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The intended use of the Ortho Solutions UltOS Plating System fixation device(s) is to draw two or more aligned small bone fragments together to facilitate healing.

The Ortho Solutions UltOS Plating System is Indicated for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones in the feet, ankles, and toes skeleton.

This implant should only be used with the Ortho Solutions UltOS Plating System. Combination with other implants or instrumentation is not permissible.

The Ortho Solutions UltOS Plating System is not intended for spinal use.

The Ortho Solutions UltOS Plating System is designed to address a variety of indications in rearfoot, midfoot, and forefoot reconstuctive fixation surgery. The overall system is composed of Twelve(12) Plate Types that accept both a smaller 2.7mm and larger 3.5mm Locking/ Non-locking Screw ( in various lengths of 8mm thru 50mm) with all screw heads of uniform size to fit any plate type. The UltOS System 'Twelve(12) Plate Types' consist of the following:

1). A Arthrodesis Wedge Plate (AWP) in 5 sizes of 0, 2, 4, 6 & 8mm. plate wedge widths,

2). A General Fusion Straight Plate (GFS) in 2 sizes of a 2 & 4 screw hole plate.

3). A General Fusion "T" Plate (GFT) in 3 sizes of a 2, 4 & 6 screw hole plate.

4). A Metatarsophalangeal Plate (MTP) in 3 sizes, Left & Right, of a Small, Medium & Large plate size,

5). A Opening Wedge Locking Plate (OWL) in 6 sizes of 0, 3, 4, 5, 6 & 7mm plate wedge widths,

6). A Opening Wedge Plate (OWP) in 6 sizes of a 0, 2.5, 3, 4, 5 & 7mm plate wedge widths.

7). A Calcaneal Step Plate (CSP) in 3 sizes of 8, 10 & 12mm plate step heights.

8). A General Fusion "X" Plate (GFX) in 4 sizes of a Extra Small, Small. Medium & Large plate size,

9). A Lapidus Plate (LAP) in 4 sizes, Left & Right, of a 0, 2, 4 & 6mm plate offset heights,

10). A Rearfoot Reconstruction Plate (RRP) in 3 sizes of a 6, 8 & 14 screw hole plate.

11). A Tarsal Fusion Plate (TFP) in 3 sizes of a 12, 14 & 16mm plate length, and

12). A Universal Locking Plate (ULP) in 5 sizes of a 12, 16, 20, 24 & 30mm plate length.

Screw diameters of 2.7mm and 3.5mm with either Locking or Non-Locking features and Cannulated 3.5mm self tapping screws in various lengths are also included in the UltOS Plating System.

Associated instrumentation such as compression and distraction pliers, disposable drills & wires/guide wires, drill guides, T8 torx screwdrivers and ancillary instrumentation is available. All plates and screws are manufactured from Alloyed Titanium Ti-6Al-4V to ASTM F136. All plates, screws, drills and K-wires are offered both 'Sterile' and 'Non-Sterile' to the customer.

The provided text is a 510(k) summary for the Ortho Solutions UltOS Plating System, a medical device for orthopedic fixation. It discusses the device's description, intended use, and argues for its substantial equivalence to currently marketed devices.

However, the document states: "No nonclinical testing was used in the determination of substantial equivalence." This means that the submission does not contain any data from a study that proves the device meets specific acceptance criteria. The basis for regulatory clearance is substantial equivalence to predicate devices based on material, geometry, and indications, not on performance data from a specific study demonstrating compliance with acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. The document explicitly states that no such testing was performed for this submission.

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The Ortho Solutions Limited Oxford Ankle Fusion Nail (AFN) System is a tibiotalocalcaneal (TTC) solid fusion system that has been developed for the following indications:

• Failed ankle replacement
• Arthritis of ankle and subtalar joint
• Correcting neuromuscular imbalance of hindfoot, where bone fusion is required
• Revision of failed ankle and/or subtalar fusion
• Revision of failed Tibiotalocalcaneal (TTC) fusion
• Talar Avascular Necrosis (AVN)
• Charcot
• Trauma
• Neuroarthropathy
• Pseudoarthrosis
• Rheumatoid arthritis

