Search Results

The indications for the I.T.S. Intramedullary Nailing System (INS) - Proximal Femur include intramedullary treatment of fractures and stabilization after tumor resection in the area of the proximal femur, as well as combinations that additionally affect the shaft area using the long nails.

The indications for use of the I.T.S. INS Proximal Femur include:

All Nails:

• · Stable and unstable pertrochanteric fractures
• · Intertrochanteric fractures
• · Combinations of fractures listed above

Additionally for Long Nails:

• Subtrochanteric fractures
• · Proximal fractures as listed above associated with shaft fractures
• · Pathological fractures in regions as listed above
• · Nonunions and malunions in regions as listed above

The I.T.S. INS Proximal Femur Nail consists of the following implants:

1. Nails:
   The Proximal Femur Nails are designed for the treatment of femoral fractures. The Femur Nails are available in distal diameters ranging from 9 to 14mm and lengths of 180mm (short nail), 240mm (intermediate nail), and 260 to 480mm in 20mm increments (long nail). 180mm and 240mm nails have a single, oblong hole distally, while all nails with a length over 260 have a round hole, an oblong hole and another round hole for distal fixation. The oblong hole allows for both static and dynamic locking configurations. All Trochanteric Nails are locked proximally with a Lag Screw. The set screw engages with the lag screw and allows translation while preventing rotation. Endcaps close the top of the nail and are available in 0mm, 5mm, 10mm, 15mm and 20mm lengths.

2. Lag Screw
   Lag screws are cannulated with a major diameter of 10.5mm and lengths ranging from 70mm to 130mm in 5mm increments. They are available in titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

3. Set Screw
   There are two types of set screws available. Inferior short and standard with a diameter of 6.6mm. The Length of the inferior short version is 45mm and the standard lengths are 70 to 130mm in 5mm increments. They are available in titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

4. Distal Cortical Locking Screw
   Distal locking screws are fully threaded, with a diameter of 5.0mm and lengths ranging from 25mm to 120mm in 5mm increments (2.5mm increments available from 25-70mm). Thev are available in titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

5. Instrumentation
   I.T.S. INS Proximal Femoral Nail Instrumentation consists of implant-specific targeting devices which help facilitate insertion of the nails, lag screws, and distal locking screws. Targeting devices are manufactured from stainless steel and carbon fibre reinforced PEEK. Other instrumentation includes drills, drill guides, k-wires and screwdrivers.

All nails and screws are provided Sterile for single-use.

The provided text describes a 510(k) submission for the I.T.S. INS Proximal Femur Nail. This is a medical device for intramedullary fixation, and the FDA has determined it to be substantially equivalent to previously marketed predicate devices.

However, the text does not include information about AI/ML device performance, acceptance criteria normally associated with diagnostic algorithms (like sensitivity, specificity), or details about studies involving human readers or ground truth establishment relevant to AI. The nature of this submission is for a physical medical device (an intramedullary nail), not an AI-powered diagnostic tool.

Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the provided document.

Here's a breakdown of what can be extracted from the text, focusing on the mechanical evaluation of the physical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the format typically used for AI/ML performance (e.g., minimum sensitivity). Instead, the performance is evaluated against consensus standards and compared to predicate devices for substantial equivalence.

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

Not applicable. This is a physical medical device, and the testing involved mechanical performance, not a test set of data for an AI algorithm.

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

Not applicable. Ground truth establishment by experts is relevant to AI/ML diagnostic performance, not the mechanical testing of an intramedullary nail.

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

Not applicable. Adjudication methods are relevant to expert consensus for AI/ML ground truth, not mechanical device 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

Not applicable. This device is a physical implant, not an AI-assisted diagnostic tool.

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

Not applicable. There is no AI algorithm being evaluated.

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

For the mechanical testing, the "ground truth" or standard for comparison was defined by consensus standards (ASTM F543 & ASTM F1264) and the mechanical performance of predicate devices.

8. The sample size for the training set

Not applicable. There is no AI algorithm with a training set.

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

Not applicable. There is no AI algorithm with a training set or ground truth in this context.

Ask a specific question about this device

The I.T.S. Pelvic Reconstruction Systems (PRS RX & PRS Phoenix) are indicated to stabilize one or more pelvic bone fractures in the pelvis in an adult patient.

Indications for use of the I.T.S. Pelvic Reconstruction System (PRS RX) include:

• Fractures of the acetabulum
• Fractures of the pelvic ring
• Fractures of the quadrilateral surface
• Fractures of the symphysis
• Fractures of the ilium
• Fractures of the SIJ
• Ilio-iliac distance osteosynthesis
• Symphysis pubis disruptions, osteotomies, arthrodesis and sacroiliac joint dislocations
• Revision surgery of pseudoarthroses, non-unions and mal-unions
  The I.T.S. PRS RX System is not intended for spinal use.

