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510(k) Data Aggregation
(131 days)
The Cervical Spine Truss System – Stand Alone (CSTS-SA) Interbody Fusion Device is a standalone interbody fusion device indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels and is to be used with two titanium alloy screws which accompany the device. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. CSTS-SA Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment with the devices.
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes to accommodate the patient's anatomy. Screws are inserted through the anterior portion of the implant into adjacent vertebral bodies for bony fixation.
The provided text is a 510(k) summary from the FDA for a medical device called the Cervical Spinal Truss System-Stand Alone (CSTS-SA). It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study to prove performance against specific acceptance criteria for an AI/software device.
Therefore, many of the requested categories for AI/software device studies are not applicable or cannot be extracted from this document, as this is a hardware device submission.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in the typical sense for an AI/software device (e.g., sensitivity, specificity, AUC thresholds). Instead, it refers to performance standards for a physical medical implant.
| Acceptance Criteria (Performance Standards) | Reported Device Performance (Compliance) |
|---|---|
| ASTM F2077 (Static and dynamic axial compression, static and dynamic compression shear, static and dynamic torsion) | Testing completed per standard |
| ASTM F2267-04 (Subsidence Testing) | Testing completed per standard |
| Expulsion testing | Testing completed per accepted industry standard |
| MR Conditional testing (from predicate K173159): | |
| ASTM F2119 (MR Image Artifact) | Testing completed per standard |
| ASTM F2052 (MR Induced Displacement Force) | Testing completed per standard |
| ASTM F2213 (MR Induced Torque) | Testing completed per standard |
| ASTM F2182 (RF-induced Heating) | Testing completed per standard |
2. Sample size used for the test set and the data provenance
Not applicable for this type of device and submission. The "test set" would refer to the physical devices tested according to the ASTM standards. The document doesn't provide details on the number of devices or units tested for each standard. Data provenance is not relevant in the context of device mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in this context, would be the physical properties and structural integrity of the device, established through standardized engineering tests, not expert human review of data.
4. Adjudication method for the test set
Not applicable. Testing is based on objective measurements against engineering standards.
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 is a physical interbody fusion device, not an AI/software product that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used
The "ground truth" for the device's performance is established by the specified ASTM and industry standards for mechanical and MR conditional testing. Compliance with these standards indicates the device performs as expected for its intended physical function.
8. The sample size for the training set
Not applicable. This is not an AI/software device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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(105 days)
The Hammertoe Truss System (HTS) is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the Hammertoe Truss System (HTS) can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).
The 4WEB HTS implants consists of a series of titanium implants that are designed to provide stability and fixation of the lesser toes in the foot. The 4WEB HTS implants have proximal and distal fixation features to provide structural support and will be offered in multiple sizes to accommodate various patients' anatomy. The implants are manufactured from Ti6Al4V alloy. Each implant is available in a sterile/packaged form.
This document is a 510(k) summary for the Hammertoe Truss System (HTS), a medical device intended for fixation of osteotomies and reconstruction of lesser toes. It does not describe an AI/ML powered device, and therefore the requested information about acceptance criteria and studies proving the device meets them in the context of AI/ML are not applicable here.
However, I can extract the relevant performance testing information for this physical medical device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of numerical thresholds for each test. Instead, it refers to performance testing completed "per the following standards," implying that compliance with these standards and their methodologies serves as the acceptance criteria. The "reported device performance" is implicitly that the device met these standards, leading to the conclusion of substantial equivalence.
| Acceptance Criteria (Standard) | Reported Device Performance (Implicit) |
|---|---|
| ASTM F1264 – Static and Dynamic 3-Point Bend and Torque to Failure | Hammertoe Truss System meets the standard for these mechanical properties. |
| ASTM F543 – Axial Push Out | Hammertoe Truss System meets the standard for axial push out force. |
| ASTM F2119 — MR Image Artifact | Hammertoe Truss System does not present a new worst case compared to the predicate device in terms of MR image artifact. |
| ASTM F2052 - MR Induced Displacement Force | Hammertoe Truss System does not present a new worst case compared to the predicate device in terms of MR induced displacement force. |
| ASTM F2213 – MR Induced Torque | Hammertoe Truss System does not present a new worst case compared to the predicate device in terms of MR induced torque. |
| ASTM F2182 – MR Induces Heating | Hammertoe Truss System does not present a new worst case compared to the predicate device in terms of MR induced heating. |
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 refers to "Performance testing has been completed per the following standards," but does not detail the specific sample sizes used for each test or the provenance of any 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 is not applicable as this is not an AI/ML device requiring expert-established ground truth for a test set. The performance is based on physical and material testing standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI/ML device.
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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this physical medical device, the "ground truth" or standard for performance is adherence to established ASTM mechanical and MR compatibility standards.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device and therefore does not have a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device and therefore does not have a training set.
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