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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, optionally, the lag screws) are made of carbon fiber reinforced polymer and incorporate small amount of titanium/titanium alloy. Tantalum markers are embedded within the carbon fiber reinforced polymer, where applicable, to enable visualization during imaging. The distal screws, and, optionally, the lag screws, are made of titanium alloy.

The provided text describes a 510(k) premarket notification for a medical device, the Piccolo Composite® Nailing System, which is an intramedullary fixation rod. The document primarily focuses on demonstrating substantial equivalence to predicate devices. It does NOT contain information related to software or AI-driven devices, and therefore, does not discuss acceptance criteria, study methodologies, or performance results in the context of AI or machine learning.

The 510(k) summary (pages 3-5) highlights:

• Intended Use/Indications for Use: Treatment of stable and unstable proximal femur fractures.
• System Description: Includes nails, screws, and instruments made of carbon fiber reinforced polymer with titanium/titanium alloy components and tantalum markers.
• Substantial Equivalence: Claimed based on intended use, design, materials, technological characteristics, and principles of operation being similar to predicate devices.
• Performance Characteristics: Mentions "static and dynamic bending of implants construct" and "bacterial endotoxin testing" were conducted, and results were "comparable to those of predicate devices."

Therefore, I cannot provide the requested information regarding acceptance criteria, study design, or performance metrics for an AI/software device as the provided document pertains to a physical medical implant device and does not involve AI or software performance evaluation.

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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 being 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 10mm 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 from the FDA regarding the CarboFix Orthopedics Limited's Piccolo Composite® Nailing System. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

The document states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA has determined the new device is as safe and effective as another legally marketed device, but it does not require a new clinical study to prove efficacy or meet specific acceptance criteria in the same way a novel device might.

The section titled "Performance characteristics for the Piccolo Composite Proximal Femur Nailing System components included static and dynamic bending of construct, rotational stiffness of construct, lag screw cutout, lag screw pullout, proximal and distal shell attachment strength, locking screw pullout and 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." indicates that various mechanical tests were performed. However, it does not provide the specific "acceptance criteria" for these tests (e.g., "bending strength must exceed X Newtons") nor does it present the "reported device performance" in a table format as requested. It only states that the results are "comparable to those of predicate devices."

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not provided in the document.
2. Sample size used for the test set and the data provenance: Not applicable as the "study" referred to is mechanical testing, not a clinical study with a test set of patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No.
7. The type of ground truth used: Not applicable in the context of clinical performance; for mechanical tests, the "ground truth" would be the engineering specifications.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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Piccolo Composite Humeral, Proximal Humerus, Tibial and Femoral Nails: Indications include simple fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. Piccolo Composite Ankle Arthrodesis Nails: Indicated for tibiotalocalcaneal arthrodesis (fusion). Specific indications include: Avascular necrosis of the talus; Failed total ankle arthroplasty; Trauma (malunited tibial pilon fracture); Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular discase; Revision ankle arthrodesis; Neuroarthropathy; Rheumatoid arthritis; Osteoarthritis; Pseudoarthrosis; Post-traumatic arthrosis; Previously infected arthrosis; Charcot foot; Severe endstage degencrative arthritis; Severe defects after tumor resection; Pantalar arthrodesis

The Piccolo Composite Nailing Systems include nails, interlocking screws and instrumentation sets. The nails are made, in general, of carbon fiber reinforced polyetheretherketone (CFR-PEEK), and are marked with tantalum markers, to provide for their visualization under fluoroscopy. The nails provide for holes at the proximal and distal sections, designed for the insertion of the titanium-alloy-made screws.

The provided text is a 510(k) summary for the CarboFix Orthopedics Ltd. Piccolo Composite® Nailing Systems. This type of submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a novel device that requires extensive clinical studies to establish safety and effectiveness from scratch. As such, the information you're requesting regarding acceptance criteria and performance studies (often seen in PMA submissions or for novel high-risk devices) is not typically found in a 510(k) summary.

A 510(k) typically relies on:

• Comparison to predicate devices: Showing that the new device has the same intended use, similar technological characteristics, and comparable performance to a legally marketed device.
• Bench testing: Mechanical and material testing to confirm that the device meets established engineering standards and performs as intended under simulated conditions.
• Material characterization: Ensuring the materials used are biocompatible and meet specifications.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the way one might see in a clinical trial report. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The performance is assessed by comparison to these predicates and through general evaluation, not quantified against specific clinical performance metrics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. The submission refers to "evaluation of expected performance characteristics" based on comparison to predicate devices, which implies bench testing and material comparisons rather than clinical trials with patient data.

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)

Not applicable. Ground truth establishment for a test set (as in a diagnostic AI study) is not part of this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication for a test set is not part of this 510(k) 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

Not applicable. This is not a diagnostic AI device, and no MRMC study is mentioned.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. This 510(k) does not present a study requiring clinical ground truth for validation. The "ground truth" for demonstrating substantial equivalence is adherence to engineering standards and functional similarity to predicates.

8. The sample size for the training set

Not applicable. This refers to an AI training set, which is not relevant for this device.

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

Not applicable. This refers to an AI training set, which is not relevant for this device.