The Ortho Solutions Oxford Ankle Fusion Nail (AFN) System is composed of three(3) diameter (10, 11 & 12mm) sizes by two(2) lengths (150 & 180mm) as a straight nail, cannulated, to accept a 3.9mm Guide Pin. The cannulated nail is inserted through a dorsal heel incision over a guide wire using x-ray fluoroscopy within the ankle boney anatomy and distal tibia medullary canal. The guidewire is used to achieve adequate positioning. A Revision Nail in all sizes is also offered where the angled transverse hole is removed. A low-profile head 5.0mm Cortical Transverse Bone Screw (in 26 lengths of 20 - 115mm in 2 & 5mm increments) is used for proximal and distal multiple 'cross-screw' fixation after compression of the ankle joint space. Dynamization Slots(2) are located at the Proximal End of the nail. Also offered is a Standard and Locking End Cap for closing the distal end of the nail. The Locking End Cap rests and locks against the most distal Transverse 5.0mm Cortical Screw. For completion of long bone fractures, End Caps in 3 lengths (+0, +5 & +10) and in 3 diameters (10, 11 & 12mm) are used for distal IM Nail Length Extension as necessary. As well, all End Caps seal the end of the nail to avoid ingrowth of tissues. All bone hole preparation and bone screw insertion is with the assistance of intra-operative x-ray fluoroscopy. All implant components are offered 'Sterile' for Single Use. With the Intramedullary Nail inserted into the ankle bone, an instrument 'Targeting Arm' with alignment holes is attached to the distal end of the nail. This external Targeting Arm allows proper orientation, preparation, and alignment of the proper cannula for transverse and angled drilling of bone screw holes into the nail and ankle anatomy cortical and cancellous bone. The bone hole preparation is for proper alignment to the referenced transverse and angled holes within the Intramedullary Nail for insertion of Transverse 5.0mm Cortical Bone Screws. All implant components are made from 6-4 Alloyed Titanium material to ASTM F 136 and are anodized with a Type II surface preparation. The IM Nail, End Cap and Transverse Screws may be removed when long bone fracture(s) are healed or the ankle joint space is fused. A full complement of instrumentation (external Targeting Arm Main Jig. guide wire/pins, drill guides/sleeves, cannulated tissue protector sleeves, depth gauge, reamers, reaming rod, drills, drivers, cannulated guide tube & trocar, etc.) is available with the system. A 'sterile single use' disposable pack is available encompassing a guide pin, guide rod, drills, reamer, reaming rod and exchange tube. A implant extraction/removal instrumentation set is also made available.

The provided text is a 510(k) summary for the Oxford Ankle Fusion Nail (AFN) System. This document describes a medical device seeking market clearance based on substantial equivalence to previously approved devices, rather than comprehensive clinical studies proving independent acceptance criteria and performance metrics.

Therefore, the information listed below regarding "acceptance criteria" and various study details is largely not applicable (N/A) in the context of a 510(k) submission for a device like an intramedullary nail. The FDA's 510(k) pathway focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, not on establishing novel performance benchmarks through extensive clinical trials.

The summary emphasizes "equivalence" and "similarity in material, geometry design/markings, and indications" to predicate systems. The "Summary of Safety and Effectiveness" simply states the device is "shown to be safe and effective for use as 'sterile' and for single-use in a surgical setting," which typically refers to non-clinical testing (e.g., biocompatibility, sterilization validation, mechanical testing) and comparison to predicate devices, not specific performance criteria from a clinical study.

Here's an attempt to populate the requested table and sections based on the provided text, indicating "N/A" where the information is not present or not relevant to a 510(k) for this type of device:

Acceptance Criteria and Device Performance Study Analysis

1. Table of Acceptance Criteria and Reported Device Performance

Note: For devices cleared through the 510(k) pathway, detailed, statistically significant acceptance criteria and performance data from clinical studies are often not provided in the summary document. Instead, the focus is on demonstrating that the new device is "substantially equivalent" to existing, legally marketed predicate devices. This typically involves non-clinical (bench) testing, material characterization, and comparison of design and indications for use.

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

• Sample Size (Test Set): N/A (No clinical test set data from a study to prove acceptance criteria is described in this 510(k) summary.)
• Data Provenance: N/A (As no clinical test set is described, data provenance for such a set is also not applicable.)

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

• N/A (No human-adjudicated test set is described. The 510(k) process for this device type typically relies on engineering and material standards, and comparison to predicate devices, rather than expert-established ground truth from patient data for performance evaluation.)

4. Adjudication method for the test set

• N/A (No test set requiring adjudication 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

• N/A (This device is an intramedullary nail, not an AI-powered diagnostic or assistive device. Therefore, MRMC studies involving human readers and AI assistance are not relevant.)

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

• N/A (This device is a physical implant, not a software algorithm.)

7. The type of ground truth used

• N/A (For this type of 510(k), "ground truth" in the sense of clinical outcomes or expert labels is generally not derived directly from a new clinical study. Instead, the ground truth is often established by the successful performance and safety record of the predicate devices that the new device is compared against, along with non-clinical testing verifying material properties and mechanical performance.)

