(30 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 describes the Parcus Synd-EZ SS, a medical device intended for fracture repair and syndesmotic fixation. However, the document does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving the device meets them, especially in the context of AI/algorithm performance.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document provides a general statement about performance testing but does not offer a table of specific acceptance criteria or quantitative performance metrics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicit. The document states "Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions." The specific numerical thresholds for these evaluations are not provided. | "Results were compared with test data for the predicate device and demonstrated substantial equivalency." This indicates the device performed comparably to a predicate device, but specific performance numbers are absent. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The document mentions "Devices were assembled to test blocks," implying laboratory testing, but does not specify the sample size or any data provenance related to human subjects or clinical 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 information is not available in the provided text. The device described is a physical implant, not an AI or diagnostic tool that would typically involve expert-established ground truth for performance evaluation in the way you've framed the question. The "testing" referred to is mechanical.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text. Adjudication methods are typically used in clinical trials or studies involving expert interpretation, which is not described here for this mechanical 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
This information is not available in the provided text. The device is a surgical implant and does not involve AI assistance for human readers. Therefore, an MRMC study related to AI effectiveness is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not available in the provided text. The device is a physical implant and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be established through mechanical test standards and material properties. The document states that "Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions." This implies engineering and biomechanical testing, where the "ground truth" is defined by established engineering principles and benchmarks for such implants. It's not clinical "ground truth" in the sense of diagnosis or pathology.
8. The sample size for the training set
This information is not available in the provided text. The document describes a physical medical device, not an AI/machine learning model that would have a "training set."
9. How the ground truth for the training set was established
This information is not available in the provided text. This question is not applicable as there is no mention of a training set or AI model.
Summary of what the document does indicate about performance:
- Type of Study: Laboratory performance testing ("side by side with the predicate device").
- Parameters Evaluated: Strength and elongation under cyclic loading and ultimate failure conditions.
- Conclusion: The device "demonstrated substantial equivalency" to the predicate device (Parcus Synd-EZ Ti, K191783).
- Other Testing: LAL (Limulus Amebocyte Lysate) testing for pyrogenicity and a biocompatibility assessment in alignment with ISO 10993-1 were also conducted.
This document focuses on the regulatory clearance for a physical medical device based on substantial equivalence to a predicate device, primarily through mechanical testing and biocompatibility assessments. It does not pertain to the evaluation of AI systems or diagnostic performance as implied by many of your questions.
§ 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.