Summary Table (based on available information):

• Intended Use: Same as predicates.
• Design: Compared to predicates.
• Materials: Compared to predicates (Carbon Fiber Reinforced PEEK with tantalum markers).
• Technological Characteristics: Compared to predicates.
• Principles of Operation: Same as predicates. |
  | Reported Device Performance | "Evaluation of expected performance characteristics and MR Conditional labeling parameters for the Piccolo Composite Nailing Systems was based on comparison to predicate devices." Conclusion: "All the above demonstrate that the device is safe and effective for its intended use." (This points to bench testing and comparison, not clinical performance metrics). |
  | Sample Size (Test Set) | Not applicable for clinical testing, likely refers to samples for bench/material testing (details not provided in summary). |
  | Data Provenance (Test Set) | Not applicable for clinical testing. |
  | Number of Experts (Ground Truth) | Not applicable. |
  | Qualifications of Experts | Not applicable. |
  | Adjudication Method (Test Set) | Not applicable. |
  | MRMC Comparative Effectiveness Study | No. Not an AI-assisted diagnostic device. |
  | Standalone Performance Study (Algorithm Only)| No. Not an AI algorithm. |
  | Type of Ground Truth Used | Not applicable. Evaluation primarily based on engineering and material standards, and comparison to predicates. |
  | Sample Size (Training Set) | Not applicable. |
  | Ground Truth Establishment (Training Set) | Not applicable. |

In essence, a 510(k) submission like this focuses on demonstrating substantial equivalence to existing devices, relying on a dossier of engineering, materials, and functional comparisons, rather than de novo clinical studies with specific performance metrics and acceptance criteria as outlined in your request.

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Indications for the Piccolo Composite Tibial and Femoral Nails include simple fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The Piccolo Composite Tibial and Femoral Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

The Piccolo Composite Nailing System includes nails, screws and a set of instruments.

The Piccolo Composite Nail, indicated for treatment of the tibia and femur, is a cannulated, cylindrical rod, made of carbon fiber reinforced polymer. The tibial nail diameter ranges from 9 to 11 mm, with lengths in the range of 260 to 400 mm; the femoral nail diameter ranges from 10 to 12 mm, with lengths in the range of 160 to 420 mm. The nails provide for holes at the proximal and distal sections, designed for the insertion of titanium-alloy-made screws. The nail has a pointed distal end, and its proximal end incorporates a thread enabling connection of insertion/extraction instrumentation.

The provided text is a 510(k) summary for the CarboFix Orthopedics Ltd. Piccolo Composite™ Nailing System. This document describes a medical device (intramedullary nailing system) and its substantial equivalence to predicate devices, rather than an AI/ML powered medical device. Therefore, the requested information about acceptance criteria, study details, ground truth, and expert involvement for AI/ML performance is not present in this document.

The document indicates that the company performed static 4-point bending evaluation, static torsion evaluation, dynamic evaluation, and evaluation supporting MR Conditional labeling, demonstrating that the device is safe and effective for its intended use. However, explicit acceptance criteria values and the detailed results of these evaluations are not provided in this summary.

Therefore, I cannot fulfill your request for the specific table and details related to AI/ML device performance and testing.

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Indications for the Piccolo Composite Tibial and Femoral Nails include simple fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The Piccolo Composite Tibial and Femoral Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

The Piccolo Composite Nailing System includes nails, interlocking screws and a set of instruments.

The Piccolo Composite Nail indicated for treatment of the tibia and femur is a cannulated, cylindrical rod, made of carbon fiber reinforced polymer. The tibial nail diameter ranges from 9 to 11 mm, with lengths in the range of 260 to 380 mm; the femoral nail diameter ranges from 10 to 12 mm, with lengths in the range of 300 to 420 mm. The nails provide for holes at the proximal and distal sections, designed for the insertion of titanium-alloy-made screws. The nail has a pointed distal end and incorporates a thread enabling connection of insertion/extraction instrumentation.

This is a submission for a medical device called the "Piccolo Composite Nailing System," which is an intramedullary nailing system for treating bone fractures. This type of submission (510(k)) focuses on demonstrating substantial equivalence to previously cleared devices, rather than comprehensive clinical performance studies like those typically seen for new drug approvals or high-risk devices. Therefore, the information provided focuses on engineering and material performance criteria rather than acceptance criteria related to diagnostic accuracy or clinical outcomes with a human-in-the-loop.

Here's an analysis of the provided text based on your request:

1. A table of acceptance criteria and the reported device performance

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

The document does not specify a "test set" in the context of clinical data or human evaluation. The tests mentioned (static bending, torsion, dynamic, MRI compatibility) are bench tests on the device itself. Therefore, sample sizes would refer to the number of nails or components tested, and the provenance would be laboratory testing rather than patient data. No patient or human subject data is mentioned for testing.

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

This information is not applicable. The "ground truth" for this device's acceptance is based on engineering standards and performance characteristics, not expert consensus on diagnostic images or clinical outcomes.

4. Adjudication method for the test set

This information is not applicable. There is no human adjudication process involved as the tests are for device performance against engineering standards.

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 was no MRMC comparative effectiveness study done. This device is a surgical implant, not an AI diagnostic tool.

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

This information is not applicable. This device is a surgical implant, not a standalone algorithm.

7. The type of ground truth used

The ground truth used for demonstrating the device's safety and effectiveness is based on engineering standards and performance characteristic comparisons to predicate devices. Specifically, compliance with or comparability to ASTM F 1264 and the results of static and dynamic mechanical tests and MR compatibility testing.

8. The sample size for the training set

This information is not applicable. There is no training set in the context of machine learning or AI as this is a medical implant, not a diagnostic algorithm.

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

This information is not applicable for the same reasons as above.

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