Indications for use of the I.T.S. Pelvic Reconstruction System (PRS Phoenix) include:

• Fractures involving the Posterior Wall & Posterior Column
• Fractures involving the Anterior Column of the Acetabulum
• Fractures involving the Quadrilateral Surface
• Symphyseal Disruptions & Para-symphyseal Fractures
• Fractures of the ilium
• Fractures of the SIJ
• Dorsal neutralization plating for posterior pelvic ring fractures
• Osteotomies, arthrodesis and sacroiliac joint dislocations
• Revision surgery of pseudoarthroses, non-unions and mal-unions
  The I.T.S. PRS Phoenix System is not intended for spinal use.

Indications for use of the I.T.S. Infra-acetabular screw placement include:

• Fractures involving the anterior column, e.g. anterior column plus posterior hemitransverse (ACPH) and associated both column (ABC) fractures
  The I.T.S. Infra-acetabular screw is not intended for spinal use.

Indications for use of the I.T.S. 8.5mm Cannulated Screws & Washer include:

• Pelvic fractures
  The I.T.S. 8.5mm Cannulated Screws & Washer are not intended for spinal use.

The I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) encompasses a number of fracture fixation subsystems of multiple plate designs for fracture fixation and reconstruction of pelvic ring fractures in the pelvis. The I.T.S. Pelvic Reconstruction Plating System (PRS RX & PRS Phoenix) consists of the following plate types: 1) A Curved Plate at a 2.5mm thickness with 4 to 16 hole length sizes, 2) A Straight Plate at a 2.5mm thickness with 10 to 14 hole length sizes, 3) A SIJ Closed Plate at a 2.5mm thickness in a 4-hole size, 4) A SIJ L-Plate at a 2.5mm thickness in a 5-hole size, 5) A J-Plate at a 2.5mm thickness with 6 to 16 hole length sizes, 6) A Symphysis Plate at a 4.0mm thickness in a 4 & 6 hole size, 7) A Symphysis Plate Curved at a 4.0mm thickness in a 6 & 8 hole size, 8) A RIM Plate at a 2.5mm thickness in a 10 & 14 hole, Right & Left size. 9) A Posterior Wall Plate at a 2.5mm thickness in a 6 hole, Right & Left size. 10) A Posterior Wall Plate II at a 2.5mm thickness in a 7 & 8 hole, Right & Left size, 11) A Quadrilateral Column Plate at a 2.5mm thickness in a Small & Large, Right & Left size, 12) A Quadrilateral Supporting Plate at a 2.5mm thickness in a Right & Left size. 13) A Posterior Wall Plate Extended at a 2.5mm thickness in a Small & Large, Right & Left size, 14) A Posterior Column Plate at a 2.5mm thickness in a 8-hole, Right & Left size, All plate designs are low profile in thickness and made from Implant Grade 2 CP Titanium material (to ASTM F67). The PRS RX & PRS Phoenix Plating System encompasses a 3.5mm Cortical Locking and Standard Screw and a 4.2mm Cancellous Locking Screw in various lengths. All bone screws are pre-drilling and self-tapping in design and manufactured from Implant Grade 5 high strength 6-4 Alloyed Titanium (to ASTM F136). A threaded Spike allows inter-operative plate fixation to bone fragments. The Spike is also manufactured from Implant Grade 5 high strength 6-4 Alloyed Titanium material (to ASTM F136). All components (plates, screws, spike) have a anodize 'DOTIZE' Type II surface treatment preparation. Ancillary instrumentation (Drills, Drill Guides, Insertion Guides, Clamps, Bending Heaver, Measuring Gauges, and Screwdrivers) is made available for bone fragment reduction and plate/screw placement and insertion. All plates, screws, spike are provided Non-Sterile for single-use.

This document describes a medical device submission, K210935, for the I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix). This device is a metallic bone fixation appliance used to stabilize pelvic bone fractures.

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

The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics with thresholds. Instead, the substantial equivalence decision is based on comparisons to predicate devices through performance testing and engineering analysis. The "performance" described is the successful completion of these tests in accordance with recognized standards.

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

The document does not specify exact sample sizes for the performance tests (e.g., number of plates or screws tested). It states "Performance testing as a consensus standard was performed under ASTM F543 for all bone screws and under ASTM F382 for bone plates and in addition a FEA analysis simulation following ASTM F382."

