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The OrthAlign Plus® system is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instructures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® system facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length discrepancy in Total Hip Arthroplasty.

Example orthopedic surgical procedures include but are not limited to:

• Total Knee Arthroplasty
• · Total Hip Arthroplasty: Anterior/Posterior
• · Unicompartmental Knee Arthroplasty: Tibial transverse resection

The OrthAlign HipAlign® Sterile Pin Pack is indicated for use with the OrthAlign Plus® System.

Intended Use: The OrthAlign® HipAlign® Sterile Pin Pack is intended to be used with the OrthAlign Plus® system specific to Total Hip Arthroplasty.

The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display anqular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes,

The OrthAlign HipAliqn® Sterile Pin Pack is a set of sterile, single use pins used in conjunction with the OrthAlign Plus® system of instruments and electronics. The OrthAlign® HipAlign® Pin Pack includes:

• . Pelvic Fixation pins: 4.0mm in diameter and 90mm to 140mm in length
• Pelvic Fixation pins: 5mm in diameter and 170mm in length
• . Femoral registration markers: 4.0mm to 4.5mm in diameter and 16mm to 25mm in length

This document describes a Special 510(k) Premarket Notification for the OrthAlign HipAlign® Sterile Pin Pack, which is a modification to the previously cleared OrthAlign Plus® System (K171780). The focus of this notification is on the sterility and packaging of the pins and markers used with the system, rather than a a comprehensive AI/ML device. Therefore, the details requested in the prompt regarding AI/ML device performance, such as MRMC studies, training set ground truth establishment, and expert adjudication, are not applicable or available in this document.

However, based on the provided text, we can describe the acceptance criteria and study that proves the device meets the acceptance criteria as it relates to the modification of the device (sterility and packaging).

Device: OrthAlign HipAlign® Sterile Pin Pack, used with the OrthAlign Plus® System.

Purpose of this Submission: To demonstrate substantial equivalence of the modified sterile, single-use pins and markers to the previously cleared non-sterile, reusable pins and markers.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this submission is for a modification primarily related to sterility and packaging, the acceptance criteria and performance are focused on these aspects, ensuring the modified components are as safe and effective as the predicate.

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

The document does not specify exact sample sizes for the performance testing (e.g., number of packages tested for integrity, number of sterilization cycles validated). The testing described relates to device components (packaging and sterilization), not patient data or clinical performance studies.

• Sample Size: Not explicitly stated as numerical values for packaging and sterilization tests. It is implied that sufficient samples were used to meet validation standards for these types of tests.
• Data Provenance: The data is generated from in-house laboratory performance testing conducted by OrthAlign, Inc., as part of their design and development procedures. This is neither retrospective nor prospective patient data.

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

Not applicable. The "ground truth" here is compliance with engineering and quality standards for sterile medical devices (e.g., package integrity, sterilization efficacy). These are established through validated test methods and industry standards, not typically through human expert adjudication of medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. This type of submission does not involve adjudication of clinical data or expert consensus. It relies on objective engineering and microbiological test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for AI/ML diagnostic or assistive devices where human reader performance (e.g., radiologists interpreting images) is being augmented by AI. This submission is for surgical instrumentation components (pins and markers) and their sterility/packaging.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical surgical instrument set. It is not an algorithm, and therefore, standalone performance in the context of AI is irrelevant. The OrthAlign Plus® System itself is a "computer-controlled system intended to assist the surgeon," implying a human-in-the-loop system, but this specific submission focuses on the sterile pins and markers, not the performance of the computer-controlled system's algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this specific submission's performance evaluation is based on:

• Engineering Standards and Test Methods: For packaging integrity (e.g., ASTM standards for dye penetration, peel strength), and environmental conditioning.
• Sterilization Validation Standards: For demonstrating the effectiveness of the sterilization process (e.g., ISO, AAMI standards for EtO sterilization).
• Biocompatibility Standards: Implicit in the use of standard medical-grade materials.

These are objective, quantitative criteria, not subjective expert consensus or clinical outcomes data in the traditional sense of diagnostic AI.

