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510(k) Data Aggregation
(98 days)
SpineUp, Inc.
The Frida™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine in skeletally mature patients, serving as an adjunct to fusion of the cervical spine (C2 - T1). The system is intended for the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: 1) degenerative disc disease (as defined as neck pain of discogenic origin and confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) spinal stenosis, 4) trauma, 5) failed previous fusions, 6) tumors, 7) curvature deformities (kyphosis, lordosis, or scoliosis), and/or 8) pseudoarthrosis.
The Frida™ Anterior Cervical Plate System is an anterior cervical plating system that consists of single-use plates and screws, along with manual instruments for implant insertion. The plates are manufactured from titanium (Ti-6Al-4V ELI) per ASTM F136 and come in a variety of lengths to accommodate individual pathology and anatomical conditions of the patient. Plates incorporate a graft window for intraoperative visualization. Screws are manufactured from titanium (Ti-6Al-4V ELI) per ASTM F136 and are available in self-tapping and self-drilling options. Screws are available in a fixed or variable configuration, with a range of sizes to accommodate individual pathology. Plates and screws are available in single-use sterile packaging.
The provided FDA 510(k) clearance letter for the Frida™ Anterior Cervical Plate System does not contain the detailed information typically found in an AI/Software as a Medical Device (SaMD) submission regarding acceptance criteria and study results.
This document is for a traditional medical device (a mechanical implant), not a software-based device. Therefore, the "acceptance criteria" and "study proving the device meets the acceptance criteria" are related to mechanical performance and biocompatibility, not algorithmic performance or clinical effectiveness in a human-computer interaction context.
Here's how to interpret the available information based on your request, and what information is missing due to the nature of this particular device:
Device Type: This is a physical, implantable medical device (Anterior Cervical Plate System), not an AI/SaMD. The "studies" described are primarily mechanical performance tests.
Acceptance Criteria & Device Performance (as much as can be inferred for a mechanical device):
| Acceptance Criteria (Inferred from common orthopedic implant testing) | Reported Device Performance (from the 510(k) Summary) |
|---|---|
| Mechanical Strength (Static Compression): Ability to withstand axial loads without permanent deformation or failure under static conditions. | "The results of mechanical testing showed that the worst-case constructs were substantially equivalent to legally marketed devices." (Implies meeting or exceeding the performance of predicate devices). |
| Mechanical Strength (Dynamic Compression): Ability to withstand repetitive axial loads (fatigue life) without failure or excessive degradation. | "The results of mechanical testing showed that the worst-case constructs were substantially equivalent to legally marketed devices." (Implies meeting or exceeding the performance of predicate devices). |
| Mechanical Strength (Static Torsion): Ability to withstand twisting forces without permanent deformation or failure. | "The results of mechanical testing showed that the worst-case constructs were substantially equivalent to legally marketed devices." (Implies meeting or exceeding the performance of predicate devices). |
| Material Biocompatibility: Materials are safe for implantation in the human body (e.g., non-toxic, non-allergenic, non-carcinogenic). | "Plates are manufactured from titanium (Ti-6Al-4V ELI) per ASTM F136... Screws are manufactured from titanium (Ti-6Al-4V ELI) per ASTM F136." (ASTM F136 is a standard for implantable titanium, inherently implying biocompatibility for this grade). |
| Sterility: Device must be sterile for implantation. | "Plates and screws are available in single-use sterile packaging." |
Missing Information (Crucial for an AI/SaMD, but not applicable/provided for this physical device):
The following points are specifically geared towards AI/SaMD and are not found in the provided document because it pertains to a physical, mechanical medical device:
- Sample size used for the test set and data provenance: Not applicable. The "test set" here refers to physical samples of the device undergoing mechanical testing, not a dataset of patient information.
- Number of experts used to establish ground truth: Not applicable. Ground truth for a spinal plate is its mechanical performance and material properties.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is for evaluating AI-assisted human performance, not relevant for a physical implant.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI/SaMD sense. The ground truth here is the objective measurement of mechanical properties compared to established standards and predicate devices.
- Sample size for the training set: Not applicable. This device does not have a "training set" in the machine learning sense. Its design and manufacturing are based on engineering principles and material science.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria (based on the provided text):
- Study Type: Non-clinical mechanical performance testing.
- Tests Performed:
- Static compression testing
- Dynamic compression testing
- Static torsion testing
- Standards Used: ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model)
- Comparison Basis: The device's performance was compared to "legally marketed predicate devices."
- Conclusion: The tests demonstrated that the "worst-case constructs were substantially equivalent to legally marketed devices." This implies that the Frida™ Anterior Cervical Plate System's mechanical characteristics, such as strength and durability, are comparable to or better than existing devices on the market, thereby demonstrating its safety and effectiveness for its intended use.
In essence, while the prompt asks for information typically found in AI/SaMD submissions, the provided document details the regulatory clearance for a traditional orthopedic implant, focusing on mechanical and material equivalence rather than data-driven algorithmic performance.
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(165 days)
SpineUp Inc.
The Romero Cervical Cage consists of an interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one or two contiguous levels from the C2 to the T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Romero Cervical Cage includes cages with and without screw holes. For cages with internal screw holes, the provided screws must be used for internal fixation. The Romero Cervical Cage requires additional supplemental fixation cleared for the cervical spine. The Romero Cervical Cage is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK HA or PEEK OPTIMA interbody cage with tantalum radiographic markers and two Titanium (Ti-6Al-4V ELI) fixation screws for cages with screw holes. The PEEK material used conforms to ASTM F2026, the Titanium screws conforms to ASTM F136 and the Tantalum radiographic markers conforms to ASTM F560. The interbody cage is provided in 6° lordosis, anatomic (domed), and lordotic (tapered) profiles in footprints ranging from (WxD) 14x12 to 20x16 (by increments of 2 mm in either direction) and sizes ranging from 5.5 mm (H04) to 14.5 mm (H13) (excluding H04 and H05 in the (WxD) 14x12 to 14x16 footprint for the self-anchored cages). The two radiographic markers are present on the posterior wall to confirm position and orientation relative to the AP plane. The bone screws are provided as self-drilling and self-tapping options in 3.5 mm and 4.0 mm diameters and 8-20 mm lengths and feature an anti-backout / tri-lobe screw head design. Both cages and screws are available in separate, single-use sterile packaging.
The provided text is an FDA 510(k) summary for the Romero Cervical Cage, an intervertebral body fusion device. It does not describe a study involving an AI/Machine Learning (AI/ML) device, nor does it contain information about "device performance," "acceptance criteria," "sample sizes for test or training sets," "expert ground truth," "adjudication methods," or "MRMC studies."
The document focuses on demonstrating substantial equivalence of a physical medical device (a cervical cage) to predicate devices through mechanical performance testing. The "Performance Testing" section states: "Mechanical testing was performed to demonstrate substantial equivalence using static compression, static compression shear, static torsion, dynamic compression, dynamic compression shear, and dynamic torsion testing per ASTM F2077-18. Subsidence testing per ASTM F2267-04, expulsion and axial push out testing. The result showed that the worst-case constructs were substantially equivalent to legally marketed devices. No clinical or animal studies were performed."
Therefore, I cannot fulfill your request for information related to AI/ML device acceptance criteria and study details based on the provided text. The device in question is a physical implant, not an AI/ML algorithm.
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