The data provenance is from non-clinical testing (bench testing and simulations). No human clinical data was submitted.

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 as there was no clinical study, and therefore no ground truth established by medical experts for a clinical test set. The evaluation relies on engineering and material science standards.

4. Adjudication method for the test set

This information is not applicable as there was no clinical study requiring adjudication of clinical outcomes or interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The submission explicitly states: "Clinical data was not submitted."

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

This is not applicable. The device is a physical implant (pelvic reconstruction system), not a software algorithm or AI component.

7. The type of ground truth used

This is not applicable in the context of clinical "ground truth." The "ground truth" for evaluating this device's performance is based on engineering standards and specifications (ASTM F543 for screws, ASTM F382 for plates) and the characteristics of legally marketed predicate devices.

8. The sample size for the training set

This is not applicable as the device is a physical medical implant and does not involve AI/machine learning, thus no "training set" is used.

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

This is not applicable for the same reasons as above.

Ask a specific question about this device

The intended use of the I.T.S. Hand Locking Plates System - HLS is to draw two or more aligned bone fragments together to facilitate healing in an adult patient.

The I.T.S. Hand Locking Plates System - HLS is indicated for use in fracture fixation of:

• the phalanges,
• the metacarpal bones,
• the carpal bones,
• for arthrodesis,
• for corrective osteotomies, and
• for subcapital radial head fractures.

The I.T.S. Hand Locking Plates System is not for spinal use.

The I.T.S. Hand Locking Plates System -- HLS consists of Predicate small bone trauma implant components commonly found with large companies with orthopedic markets in the United States. The I.T.S. HLS System consists of 1.0 and 1.5mm thick plates in Straight, T-Shape, Y-Shape, L-Shape (Left & Right), Extended and Square Plate configurations (with multiple hole sizing) that utilize both Locking and Non-Locking self-tapping Screws in 1.5mm, 1.8mm and 2.3mm sizes in various lengths. A 2.0mm Headless Compression Screw in various lengths is also available.

All small plate components are manufactured from Commercialy Pure (CP) Titanium material to ASTM F67 and allow for minor intra-operative forming/contouring by the surgeon to fit the small bone anatomy. All screws consist of a 6-4 Alloyed Titanium material to ASTM F136. All I.T.S. small plates and screws are processed with an anodize DOTIZE surface treatment. The low-profile and contoured small plate design minimizes soft-tissue irritation for the patient. Associated instrumentation such as Plate Holder, Drills, Drill Guides, Depth Guage, Countersink Reamers, Guide Wire and ancillary instrumentation is available. All small plates and screws are provided Non-Sterile.

This document is a 510(k) summary for the I.T.S. Hand Locking Plates System - HLS, a metallic bone fixation device. It outlines the regulatory classification, device description, intended use, and claims of substantial equivalence to predicate devices. However, it explicitly states that no nonclinical testing was used in the determination of Substantial Equivalence (SE).

Therefore, based on the provided text, there is no study described that proves the device meets specific performance acceptance criteria. The document relies on a comparison to existing predicate devices already on the market through a claim of "Substantial Equivalence."

Here's an analysis based on your requested information, noting that most of the requested details are not present in this type of regulatory submission because an actual performance study was not conducted as part of this specific 510(k) application:

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

   • Not provided. This document does not present acceptance criteria for device performance (e.g., mechanical strength, fatigue life, biological compatibility) nor does it report performance data from any conducted studies against such criteria. The basis for clearance is Substantial Equivalence to predicate devices.

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. No test set or data provenance is mentioned because no non-clinical testing was used for the determination of substantial equivalence.

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. No experts were used to establish ground truth for a test set as no performance study was conducted.

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

   • Not applicable. No test set or adjudication method is mentioned.

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 bone fixation device, not an AI-based diagnostic tool. No MRMC study was conducted or is relevant.

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

   • Not applicable. This is a bone fixation device, not an algorithm. No standalone performance evaluation was conducted.

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

   • Not applicable. No ground truth was established as no performance study was conducted.

8. The sample size for the training set:

   • Not applicable. There is no training set mentioned or implied as no algorithm or machine learning component is involved.

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

   • Not applicable. There is no training set or associated ground truth establishment process mentioned.

Summary based on the document:

The device, I.T.S. Hand Locking Plates System - HLS, obtained FDA clearance based on Substantial Equivalence (SE) to legally marketed predicate devices (Stryker - Hand Plating System, Synthes - LCP Compact Hand 1.5, Biomet/DePuy - ALPS Small Bone Locked Plating System, I.T.S. GmbH - Extremity Fixation Systems). The key statement providing this information is:

"The I.T.S. GmbH Hand Locking Plates System - HLS is Substantially Equivalent (SE) to the Stryker, Synthes, Biomet/DePuy and I.T.S. GmbH bone plate/screw systems. No nonclinical testing was used in the determination of Substantial Equivalence (SE)."