8. The Sample Size for the Training Set

Not applicable. There is no software algorithm or AI model being "trained" in this submission. The device is a physical product (sterile pins and markers).

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

Not applicable, as there is no training set for an AI model.

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The intended use of the BioPro Foot Plating Systems is to draw two or more aligned bone fragments together to facilitate healing in an adult patient and is composed of the following bone plate categories:

I. Forefoot System:
The BioPro Forefoot Plating System is Indicated for Use in fixation of small bones and small bone fragments in the foot (Phalanges and Metatarsals) for stabilization of fractures, joint fusions, osteotomies , nonunions, malunions, reconstruction of small bones, revision surgeries and replantations in an adult patient. The Forefoot System is not for Spinal Use.

II. Mid & Hindfoot System:
The BioPro Mid & Hindfoot Plating System is Indicated for Use in fixation of medium/large bones and medium/large bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) for stabilization of fractures, joint fusions, osteotomies, malunions, reconstruction of medium/large bones, revision surgeries and replantations in an adult patient.

The Mid & Hindfoot System is not for Spinal Use.

III. Ankle Fracture System:
The BioPro Ankle Fracture System is Indicated for Use in:
1). Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, perarticular fractures, corrective osteotomies, non-unions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures;
2). In intra- and extra articular fractures, osteotomies, medial malleolar fractures and non-unions of the metaphyseal and diaphyseal region of the distal fibula;
3). In distal tibia/fibula long bones which include the metaphyseal and diaphyseal regions of the tibia and fibula in the ankle.

The Ankle Fracture System is not for Spinal Use.

The BioPro Foot Plating Systems consists of Predicate Foot and Ankle Bone Plate and Locking Screw implant components found with many companies with orthopedic markets in the United States. These Foot Bone Plate Systems fracture fixation & osteotomy implant devices consist of the following categories:

• 1. Forefoot System
• 2. Mid & Hindfoot System
• 3. Ankle Fracture System

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

1. The BioPro Forefoot System is designed to address a variety of indications in forefoot reconstruction fixation/osteotomy surgery. The system is composed of many locking plate types which include: 1). Straight Fracture Plates, 2). T-Shaped Fracture Plates, 3). Y-Shape Fracture Plates, 4). L-Shaped Fracture Plates, 5). Cloverleaf Fracture Plates, 6). TMT 1 Medial Fusion Plates, 7). Open Wedge Fusion Plates, 8). MTP Fusion Plates, 9). MTP Fusion Revision Plates, and 10). Dorsal TMT 1 Step Fusion Plates, - in various plate lengths, Right & Left versions. The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 2.0mm, 2.5mm, 3.0mm and 3.5mm sizes in various lengths. All plates are composed of Medical Grade CP Titanium material (to ASTM F67) with an Anodized Type II surface treatment. All screws are composed of Medical Grade 6-4 Alloyed Titanium material (to ASTM F136) color anodized for sizing.

A full set of Ancillary Instrumentation (Depth Gauge, Drill Guides, Drill Bits, Screwdrivers, Retractors, Bending Irons, K-wire with stop, Distraction/ Compression Device and MTP Fusion Reamers) is available with the system. The BioPro Forefoot System is offered both EO STERILE and Non-sterile for single-use.

2. The BioPro Mid & Hindfoot System is designed to address a variety of indications in midfoot & hindfoot reconstruction fixation/osteotomy surgery. The system is composed of many locking plate types which include:

1). Straight Fracture/Fusion Plates, 2). T-Shaped Fracture/Fusion Plates, 3). L-Shaped Fracture/Fusion Plates, 4). Cloverleaf Fracture/Fusion Plates, 5). X-Shaped Fracture/Fusion Plates, 6). Retangular Fracture/Fusion Plates, 7). Cotton Osteotomy Plates, 8). Dwyer Step Plates, 9). Evans Osteotomy Plates, 10.) Plantar TMT Plates, 11). Distal Medial & 3 - 4 Column Plates and 11). ORIF & Standard Calcaneal Plates - in various plate lengths, Right & Left versions.

