(76 days)
The MIDLINETM 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™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
The MIDLINE™ system must be used with bone grafting material (autograft only).
Here's an analysis of the provided text regarding the MIDLIN E™ device, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on the device's mechanical performance relative to predicate devices, rather than clinical efficacy. Therefore, the "acceptance criteria" are based on established mechanical testing standards for intervertebral body fusion devices.
| Acceptance Criteria (Mechanical Testing Standards) | Reported Device Performance |
|---|---|
| ASTM F2077-11: | MIDLINE™ was shown to be as mechanically sound as predicate devices. The following tests were performed: |
| - Static Compression | - Successfully tested |
| - Dynamic Compression | - Successfully tested |
| - Static Compression-Shear | - Successfully tested |
| - Dynamic Compression-Shear | - Successfully tested |
| - Static Torsion | - Successfully tested |
| - Dynamic Torsion | - Successfully tested |
| ASTM F2267-04(2011): | |
| - Subsidence | - Successfully tested |
| - Expulsion | - Successfully tested |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices) used for each mechanical test. Mechanical tests typically use a small, representative sample of devices.
The data provenance is from laboratory mechanical testing conducted by the manufacturer, Centinel Spine, Inc. It is not patient or clinical data, so terms like "country of origin" or "retrospective/prospective" don't directly apply in the clinical sense. These are engineering/material science tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable in the context of this submission. The "ground truth" for mechanical performance tests is established by adherence to the specified ASTM standards and the measurements obtained from the testing equipment, not by human expert consensus or clinical assessment of a test set.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or subjective assessment. For mechanical testing, the results are objectively measured against predefined criteria in the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission pertains to a 510(k) for a medical device (intervertebral body fusion device), which typically relies on mechanical and material equivalence to predicate devices, not clinical efficacy studies involving human readers and AI. The document does not mention any AI component or human-in-the-loop performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance study was not done. This refers to mechanical testing of a physical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this submission is the established mechanical performance characteristics required by the ASTM standards (F2077-11 and F2267-04(2011)) for intervertebral body fusion devices. The device's performance was compared to these standards and to the performance of predicate devices.
8. The Sample Size for the Training Set
This question is not applicable. "Training set" refers to data used to train an algorithm, typically in the context of AI or machine learning. This submission is for a physical medical device and its mechanical equivalence, not an algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" in the context of this device's submission.
Summary of the Study:
The study described is a series of bench-top mechanical performance tests comparing the MIDLINE™ device to its predicate devices and against recognized industry standards (ASTM F2077-11 and ASTM F2267-04(2011)). The goal was to demonstrate substantial equivalence in mechanical characteristics. The tests covered various loading conditions relevant to an intervertebral body fusion device, including compression, compression-shear, torsion, subsidence, and expulsion. The conclusion was that the MIDLINE™ device is "as mechanically sound as predicate devices," thereby supporting its substantial equivalence claim for 510(k) clearance.
§ 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.