This means the device's acceptance was based on its similarity in material, geometry, design, and indications for use to already cleared devices, rather than on new performance data demonstrating its ability to meet specific acceptance criteria.

Ask a specific question about this device

The intended use of the I.T.S. IM Nail Systems is to stablilize and fix long bone fractures to facilitate healing in an adult patient and is composed of the following categories:

The I.T.S. CFN - Cannulated Femur Nail System is indicated for use in long bone femur fracture fixation which include:

Open and closed femur shaft fractures; Intertrochanteric, supracondylar and ipsilateral fractures; High subtrochanteric fractures; Combined inter and subrochanteric fractures; Pertrochanteric fractures; Pseudoarthrosis and correction osteotomy; Non-union, malunion and delayed union fractures; Pathological fractures, impending pathologic fractures, and tumor resections and; Fractures proximal to a total knee arthroplasty; The system is not for spinal use.

The I.T.S. CTN - Cannulated Tibia Nail System is indicated for use in long bone tibia fracture fixation which include:

Proximal, metaphyseal, epiphyseal and distal shaft fractures; Segmental, simple, compound and comminuted fractures; Transverse, oblique and spiral fractures; Surgically created defects using osteotomies,such as for leg length discrepencies or deformity; Pathologic fractures; Pseudoarthrosis, non-union, mal-union and delayed union of the tibia; Fractures involving osteopenic and osteoporotic bone; Open fractures of the tibia and; Reconstruction of the tibia after tumor resection and/or bone loss.

The system is not for spinal use.

The I.T.S. CHN - Cannulated Humeral Nail System is indicated for use in long bone humerus fracture fixation which include:

Dislocated, unstable 2, 3 and 4 part fractures of the proximal humerus; Valgusimpacted 4 part fractures of the proximal humerus; Proximal humeral fractures with diaphyseal extension into the shaft; Pseudoarthrosis, non-unions, mal-unions and malalignments of the proximal humerus and; Pathological and impending pathological fractures.

The system is not for spinal use.

The I.T.S. IM Nail Systems CFN-CTN-CHN consists of Predicate type intramedullary nail trauma implant components commonly found with large companies with orthopedic markets in the United States. These 'Intramedullary (IM) Nail trauma implant devices' consist of the following categories:

1. CFN - Cannulated Femur Nail System
2. CTN - Cannulated Tibia Nail System
3. CHN - Cannulated Humeral Nail System

A brief and concise description of each system is enclosed as follows:

1. CFN - Cannulated Femur Nail System: The I.T.S. CFN -Cannulated Femur Nail System is a curved/bowed Intramedullary(IM) Nail in a right and left configuration to fit the natural bow of the femur and is inserted proximally/antegrade over 3.5/3.0mm calibrated guide wires. The CFN - IM Nail is composed of various nail diameters in sizes of 9.0, 10.0, 11.0, 12.0 and 13.0mm and various lengths from 240mm to 480mm in 20mm increments. The CFN - IM Nail accepts a 6.5mm Cortical Screw in various lengths for cross-screw fixation in the larger diameter proximal region of the nail and a 4.7mm Triple-lead Cortical Screw in various lengths for crossscrew fixation in the distal portion of the nail. A dynamization slot is located in the distal portion of the nail and an End Cap (in +0, +5, +10, +15, +20, +25 & +30 lengths) is available for proximal closing of the nail. The nail proximal cross-screw insertion uses Insertion Guide instrumentation for location of the hole and screw insertion preparation throught the bone cortex and nail. The nail distal cross-screw insertion uses x-ray fluoroscopic imaging for nail distal hole/slot location.

All CFN - JM Nail, End Cap and Screw components are manufactured from Alloyed 6-4 Titanium material to ASTM F136 and are processed with an anodize DOTIZE surface treatment.

Associated instrumentation such as Insertion Guide accessories, guide pins, drill sleeves, drill guides, drills, screwdriver, depth gauge with removal instruments are available with the system. All CFN - IM Nails, End Caps and Screws are provided Non-Sterile.