The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 3.0mm, 3.5mm and 4.0mm sizes in various lengths. All plates are composed of Medical Grade CP Titanium material (to A.STM F67) with an Anodized Type II surface treatment. All screws are composed of Medical Grade 6-4 Alloyed Titanium material (to ASTM F136) color anodized for sizing.

A full set of Ancillary Instrumentation (Depth Gauge, Drill Guides, Drill Bits, Screwdrivers, Retractors, Reduction Forcepts, Bending Pliers, Osteotomes, K-Wires with stop and Distraction/Compression Device) is available with the system.

The BioPro Mid & Hindfoot System is offered both EO STERILE and Non-sterile for single-use.

3. The BioPro Ankle Fracture System is designed to address a variety of indications in ankle reconstruction mid-shaft and distal tibia/fibula fixation surgery. The system is composed of many locking plate types which include:

1). Distal Fibula Plates, 2). Medial Distal Tibia Plates, 3). AnteroLateral Distal Tibia Plates, 4). Posterior Distal Tibia T-Plates, 5). Straight Low Contact Plates, and 6). Straight 1/3 Tubular Plates - in various plate shapes, lengths, Right & Left versions. The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 2.8mm, 3.0mm, 3.5mm and 4.0mm sizes in various lengths. All plates are composed of either Medical Grade CP Titanium (to ASTM F67) or 6-4 Alloyed Titanium (to ASTM F136) materials with an Anodized Type II surface treatment. All screws are composed of Medical Grade 6-4 Alloyed Titanium material (to ASTM F136) color anodized for sizing. A full set of Ancillary Instrumentation (Depth Gauge, Drill Guides, Drill Bits, Screwdrivers, Retractors, Reduction Forcepts, Bending Pliers, Osteotomes, K-Wires with stop, and Distraction/Compression Device) is available with the system. The BioPro Ankle Fracture System is offered both EO STERILE and Non-sterile for single-use.

The provided text describes a 510(k) premarket notification for the BioPro Foot Plating Systems, asserting its substantial equivalence to legally marketed predicate devices. This type of submission relies on demonstrating similarity to existing devices and typically does not include a clinical study or acceptance criteria related to device performance in a clinical setting in the way an AI/software device would. Instead, the "acceptance criteria" here refer to regulatory requirements and engineering performance tests.

Therefore, the following information will be based on the provided text, which states what was done to support the claim of substantial equivalence for a hardware medical device, rather than the performance of an AI model.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "CLINICAL TESTING: Clinical data was not submitted."

Therefore, there are no "test sets" or "data provenance" in the context of clinical performance for this device, as it is a hardware device seeking 510(k) clearance based on substantial equivalence to existing devices, supported by non-clinical engineering analyses. The "test set" would refer to the mechanical test samples.

• Sample size for mechanical testing: Not specified in the provided text. The document refers to "An Engineering Analysis" which implies that samples of the plates and screws were subjected to mechanical tests.
• Data provenance: Not applicable in the context of clinical data. The mechanical testing would have been performed in a laboratory setting by the manufacturer or a contract lab.

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

Not applicable. "Ground truth" in this context typically refers to clinical diagnosis or outcome data, which was not used for this submission. The "ground truth" for the engineering analyses would be established by validated test methods and engineering standards.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication. Mechanical tests follow predefined protocols and analysis methods, not expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This is a hardware medical device, not a diagnostic AI/software device. MRMC studies are not relevant here.

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

No. This is a hardware medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the submission is the mechanical and material specifications outlined in recognized standards (e.g., ASTM F67, ASTM F136) and internal engineering requirements for plate strength, stiffness, screw torque, and pullout strength. The biological ground truth for biocompatibility is established through risk assessment and LAL testing for endotoxin levels, adhering to relevant standards. The ultimate "ground truth" for regulatory approval is the demonstration of substantial equivalence to predicate devices based on these engineering and material properties and intended use.

8. The Sample Size for the Training Set

Not applicable. This is a hardware medical device, not an AI/software device that requires a training set. The design of the device is based on engineering principles and knowledge of existing predicate devices.

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

Not applicable. As there is no training set for an AI model, there is no ground truth established in this manner. The design and validation relied on established engineering standards, material science, and comparisons to legally marketed predicate devices.

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