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The Gamma3 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).

The U-Blade Lag Screw is also indicated for rotationally unstable fractures.

The Gamma3 System consists of Trochanteric Nails, Long Nails, standard Lag Screws, U-Blade Lag Screws, end caps, set screws, distal locking screws, and instrumentation. The purpose of this traditional 510(k) is to update and consolidate system indications and intended use, update MR labeling to reflect new testing, update the mechanical testing analysis, and reference Ø5mm IMN Screws System Locking Screws as compatible components. Additional labeling changes were also made, including operative technique consolidation, safety information updates, and the addition of the MR Conditional symbol to package labels.

This document is a 510(k) premarket notification for the Stryker Trauma GmbH Gamma3 System, an intramedullary fixation rod system. This device is not an AI/ML device, and therefore does not have acceptance criteria, a study that proves the device meets acceptance criteria, test set information, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance information.

Here's the relevant information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. This document refers to non-clinical laboratory testing, not clinical studies with human test sets. The "test set" for mechanical and MR compatibility testing would refer to the physical devices tested, but specific quantities are not provided in this summary.
• Data Provenance: Not applicable for human data. The non-clinical testing was performed in a laboratory setting.

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

• Not applicable. This device is a medical implant, and its performance is evaluated through mechanical and materials testing, not through expert review of data/images.

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

• Not applicable. This device is a medical implant, and its performance is evaluated through mechanical and materials testing, not through adjudication of human perceptions.

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 a medical implant (intramedullary fixation rod system), not an AI/ML diagnostic or assistive device. No MRMC study was conducted.

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

• Not applicable. This is a medical implant, not an algorithm or AI/ML product.

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

• Ground Truth Type: Not applicable in the context of expert review or diagnostic accuracy. For mechanical and MR compatibility testing, the "ground truth" would be established by the physical properties and behavior of the materials and device under controlled laboratory conditions, as defined by recognized industry standards (e.g., ASTM F2052, F2213, F2182, F2119) and FDA guidance.

8. The sample size for the training set:

• Not applicable. This device is a medical implant, not an AI/ML product that requires a training set.

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

• Not applicable. This device is a medical implant, not an AI/ML product.

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The indications for use of this internal fixation device include:

• Open and closed tibial fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures, and tumor resections
• Fractures involving osteopenic and osteoporotic bone
• Nonunion and malunion
  The End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF may also be used in conjunction with the T2 Alpha Femur Antegrade GT/PF Nailing System.

The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.

The T2 Alpha Tibia Nailing System is a fracture fixation system and includes sterile implants (tibial nails in various diameters, compression screw tibia and end caps) as well as non-sterile instruments (targeting devices). The sterile implants are made of titanium alloy (Ti6A14V ELI) per ASTM F136. The adapters and nail holding screws are manufactured from stainless steel. The Targeting Arm Tibia and Adjusting Device Tibia are made of stainless steel. PEEK unreinforced as well as PEEK with 30% and 50% carbon fibers. The Distal Targeting Arm Tibia is made of PEEK with 30% and 50% carbon fibers.

The IMN Screws System includes bone screws (locking screws and advanced locking screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct. All screws are made of titanium allov (Ti6Al4V ELI) per ASTM F136.

The provided FDA 510(k) summary (K193308) for the Stryker T2 Alpha Tibia Nailing System and IMN Screws System does not contain information related to software-based medical devices, AI/ML performance, or human-reader studies. Therefore, I cannot extract the acceptance criteria and study details as requested for such systems.

The document discusses implantable medical devices (intramedullary rods and bone screws) and focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and material compatibility analyses.

Here’s a breakdown of what is available in the document, which falls under traditional medical device clearance, not AI/software:

1. Table of Acceptance Criteria and Reported Device Performance

This table would typically be relevant for software performance metrics (e.g., sensitivity, specificity, AUC). For this device, the "acceptance criteria" are implied by the mechanical testing standards and successful demonstration of substantial equivalence.

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

This information is not applicable. The "test set" here refers to physical samples for mechanical and biological testing, not a dataset for an AI model.

• Sample Size: Not specified in terms of number of devices tested, but mechanical tests were performed.
• Data Provenance: Not applicable in the context of clinical data for AI. These are laboratory-based mechanical and material test results.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. "Ground truth" in this context would be the physical properties confirmed by mechanical tests and material analyses, not human interpretation of medical images or data.

4. Adjudication Method

Not applicable. There is no adjudication process described for the mechanical test results.