8. The sample size for the training set

• N/A (No training set is mentioned or applicable as this is not a machine learning/AI device.)

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

• N/A (No training set is mentioned or applicable.)

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The intended use of the Ortho Solutions Trauma Plates for Osteosynthesis of fixation device(s) is to draw two or more aligned bone fragments together to facilitate healing.

Ortho Solutions Bone Plates, Bone Screws, and Washers System is indicated for use in fixation of various fractured bones. Mini plates and screws 3.5mm or smaller are intended for use in small bones in the hand or foot and include the metacarpal, metatarsal, and phalange bones. Small and large plates and screws 4.0mm and larger are intended for use in large and long bones which can include the clavicle, scapula, pelvis, calcaneus, talus and long bones (humerus, ulna, radius, femur, tibia, and fibula) in the skeletal anatomy.

Ortho Solutions Compression Hip Screw CHS/SCS System is indicated for fracture fixation in the proximal and distal regions of the human anatomy skeletal femur. Specific indications include: intracapsular fractures of the femoral neck; trochaneric and subtrochanteric neck fractures; osteotomies for patients with diseases or deformities of the hip; hip arthrodesis; supracondylar fractures and distal femoral fractures.

The Ortho Solutions Trauma Plates for Osteosynthesis is not intended for spinal use.

The Ortho Solutions Trauma Plates for Osteosynthesis consists of general predicate type trauma implant components commonly found with large companies with orthopedic markets in the United States. These 'general trauma implant devices' consist of the following categories:

1. Bone Plates, Bone Screws and Washers System

2. Adult Compression Hip Screw (CHS/SCS) System

3. Bone Plates, Bone Screws and Washers System: This implant system consists of a Mini Fragment System (MFS), a Small Fragment System (SFS), and a Large Fragment System (LFS).

The Mini Fragment System is composed of 2.7mm A.C.P Plates in various hole lengths. These mini plates are secured to bone using 1.5mm, 2.0mm, and 2.7mm Cortical Screws. All Mini Fragment System plates and screws are intended for use in small bone extremity skeletal anatomy. The Small Fragment System is composed of 1/3 Tubular, 3.5mm A.C.P., 3.5mm Reconstruction, 3.5mm Cloverleaf, and 3.5mm 'T' - Plates in various hole lengths, Left, Right, and Oblique configurations. These small fragment plates are secured to bone using 3.5mm and 4.0mm cortical and cancellous screws, selftapping, partial, and fully threaded. A 7 x 3.6mm Washer is also offered. All Bone Screws with or without the washer can be used separate from the plates. All Small Fragment plates and screws are intended for use in small bone skeletal anatomy. The Large Fragment System is composed of 4.5mm Narrow A.C.P, 4.5mm Broad A.C.P., 'T', 'T-Buttress', and 'L-Buttress' Left & Right Angled Plates in various hole length configurations. These large plates are secured to bone using 4.5mm, 4.0mm Malleolar, and 6.5mm cortical and cancellous screws, self-tapping, partial, and fully threaded. A washer is also offered. All bone screws with or without the washer can be used separate from the plates. All large fragment plates and screws are intended for use in large and long bone skeletal anatomy. All bone plates, bone screws, and washers are made of surgical grade 316LVM Stainless Steel to ASTM F138. All plates, screws, and washers are offered 'sterile' to the customer.

2. Adult Compression Hip Screw (CHS/SCS) System: This implant system consists of various angled (950 for SCS, 130°, 135°, and 150° for CHS) high strength forged plates in multiple hole lengths, various Lag Screw lengths with various length Compression Screws, and various length 4.5mm Cortical Screws for securing the plate to femoral bone. Associated guide pin, drills, and ancillary instrumentation is available. The system is intended for use in repair of fractures of the femoral hip neck/head and supra-condylar area of the skeletal femur. All components are manufactured of surgical grade 316LVM Stainless Steel to ASTM F138. All plates and screws are offered 'sterile' to the customer.

This 510(k) summary for the Ortho Solutions Trauma Plates for Osteosynthesis does not contain the kind of detailed study information (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, etc.) that would typically be described for a device employing AI or requiring such rigorous validation.

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on material, geometry, design/markings, and indications for use. It's a regulatory submission for a traditional, hardware-based medical device (bone plates, screws, and washers), not a software or AI-driven diagnostic or treatment device.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, as typically understood for AI/software-based devices, is not present in this document.

