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510(k) Data Aggregation
(27 days)
The CarboClear® X Pedicle Screw System is intended to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with deqenerative disc disease (DDD) at one level from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment.
The CarboClear® X Pedicle Screw System is intended to be used with an intervertebral body fusion device implanted at the same spinal level with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
CarboClear® X Navigated Instruments are intended to be used during the preparation and placement of CarboClear® X Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClear® X Navigated Instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
The CarboClear® X Pedicle Screw System is composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants.
The implants include pedicle screws, rods, and a locking element (set screw). They are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell. The implants may include tantalum markers. Titanium alloy rod is also available.
The implants are supplied sterile, and are intended for single use.
The CarboClear® X implants may be implanted in an open approach or using a minimally invasive surgery (MIS) approach.
The CarboClear® X Navigated Instruments are manually operated instruments, intended to be used with Medtronic's StealthStation® Navigation System, to assist surgeons in precisely locating anatomical structures for preparation and placement of CarboClear® X pedicle screws during spinal surgery.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets specific acceptance criteria in the context of AI/ML or medical imaging performance. The document is an FDA 510(k) clearance letter for the CarboClear® X Pedicle Screw System and CarboClear® X Navigated Instruments, which are physical medical devices (implants and surgical instruments) for spinal surgery.
The performance data mentioned relates to mechanical testing of the pedicle screw system (e.g., static and dynamic bending, torsion) according to ASTM standards, not to the performance of an AI algorithm or a diagnostic imaging system. Therefore, I cannot extract the information required to populate the requested table and answer the questions about AI/ML model performance, ground truth, expert consensus, or MRMC studies.
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(90 days)
The Piccolo Composite Proximal Tibia Plate System is intended to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused.
For Lateral Plates - non-unions, and factures including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.
For Medial Plates - intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia.
The Piccolo Composite Proximal Tibia Plate System comprises implants (pre-contoured lateral and medial plates (in left and right configurations), and screws) in different dimensions, and instruments.
The Piccolo Composite proximal tibia plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK) and incorporate tantalum markers. The screws are made of titanium alloy.
The provided text is a 510(k) summary for a medical device (Piccolo Composite Proximal Tibia Plate System) and focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing. It does not contain information about studies involving human readers, AI, or diagnostic performance metrics typically associated with acceptance criteria for such studies.
Therefore, many of the requested sections about acceptance criteria, human reader performance, AI, and ground truth establishment cannot be answered from the provided document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Mechanical Performance) | Reported Device Performance |
|---|---|
| Performed per ASTM F 382 (for plate static and dynamic bending) | Comparable to predicate devices |
| Screw pushout from the plate | Comparable to predicate devices |
| Screw insertion torque | Comparable to predicate devices |
| Screw pull out force | Comparable to predicate devices |
| Screw dimensional equivalence | Comparable to predicate devices |
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 provided in the document. The performance testing described is mechanical, not clinical, and thus terms like "test set" for human or AI performance or "data provenance" in this context are not applicable.
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 provided. The "ground truth" in this context refers to engineering standards and comparisons to predicate devices, not expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Arbitration methods are typically used for clinical studies with human observers, which is not the type of study described.
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
There is no indication that an MRMC comparative effectiveness study was done. This document describes the mechanical testing of a bone plate system, not a diagnostic or AI-assisted device. Therefore, no information on AI assistance or human reader improvement is available.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no indication that a standalone algorithm performance study was done. The device is a physical bone plate system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the mechanical performance testing appears to be established engineering standards (ASTM F 382) and performance data from legally marketed predicate devices.
8. The sample size for the training set
This information is not provided. The concept of a "training set" is not applicable to the mechanical performance testing described for this physical device.
9. How the ground truth for the training set was established
This information is not provided. The concept of a "training set" and its ground truth is not applicable to the mechanical performance testing described for this physical device.
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(27 days)
The Piccolo Composite Proximal Femur Nails are indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteric, intertrochanteric high subtrochanteric fractures, and combinations of these fractures), including, fractures resulting from trauma, nonunions, pathological fractures, impending pathological fractures, tumor resections, and revision procedures.
The Piccolo Composite Nailing System includes nails, screws and a set of instruments. The Piccolo Composite nail indicated for treatment of the proximal femur is a cylindrical rod. Nail mid-shaft diameter is 11mm, with the proximal end diameter of up to 17mm. Nail lengths are 180mm, 200mm, and in the range of 300 – 460mm. The nail provides for holes at the proximal and distal sections, designed for the insertion of a lag screw and interlocking screws. The lag screw is of 10.4mm diameter, with its length being in the range of 80mm to 110mm. The nails and lag screws are made of carbon fiber reinforced polymer and incorporate small amount of titanium alloy. Tantalum markers are embedded within the carbon fiber reinforced polymer, where applicable, to enable visualization during imaging. The distal screws are made of titanium alloy.
This document is a 510(k) premarket notification for a medical device called the "Piccolo Composite® Nailing System - Proximal Femur." It focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, sections related to study design, sample sizes, ground truth establishment, or expert involvement are not applicable or detailed in this document.
However, the document does mention "Performance characteristics for the Piccolo Composite Proximal Femur Nailing System components included static and dynamic bending of construct, and lag screw torque to failure, and are comparable to those of predicate devices (as applicable), thus demonstrating that the device is safe and effective for its intended use." This indicates that mechanical testing was performed to demonstrate that the new device performs similarly to existing, legally marketed devices.
Based on the provided document, here's what can be extracted and what information is not included:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that performance characteristics were "comparable to those of predicate devices (as applicable)," but it does not provide specific numerical acceptance criteria or the reported performance values for the Piccolo Composite Proximal Femur Nailing System. It mentions the types of tests performed.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Static bending of construct comparable to predicate devices | Performed; results comparable to predicate devices. |
| Dynamic bending of construct comparable to predicate devices | Performed; results comparable to predicate devices. |
| Lag screw torque to failure comparable to predicate devices | Performed; results comparable to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document refers to "Performance characteristics for the Piccolo Composite Proximal Femur Nailing System components," suggesting mechanical testing rather than a clinical human subject study. The sample size would refer to the number of devices or components tested.
- Data Provenance: Not specified, but the tests would be laboratory-based and conducted by CarboFix Orthopedics Ltd.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. This document describes engineering performance tests, not a clinical study involving human judgment on images or outcomes. Therefore, there is no "ground truth" to be established by clinical experts in this context.
4. Adjudication Method for the Test Set:
- Not Applicable. As this primarily describes mechanical testing, an adjudication method for a test set based on expert review is not relevant.
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-powered device, nor is it a clinical comparative effectiveness study involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware medical device (intramedullary nailing system), not an algorithm or AI.
7. The type of ground truth used:
- Not Applicable. For mechanical testing, the "ground truth" would be the engineering specifications and performance data of the predicate devices against which the new device's performance is compared. No clinical ground truth (e.g., pathology, outcomes data, expert consensus) is mentioned or relevant here.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI or machine learning device being trained.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
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