Search Results

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. Pelvic Reconstruction System (PRS) is to stabilize one or more pelvic bone fractures in the 'pelvic ring' area of the pelvis of an adult or pediatric patient which include the use of the following pelvic fracture fixation systems.

Indications for use of the I.T.S. PRS Low Profile - Multiple Type - Pelvic Plating System include:

1. Fracture reconstruction of the acetabulum, sacrum, illium, and entire pelvic ring,
2. Revision surgery of pseoduarthroses, non-unions and mal-unions,
3. Ilio-Iliac distance osteosynthesis,
4. Osteotomies,
5. Arthrodesis,
6. Sacroiliac joint dislocations, and
7. Symphysis pubis disruptures

Indications for use of the I.T.S. PRS Sacral Rod System include:

1. Fixation of fractures of the posterior pelvis,
2. Fixation of fractures of the posterior iliac spine,
3. Fixation of fractures of the posterior inferior illac spine,
4. Dorsal stabilization of the posterior pelvic ring for unstable pelvic ring injuries,
5. Fixation of sacral fractures, and
6. Fracture dislocations of the sacro-iliac joint

Indications for use of the I.T.S. PRS 7.3mm Cannulated SIJ Traction Screw & Washer include fracture fixation of pelvic bone fractures where indicated and for periacetabular osteotomies.

The system(s) has not been studied in spinal use, and is not intended for use in vertebral column fracture or fusion procedures.

The I.T.S. Pelvic Reconstruction System (PRS) encompasses a number of fracture fixation subsystems (multiple pelvic plate designs, sacral threaded rod, and cannulated screw & washer) for facture fixation and reconstruction of pelvic ring fractures in the pelvis.

The I.T.S. PRS Low Profile - Multiple Type - Pelvic Plating System consists of the following plate types: 1) A Straight Plate at a 2.5mm thickness with 10 to 14 hole length sizes, 2) A Curved Plate with a 108mm radius at a 2.5mm thickness with 4 to 16 hole length sizes, 3) A Curved Plate with a 88mm radius at a 2.5mm thickness also with 4 to 16 hole length sizes, 4) A Symphysis Plate at a 4.0mm thickness in both a 4 & 6 hole size, 5) A SacroIlliac-Joint (SIJ) L-Shaped Plate at a 2.5mm thickness in a left and right 5 hole size, and 6) A SIJ Closed Plate at a 2.5mm thickness in a 4 hole size.

All plate designs are low profile in thickness and made from CP of Cancellous (5.9mm std.compression & 5.9mm Locking screws) and Cortical (4.5mm std.compression screw) screw types and length sizes. All bone screws are pre-drilling and self-tapping in design and manufactured from high strength 6-4 Alloyed Titanium. All components (plates & screws) have a TIODIZE II surface treatment preparation. The I.T.S. PRS Sacral Rod System consists of a threaded pin, wedgeshaped washers, and nut/locknut design with one end of the threaded pin having a trocar point. The assembled unit is used to stabilize ilio-iliac posterior pelvic ring disruption injuries. All components are manufactured from high strength 6-4 Alloyed Titanium material and have the TIODIZE II surface preparation. The I.T.S. PRS 7.3mm Cannulated SIJ Traction Screw & Washer is a pre-drilling, self-tapping, and back-tapping screw design for guided reduction of pelvic bone fractures. Washers (flat & curved) are available for use with the screw. All 7.3mm Cannulated Screws & washers are manufactured from high strength 6-4 Alloyed Titanium and have the TIODIZE II surface preparation.

This document is a 510(k) summary for a medical device called the Pelvic Reconstruction System (PRS). It does not contain information about studies proving the device meets acceptance criteria for a medical device that analyzes data or images. This is a submission for a physical implantable device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert involvement, as these elements are not relevant to the type of device and submission described in the provided text.

The document primarily focuses on:

• Device Description: What the Pelvic Reconstruction System is and its components (plates, screws, sacral rod).
• Intended Use/Indications for Use: The medical conditions and procedures for which the device is designed to be used (e.g., stabilizing pelvic bone fractures, revision surgery, osteotomies).
• Substantial Equivalence: A comparison to existing, legally marketed devices to demonstrate that the new device is as safe and effective. This is the primary basis for clearance for this type of device.

No information regarding algorithm performance, reader studies, AI assistance, or data-driven acceptance criteria is present.

Ask a specific question about this device