However, I can extract the information that is implicitly part of a substantial equivalence claim for a traditional medical device:

Implicit Acceptance Criteria and "Study" for Substantial Equivalence

For a traditional device like the Ortho Solutions Trauma Plates, the "acceptance criteria" and "study" are interpreted through the lens of regulatory substantial equivalence. The "study" isn't a clinical trial or algorithm performance test, but rather a comparison to legally marketed predicate devices. The "acceptance criteria" are the demonstration that the new device is as safe and effective as the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

                                                                                                                                                                                                                                                                                                                                                                                                                                |

| Safety and Effectiveness: Implied by equivalence to predicates that are already deemed safe and effective. New device is safe and effective in its 'sterile' and 'single-use' condition. | "The Ortho Solutions Trauma Plates for Osteosynthesis is shown to be safe and effective for use as 'sterile' and for single-use in a surgical setting." (Page 3) The FDA's substantial equivalence determination implies that the device is considered as safe and effective as the predicate devices for its stated indications. |
| Sterility & Biocompatibility: Device components can be supplied sterile and are biocompatible for implantation. (Implicit, as 316LVM Stainless Steel is a well-established implant material) | "All plates, screws, and washers are offered 'sterile' to the customer." (Page 2) "All plates and screws are offered 'sterile' to the customer." (Page 2) Implicitly, surgical grade 316LVM Stainless Steel is known to be biocompatible for its stated use. |
| Manufacturing Quality: Device is manufactured under appropriate quality systems. (Implicit, as a requirement for all medical devices cleared by FDA) | The FDA letter mentions: "good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820)." (Page 4) This is a general regulatory requirement for the firm, not a specific performance metric, but central to device safety and effectiveness. |

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

• Sample Size: Not applicable in the context of an "algorithm only" or "human-in-the-loop" study. The "test set" here refers to the comparison of the device's specifications against predicate devices. The "sample" is the detailed technical specifications and intended use of the Ortho Solutions device components compared to the listed predicate devices.
• Data Provenance: Not applicable. This is a comparison of technical specifications and regulatory clearances, not clinical data or images.

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

• Number of Experts: Not applicable. Establishing "ground truth" with experts, typical for diagnostic software, is not relevant here. The ground truth for substantial equivalence is the established safety and effectiveness of the predicate devices as determined by regulatory bodies and clinical consensus over time.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no human adjudication of algorithm output in this context. The "adjudication" is the FDA's regulatory review process, determining if the comparison to predicate devices is sufficient for substantial equivalence.

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

• MRMC Study: No, this type of study is entirely irrelevant for a bone fixation hardware device. There are no "human readers" or "AI assistance" involved in the device's function.

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

• Standalone Study: No, this device does not involve any algorithms. It is a physical implant.

7. The type of ground truth used

• Ground Truth: The "ground truth" implicitly used for this type of submission is the established safety and effectiveness profile of the legally marketed predicate devices against which the Ortho Solutions device is compared. This is based on years of clinical use, regulatory review, and scientific understanding of biomechanics and biomaterials.

8. The sample size for the training set

• Sample Size: Not applicable. There is no "training set" as this device does not use machine learning or AI.

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

• Ground Truth Establishment: Not applicable. Refer to point 8.

In summary, the provided document is a 510(k) summary for a traditional medical device (bone plates and screws), demonstrating substantial equivalence to existing products. The framework for "acceptance criteria" and "study" in your request is designed for AI/software devices and therefore does not directly apply to this submission. The "study" here is the comparative analysis presented in the 510(k) demonstrating that the new device is "similar in material, geometry design/markings, and indications" to cleared predicate devices.

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The intended use of the Ortho Solutions Extremity Fixation Implants for Osteosymthesis System of bundled fixation device(s) is to draw two or more aligned small bone fragments together to facilitate healing. The Ortho Solutions Extremity Fixation Implants for Osteosynthesis System is used in adult patients.

The Ortho Solutions Foot Plating System (FPS) is indicated for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the feet, ankles, and toes skeleton.

The Ortho Solutions Memo Staple System is indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis. The Memo Staple is also indicated for use in fixation of soft tissue to bone such as anterior cruciate reconstruction.

The Ortho Solutions Foot Osteotomy System (FOS) is indicated for alignment and stabilization of small bone fractures including: fixation of small bones, such as those in the foot and ankle for treatment of fractures, non-unions, or mal-unions; ligament reconstructions; osteochondritis dissecans; arthrodesis of the foot and ankle; small bone osteotomies, including first metatarsal head osteotomy and metatarsal osteotomies.

The Ortho Solutions Staples System is indicated for fixation of bone fractures or bone reconstruction. The staples are also indicated for use in fixation of soft tissue to bone.

