(192 days)
The Lateral Spine Truss System (STS) is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation and must be used with autograft bone. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The device is available in a variety of sizes to accommodate the patient's anatomy. The implant is made from Ti6Al4V alloy (ASTM F-1108).
This document refers to a 510(k) premarket notification for a medical device called the "LATERAL Spine Truss System." It is a regulatory submission, not a study report, and therefore does not contain details about specific acceptance criteria or a study that "proves" the device meets acceptance criteria in the way a clinical trial or performance study would.
Instead, the document details the regulatory process by which the device was found substantially equivalent to existing devices. Substantial equivalence in the FDA 510(k) pathway means proving that a new device is as safe and effective as a legally marketed predicate device. This is often demonstrated through comparative analysis of technological characteristics, materials, indications for use, and sometimes non-clinical performance testing.
Here's an attempt to answer your questions based on the provided text, while also highlighting what information isn't present:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria in the typical sense (e.g., target accuracy, sensitivity, specificity values) for a diagnostic AI device, nor does it present "reported device performance" in terms of clinical outcomes or diagnostic metrics. This is a spinal implant, and the "performance" discussed is in terms of mechanical testing and equivalence to predicates.
Here's what can be inferred for mechanical testing:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical performance comparable to predicate devices under various loading scenarios (compression, combined compression and shear). | "Validated FEA... was conducted to evaluate the mechanical performance of the devices under different loading scenarios, including pure compression and combined compression and shear." |
| Subsidence performance meeting ASTM F2267-04. | "Other mechanical tests included subsidence per ASTM F2267-04." |
| Expulsion performance meeting industry accepted methodology. | "and expulsion testing per an industry accepted methodology." |
| Overall safety and effectiveness comparable to predicate devices. | "These comparisons demonstrate substantial equivalence to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes mechanical testing, not a clinical study involving a "test set" of patient data in the context of AI. The "test set" would typically refer to a dataset used to evaluate an AI model's performance on unseen data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. This document is for a spinal implant, and the assessment of its substantial equivalence relies on mechanical testing and comparison to predicate devices, not on expert ground truth labeling of medical images or diagnostic classification.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. This concept is relevant for studies involving human readers or AI in diagnostic tasks, where disagreements in labels or interpretations might need an adjudication process. It does not apply to the mechanical testing described.
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
This information is not provided. MRMC studies are used to evaluate diagnostic systems, especially AI-assisted ones, and compare them against human performance. This document is for a physical orthopedic implant and does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The device is a physical implant, not an algorithm. Therefore, "standalone" algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" implicitly refers to established engineering standards and measurements (e.g., ASTM F2267-04) and the performance characteristics of the predicate devices. The goal is to show the new device performs equivalently or acceptably according to these engineering benchmarks, rather than clinical ground truth like pathology or outcomes data in the context of an AI study.
8. The sample size for the training set
This information is not provided. The concept of a "training set" applies to machine learning algorithms. This document is for a physical medical device.
9. How the ground truth for the training set was established
This information is not provided as it's not applicable. There is no "training set" in the context of this regulatory submission for an orthopedic implant.
§ 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.