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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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (Implied)	Reported Device Performance
Plate bending strength	Performance testing under ASTM F382 and FEA analysis simulation following ASTM F382 were performed. (Details of specific values or passing thresholds are not provided in this document).
Plate bending stiffness	Performance testing under ASTM F382 and FEA analysis simulation following ASTM F382 were performed. (Details of specific values or passing thresholds are not provided in this document).
Screw insertion/removal	Performance testing under ASTM F543 was performed. (Details of specific values or passing thresholds are not provided in this document).
Screw yield torque	Performance testing under ASTM F543 was performed. (Details of specific values or passing thresholds are not provided in this document).
Screw self-tapping torque	Performance testing under ASTM F543 was performed. (Details of specific values or passing thresholds are not provided in this document).
Screw axial pullout strength	Performance testing under ASTM F543 was performed. (Details of specific values or passing thresholds are not provided in this document).
Biocompatibility	Biocompatibility Risk Assessments were performed. (Specific results not detailed).
Material equivalence	Identical CP titanium grade 2 for all plate components (to ASTM F67) and identical titanium alloy 6Al-4V for all screw components (to ASTM F136) as the predicate device.
Geometry/Dimensions/Design equivalence	Comparable in plate sizes, thickness, width, and locking features to the predicate device.
Manufacturing equivalence	Identical manufacturing steps to the predicate device.
Surface treatment equivalence	Identical anodization with Type II to the predicate device.

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.

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