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

No. The document explicitly states: "No clinical testing of the T2 Alpha Tibia Nailing System has been conducted." and "No clinical testing of the IMN Screws System has been conducted."

6. Standalone (Algorithm Only) Performance

Not applicable. This device is not an algorithm or software.

7. Type of Ground Truth Used

For mechanical testing, the "ground truth" is defined by the physical behaviors and material properties measured according to established ASTM standards (e.g., ASTM F1264 for intramedullary fixation rods, ASTM F543 for metallic bone fixation fasteners). For MR compatibility, it relates to the measured displacement, torque, heating, and artifact characteristics in an MR environment. For bacterial endotoxin, it refers to a specified endotoxin limit.

8. Sample Size for the Training Set

Not applicable. This device does not use a "training set" in the context of AI/ML.

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

Not applicable.

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The indications for use of these internal fixation devices include:

• Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comminuted proximal femoral shaft fractures
• Femoral fixation required as a result of pathological disease
• Temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur
• Open and closed femoral fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures and tumor resections
• Ipsilateral femur fractures
• Fractures proximal to a total knee arthroplasty
• Nonunions and malunions
• Fractures involving osteopenic and osteoporotic bone

The indications for use of this internal fixation device include:

• Open and closed tibial fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures, and tumor resections
• Fractures involving osteopenic and osteoporotic bone
• Nonunion and malunion
  The End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF may also be used in conjunction with the T2 Alpha Femur Antegrade GT/PF Nailing System.

The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.

The IMN Instruments System is intended to enable the implantation of intramedullary nail and screw.

A Special 510(k) submission is being supplied to the U.S. FDA to gain clearance for modifications to the existing T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System and IMN Instruments System previously cleared in K180436. Modifications include an increase of shelf-life from 5 years to 10 years for the sterile implants and a change of dimensional specifications for the Advanced Locking Screw, Targeting Arm Femur GT and Targeting Arm Femur PF.

The T2 Alpha Femur Antegrade GT/PF Nailing System previously cleared in K180436 is a fracture fixation system and includes sterile implants (femoral nails in various diameter and sizes, compression screw femur, set screws and end caps) as well as non-sterile instruments (targeting devices).

The T2 Alpha Tibia Nailing System previously cleared in K180436 is a fracture fixation system and includes sterile implants (tibial nails in various diameter, compression screw tibia and end caps) as well as non-sterile instruments (targeting devices).

The IMN Screws System previously cleared in K180436 includes bone screws (locking screws and advanced locking screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct.

The IMN Instruments System includes the distal targeting device femur antegrade previously cleared in K180436. There are also associated surgical instruments (class I devices) that support the implantation and extraction of intramedullary nails and screws.

This document describes a Special 510(k) Premarket Notification for modifications to existing intramedullary nailing systems (T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, and IMN Instruments System). The submission's purpose is to demonstrate substantial equivalence to the previously cleared predicate device (K180436) for these modifications.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document explicitly states: "No clinical testing of the T2 Alpha Femur Antegrade GT/PF Nailing System has been conducted." This indicates that there was no "test set" in the context of clinical performance evaluation. The data provenance supporting the modifications (shelf-life increase and dimensional changes) would be from in-house engineering and quality testing, likely conducted by Stryker Trauma GmbH in Schoenkirchen, Germany. These are likely retrospective data based on existing product infrastructure.

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

As no clinical testing was conducted and the performance data primarily relates to engineering and quality assessments for modifications, there is no mention of "experts" establishing ground truth in the context of a clinical test set. The validation would have been performed by qualified engineers and quality control personnel within Stryker Trauma GmbH.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication by experts was used for this Special 510(k) submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned or performed. The submission is for modifications to an existing device, and clinical efficacy was not under evaluation, nor was comparison with human readers.

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

Not applicable, as this device is a physical medical implant system, not a software algorithm or AI-powered device.

7. Type of Ground Truth Used:

The "ground truth" for this submission's modifications primarily relies on:

• Engineering specifications and data: For dimensional changes, ensuring the modified components still meet their intended design parameters.
• Packaging integrity and sterility data: For the shelf-life extension, ensuring the packaging maintains sterility and functionality over the new extended period.
• Risk analysis methodology: As per DIN EN ISO 14971, to confirm that the changes do not introduce new hazards or increase existing risks.

These are established through internal quality and engineering testing, not clinical outcomes, pathology, or expert consensus on patient data.

