(113 days)
The MIDLINE II™ / MIDLINE II -Ti™ is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I 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. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.
The MIDLINE II™ / MIDLINE II -Ti™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
The MIDLINE II™ / MIDLINE II -Ti™ system must be used with bone grafting material (autograft only).
The MIDLINE II™ / MIDLINE II-Ti™ is a radiolucent intervertebral body fusion device manufactured from either PEEK-OPTIMA® LT1 supplied by Invibio or Zeniva ZA PEEK supplied by Solvay per ASTM F2026 with three metallic X-ray markers manufactured from unalloyed Tantalum (ASTM F560) and plasma sprayed with optional commercially pure titanium (CPT) per ASTM F1580. The device is secured with titanium (Ti-6A1-4V per ASTM F136) unicortical cancellous bone screws provided and is intended to be used without supplemental fixation. The purpose of this 510(k) is to modify the MIDLINE™ (K133286) to include a titanium coating (ASTM F1580-12) and an additional lordotic option.
The MIDLINE II™ / MIDLINE II-Ti™ is provided in 11-21mm heights, 30-42mm widths, 24-30.2mm lengths, and lordotic angles ranging from 8°-20°. The devices are provided sterile.
The provided text describes a medical device, the MIDLINE II™ / MIDLINE II-Ti™, and its substantial equivalence to predicate devices, rather than an AI/ML powered device. As such, the request for acceptance criteria and a study proving an AI device's performance cannot be fully addressed in the format requested.
However, I can extract information regarding the device's mechanical performance acceptance criteria and the study (testing) that demonstrates it meets these criteria, as detailed in the "Substantial Equivalence" section.
Here's the relevant information paraphrased to fit the spirit of the request, focusing on the device's mechanical performance rather than AI performance.
Acceptance Criteria and Study for MIDLINE II™ / MIDLINE II-Ti™ (Mechanical Performance)
Since the document describes a traditional medical implant (intervertebral body fusion device) and not an AI/ML powered device, the typical AI-specific metrics like AUC, sensitivity, specificity, and MRMC studies are not applicable. Instead, the acceptance criteria and study focus on mechanical integrity and performance of the implant.
1. Table of Acceptance Criteria and Reported Device Performance (Mechanical)
| Acceptance Criteria Category | Specific Test | Acceptance Standard | Reported Device Performance |
|---|---|---|---|
| Mechanical Strength | Static Compression | Meets predicate device performance (K133286, K101301) | Performance indicates mechanical soundness, met acceptance criteria. |
| Static Compression-Shear | Meets predicate device performance (K133286, K101301) | Performance indicates mechanical soundness, met acceptance criteria. | |
| Dynamic Compression | Meets predicate device performance (K133286, K101301) | Performance indicates mechanical soundness, met acceptance criteria. | |
| Dynamic Torsion | Meets predicate device performance (K133286, K101301) | Performance indicates mechanical soundness, met acceptance criteria. | |
| Dynamic Compression-Shear | Meets predicate device performance (K133286, K101301) | Performance indicates mechanical soundness, met acceptance criteria. | |
| Expulsion | Meets predicate device performance (K133286, K101301) | Performance indicates mechanical soundness, met acceptance criteria. | |
| Subsidence | Meets predicate device performance (K133286, K101301) | Performance indicates mechanical soundness, met acceptance criteria. | |
| Coating Integrity | Static Tensile Bonding (for Ti coating) | Validation performed against relevant standards | Testing performed, criteria met. |
| Shear Bonding (for Ti coating) | Validation performed against relevant standards | Testing performed, criteria met. | |
| Taber Abrasion Testing (for Ti coating) | Validation performed against relevant standards | Testing performed, criteria met. |
Note: The document explicitly states that the "results demonstrate that the acceptance criteria defined by predicate device performance were met." The specific numerical thresholds for "predicate device performance" are not provided in this summary but would typically be detailed in a full test report.
2. Sample Size and Data Provenance for Test Set
- Sample Size: Not explicitly stated in the provided text. For mechanical testing of medical devices, sample sizes are typically determined by relevant ASTM standards (e.g., ASTM F2077-11 and F2267-04 mentioned).
- Data Provenance: The data is generated from mechanical testing of the physical device samples, likely performed in a laboratory setting. This is not patient-derived data for AI.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable for mechanical testing. Ground truth for device mechanical performance is established by objective physical measurements and adherence to engineering standards and safety margins, not by expert human consensus.
4. Adjudication Method for Test Set
- Not applicable for mechanical testing. Test results are objective measurements (e.g., force, displacement, cycles to failure) compared against predefined engineering thresholds and predicate device performance, not subject to human adjudication in the context of diagnostic interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This study type is relevant for AI-assisted diagnostic tools involving human readers interpreting medical images. The MIDLINE II™ / MIDLINE II-Ti™ is a physical surgical implant.
6. Standalone Performance (Algorithm Only)
- Not applicable. This term relates to the performance of an AI algorithm without human intervention. The device in question is a physical implant.
7. Type of Ground Truth Used
- Engineering Standards and Predicate Device Performance: The "ground truth" (or acceptance standard) for this device's mechanical performance is defined by compliance with established ASTM standards (F2077-11, F2267-04) and the performance characteristics of previously cleared, substantially equivalent predicate devices (K133286, K101301). This involves objective physical measurements and engineering analyses.
8. Sample Size for Training Set
- Not applicable. This device does not involve an AI algorithm with a training set.
9. How Ground Truth for Training Set Was Established
- Not applicable. This device does not involve an AI algorithm with a training set.
§ 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.