(89 days)
The ProAM ACDF System is a standalone intervertebral body fusion system intended for spinal fusion procedures of the cervical (C2-T1) spine in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (radiographs, CT, MRI).
The ProAM ACDF System is intended to be used at multiple contiguous levels of the cervical spine (C2-T1). The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.
The ProAM ACDF System is intended for use on patients who have had at least six weeks of nonoperative treatment. It is intended to be used with autogenous and/or allogeneic bone graft comprised of cortical, cancellous, and/or corticocancellous bone graft.
The ProAM™ ACDF System is an intervertebral body fusion system that consists of an intervertebral body fusion device manufactured from titanium alloy (Ti-6Al-4V conforming to ASTM F3001) and screws manufactured from titanium alloy (Ti-6Al-4V conforming to ASTM F136).
The intervertebral body fusion device has a cross-sectional shape that is trapezoidal, and the device is otherwise box-shaped in stature with cavities for containment of bone graft material. The device is available in sizes that vary in footprint size, height, and lordotic angle. It is meant for direct anterior insertion and has 2 holes through which screws are placed to affix to bone. All devices have an open, porous architecture throughout and a pyramidal textured porous surface at the endplate contacting surfaces that helps prevent device migration.
The screws are available in various diameters and lengths. Screws engage the vertebral bodies by passing through the intervertebral body fusion device and into bone. They are turned to fixate to the bone.
The provided text describes a 510(k) premarket notification for a medical device called the ProAM ACDF System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance data related to mechanical testing for orthopedic implants.
The document does NOT contain information related to software, human-in-the-loop performance, or AI assistance. Therefore, it is not possible to answer questions 2, 3, 4, 5, 8, and 9 as they pertain to such studies.
Here's an analysis of the available information:
1. Table of acceptance criteria and the reported device performance:
The document broadly states that "The mechanical testing demonstrated that the device performs as well or better than the predicates." However, it does not provide specific numerical acceptance criteria or the reported performance values. The tests performed are listed as:
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Static and dynamic compression testing per ASTM F2077 | Performed as well or better than the predicates. |
| Static and dynamic compression-shear testing per ASTM F2077 | Performed as well or better than the predicates. |
| Static and dynamic torsion testing per ASTM F2077 | Performed as well or better than the predicates. |
| Subsidence testing per ASTM F2267 | Performed as well or better than the predicates. |
| Expulsion | Performed as well or better than the predicates. |
2. Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document mentions "mechanical testing" but does not provide details on the number of samples used for each test.
- Data Provenance: The data is generated from in vitro mechanical testing of the device itself. The country of origin for the data is not explicitly stated, but the company is based in Carlsbad, CA, suggesting the testing was likely conducted in the US or by a US-affiliated lab. The testing is for prospective device performance evaluation based on design and manufacturing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This question typically refers to studies involving human interpretation (e.g., image analysis by radiologists). The described study is mechanical testing of a physical implant, where ground truth is established by engineering standards (ASTM F2077, ASTM F2267) and test results.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. See reasoning for question 3. Adjudication methods are typically used for subjectively assessed data, not objective mechanical tests.
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 study is a 510(k) submission for a physical intervertebral body fusion device and does not involve AI assistance or human reader studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This submission is for a physical medical device, not a software algorithm.
7. The type of ground truth used:
The ground truth for this device's performance is established by engineering standards and specifications (ASTM F2077, ASTM F2267). The device's performance is compared against these established standards and against the performance of predicate devices as a benchmark for substantial equivalence.
8. The sample size for the training set:
Not applicable. Training set refers to data used for machine learning models. This is mechanical testing of a physical device.
9. How the ground truth for the training set was established:
Not applicable. Refer to reasoning for question 8.
§ 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.