8. Sample Size for the Training Set:

Not applicable, as this is a physical medical device and not an AI/ML algorithm requiring a training set.

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

Not applicable, for the reasons stated above.

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The indications for use of this internal fixation device include:

• Open and closed tibial fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures, and tumor resections
• Fractures involving osteopenic and osteoporotic bone
• Nonunion and malunion
  The End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF may also be used in conjunction with the T2 Alpha Femur Antegrade GT/PF Nailing System.

The indications for use of these internal fixation devices include:

• Fixation of subtrochanteric, ipsilateral neck/shaft, comminuted proximal femoral shaff fractures
• Femoral fixation required as a result of pathological disease
• Temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur
• Open and closed femoral fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures and tumor resections
• Ipsilateral femur fractures
• Fractures proximal to a total knee arthroplasty
• Nonunions and malunions
• Fractures involving osteopenic and osteoporotic bone

The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.

The IMN Instruments System is intended to enable the implantation of intramedullary nail and screw.

The T2 Alpha Tibia Nailing System is a fracture fixation system and includes sterile implants (intramedullary nails in various diameter, compression screw and end caps) as well as non-sterile instruments (targeting devices). The sterile implants are made of titanium alloy (Ti6A14V ELI) as per ASTM F136. The T2 Alpha Tibia Nailing System will be used with the locking screws cleared in K003018 (Titan Tibial Nail) and K172774 (IMN Screws System). Further, End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF of T2 Alpha Tibia Nailing System can be used with T2 Alpha Femur Antegrade GT/PF Nailing System (K172774). The T2 Alpha Tibia Nailing System will be used with the existing instruments previously cleared in K131365 (T2 Tibial Nailing System) and 510(k) exempt devices. The T2 Alpha Tibia Nailing System is intended for use with IMN Screws System and IMN Instruments System.

The IMN Screws System includes bone screws (locking screws previously cleared in K172774 and advanced locking screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct. The screws are made of titanium alloy (Ti6A14V ELI) as per ASTM F136. The IMN Screws System is intended for use with T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System and IMN Instruments System.

The IMN Instruments System includes distal targeting device femur antegrade previously cleared in K172774 as well as surgical instruments that support the implantation and extraction of intramedullary nails and screws. The IMN Instruments System is intended for use with T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System and IMN Screws System.

The T2 Alpha Femur Antegrade GT/PF Nailing System previously cleared in K172774 is a fracture fixation system and includes sterile implants (femoral nails in various diameter and sizes, compression screw, set screws and end caps) as well as non-sterile instruments.

The T2 Alpha Femur Antegrade GT/PF Nailing System will be used with the locking screws originally cleared in K003018 (Titan Tibial Nail) that have subsequently also received clearance for use in locking femoral nailing systems (K010801, T2 Femoral Nail System) as well as locking screws previously cleared in K172774 (IMN Screws System) and the T2 Lag Screw Recon previously cleared in K032898 (T2 Recon Nail System). Further, it will be used with the existing instruments previously cleared in K172774 (IMN Instruments System) and 510(k) exempt devices. The T2 Alpha Femur Antegrade GT/PF Nailing System is intended for use with IMN Screws System and IMN Instruments System.

The provided document is a 510(k) Premarket Notification for a medical device, specifically orthopaedic implants and instruments (T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, and IMN Instruments System).

This document does not describe a study involving an AI or software-as-a-medical-device (SaMD) product that requires human-in-the-loop or standalone performance evaluation with clinical data and expert ground truth. Instead, it focuses on demonstrating substantial equivalence of traditional medical devices to previously cleared predicate devices through bench testing and biocompatibility assessments. Therefore, most of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert qualifications, ground truth establishment methods, MRMC studies, and effect sizes of AI assistance are not applicable to this type of submission.

The document describes non-clinical performance data primarily from bench testing to demonstrate the substantial equivalence of the new devices or line extensions to previously cleared devices.

Here's a breakdown of the applicable and non-applicable information based on the provided text:

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

The document does not provide a quantitative table of acceptance criteria and reported device performance in the format typically seen for AI/SaMD studies. Instead, it states that "Testing demonstrated that T2 Alpha Tibia Nailing System is equivalent in mechanical performance to the predicate devices (K003018, K082770, and K040762)." Similar statements are made for the other systems.