The Ortho Solutions Compression Screws System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

The Ortho Solutions TwistFix™ Snap-Off Screws System is indicated for fixation of bone fractures or for bone reconstruction. Examples include: 1) Fixation of small bone fragments, 2) Weil Osteotomy, 3) Mono-cortical fixation, and 4) Osteotomies and fractures fixation in the foot and hand.

The Ortho Solutions Extremity Fixation System (EFS) of a low profile head screw is indicated for use in fixation of small bone fractures, nonunions, arthrodesis, and osteotomies of the small bones in the hand or foot.

The Ortho Solutions Extemity Fixation Implants for Osteosynthesis System is not intended for spinal use.

The Ortho Solutions Extremity Fixation Implants for Osteosynthesis consists of Predicate Trauma Implant components commonly found with large companies with orthopedic markets in the United States. These 'small bone extremity trauma implant devices' consist of the following categories:

1. Foot Plating System (FPS)
2. Memo Staple System
3. Foot Osteotomy System (FOS)
4. Staples System
5. Compression Screws System
6. TwistFix™ Snap-Off Screws System
7. Extremity Fixation System (EFS)

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

1. Foot Plating System (FPS): The Ortho Solutions Foot Plating System (FPS) is designed to address a variety of indications in rearfoot, midfoot, and forefoot reconstuctive fixation surgery. The overall system is composed of a smaller 2.7mm and larger 3.5mm locking/nonlocking plating category of system(s). The 2.7mm system of three(3) plate designs consisting of a Universal Locking Plate 2.7 (ULP-2.7), a MetaTarso Phalangeal Plate (MPT), and a Open Wedge Locking Plate (OWL) - all utilized with either a locking or non-locking 2.7mm Screw in various lengths. The 3.5mm system of seven(7) plate designs consisting of a Universal Locking Plate 3.5 (ULP-3.5), a Lapidus Plate(LAP), a Arthrodesis Wedge Plate (AWP), a Rearfoot Reconstuction Plate (RRP), a Tarsal Fusion Plate (TFP), a Calcaneal Step Plate (CSP), and a Calcaneal Locking Plate (CLP) - all utilized with either a locking or non-locking 3.5mm Screw in various lengths. A 3.5mm Cannulated Screw System in various lengths with Washer is also included in the FPS System. Associated instrumentation such as trial plates, disposable drills & wires/guide wires, and ancillary instrumentation is available. All plates, screws, and washer are manufactured from high strength 6-4 Alloyed Titanium to ASTM F136. All plates, screws and washer are offered 'sterile' to the customer.

2. Memo Staple System: The Ortho Solutions Memo Staple System consists of four(4) staple sizes (at 10mm, 12mm, 20mm, and 25mm) manufactured from a Nickel-Titanium Nitinol material according to ASTM 2063 for foot reconstruction fixation/arthrodesis procedures. Only the room temperature superelastic properties of the nitinol material with the use of 'spreader/expander instrumention' is utilized in the surgical procedure to enact compression. Associated instrumentation such as templates, spreaders, expanders, guides, disposable drills and ancillary instrumentation is available. All Memo Staples are offered 'sterile' to the customer.

3. Foot Osteotomy System (FOS): The Ortho Solutions Foot Osteotomy System(FOS) consists of a Nail Plate/Staple with Screws in various lengths and Cannulated/Non-cannulated Compression Screws in various lengths for performing metatarsal/phalangeal osteotomies and/or small bone fixation reconstruction. All components are manufactured from CP Titanium to ASTM F67 and high strength 6-4 Alloyed Titanium to ASTM F136. Associated instrumentation such as guide wires, disposable drills and ancillary instrumentation is available. All staple plate/screw and compression screws are offered 'sterile' to the customer.

4. Staples System: The Ortho Solutions Staples System is composed of a Varisation Staple (smooth), a Compression Varisation Staple (tapered and ribbed), a Compression Staple (in 11mm, 12mm, 13mm, 15mm, and 20mm and width sizes), and a Blount Staple (in 22mm and width sizes) that are barbed/ribbed, angled, and smooth staple components manufactured from high strength 316LVM surgical grade stainless steel material according to ASTM F138. These staple systems are utilized for fixation of bone fractures or bone reconstruction and for fixation of soft tissues. A 'spreader instrument' is used to deform the compression staple diamond shape for bone compression fixation. Associated instrumentation such as spreaders and expanders with disposable drills and ancillary instrumentation is available. All Staples are offered 'sterile' to the customer.

