Search Results

The Piccolo Composite Distal Femur Plate System is indicated for buttressing multifragmentary distal femur fractures including supra-condylar, intra-articular and extra-articular condylar fractures, periprosthetic fractures in normal or osteopenic bone, nonunions and malunions.

The Piccolo Composite Distal Femur Plate System comprises implants (plates and screws), and a set of instruments.

The plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), and are marked with a tantalum thread, to provide for their visualization under fluoroscopy. The screws are made of titanium alloy. Both non-locking screws and locking screws are available, in various dimensions.

This document describes the Piccolo Composite® Plate System, a medical device for bone fixation. Since this is a 510(k) summary for a medical device and not an AI/software product, the provided text does not contain information about acceptance criteria, study details, or ground truth relevant to AI performance. Therefore, I cannot extract the requested information.

The document discusses the substantial equivalence of the device to predicate devices based on intended use, design, materials, technological characteristics, principles of operation, and performance characteristics as evaluated per ASTM F 382. It does not involve a study of an AI algorithm.

Ask a specific question about this device

The Piccolo Composite Diaphyseal Plate is indicated for the fixation of various long bones, such as the humerus, femur and tibia, including osteopenic bone, osteotomies, and nonunions or malunions in adult patients.

These plates are also indicated for fracture fixation of diaphyseal areas of long bones in pediatric patients.

The Piccolo Composite Plate System comprises implants (plates and screws), and a set of instruments.

The plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), and are marked with a tantalum thread, to provide for their visualization under fluoroscopy.

The Piccolo Composite Diaphyseal Plate is either 4.5mm, or 5.3mm thick; 14.5mm or 17.5mm wide; and is provided in lengths of 82 - 220mm (4 - 13 holes), depending on plates thickness and width.

The screws are made of titanium alloy. Both locking (04.0mm and Ø5.0mm) and nonlocking (04.5mm) screws are available in a range of lengths.

This document describes the mechanical testing performed to demonstrate the substantial equivalence of the Piccolo Composite® Plate System.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size for the mechanical testing. However, it indicates that "Performance characteristics... were evaluated per ASTM F 382 - Standard Specification and Test Method for Metallic Bone Plates." This implies that the sample sizes used would have conformed to the requirements of ASTM F382 for such testing.

The data provenance is from laboratory testing conducted by CarboFix Orthopedics Ltd. There is no information regarding country of origin of data in terms of clinical data, as this study refers to mechanical testing. This was a prospective study in the sense that the tests were specifically designed and executed to evaluate the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This study involves mechanical performance testing of a medical device against an ASTM standard and predicate devices, not the evaluation of clinical data requiring expert review for ground truth.

4. Adjudication Method for the Test Set

Not applicable. This is mechanical testing, not a clinical study requiring adjudication of expert opinions. The "adjudication" is met by comparing test results against the established ASTM standard and predicate device data.

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

Not applicable. This document describes the mechanical testing of a bone plate system, not an AI-assisted diagnostic or therapeutic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This document describes the mechanical testing of a bone plate system, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this study is defined by:

• ASTM F382 - Standard Specification and Test Method for Metallic Bone Plates: This standard provides the methodologies and acceptable performance benchmarks for bone plates.
• Performance of Predicate Devices: The measured performance of existing, legally marketed devices (Piccolo Composite® Plate System K102597, K120409, and Synthes Locking Compression Plate System e.g., K000682, K082807) served as the comparative "ground truth" to establish substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is mechanical testing of a physical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, this is mechanical testing, not machine learning.

Ask a specific question about this device

Piccolo Composite™ Distal Fibula Plate System: The Piccolo Composite™ Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, including in osteopenic bone.
Piccolo Composite™ One-Third Tubular Plate System: The Piccolo Composite™ One-Third Tubular Plates are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, radius, ulna, pelvis, and fibula including in osteopenic bone.
Piccolo Composite™ Proximal Humerus Plate System: The Piccolo Composite™ Proximal Humerus Plate is indicated for fractures, fracture dislocations, osteotomies, and nonunions of the proximal humerus, including in osteopenic bone.
Piccolo Composite™ Distal Volar Radius Plate System: The Piccolo Composite™ Distal Volar Radius Plate is indicated for fractures and osteotomies of the distal volar radius.

The Piccolo Composite™ Distal Fibula and One Third Tubular Plate Systems comprise implants (plates and screws), and sets of instruments. The Plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), and are marked with a tantalum thread, to provide for their visualization under fluoroscopy. The Screws are made of titanium alloy. Both non-locking screws and locking screws are available, in various dimensions. The general description of the Piccolo Composite™ Proximal Humerus and Distal Volar Radius Plate Systems is not changed as compared to the predicates.

The provided document describes a 510(k) premarket notification for a medical device, the Piccolo Composite™ Plate System. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting clinical studies with specific acceptance criteria in the way a pharmaceutical or novel high-risk device might.

Therefore, the information requested regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance as typically applied to AI or diagnostic imaging devices is not applicable to this submission.

Instead, the "study" proving the device meets its acceptance criteria here is a series of biomechanical and material performance tests compared against relevant ASTM standards and predicate devices.

