(90 days)
The Synthes 1.0mm, 1.5mm, 2.0mm, and 2.4mm Cortex Screws are intended for use in trauma procedures, reconstructive procedures, and general surgery of the hand, wrist, and other small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The Synthes 2.7mm Cortex Screw is intended for fractures and osteotomies of small bones and bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The Synthes 2.7mm Cortex Screw may also be used in fusion applications in adults and adolescents (12-21years) when used with the Synthes 2.4mm/2.7mm Variable Angle LCP Forefoot/Midfoot System (K100776) and in adults and pediatric patients (2-12 years) when used with the Synthes Ti Wrist Fusion Plate (K023879).
The Synthes 3.5mm and 4.0mm Cortex Screws are intended for fixation of fractures. osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The Synthes 4.5mm Cortex Screw is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
Screws have self-tapping features, stardrive, hexdrive, or cruciform head recesses, and are manufactured from stainless steel, commercially pure titanium, and/or titanium alloy. Cortex screws are offered both sterile and non sterile and are available in various lengths. Screws may be used independently or with any Synthes plate which accepts 1.0mm, 1.3mm, 2.0mm, 2.4mm, 2.7mm, 3.5mm, 4.0mm, and 4.5mm cortex screws. The subject screws, when used in pediatric applications, may be used independently or with compatible Synthes plates which are also indicated for pediatric populations.
The provided text describes Synthes Cortical Screws and their intended uses, focusing on expanding indications for pediatric populations. The study primarily relies on demonstrating substantial equivalence to predicate devices and does NOT involve an AI device. Therefore, many of the questions related to AI-specific studies, such as sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance, are not applicable.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail table format for the device as a whole. Instead, it details the basis for substantial equivalence to existing predicate devices.
| Acceptance Criterion (Basis for Substantial Equivalence to Predicate Devices) | Reported Device Performance/Comparison (Synthes Cortical Screws vs. Predicates) |
|---|---|
| Indications for Use (Adults) | Similar indications for use in trauma, reconstructive procedures, and general surgery of various bones. |
| Indications for Use (Pediatric Expansion) | Supported by published clinical literature concerning the use of existing Synthes Cortex Screws in pediatric populations (ages 2-12 years and 12-21 years), specifically where growth plates have fused or will not be crossed by screw fixation. |
| Design | Similar design. |
| Fundamental Product Technology | Incorporate the same fundamental product technology. |
| Materials | Composed of the same materials (stainless steel, commercially pure titanium, and/or titanium alloy). |
| Mechanical Properties (In Vitro Testing) | Calculations performed comparing: |
- Torsional strength
- Insertion torque
- Axial pullout
- Bending strength
(The document states these calculations "additionally support substantial equivalence" and that screw length has "no bearing on the cortical screws' performance or technical function," implying comparable performance to predicates) |
2. Sample size used for the test set and the data provenance:
- Not applicable (N/A) for an AI device. This submission concerns physical medical devices (screws). The "test set" in this context refers to the in-vitro mechanical testing conducted, not a dataset for an algorithm.
- Data Provenance: The document mentions "Published, clinical literature" to support pediatric use and "calculations comparing torsional strength, insertion torque, axial pullout, and bending strength" for mechanical properties. The specific details of these studies (e.g., number of screws tested, exact literature cited, countries of origin) are not provided in this summary. These would typically be detailed in a more comprehensive 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A for an AI device. Ground truth for an AI algorithm is typically established by human experts reviewing data. For this device, "ground truth" relates to the performance characteristics of the screws, established through engineering tests and scientific literature.
4. Adjudication method for the test set:
- N/A for an AI device. Adjudication methods like "2+1" or "3+1" are used to establish consensus among multiple human reviewers for AI algorithm ground truth. This is not relevant for a physical device submission.
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:
- No. This is not an AI device. Therefore, no MRMC comparative effectiveness study was conducted with human readers assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI device.
7. The type of ground truth used:
- For the expanded pediatric indications: Published clinical literature on the use of similar Synthes Cortex Screws.
- For mechanical properties: Engineering calculations and in-vitro mechanical testing data (torsional strength, insertion torque, axial pullout, bending strength). Comparison against predicate device specifications or established industry standards would serve as the "ground truth" for demonstrating equivalence.
8. The sample size for the training set:
- N/A. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established:
- N/A. As there is no training set for an AI algorithm, no ground truth was established for it.
§ 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.