5. Compression Screws System: The Ortho Solutions Compression Screws System consists of Cannulated Meta Compression and Cannulated Compression Screws in various lengths at a diameter of 3.0mm and is used for bone reconstruction in small bone extremities. All compression screws are manufactured from high strength alloyed Titanium to ASTM F136. Associated instumentation such as guide wires and disposable drills and ancillary instrumentation is available. All compression screws are offered 'sterile' to the customer.

6. TwistFix™ Snap-Off Screws System: The Ortho Solutions TwistFix™ Snap-Off Screws System comes in a 2.0mm and 2.5mm diameter with various lengths. All TwistFix™ Snap-Off Screws are manufactured from high strength 6-4 Alloyed Titanium to ASTM F136 and CP Titanium to ASTM F67 and are utilized in metatarsal/ phalangeal small bone fixation/osteotomy procedures. Ancillary instrumentaion with disposable drills is available. All TwistFix™ Snap-Off screws are offered 'sterile' to the customer.

7. Extremity Fixation System (EFS): The Ortho Solutions Extremity Fixation System (EFS) consists of various Cannulated and Non-cannulated Flat Head low profile Fixation Screws in diameter sizes of 2.0mm, 2.4mm, 2.7mm, and 3.5mm, in various lengths and are manufactured from high strength 6-4 Alloyed Titanium material to ASTM F136. These flat head screws allow for a low-profile head-on the cortex bone surface for reduction of tissue irritation. Associated instrumentation such as guide wires, disposable drills and ancillary instrumentation is available. All Flat Head Screws are offered 'sterile' to the customer.

The provided text is a 510(k) summary for the Ortho Solutions Extremity Fixation Implants for Osteosynthesis and does not contain information about acceptance criteria or a study proving device performance against such criteria.

The 510(k) summary focuses on establishing "substantial equivalence" to legally marketed predicate devices, meaning the device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness. This process typically relies on comparing the new device's technological characteristics and intended use to existing devices, and often involves engineering tests (e.g., mechanical strength, material biocompatibility) rather than clinical studies that establish "acceptance criteria" and "device performance" in terms of clinical outcomes or diagnostic accuracy.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from this document. The document describes:

• Device Description: Various orthopedic fixation systems (plates, screws, staples) made of titanium or stainless steel for small bone fixation in extremities.
• Intended Use: Fixation of small bone fragments, fractures, osteotomies, fusions, and soft tissue in the hand, foot, and ankle.
• Substantial Equivalence: Listing of predicate devices to which the Ortho Solutions system is considered equivalent.
• Safety and Effectiveness Summary: A general statement about being safe and effective for use as 'sterile' and for single-use, based on equivalence to predicate devices and presumably non-clinical testing.

The document does NOT include information on:

1. Acceptance Criteria and Reported Device Performance (Table): No specific performance metrics or thresholds are defined, nor are results of a study against such criteria presented.
2. Sample Size and Data Provenance (for test set): There is no mention of a "test set" in the context of clinical or diagnostic performance evaluation. The substantial equivalence is based on device characteristics, materials, and intended use.
3. Number and Qualifications of Experts for Ground Truth: Not applicable, as there is no ground truth established for a performance study.
4. Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No such study is mentioned.
6. Standalone Performance Study: No clinical or diagnostic standalone performance study is described.
7. Type of Ground Truth Used: Not applicable, as no clinical performance study is detailed.
8. Sample Size for Training Set: Not applicable, as this is not a machine learning device.
9. How Ground Truth for Training Set Was Established: Not applicable.

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The intended use of the Ortho Solutions Trauma Implants for Osteosynthesis System is to draw two or more aligned bone fragments together to facilitate healing.

Ortho Solutions K-Wires, Steinman Pins, Guide Pins, Fixation Pins, & Rush Pins are indicated for use in fixation of bone fractures, for bone reconstruction, for skeletal traction in alignment of long bone fractured segments, and as guide pins & wires for insertion of other implants.

Ortho Solutions Cerclage Wire is indicated for use for bone fracture fixation. osteotomy, arthrodesis, correction of deformity, revision procedures where other treatments or devices have been unsuccessful, and bone reconstruction procedures.

