(137 days)
The Precice Max System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones in patients age 18 years and older and indicated for limb lengthening of the femur and tibia in pediatric patients (greater than 12 years old).
The subject Precice Max System has identical indications for use as the predicate Precice Intramedullary Limb Lengthening System (K220234), which is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, and bone transport of long bones in bones in patients age 18 years and older and indicated for limb lengthening of the femur and tibia in pediatric patients (greater than 12 years old). The subject system is designed to achieve limb correction through gradual lengthening or compression and provide intramedullary fixation for fractures of long bones. The Precice Max System includes similar devices as within the predicate Precice Intramedullary Limb Lengthening System (K220234): nail, endcaps, locking screws, surgical instruments, and remains compatible with the external remote controllers (ERC) (ERC 1, cleared via K113219; ERC 2P, cleared via K131490; or ERC 3P, cleared via K170169; or ERC 4P, cleared via K202348). The Precice Max intramedullary nail is available in various designs, lengths, and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The screws are also available in a variety of different lengths and diameters. The subject device components are manufactured from medical grade titanium alloy per ASTM F136 Standard Specification for Wrought Titanium-6Aluminum- 4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The Precice Max nail is implanted using locking screws and reusable surgical instruments.
This is a 510(k) summary for the Precice Max System, an orthopedic device, not an AI/ML powered medical device. Therefore, many of the requested categories are not applicable. However, I will extract the information that is available within the provided document.
Here's the breakdown of the acceptance criteria and study information available from the 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
For this orthopedic device, the "acceptance criteria" are typically defined by recognized ASTM standards for implantable devices, and "device performance" is demonstrated by meeting or exceeding these standards. The document states that testing was performed to demonstrate substantial equivalence to the predicate device.
| Test Description | Acceptance Criteria (Standard Reference) | Reported Device Performance (Summary) |
|---|---|---|
| Static Compression Bending Strength | ASTM F1264 – Standard Specification and Test Methods for Intramedullary Fixation Devices | Demonstrated substantial equivalence to predicate. |
| Dynamic Compression Bending Strength | ASTM F1264 – Standard Specification and Test Methods for Intramedullary Fixation Devices | Demonstrated substantial equivalence to predicate. |
| Torsion | ASTM F1264 – Standard Specification and Test Methods for Intramedullary Fixation Devices | Demonstrated substantial equivalence to predicate. |
| Dynamic 3-Point Bending | ASTM F1264 – Standard Specification and Test Methods for Intramedullary Fixation Devices | Demonstrated substantial equivalence to predicate. |
| Torque Resistance | ASTM F543 – Standard Specification and Test Methods for Metallic Medical Bone Screws | Demonstrated substantial equivalence to predicate. |
| Axial Pullout Strength | ASTM F543 – Standard Specification and Test Methods for Metallic Medical Bone Screws | Demonstrated substantial equivalence to predicate. |
| Tensile Strength | ASTM F543 – Standard Specification and Test Methods for Metallic Medical Bone Screws | Demonstrated substantial equivalence to predicate. |
| Distraction Force | N/A (implied internal acceptance based on predicate) | Demonstrated substantial equivalence to predicate. |
| Wear Debris Testing | N/A (implied internal acceptance based on predicate) | Demonstrated substantial equivalence to predicate. |
| Corrosion Testing | N/A (implied internal acceptance based on predicate) | Demonstrated substantial equivalence to predicate. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the "acceptance criteria" is a nonclinical performance verification testing program. The document explicitly states:
"Nonclinical performance verification testing was performed to demonstrate that the subject Precice Max System is substantially equivalent to the predicate device, Precice Intramedullary Limb Lengthening System (K220234)."
2. Sample size used for the test set and the data provenance
This information is not provided in the 510(k) summary. For nonclinical performance testing of medical devices, sample sizes are typically determined by statistical methods and regulatory guidance for biomechanical testing, but the specifics are generally not included in the public 510(k) summary. Data provenance for such tests is typically from internal lab testing conducted by the manufacturer or a contracted lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as this is not an AI/ML device relying on expert-established ground truth from a test set. The performance is assessed against established engineering standards (ASTM).
4. Adjudication method for the test set
This is not applicable. The performance is assessed against established engineering standards (ASTM) through physical 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
This is not applicable. This is an orthopedic implant, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is an orthopedic implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on established engineering standards (ASTM) for implantable devices, representing objective physical and mechanical properties.
8. The sample size for the training set
This is not applicable as this is not an AI/ML device that requires a training set. The device's design and manufacturing rely on established engineering principles and materials science.
9. How the ground truth for the training set was established
This is not applicable.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.