(64 days)
The Parcus Synd-EZ SS 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 SS 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 SS 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 Synd-EZ Ti, the Synd-EZ SS is easily adjusted for length and resists elongation without requiring knots to secure the fixation. The device is made from medical grade titanium, stainless steel and UHMWPE suture and is provided sterile.
The provided text is a 510(k) premarket notification summary for a medical device called "Parcus Synd-EZ SS." This document is a regulatory filing that demonstrates substantial equivalence to a predicate device, and as such, it does not contain acceptance criteria or detailed study information for new device performance.
The primary purpose of this 510(k) is a labeling change for MR conditional parameters, indicating that the design, materials, and manufacturing processes of the device itself have not changed since its previous clearance (K192964). Therefore, the document explicitly states: "No new testing was completed, apart from the testing required to support MR Conditional parameters that was provided in this submission."
Given this, I cannot extract the information you requested about acceptance criteria and proof of device performance for the medical functions of the Parcus Synd-EZ SS from this document. The document primarily focuses on the MR Conditional testing.
However, I can provide the available information regarding the MR Conditional testing:
Regarding MR Conditional Testing:
1. Table of Acceptance Criteria and Reported Device Performance (for MR Conditional Parameters):
| Acceptance Criteria (MR Conditional) | Reported Device Performance |
|---|---|
| Magnetically induced force | Device was tested for magnetically induced force and the results were used to establish MR system conditions suitable for safe use. (Specific values or thresholds not provided in the summary). |
| Magnetically induced torque | Device was tested for magnetically induced torque and the results were used to establish MR system conditions suitable for safe use. (Specific values or thresholds not provided in the summary). |
| Heating by RF fields | Device was tested for heating by RF fields and the results were used to establish MR system conditions suitable for safe use. (Specific values or thresholds not provided in the summary). Note: The document indicates "The Synd-EZ SS was evaluated for use in the MR Environment and were determined to fit the definition of MR Conditional." This implies it met the relevant safety thresholds. |
| Image artifact | Device was tested for image artifact and the results were used to establish MR system conditions suitable for safe use. (Specific values or thresholds not provided in the summary). |
2. Sample size used for the test set and the data provenance:
- Sample Size: "worst-case device was selected for testing." The exact number of devices tested is not specified, but it implies a single representative device or a small number to characterize the "worst-case."
- Data Provenance: Not explicitly stated, but assumed to be from internal testing conducted by Parcus Medical, LLC (or a contracted lab) to comply with FDA guidance and ASTM standards. This would be prospective testing specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for MR Conditional testing. MR Conditional testing relies on standardized physical measurements and engineering evaluations against defined limits, not expert clinical consensus on a "ground truth" derived from patient data.
4. Adjudication method for the test set:
- Not applicable. MR Conditional testing involves objective measurements rather than adjudication of interpretations.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. This type of study is for evaluating human performance with and without AI assistance, which is not relevant to MR Conditional testing of a physical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/algorithm-based device.
7. The type of ground truth used:
- For MR Conditional testing, the "ground truth" is defined by the safety limits and thresholds established in regulatory guidance (FDA Guidance Document - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment) and applicable ASTM standards.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, this document is a regulatory submission focused on demonstrating substantial equivalence and providing MR Conditional labeling. It does not provide detailed performance data or clinical study results for the device's primary indications, as those would have been covered in the original 510(k) clearances (K191783 and K192964) to which this device is substantially equivalent.
§ 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.