Ortho Solutions Cannulated Bone Screws and Washers are indicated for use over a guide pin or wire for aligned bone fracture fixation and bone fragment fixation. Washers of matching size to the cannulated bone screw may be used in certain applications. Cannulated bone screw sizes (with optional washer) of 4.0mm. 4.5mm. 5.0mm, 6.5mm, and 8.0mm are to be used with large and long bones in the skeletal anatomy. Specific indications, which are dependent in part on the diameter of the screw include: Minimally invasive fracture/joint reconstructions: Additive osteosynthesis for complex joint fractures; Multiple-fragment joint fractures; Femoral neck and femoral head fractures; Femoral supracondylar fractures; Tibial plateau fractures; Fractures of the head of the humerus & tibia; Cooper fractures of the tibia; Fractures of radius, wrist, ankle, elbow, and shoulder: Ligament fixation of the proximal humerus: Fractures of the acetabulum and dorsal pelvic ring: Condylar fractures; Ligament avulsion injuries; Malleolar and navicular fractures; Fractures of the calcaneus and talus; Arthrodesis of the ankle joint; and Avulsion fractures.

The Ortho Solutions Trauma Implants for Osteosynthesis System is not intended for spinal use.

The Ortho Solutions Trauma Implants for Osteosynthesis consists of general predicate type trauma implant components commonly found with large companies with orthopedic markets in the United States. These 'general trauma implant devices' consist of the following categories:

1. K-Wires, Steinman Pins, Guide Pins, Fixation Pins, Rush Pins, and Cerclage Wire
2. Cannulated Bone Screws & Washers

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

1. K-Wires, Steinman Pins, Guide Pins, Fixation Pins, Rush Pins and Cerclage Wire: These implant devices are offered in various diameters and lengths. These devices are also offered in various point configurations on one or both ends and can be partially threaded, fully threaded, smooth, or calibrated. K-Wires, Steinman Pins and Rush Pins_position and draw fractured bone together to facilitate healing. Guide Pins are used to guide other implant devices into a fractured bone site area. External Fixation Pins are driven through the skin into bone and provide position and traction of fractured bone to allow bone healing. Cerclage Wire is soft to allow a 'wrap around' of fractured bones and draw fractured bone together to facilitate healing. All K-Wires, Steinman Pins, Guide Pins, Fixation Pins, Rush Pins and Cerclage Wires are made of surgical grade 316LVM Stainless Steel to ASTM F138 and/or 6-4 Alloyed Titanium to ASTM F136. All K-Wires, Steinman Pins, Guide Pins, Fixation Pins, Rush Pins and Cerclage Wires are offered 'Sterile' to the customer.

2. Cannulated Bone Screws & Washers: These implant devices consist of various length cannulated cortical and cancellous screws in a 4.0mm, 4.5mm, 5.0mm, 6.5mm, and 8.0mm thread diameter size in a full, partial, reverse-cutting, and self-tapping configurations. Washers of various sizes are matched to each screw type. Associated guide pin, drills, and ancillary instrumentation is available. The cannulated screws are intended for use over a guide pin or wire for bone fracture and bone fragment fixation. All cannulated screws and washers are manufactured from high strength 6-4 Alloyed Titanium to ASTM F136. All cannulated screws and washers are offered 'sterile' to the customer.

This document is a 510(k) Summary of Safety and Effectiveness for the Ortho Solutions Trauma Implants for Osteosynthesis. It is a premarket notification for a medical device and therefore describes the device's indications for use and substantial equivalence to previously cleared devices, rather than presenting a study of its performance against specific acceptance criteria.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not report specific acceptance criteria or performance metrics (e.g., accuracy, sensitivity, specificity, or mechanical properties with thresholds) for the device. Instead, it relies on demonstrating substantial equivalence to existing legally marketed predicate devices.

• Mechanical properties: (e.g., tensile strength, torsional strength, fatigue life, bending strength, pull-out strength) meeting established ASTM or ISO standards for similar devices.
• Biocompatibility: (e.g., non-toxic, non-allergenic) as per ISO 10993 standards.
• Sterility assurance level (SAL).
• Clinical efficacy/safety in terms of successful fracture healing, low complication rates, etc. | The device is substantially equivalent to a long list of legally marketed predicate devices in terms of:
• Material: Surgical grade 316LVM Stainless Steel to ASTM F138 and/or 6-4 Alloyed Titanium to ASTM F136.
• Geometry Design/Markings: Similar to predicate devices.
• Indications for Use: The stated indications for individual components (K-Wires, Steinman Pins, Guide Pins, Fixation Pins, Rush Pins, Cerclage Wire, Cannulated Bone Screws & Washers) are consistent with the predicate devices.
• Safety and Effectiveness: Shown to be safe and effective for use as 'sterile' and for single-use in a surgical setting, based on equivalence. |

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

• This document is a 510(k) premarket notification for a Class II medical device (smooth or threaded metallic bone fixation fastener). For such devices, a clinical study with a specific test set and sample size is typically not required if substantial equivalence can be demonstrated through comparison to legally marketed predicate devices.
• Therefore, no specific test set or data provenance (country of origin, retrospective/prospective) related to a clinical performance study is described in this document. The "study" implicitly involved a detailed comparison of the new device's design, materials, and indications for use against the established characteristics of numerous predicate devices.