The types of tests performed indicate the implicit acceptance criteria:

• T2 Alpha Tibia Nailing System:
  • Testing of mechanical properties per ASTM F1264
  • Fatigue strength testing (proximal and distal)
  • Cut-out testing
  • Targeting accuracy testing
  • Biocompatibility testing (ISO 10993-1, -5, -18)
  • Bacterial Endotoxin Testing
• IMN Screws System (advanced locking screws):
  • Testing of mechanical properties as per ASTM F543
  • Biocompatibility assessment (ISO 10993-1)
  • Bacterial Endotoxin Testing
• IMN Instruments System:
  • Performance testing in cadaver lab
  • Compatibility evaluation
  • Biocompatibility testing (ISO 10993-1, -5, -18)
• T2 Alpha Femur Antegrade GT/PF Nailing System:
  • Compatibility assessment

The reported "performance" is primarily a statement of equivalence or suitability to the predicate devices based on these tests. No specific numerical thresholds or results are presented.

2. Sample sizes 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 typical AI/SaMD study terms. The "test set" here refers to samples of the physical medical devices used in bench testing. The document does not specify the number of physical samples tested for each mechanical or biocompatibility test. Data provenance in terms of 'country of origin of data' or 'retrospective/prospective' is not relevant as it's not a clinical study on human subjects with data collection over time.

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 in the context of this submission refers to the established mechanical properties, biocompatibility standards, and functional performance of the devices as measured by standardized tests. It does not involve expert readers reviewing clinical cases.

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

Not applicable. There is no adjudication method described as it is not a clinical study requiring consensus among multiple readers.

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 submission is for traditional medical devices (implants and instruments), not an AI/SaMD product. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This document describes physical medical devices, not an algorithm.

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

The "ground truth" for this submission is established through objective, standardized bench testing for mechanical properties, biocompatibility standards (e.g., ISO standards), and functional performance (e.g., targeting accuracy, cadaver lab performance). It is not derived from expert consensus on medical images, pathology, or clinical outcomes data.

8. The sample size for the training set

Not applicable. This is not an AI/ML product that requires a training set.

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

Not applicable. This is not an AI/ML product that requires a training set.

In summary, this 510(k) submission for conventional orthopaedic devices focuses on demonstrating substantial equivalence through non-clinical bench testing and adherence to recognized standards, rather than clinical studies or evaluations of AI performance. Therefore, most of the detailed questions about acceptance criteria, sample sizes, expert involvement, and ground truth establishment methods as typically understood for AI/SaMD products are not relevant to this document.

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The indications for use of these internal fixation devices include:

• Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comminuted proximal femoral shaft fractures
• Femoral fixation required as a result of pathological disease
• Temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur
• Open and closed femoral fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures and tumor resections
• Ipsilateral femur fractures
• Fractures proximal to a total knee arthroplasty
• Nonunions and malunions
• Fractures involving osteopenic and osteoporotic bone

The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.

The IMN Instruments System is intended to enable the implantation of intramedullary nail and screw.

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, and IMN Instruments System. This submission encompasses multiple systems that have similar intended use and will be used together during the surgical procedure.

T2 Alpha Femur Antegrade GT/PF Nailing System: The T2 Alpha Femur Antegrade GT/PF Nailing System is a fracture fixation system and includes sterile implants (intramedullary nails in various diameter and sizes, compression screw, set screws and end caps) as well as non-sterile instruments (targeting devices). The femoral nails, compression screw and end caps are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136. The set screws are manufactured from titanium alloy (Ti6Al4V ELI) as per ASTM F136 and PEEK.

IMN Screws System: The IMN Screws System includes locking screws that are inserted through the intramedullary nail to stabilize the nail-bone construct. The locking screws are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136.

IMN Instruments System: The IMN Instruments System includes instruments that support the implantation and extraction of intramedullary nails and screws.

This FDA 510(k) summary describes the substantial equivalence of the Stryker Trauma GmbH devices: T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, and IMN Instruments System, to predicate devices. The document details performance data, but does not provide specific acceptance criteria or reported device performance in a table format, nor does it detail a study proving the device meets acceptance criteria in the way one might expect for a diagnostic or AI device. Instead, the studies aim to demonstrate mechanical equivalence and biocompatibility to existing, legally marketed predicate devices.

Here's an attempt to extract and synthesize the requested information, noting where specific details are not provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria with corresponding reported device performance values in a table format for clinical efficacy or diagnostic accuracy. Instead, the "acceptance criteria" are implied by the successful completion of various non-clinical tests demonstrating equivalence to predicate devices, biocompatibility, and MR Conditional status.