2. CTN - Cannulated Tibia Nail System: The I.T.S. CTN -Cannulated Tibia Nail System is a universal straight Intramedullary(IM) Naïl with a 50 proximal and distal bend configuration to fit the anatomy of the tibia and is inserted proximally/antegrade over 3.5/3.0mm calibrated guide wires. The CTN - IM Nail is composed of various nail diameters in sizes of 9.0, 10.0. 11.0. and 12.0mm and various lengths from 240mm to 420mm in 1 5mm increments. The CTN - IM Nail accepts only the 4.7mm Triple-lead Cortical Screw in various lengths for cross-screw fixation in both the proximal/distal portion of the nail. A dynamization slot is located in the proximal portion of the nail and an End Cap (in +0, +5, +10, +15, +20, +25, +30 lengths) is available for proximal closing of the nail. The nail proximal cross-screw insertion uses Insertion Guide instrumentation for location of the hole/slot and screw insertion preparation throught the bone cortex and nail. The nail distal cross-screw insertion uses x-ray fluoroscopic imaging for nail distal hole location.

All CTN - IM Nail, End Cap and Screw components are manufactured from Alloved 6-4 Titanium material to ASTM F136 and are processed with an anodize DOTIZE surface treatment.

Associated instrumentation such as Insertion Guide accessories, guide pins, drill sleeves, drill guides, drills, screwdriver, depth gauge and removal instruments are available with the system. All CTN - IM Nails, End Caps and Screws are provided Non-Sterile.

3. CHN - Cannulated Humeral Nail System: The I.T.S. CHN -Cannulated Humeral Nail System is a right and left Intramedullary (IM) straight Nail with a 4 proximal bend configuration to fit the anatomy of the humerus and is inserted proximally over 2.0/2.5mm calibrated guide wires. The CHN - IM Nail is composed of various nail diameters in sizes of 7.0. 8.0. and 9.0mm and various lengths from 140mm to 320mm in 10 and 20mm increments. The CHN - IM Nail accepts only a 3.5mm Double-lead Cortical Screw in various lengths for cross-screw fixation in both the proximal/distal portion of the nail. An End Cap (in +0, +5, +10, +15, +20, +25 & +30 lengths) is available for proximal closing of the nail. The nail proximal cross-screw insertion uses Insertion Guide instrumentation for location of the hole and screw insertion preparation throught the bone cortex and nail. The nail distal cross-screw insertion uses x-ray fluoroscopic imaging for nail distal hole location.

All CHN - IM Nail, End Cap and Screw components are manufactured from Alloyed 6-4 Titanium material to ASTM F136 and are processed with an anodize DOTIZE surface treatment.

Associated instrumentation such as Insertion Guide accessories, guide pin, drill sleeves, drill guides, drills, screwdriver, depth gauge and removal instruments are available with the system. All CHN -IM Nails, End Caps and Screws are provided Non-Sterile.

The provided text is a 510(k) summary for the I.T.S. IM Nail Systems CFN-CTN-CHN, which describes various intramedullary nails for stabilizing and fixing long bone fractures. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study to prove acceptance criteria based on device performance metrics like sensitivity, specificity, or accuracy.

Therefore, the following information cannot be fully extracted as it is not contained within the provided 510(k) summary:

• A table of acceptance criteria and the reported device performance: This document does not establish specific performance acceptance criteria or report a study comparing the device's performance against such criteria.
• Sample size used for the test set and the data provenance: No test set is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described for a test set.
• Adjudication method for the test set: No adjudication method is described.
• 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 MRMC study is mentioned, nor is AI involved in this device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This pertains to algorithm performance and is not relevant to a physical medical device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no ground truth is established for a performance study.
• The sample size for the training set: Not applicable as this is not an AI/algorithm-based device and does not involve training sets.
• How the ground truth for the training set was established: Not applicable.

The 510(k) summary explicitly states the method used for demonstrating the device meets acceptance criteria:

Equivalence and Study that Proves the Device Meets Acceptance Criteria:

The acceptance criterion for this device is "Substantial Equivalence" to legally marketed predicate devices. The study that proves the device meets this acceptance criterion is a comparison of technological characteristics to predicate devices.

The document states:

• "The I.T.S. IM Nail Systems CFN-CTN-CHN are Substantially Equivalent(SE) to the various predicate IM Nail, End Cap and Screw Systems as listed." (Page 3)
• "No nonclinical testing was used in the determination of substantial equivalence." (Page 3)
• "The I.T.S. IM Nail Systems CEN-CTN-CHN are Similar in Material, Geometry Design/Markings, and Indications to predicate system(s) currently sold in the U.S. market." (Page 3)

This means the "study" for this 510(k) submission was a documentary comparison, not a clinical trial or performance study typical for AI/software devices. The device meets "acceptance criteria" by demonstrating that its materials, design, and intended uses are sufficiently similar to devices already approved by the FDA, thereby inferring the same safety and effectiveness.

