(98 days)
The Parcus Synd-EZ Ti is intended to be used as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
The Parcus Synd-EZ Ti is intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of the syndesmosis (syndesmosis disruptions) in connection with Weber B and Weber C ankle fractures.
The Parcus Synd-EZ Ti consists of two buttons with suture connecting them and are designed to be used for stabilizing the syndesmosis during healing. Building upon the technology of the Parcus GFS Ultimate, the Synd-EZ Ti is easily adjusted for length and resists elongation without requiring knots to secure the fixation. The device is made from medical grade titanium and UHMWPE suture and is provided sterile.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Parcus Synd-EZ Ti device:
Based on the provided FDA 510(k) summary (K191783), there are no mentions of AI assistance, expert readers, or ground truth establishment in a medical imaging context. This document describes a medical device, the Parcus Synd-EZ Ti, which is a hardware implant for syndesmosis fixation, and not a software device or an AI/ML algorithm.
Therefore, many of the requested criteria related to AI/ML software performance are not applicable to this submission. The 510(k) summary focuses on the physical and mechanical properties of the device.
Here's the information that can be extracted from the provided text, adapted to the closest relevant categories:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Resist elongation under cyclic loading conditions. | Evaluated for strength and elongation under cycle loading and ultimate failure conditions. Results "demonstrated substantial equivalency" to the predicate device. |
| Ultimate Failure | Withstand ultimate failure conditions. | Evaluated for strength and elongation under cycle loading and ultimate failure conditions. Results "demonstrated substantial equivalency" to the predicate device. |
| Material Biocompatibility | Made from medical grade materials. | Made from medical grade titanium and UHMWPE suture. |
| Pyrogenicity | Non-pyrogenic. | LAL testing conducted on a representative device concluded that the Synd-EZ Ti "does not raise any additional concerns regarding pyrogenicity." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document states "Devices were assembled to test blocks" and "testing was conducted on the worst case configurations." It does not specify a numerical sample size (e.g., number of devices tested).
- Data Provenance: Not explicitly stated, but it's implied that the testing was conducted by the manufacturer, Parcus Medical, LLC, which is based in Sarasota, Florida, USA. The testing is prospective for the purpose of demonstrating substantial equivalence to the predicate.
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 applicable. This device is a mechanical implant, not a diagnostic imaging aid. Ground truth was established by direct physical measurement and material testing, not expert interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human readers or interpretation. The performance data is derived from mechanical testing.
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 not an AI-assisted device, nor does the document describe any human reader effectiveness studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an algorithm. Performance refers to the physical characteristics of the implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance would be the direct physical and mechanical properties measured during the testing (e.g., actual tensile strength, elongation, pyrogenicity test results). These are objective, quantifiable measurements from material science and engineering, not medical interpretation categories.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.