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

This is a non-clinical submission for mechanical and biocompatibility testing of medical devices (intramedullary nails, screws, and instruments). Therefore, the concept of a "test set" in the context of clinical data or diagnostic accuracy (e.g., patient samples) does not apply. The tests described are bench tests or laboratory assessments of materials and mechanical functionality.

• Sample Size for Tests: Not explicitly detailed for each specific test. The document generally states "Non-clinical testing was performed..."
• Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. The country of origin for the data is implied to be Germany, where the manufacturer (Stryker Trauma GmbH) is located. The tests are "retrospective" in the sense that they are performed on manufactured components rather than gathered from prospective clinical trials.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to a non-clinical submission for mechanical and biocompatibility testing. Ground truth in this context refers to established material standards (e.g., ASTM F136, ASTM F543, ASTM F1264) and biological safety guidelines (ISO 10993-1). Experts would be involved in designing and conducting these tests and interpreting the results against these standards, but not in establishing a "ground truth" derived from clinical judgment, pathology, or outcomes in the way one would for a diagnostic device.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or diagnostic accuracy studies where there might be disagreement among human readers or observers about a clinical finding or ground truth.

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

No MRMC study was performed or mentioned. The device is an orthopedic implant system and associated instruments, not an AI or diagnostic tool where human reader performance (with or without AI assistance) would be relevant.

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

Not applicable. This device is a physical implant and instrument system, not an algorithm or software requiring standalone performance testing.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests described is based on:

• Mechanical Standards: ASTM F1264, ASTM F543, and the mechanical properties of the predicate devices. The goal is to demonstrate equivalence to these established standards and predicate devices.
• Biocompatibility Standards: International Standard ISO 10993-1.
• Material Standards: ASTM F136 for titanium alloys, and characteristics of PEEK.
• Endotoxin Limits: Specified endotoxin limits for sterile devices.

8. Sample Size for the Training Set

Not applicable. This is a non-clinical submission for physical medical devices. There is no AI algorithm or "training set" involved.

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

Not applicable for the same reason as above.

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The Stryker SonicPin System is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization (e.g. rigid fixation implants, cast and brace). The Stryker SonicPin is designed only to be inserted with the SonicFusion equipment.

The Stryker SonicPin System consists of a sterile bioresorbable pin (implant), the SonicFusion equipment as well as associated accessories and is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization. The bioresorbable pin is implanted by the controlled application of ultrasound (SonicFusion technology). The ultrasonic energy is employed to liguefy the polymeric interface between the implant and the host bone to ensure a strong fixation with the bone after solidification.

The provided text is a 510(k) Premarket Notification from the FDA for the Stryker SonicPin System. It describes the device, its intended use, indications for use, and summaries of non-clinical tests performed to demonstrate substantial equivalence to a predicate device.

Crucially, the document explicitly states: "Clinical testing was not required for this submission."

This means that the device's acceptance criteria and performance were not evaluated through a study involving human subjects or AI-assisted diagnostic performance. Instead, the clearance was based on demonstrating substantial equivalence to a previously cleared predicate device fundamentally through non-clinical testing.

Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets those criteria (especially points 1 through 7, and 9 for a clinical context) cannot be extracted from this document, as a clinical study was not performed.

Here's what can be addressed based on the provided text:

Acceptance Criteria and Device Performance

Since no clinical study was conducted for this 510(k) submission, there are no acceptance criteria related to a diagnostic device's performance (e.g., sensitivity, specificity, or human improvement with AI). The acceptance here is based on the device demonstrating equivalence to its predicate through non-clinical means.

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

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

• This information is not applicable as no clinical test set was used for patient outcomes or diagnostic performance evaluation. The "test set" would refer to the physical devices subjected to non-clinical mechanical, material, and biocompatibility tests. The provenance of the data is from the manufacturer's (Stryker Trauma GmbH) non-clinical laboratory testing.

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

• Not applicable as no clinical test set requiring expert ground truth for diagnostic or outcome assessment was used.

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

• Not applicable as no clinical test set requiring adjudication was used.

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 bioresorbable pin for bone fixation, not an AI diagnostic tool. No MRMC study was performed.

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

• Not applicable. This is a physical medical device, not a standalone algorithm.

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

• Not applicable for a clinical context. The "ground truth" for this submission was the established performance and safety profiles of the predicate device, against which the modified device's non-clinical performance was compared to demonstrate equivalence.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

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The Stryker SonicPin System is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization (e.g. rigid fixation implants, cast and brace). The Stryker SonicPin is designed only to be inserted with the SonicFusion equipment.