Here's a breakdown of the available information in the requested format, adapted for a device submission of this nature:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated as a number of "cases" or "patients." Instead, the "test set" consists of physical samples of the device components (plates and screws) that undergo biomechanical testing. The number of samples for each specific test (e.g., 4-point bending, axial bending) is not detailed in the provided summary.
• Data Provenance: The tests are likely conducted in a controlled laboratory environment. The document does not specify a country of origin for the testing data, but the applicant's address is in Herzeliya, Israel. The data is prospective in the sense that the tests are performed specifically to support this regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. For this type of device (bone plate system), ground truth is established through adherence to standardized engineering and material science testing protocols (e.g., ASTM F 382) and comparison to the known performance of predicate devices, not through expert consensus on clinical cases. The "ground truth" is the objective outcome of these physical tests.

4. Adjudication method for the test set

• Not applicable. Adjudication typically applies to ambiguous clinical or imaging data reviewed by multiple experts. For biomechanical testing, the results are typically quantitative measurements that are compared directly to predefined standards or predicate device data.

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

• Not applicable. This device is a bone plate system, not an AI or diagnostic imaging device. MRMC studies are not relevant to its regulatory approval process.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical medical implant, not an algorithm or AI system.

7. The type of ground truth used

• Engineering Standards and Predicate Device Performance: The "ground truth" for this submission is established by the requirements of recognized industry standards like ASTM F 382 for metallic bone plates, and the known, legally marketed performance characteristics (material, mechanical properties) of the identified predicate devices.

8. The sample size for the training set

• Not applicable. This device approval does not involve a "training set" in the context of machine learning or AI. The design and manufacturing process would involve internal development and testing, but not a formally defined "training set" for regulatory purposes here.

9. How the ground truth for the training set was established

• Not applicable. As a physical implant and not an AI system, there is no "training set" or corresponding "ground truth" to be established in this context. The engineering design and manufacturing processes follow established medical device quality systems.

Ask a specific question about this device

Piccolo Composite™ Diaphyseal Plate: The Piccolo Composite™ Diaphyseal Plate is indicated for the fixation of various long bones, such as the humerus, femur and tibia, including osteopenic bone, osteotomies, and nonunions or malunions in adult patients. These plates are also indicated for fracture fixation of diaphyseal areas of long bones in pediatric patients.

Piccolo Composite™ Proximal Humerus Plate: The Piccolo Composite™ Proximal Humerus Plate is indicated for fractures, fracture dislocations, osteotomies, and nonunions of the proximal humerus, including in osteopenic bone.

Piccolo Composite™ Distal Volar Radius Plate: The Piccolo Composite™ Distal Volar Radius Plate is indicated for fractures and osteotomies of the distal volar radius.

The Piccolo Composite Plate System comprises implants (plates and screws/pegs), and a set of instruments. The Plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), and are marked with a tantalum thread, to provide for their visualization under fluoroscopy. The following types of plates are available: Diaphyseal Plates (thickness: 4.5 mm or 5 mm); Proximal Humerus Plate (thickness: 3.7 mm); Distal Volar Radius Plate (thickness: 2.4 mm). The Screws (and Pegs) are made of titanium alloy. Various screw types are available, such as cortical screws and locking screws, as well as pegs (to be used only with the Distal Radius Plate), in various dimensions.

The Piccolo Composite™ Plate System is a bone plating system, and its acceptance criteria and supporting study are described below, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific numerical sample sizes for the mechanical testing (static and dynamic bending) or MR Conditional testing. It simply states that "Performance characteristics... were evaluated" and "Testing in support of the MR Conditional labeling parameters was also provided."

The data provenance is intrinsic to the device development and testing, meaning the tests were conducted in a controlled environment to assess the physical properties of the device (likely in a lab setting). This is prospective in the sense that the tests were designed and executed to evaluate the new device. There is no indication of retrospective data or country of origin for the data beyond the manufacturer's location (Israel).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable. The "test set" in this context refers to the physical devices undergoing mechanical and material property testing, not an AI algorithm evaluated against expert-established ground truth. The "ground truth" for these tests are objective, measurable physical properties, not subjective expert interpretations.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth from multiple human reviewers, which is not relevant for the mechanical and material testing performed for this device. The results of the mechanical tests are quantitative measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a mechanical implant, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. This device is a physical implant, not an algorithm. Therefore, there is no "standalone" algorithm performance to evaluate. The performance discussed is the physical integrity and characteristics of the plate itself.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation of the Piccolo Composite™ Plate System was based on:

• ASTM F 382 Standard Specification: This provides the defined methodology and criteria for evaluating the mechanical properties (static and dynamic bending) of metallic bone plates. The acceptance is based on the device's performance relative to these established standards and its predicate devices.
• Material Properties and MRI Compatibility Standards: For the CFR-PEEK material, previous clearances (K091425, K100497) established its material properties. For MR Conditional labeling, defined standards and guidelines for MRI safety testing would have been used.

8. Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI algorithm. There is no concept of a "training set" for its development in the context of machine learning. The device's material (CFR-PEEK) was previously cleared, indicating prior testing and validation for its use in medical devices.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" for this device. The "ground truth" for the material and design principles of the device would have been established through extensive material science research, engineering principles, and prior regulatory clearances for similar materials and device types.

Ask a specific question about this device