(182 days)
The PediatrOS™ RigidTack™/ FlexTack™ bone staples are indicated for pediatric patients (children/ adolescents) with angular deformities or leg length discrepancies. Therefore PediatrOS™ RigidTack™ / FlexTack™ is intended to redirect the angle of growth of long bones and to correct leg length discrepancies by inhibition of longitudinal growth of the physis (growth plate) in growing children and adolescents.
Specific pediatric conditions/diseases for which the devices will be indicated include:
- Valgus, varus, or flexion, extension, deformities of the knee (femur and/or tibia) ●
- Valqus or varus deformities of the elbow (humerus) ●
- Leg length discrepancies ●
PediatrOS™ RigidTack™
The PediatrOS™ RigidTack™ bone staples are used to correct leg length discrepancies through (dual) epiphysiodesis of long bones. The PediatrOS™ RigidTack™ has a trapezoidal shape which allows the staples to fit well to the epiphyseal bone. The staples are made from titanium alloy TiAl6V4 ELI and are available in several sizes, so they can be used for children of various age groups (before reaching skeletal maturity). The jagged surfaces of the staples' legs help secure it into the bone to prevent loosening. The staples have cannulated legs to facilitate placement through K-wires. In order to achieve a stiff mechanical behavior, the staples are equipped with a support strut. Female threads, built in the cannulated legs, help to remove the staples with threaded K-wires and the appropriate explantation instruments.
PediatrOS™ FlexTack™
The PediatrOS™ FlexTack™ bone staples are used to correct axial deformities through hemiepiphysiodesis of long bones. The PediatrOS™ FlexTack™ has a trapezoidal shape which allows the staples to fit well to the epiphyseal bone. The staples are made from titanium alloy TiAl6V4 ELl and are available in several sizes, so they can be used for children of various age groups (before reaching skeletal maturity). The jagged surface of the staples' legs help secure it into the bone to prevent loosening. The staples have cannulated legs to facilitate placement through K-wires as well as a flexible middle part which can be bent in vivo by the strength of bone growth permitting successive growth delay. Female threads, built in the cannulated legs, help to remove the staples with threaded K-wires and the appropriate explantation instruments.
The provided document is a 510(k) premarket notification for a medical device (bone staples) and focuses on demonstrating substantial equivalence to existing predicate devices based on mechanical properties and indications for use. It is not a study that evaluates the performance of an AI/ML-driven medical device in terms of diagnostic accuracy or clinical outcomes.
Therefore, many of the requested items related to AI/ML device performance, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this document. This document details the mechanical testing performed to demonstrate equivalence, not clinical performance metrics.
Here's an attempt to address the relevant points based on the provided text, while clearly stating what information is not available:
Acceptance Criteria and Device Performance Study (for Non-AI Device)
This submission describes the PediatrOS™ RigidTack™/FlexTack™ bone staples, which are mechanical medical devices. The "study" referenced in the document is a series of mechanical analyses and functional worst-case tests, not a clinical trial or an AI/ML performance study. The acceptance criteria are related to the mechanical properties of the staples compared to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate devices' performance) | Reported Device Performance (PediatrOS™ RigidTack™/FlexTack™) |
|---|---|---|
| Mechanical Strength | - Mechanical strength at least as high as or higher than the predicate devices (K031493 Guided Growth Plate, Blount Zimmalloy staple). |
- Ability to withstand forces encountered during bone growth without failure. | - "The mechanical strength is as high or higher than the strength of the predicate device."
- "All products have successfully passed the tests."
- "The PediatrOS™ RigidTack™ / FlexTack™ bone staples have hereby been proven to be mechanically as good as or better than the compared predicate devices." |
| Stiffness | - Stiffness comparable to both predicate devices. | - "The stiffness is comparable to both predicate devices, too." |
| Mechanical Behavior | - For FlexTack™: Demonstrate flexible bending zone deforms under small loads and allows larger opening angles than physiologically possible, as intended for successive growth delay. - For RigidTack™: Demonstrate stiff mechanical behavior. | - "The mechanical behavior comparison illustrated that the flexible bending zone in FlexTack™ deforms under small loads as intended and allows larger opening angles than physiological possible."
- "In order to achieve a stiff mechanical behavior, the staples are equipped with a support strut." (RigidTack™ description)
- "All products have successfully passed the tests." |
| Fixation into Bone | - Secure fixation into the bone to prevent loosening. | - "A secure fixation into the bone was proven." - "The jagged surfaces of the staples' legs help secure it into the bone to prevent loosening." (Device description)
- "All products have successfully passed the tests." |
| Compliance with Standards| - If applicable, tests performed according to valid standards (e.g., ASTM-F564-10(2015)). | - "If applicable the tests were performed according to valid standards as ASTM-F564-10(2015)." |
| Material Composition | - Made from biocompatible and appropriate materials (Titanium alloy TiAl6V4 ELI). | - "The staples are made from titanium alloy TiAl6V4 ELI." (Device description) |
| Sterility/Biocompatibility| (Implicit in any medical device submission, though not detailed as a performance test here beyond the material choice. Typically covered by other sections of a 510(k) not provided in these snippets.) | (Not explicitly detailed as a performance test in the provided text, but assumed to be addressed as part of general FDA requirements for the material and manufacturing process.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in terms of number of patients or cases. The tests described are mechanical tests performed on the devices themselves. The number of individual staples or test configurations tested is not provided.
- Data Provenance: Not applicable in the context of clinical data. The tests are laboratory mechanical tests, likely performed at Merete Medical GmbH or a contracted testing facility.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a mechanical device submission. There is no "ground truth" established by human experts in the context of diagnostic accuracy or clinical outcomes for these mechanical tests. The "ground truth" for these tests are the physical laws and engineering specifications used to define satisfactory mechanical performance.
4. Adjudication Method for the Test Set
- Not Applicable. There is no adjudication method in the sense of expert consensus for resolving discrepancies, as these are mechanical tests with objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is not an AI/ML diagnostic device, and thus no MRMC study, which assesses human reader performance with and without AI assistance, was performed.
6. If a Standalone Performance study was done
- Yes (for mechanical function). The document describes standalone mechanical testing of the PediatrOS™ RigidTack™/FlexTack™ staples to evaluate their strength, stiffness, mechanical behavior, and fixation into bone. This is a "standalone" evaluation of the device's physical properties.
7. The Type of Ground Truth Used
- For the mechanical tests, the "ground truth" is defined by:
- Engineering specifications and design requirements: How the device should perform structurally.
- Performance of predicate devices: The established mechanical properties of the legally marketed predicate devices serve as benchmarks for equivalence.
- Relevant ASTM standards: Such as ASTM-F564-10(2015), which provide methodologies and acceptance criteria for bone staples.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device; therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.