(177 days)
The Paragon 28 MAVEN™ Patient-Specific Instrumentation is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in guiding the marking of bone before cutting. The Paragon 28 MAVENTM Patient-Specific Instrumentation is intended for use with the Paragon 28 APEX 3D Total Ankle Replacement System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans. The Paragon 28 MAVEN™ Patient-Specific Instrumentation is intended for single use only. The Paragon 28 TAR Patient-Specific Case Reports are intended for use with the Paragon 28 APEX 3D Total Ankle Replacement System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans.
The Paragon 28 MAVENTM Patient-Specific Instrumentation is used in conjunction with the APEX 3D Total Ankle Replacement System instrumentation (K192994). The guides are created to fit the anatomy of the patient's distal tibia and proximal talus, and when used in combination with the APEX 3D instruments, facilitate positioning of the APEX 3D implants.
The provided text is a 510(k) Summary for the Paragon 28 MAVEN™ Patient-Specific Instrumentation. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on performance data. However, the document does not contain the detailed acceptance criteria or the specifics of the study that proves the device meets those criteria in the format requested.
Here's a breakdown of what is and is not available in the provided text:
1. A table of acceptance criteria and the reported device performance
- Not available. The document states that "The device performance was characterized via Guide Design Process Validation, Pre-operative vs Post-Operative Analysis of Implant Placement and Resection Location, and Software Validation." However, it does not provide specific acceptance criteria (e.g., maximum allowable deviation for implant placement) or the quantitative results of these performance characterizations.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not available. The document mentions "Pre-operative vs Post-Operative Analysis of Implant Placement and Resection Location" but does not specify the sample size of patients or images used for this analysis, nor does it describe the data provenance.
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)
- Not available. The document does not describe any expert-based ground truth establishment or the involvement of experts in the performance characterization studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not available. Since no explicit ground truth establishment process involving experts is described, there is no mention of an adjudication method.
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 available. The document describes a "Patient-Specific Instrumentation" (PSI) system, which is a physical guide to assist surgeons, not an AI-assisted diagnostic or interpretation tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device type.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not explicitly stated. The device is "Patient-Specific Instrumentation" intended to be used intraoperatively by surgeons. While there is a "Software Validation" mentioned, the performance characterization seems to be related to the accuracy of the physical guides and the resulting implant placement, rather than a standalone algorithm's diagnostic performance. The document itself focuses on the instrument's ability to facilitate positioning, inherently a human-in-the-loop process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Inferred, but not explicitly stated. For "Pre-operative vs Post-Operative Analysis of Implant Placement and Resection Location," the ground truth would likely be the intended implant placement/resection location based on the surgical plan (pre-operative) compared to the actual post-operative placement, possibly verified by post-operative imaging. However, the document does not explicitly define how this "ground truth" was established or measured.
8. The sample size for the training set
- Not applicable/Not available. As this device is a patient-specific surgical instrumentation system rather than a machine learning model that requires a training set, the concept of a training set sample size is not relevant in the context usually meant for AI/ML devices. The "Guide Design Process Validation" implies internal software validation, but not a training set for an AI model.
9. How the ground truth for the training set was established
- Not applicable/Not available. See point 8.
In summary, the provided document offers a high-level overview of the device and its claimed equivalence but lacks the granular details of performance criteria and study results requested. It indicates that "Clinical data are not needed to support the safety and effectiveness of the subject device," suggesting that the performance data presented (Guide Design Process Validation, Pre-operative vs Post-Operative Analysis, Software Validation) were considered sufficient without specific clinical trials.
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.