(105 days)
When used as a lumbar intervertebral fusion device, TrellOss™-L MPF is indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, TrellOss™-L MPF can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. TrellOss™-L MPF is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.
TrellOss™-L MPF interbody implants with 14° lordosis or greater are only indicated for lumbar levels L2-L5 and are to be used with at least a 1-hole Timberline® MPF plate and screw construct.
TrellOss™-L MPF is a 3D printed, lateral interbody fusion device. The inferior/superior aspects of the TrellOss™-L MPF interbody incorporates two large vertical cavities which can be packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft material. Each interbody comprises an external structural frame having a roughened surface (~7µm). The intervening geometric lattices have pores 300-700μm.
The TrellOss™-L MPF interbody can be used in conjunction with the Timberline® MPF plates and screws. The plate implants are offered having 1-, 2-, 3- or 4-holes to accommodate the vertebral screws. Cover plates secure the construct.
TrellOss™-L MPF interbody implants are provided sterile while the Timberline® MPF plate and screw implants are provided non-sterile. All devices are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient.
The provided text describes the TrellOss™-L MPF, a 3D printed, lateral interbody fusion device. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of a diagnostic AI product.
Instead, the document is a 510(k) summary for the FDA, focusing on establishing substantial equivalence for a medical device (an intervertebral body fusion device) to predicate devices already on the market. The performance data mentioned relates to mechanical testing of the device, not clinical or diagnostic performance evaluated against acceptance criteria in the way an AI algorithm would be.
Here's why the requested information cannot be extracted from this document based on the standard context of AI/ML software performance:
- Acceptance Criteria & Device Performance (Table): The document does not define acceptance criteria in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC) or precision. The "performance data" refers to mechanical tests like static and dynamic compression shear testing for structural integrity.
- Sample Size (Test Set) & Data Provenance: Not applicable in the context of diagnostic AI. The "test set" here refers to physical devices undergoing mechanical tests, not clinical data for an algorithm.
- Number of Experts & Qualifications (Ground Truth): Not applicable. Ground truth for an AI algorithm requires expert annotation of clinical data. For this device, the "ground truth" is defined by engineering standards (e.g., ASTM F2077) for mechanical properties.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study compares human readers with and without AI assistance, which is not relevant to a physical interbody fusion device.
- Standalone Performance: While the mechanical tests can be seen as "standalone" for the device's physical properties, this is not equivalent to standalone performance of a diagnostic AI algorithm.
- Type of Ground Truth: The ground truth used is engineering standards (ASTM F2077) for mechanical performance, not expert consensus, pathology, or outcomes data typically associated with diagnostic algorithms.
- Sample Size (Training Set): Not applicable, as this is not an AI/ML algorithm that requires training data.
- How Ground Truth for Training Set Was Established: Not applicable.
Summary based on the provided text:
The "performance data" section in the document states:
- Study Performed: The modified TrellOss™-L MPF interbody was evaluated via dimensional analyses with confirmatory static compression and dynamic compression shear testing per ASTM F2077.
- Goal of Study: To demonstrate the performance of the modified TrellOss™-L MPF is substantially equivalent to the predicate (NEXXT MATRIXX® System (Nexxt Spine, LLC – K171140)).
- Acceptance Criteria (Implicit): Meeting the requirements and performance limits defined by the ASTM F2077 standard and demonstrating comparable performance to the predicate device in these mechanical tests.
- Reported Device Performance: The results demonstrated that the device's performance is substantially equivalent to the predicate. Specific numerical values for the tests are not provided in this summary document.
- Ground Truth: ASTM F2077 standard for intervertebral body fusion device mechanical testing.
Conclusion:
This document is a regulatory submission for a physical medical device (intervertebral body fusion device), not a diagnostic AI/ML product. Therefore, the requested information regarding acceptance criteria, ground truth, sample sizes, and study types related to AI/ML performance is not present in the provided text. The "study" described is a series of mechanical tests to ensure material and structural integrity against established engineering standards and comparison to a predicate device.
§ 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.