Key information explicitly found in the document related to acceptance criteria and the "study":

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

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

• Not applicable. No test set was used for a performance study. The evaluation was based on a comparison of device specifications and indications for use against predicate devices.

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

• Not applicable. No ground truth was established by experts for a test set. The review was primarily regulatory, comparing the new device's characteristics to existing predicate devices.

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

• Not applicable. No 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:

• No MRMC study was done. This device is a physical intramedullary nail system and does not involve AI or human readers for diagnostic interpretation.

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

• Not applicable. This device is a physical intramedullary nail system and does not involve algorithms.

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

• Not applicable. For a substantial equivalence claim for a physical device like an intramedullary nail, the "ground truth" implicitly refers to the established safety and effectiveness of the predicate devices based on their prior approval and post-market experience.

8. The sample size for the training set:

• Not applicable. This is not an AI/algorithm-based device.

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

• Not applicable. This is not an AI/algorithm-based device.

Ask a specific question about this device

The intended use of the I.T.S. Extemity Fixation Systems is to draw two or more aligned bone fragments together to facilitate healing in an adult patient and is composed of the following catagories:

The I.T.S. FLS - Foot Locking Plates System is indicated for use in internal fixation, reconstruction or arthrodesis of small bones including the fore, mid and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and treatment of fractures. Not for spinal use.

The I.T.S. HCS - Headless Compression Screw System for sizes of 3.5mm or smaller is indicated for use in fixation small bone fractures or for small bone reconstruction including; mono or bicortical osteotomies in the foot or hand; distal or proximal metatarsal or metacarpal osteotomies; weil osteotomy; fusion of the first metatarsalphalangeal joint and interphalageal joint; fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.); Akin type osteotomy; distal radius fractures (articular fragments), ulnar styloid fractures, radial head fractures, capitellum fractures, humeral head fractures, glenoid fractures, intercarpal distal and proximal fusions, malleolar fractures, patellar fractures, osteochondral fractures, talonavicular fusions, tibeo-talar fusions, and cuboid fusions.

And for sizes 4.3mm or larger is indicated for use for fractures, corrective osteotomies, pseudoarthrosis, degeneralive transformations of long bones in the hindfoot and large bone intra-articular fractures of the humerus, femur, and tibia. The size of the chosen compression screw should be adapted to the specific indication. Not for spinal use

The I.T.S. HOL – Hallyx Osteotomy Locking Plate System is indicated for use as an intramedullary self-locking plate for distal metatarsal osteotomies and for Hallux Valgus osteotomies up to a corrective angle of 25°. Not for spinal use.

The I.T.S. Twist-Off Screw System is indicated for use for small bone fixation of bone fractures or for bone reconstruction. Examples include small bone fragments, Weil-Osteotomy, Mono-Cortical fixation, Osteotomies and fractures fixation in the foot and hand. Not for spinal use.

The I.T.S. Extremity Fixation Systems consists of Predicate extremity trauma implant components commonly found with large companies with orthopedic markets in the United States. These 'extremity trauma implant devices' consist of the following categories:

1. FLS - Foot Locking Plates System
2. HCS - Headless Compression Screw System
3. HOL- Hallux Osteotomy Locking Plate
4. Twist-Off Screws

A brief and concise description of each system is enclosed as follows:

1. FLS - Foot Locking Plates System: The I.T.S. FLS - Foot Locking Plates System is composed of various plate types(13) designed to address a wide variety of indications for fractures in the foot. The overall system is composed of a smaller bone series of locking plates (12 types) utilizing 2.4mm, 2.7mm and 3.0mm locking/non-locking screws and a larger bone calcaneus plate utilizing 3.5mm and 4.2mm locking/non-locking screws. The smaller bone system of twelve(12) plate designs consist of the following: (1) MTP Plate, (2) Curved Plate, (3) Straight Plate, (4) H-Shape Plate, (5) Square Plate, (6) I -- Shape Plate, (7) L-Shape Extended Plate, (8) L-Shape Extended, 1mm Step Plate, (9) L-Shape Extended 45º Plate, (10) T-Shape Plate, (11) T-Shape Extended Plate, and (12) TMT Plate. The larger bone system consists of a (13) Calcaneus Plate. All plate systems are manufactured from Commercially Pure (CP) Titanium material to ASTM F67 and allow for minor intra-operative forming/ contouring by the surgeon to fit the bone anatomy. All screws consist of 6-4 Alloyed Titanium material to ASTM F136. Small holes in the plate allow intermediate 'k-wire' bone fracture segment positioning for reducing and aligning the fracture bone segments while positioning the plate and introduction of multiple sizes of locking/non-locking screws as needed for stabilizing the fracture - when using x-ray fluroscopy. All I.T.S. Plates and Screws are processed with an anodize DOTIZE surface treatment. The low-profile and contoured plate design minimizes soft-tissue irritation for the patient.