The Stryker SonicAnchor System is intended to be used for suture or tissue fixation in open procedures in the foot, ankle, knee, hand, wrist, elbow and shoulder. The Stryker SonicAnchor is designed only to be inserted with the SonicFusion equipment.
Indications Include:
Foot/Ankle
• Achilles Tendon Repair
• Lateral Stabilization
• Medial Stabilization
• Hallux Valgus Reconstruction
• Midfoot Reconstruction
• Metatarsal Ligament Repair
• Digital Tendon Transfer
Shoulder
• Acromio-Clavicular Separation Repair
• Proximal Deltoid Repair
Elbow
• Ulnar or Radial Collateral Ligament Reconstruction
Knee
• Patellar Tendon Repair
Hand/Wrist
• Scapholunate Ligament Reconstruction
• Carpal Ligament Reconstruction
• Repair/Reconstruction of Collateral Ligaments

Stryker SonicPin System: The Stryker SonicPin System consists of a sterile bioresorbable pin implant, the SonicFusion equipment and associated accessories intended for the internal fixation of bone fractures and fragments. The pin is made of PLDLLA (Poly(L-lactide-co-D.L-lactide) which has been evaluated for magnetic resonance safety and is implanted using SonicFusion technology which is a process that employs ultrasonic energy to liquefy a polymer and facilitate a fixed interface between the implant and host bone. The associated accessories include: SonicFusion equipment, Drill, Handpiece Tip, TipTool, Direct Depth Gauge.

Stryker SonicAnchor System: The Stryker SonicAnchor System consists of a bioresorbable anchor with suture implant, the SonicFusion equipment and associated accessories intended for the fixation of suture or soft tissue to cancellous bone. The implant is comprised of the anchor, made of PLDLLA (Poly(L-lactide-co-D,L-lactide) which has been evaluated for magnetic resonance safety and a Teleflex Force Fiber suture, made of braided ultrahigh molecular weight polyethylene (UHMWPE) and polypropylene (PP) strands. The associated accessories include: SonicFusion equipment, Drill, Handpiece Tip, TipTool.

This document describes the Stryker SonicPin System and the Stryker SonicAnchor System, both of which utilize the SonicFusion equipment. The information provided outlines the regulatory clearance for these devices based on substantial equivalence to predicate devices, supported primarily by non-clinical testing.

Here's an analysis of the acceptance criteria and the supporting study information based on the provided text:

• Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving performance against specific acceptance criteria for a novel device. Therefore, the "acceptance criteria" here are implicitly defined by the performance of the predicate devices and general safety/effectiveness standards for the device type. The "reported device performance" refers to the results of the non-clinical tests conducted to demonstrate this equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify sample sizes for any of the mechanical, biocompatibility, electrical safety, EMC, or software verification tests.
• The data provenance is not explicitly stated as country of origin, retrospective, or prospective. However, based on the nature of the tests (mechanical, biocompatibility, electrical, software), these are typically performed in a controlled laboratory or testing facility environment, usually prospective for a regulatory submission. The submitter is Stryker Trauma GmbH, Germany.

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 applicable as the studies are primarily non-clinical engineering and laboratory tests (mechanical, biocompatibility, electrical, software). There is no mention of expert-established ground truth in a clinical context for these tests.

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

• This information is not applicable. Adjudication methods are typically used in clinical trial settings, especially for establishing ground truth from multiple readers/observers. The described studies are non-clinical engineering and laboratory tests.

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, an MRMC comparative effectiveness study was not done. This submission is for medical devices (pins and anchors) and associated equipment, not an AI or imaging diagnostic device.

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

• This concept is not applicable to these medical devices. These are physical implants and associated surgical tools, not an algorithm.

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

• For the mechanical testing, the "ground truth" is defined by established engineering principles and standards for evaluating material properties and device performance (e.g., tensile strength, fatigue strength).
• For biocompatibility testing, the "ground truth" is established by recognized international standards (ISO 10993 series) and FDA guidance for biological evaluation.
• For electrical safety and EMC, the "ground truth" is compliance with international standards (IEC 60601-1, IEC 60601-1-2).
• For software verification and validation, the "ground truth" is the successful execution of planned tests according to predefined specifications as outlined in FDA guidance.
• No expert consensus, pathology, or outcomes data (clinical ground truth) were used, as clinical testing was not required.

8. The sample size for the training set

• This information is not applicable. There is no "training set" as these are not machine learning or AI models.

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

• This information is not applicable as there is no "training set."

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