, this would assess if human performance (e.g., radiologists' accuracy) improved when assisted by the AI compared to working without it. The effect size would quantify this improvement. Not applicable here.
6. Standalone (Algorithm Only) Performance:
This would describe the performance of the AI algorithm operating independently without human intervention. Not applicable here.
7. Type of Ground Truth Used:
For an AI device, this would specify how the "truth" was determined for the test cases (e.g., consensus of multiple experts, pathological confirmation, long-term patient outcomes). For a physical implant, ground truth relates to mechanical properties validated by ASTM standards.
8. Sample Size for the Training Set:
For an AI device, this is the number of data points used to train the algorithm. This is not mentioned as no AI is involved.
9. How Ground Truth for the Training Set was Established:
For an AI device, this would explain the process for labeling the data used to train the model, often involving similar expert annotation or established medical records. This is not applicable to this physical device.
What the document does describe under "Performance Data" (relevant to the physical implant):
The performance data listed relates to biocompatibility and mechanical testing of the Zavation IBF System implants, particularly concerning the addition of a titanium coating. This includes:
- ASTM F2077, Test Methods for Intervertebral Body Fusion Devices:
- Static Axial Compression
- Dynamic Axial Compression
- Static Torsion (cervical)
- Dynamic Torsion (cervical)
- Coating properties evaluated using:
- ASTM F1147 (Tensile Bond Strength)
- ASTM F1044 (Shear Fatigue Strength)
- ASTM F1160 (Static Shear Strength)
- ASTM F1854 (Abrasion Test)
- ASTM F1978 (Metallurgical Testing and Image Analysis)
The document states that "no additional testing was performed for the purpose of this submission" because the new titanium coating's specifications were identical to an already cleared predicate device (K150061 Lucent Ti-Bond®), and the original Zavation IBF System (K181246) had already undergone the listed ASTM tests. This implies that the acceptance criteria for this modification were met by demonstrating equivalence to previously cleared devices through adherence to established ASTM standards for intervertebral body fusion devices and their coatings.
§ 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.