Associated instrumentation such as disposable drills, mills & wires/guide wires, and ancillary instrumentation is available. All plates and screws are provided Non-Sterile.

HCS - Headless Compression Screw System: The I.T.S. 2. HCS - Headless Compression Screw System consists of six(6) sizes of compression screws (in sizes 2.0, 2.5, 3.0, 3.5, 4.3 and large/long bone 7.5mm) for small bone extremity and reconstruction fixation/arthrodesis procedures. All screws consist of a 6-4 Alloyed Titanium material to ASTM F136. All I.T.S. Compression Screws are processed with an anodize DOTIZE surface-treatment.

Associated instrumentation such as disposable wires/guide wires, cannulated spiral drills, countersink drills, and ancillary instrumentation is available. All screws are provided Non-Sterile.

3. HOL - Hallux Osteotomy Locking Plate: The I.T.S. HOL -Hallux Osteotomy Locking Plate consists of a Nail Plate in three(3) sizes with Screws in various lengths for Halux and distal metatarsal foot/toe bone deformities. The Nail Plate is manufactured from CP Titanium to ASTM F67 and the Screws from 6-4 Alloyed Titanium to ASTM F136. All I.T.S. Nail Plate and Screws are processed with an anodize DOTIZE surface treatment.

Associated instrumentation such as guide wire, disposable drill, template, insertion/removal and ancillary instrumentation is available. All Plates and Screws are provided Non-Sterile.

4. Twist-Off Screws: The I.T.S. Twist-Off Screws consist of a 2.0mm and 2.7mm twist-off shank screws in various lengths. All Turn-Off Screws are manufactured from 6-4 Alloyed Titanium to ASTM F136 and are utilized in metatarsal/phalangeal small bone fixation/osteotomy procedures. All I.T.S. Twist-Off Screws are processed with an anodize DOTIZE surface treatment. All Screws are provided Non-Sterile.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the I.T.S. Extremity Fixation Systems, structured according to your requested information.

It's important to note that this document is a 510(k) Summary for a medical device, which typically emphasizes substantial equivalence to predicate devices rather than novel performance studies demonstrating specific acceptance criteria.

Acceptance Criteria and Study Details for I.T.S. Extremity Fixation Systems

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not report any specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective) for performance testing.

The clearance is based on a comparison to predicate devices: "No nonclinical testing was used in the determination of substantial equivalence." This implies that the device's performance was not evaluated through a new, independent test set but rather by demonstrating similarity to existing, approved devices.

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

Not applicable. No independent test set with expert-established ground truth was reported for performance evaluation.

4. Adjudication Method for the Test Set

Not applicable. No independent test set requiring adjudication was reported.

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

No. The document explicitly states: "No nonclinical testing was used in the determination of substantial equivalence." Therefore, no MRMC study or assessment of human reader improvement with AI assistance (as this is not an AI device) was conducted or reported.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a mechanical fixation system, not an algorithm or AI-driven diagnostic tool. Therefore, a standalone algorithm performance study is irrelevant to this submission.

7. Type of Ground Truth Used

Not applicable in the context of device performance data. The "ground truth" for this 510(k) submission is the existence and established performance of the predicate devices to which the I.T.S. Extremity Fixation Systems are compared. The substantial equivalence argument relies on the well-understood clinical use and safety profile of these existing devices.

8. Sample Size for the Training Set

Not applicable. As this is a mechanical medical device, there is no "training set" in the context of machine learning or algorithms. The design and manufacturing are based on established engineering principles and material science.

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

Not applicable. See point 8.

Ask a specific question about this device

The Indications for Use of the I.T.S. GmbH - Distal Ulna Locking (DUL) and Ulna Osteotomy Locking (UOL) Plate Systems is to stabilize fractures/osteotomy in the long bone of the distal and mid-ulna of an adult patient.

The I.T.S. GmbH - Ulna Locking Plate (DUL & UOL) Systems are not intended for spinal use.

The I.T.S. Ulna Locking Plates are composed of the DUL (Distal Ulna Locking) & UOL (Ulna Osteotomy Locking) Systems which are fracture fixation plating systems for repairing bone factures located in the distal and mid-ulna bone in the human body. The DUL System consist of three(3) Standard plate lengths of 3, 4, & 6 hole and one(1) Small pre-contoured plate shape in a left/right configuration to fit the distal ulna. The UOL System consists of a single, 5 hole, straight plate for mid-ulna bone osteotomy procedures. Both plate systems are manufactured from Commercialy Pure (CP) Titanium material to allow for minor intra-operative forming/contouring by the surgeon. The plate design concept offers various type locking screw fixed-angle constructs using angular stability locking screws into the plate. Both locking and non-locking high strength 6-4 Alloyed Titanium screws in sizes of 2.4mm cortex locking, 2.7mm cortical non-locking, and 3.0mm cancellous/ cortical locking screws are offered. All screws are self-tapping for insertion into bone. Small holes in the plate allow intermediate 'k-wire' bone fracture segment positioning for reducing and aligning the fracture bone segments while positioning the plate and introduction of multiple sizes of locking/non-locking screws as needed for stabilizing the fracture -- when using x-ray fluroscopy.

All I.T.S. Ulna Locking Plates and Screws are processed with an anodize 'DOTIZE' surface treatment. The low-profile and contoured plate design minimizes soft-tissue irritation for the patient. A full compliment of instrumentation is available for use with the system.

The provided text is a 510(k) summary for the I.T.S. GmbH Ulna Locking Plates (DUL/UOL) Systems. This type of regulatory submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies.

Therefore, the prompt's request for detailed information about acceptance criteria and study design (like sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not applicable to this document.

Here's why and what information can be extracted:

• No acceptance criteria or device performance reported: The document explicitly states: "No nonclinical testing was used in the determination of substantial equivalence." This means the submission did not include new performance data from studies directly comparing the device against pre-defined acceptance criteria. Instead, it relied on the established safety and effectiveness of predicate devices.
• No study proving device meets acceptance criteria: Since no nonclinical testing was used and the determination was based on substantial equivalence, there isn't a study report proving the device meets specific performance acceptance criteria.
• Focus on Substantial Equivalence: The primary objective of this 510(k) is to demonstrate that the I.T.S. GmbH Ulna Locking Plate DUL & UOL Systems are substantially equivalent to established predicate devices already on the market regarding material, geometry design/markings, and indications for use.

Information that can be provided from the document:

1. Acceptance Criteria and Reported Device Performance:

There are no explicit acceptance criteria or reported device performance metrics in this 510(k) summary because the submission relies on demonstrating substantial equivalence to predicate devices rather than providing new performance data from the device itself.

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

Not applicable. No test set or associated data provenance is mentioned as no nonclinical testing was used for the determination of substantial equivalence.

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

Not applicable. No ground truth was established by experts for a test set, as no nonclinical testing was conducted.

4. Adjudication method for the test set:

Not applicable. No test set or adjudication method is 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:

Not applicable. This device is a bone plate system, not an AI-assisted diagnostic tool, and no MRMC study was performed or mentioned.

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

Not applicable. This device is a bone plate system, not an algorithm, and no standalone performance was assessed.

7. The type of ground truth used:

Not applicable. No ground truth definition is relevant or mentioned for this type of medical device submission. The "ground truth" here is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

Not applicable. As a physical medical device (bone plate), there is no "training set" in the context of an algorithm or AI model development.

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

Not applicable. There is no training set for this physical medical device.

Summary of what the document does state regarding equivalence:

The I.T.S. GmbH Ulna Locking Plate DUL & UOL Systems are considered substantially equivalent based on:

• Material: Composed of Commercial Purity (CP) Titanium material and high strength 6-4 Alloyed Titanium screws.
• Geometry Design/Markings: Similar to predicate systems.
• Indications for Use: To stabilize fractures/osteotomy in the long bone of the distal and mid-ulna of an adult patient.

Predicate Devices:

• Medartis AG - APTUS Ulna Plates (K103332)
• Zimmer - Periarticular Ulna Plate Systems (K082078)
• Acumed - Congruent System Acu-Loc 2 Plate (K120903 & K071715)
• TriMed - Ulnar Osteotomy Plate (K043263)
• Synthes - 2.7mm LCP Ulna Osteotomy System (K113364)
• OrthoPro - DC Ulnar Shortening System (K073228)
• I.T.S. GmbH - Straight Plate w/Angular Stability (K060156)

Conclusion:

This 510(k) summary does not contain the type of study data requested. Its purpose is to demonstrate substantial equivalence to existing devices through comparison of technological characteristics and indications for use, rather than presenting novel performance testing against specific acceptance criteria.

Ask a specific question about this device