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

• Since there was no explicit clinical or performance study with a "test set" in the traditional sense, no experts were used to establish ground truth for such a set.
• The "ground truth" for substantial equivalence is based on regulatory standards and the characteristics of predicate devices already deemed safe and effective by the FDA. The review process itself involves FDA experts (e.g., within the Division of Surgical, Orthopedic and Restorative Devices).

4. Adjudication Method for the Test Set:

• No adjudication method is mentioned as there was no test set requiring human interpretation or consensus. The review process is regulatory, comparing the new device to predicates based on objective criteria (materials, design, intended use).

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typical for diagnostic imaging devices where human readers interpret images, often with and without AI assistance. The Ortho Solutions product is a sterile, single-use surgical implant, not a diagnostic tool where reader performance is assessed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• No, a standalone performance study was not done. This concept applies to AI algorithms that operate independently. The Ortho Solutions product is a physical implant, not an algorithm. Its "performance" is inherent in its physical properties and how it functions in the body when used by a surgeon.

7. The Type of Ground Truth Used:

• The "ground truth" in this context is the established safety and effectiveness of the predicate devices. The applicant demonstrates that their device shares the same fundamental scientific technology, materials, design, and intended use as these predicates, implying it will be equally safe and effective.
• For the manufacturing aspects, ground truth would also involve adherence to established material specifications (e.g., ASTM F138, ASTM F136) and Good Manufacturing Practices (GMP).

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical implant, not an AI model or algorithm that requires a "training set" of data.

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

• Not applicable. As a physical implant, there is no training set or associated ground truth in the AI/machine learning sense.

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Ortho Solutions sterile drill bits are intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc.

All Ortho Solutions Sterile Single-Use Drills Bits are manufactured from common Stainless Steel materials that are either cold-worked or heat treated for hardness cutting durability and for corrosion resistance. Ortho Solutions sterile drill bits are available in various sizes and lengths, have a fluted design, and are either in a solid or cannulated form and may be calibrated. The Ortho Solutions drill bits have various end coupling mechanisms. Ortho Solutions drill bits will be provided to the user 'sterile'. Gamma Radiation will be used to sterilize the device.

The provided 510(k) summary for Ortho Solutions Sterile Drill Bits (K102743) states that the device is substantially equivalent to the Synthes K962913 Sterile Drill Bits. This means that the device's acceptance criteria and the study proving it meets these criteria are based on demonstrating equivalence, rather than a standalone clinical study with detailed performance metrics.

Here's the information extracted from the provided text, recognizing the nature of a 510(k) SE submission:

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

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

• Sample size: Not explicitly stated as a separate test set. The claim of "identical" in material, geometry, and indications implies that the design and manufacturing specifications of the Ortho Solutions drill bits conform to the established characteristics of the predicate device (Synthes K962913). Demonstrating this identity typically involves detailed engineering comparisons and possibly verification testing on a sample of the manufactured devices, rather than a clinical "test set" in the traditional sense of a clinical trial.
• Data provenance: Not applicable in the context of a comparative effectiveness study or clinical trial. The data provenance would relate to the manufacturing specifications and design verification documentation of the Ortho Solutions device, showing its equivalence to the predicate. The predicate device's country of origin is not specified, but the manufacturing firm for the new device is based in the United Kingdom.

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

• Not applicable. Ground truth as established by experts for a test set (e.g., in an AI or diagnostic device context) is not part of this type of 510(k) submission. The "truth" here is the equivalence to the predicate device, which is a regulatory and technical assessment.

4. Adjudication method for the test set:

• Not applicable. There was no clinical "test set" requiring adjudication in the context of a clinical trial. The adjudication is regulatory, based on the FDA's assessment of the provided documentation for substantial equivalence.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially imaging) involving human interpretation with or without AI assistance, which is not applicable to a surgical drill bit.

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

• No, a standalone (algorithm-only) performance study was not done. This is also relevant for AI/software-as-a-medical-device (SaMD) products, which does not apply to a physical surgical instrument.

7. The type of ground truth used:

• The "ground truth" in this context is the identity and performance characteristics of the predicate device (Synthes Sterile Drill Bits, K962913). The Ortho Solutions device's performance is demonstrated to be equivalent to this established standard. This is based on a technical and regulatory comparison, rather than pathology, expert consensus on clinical cases, or outcomes data from the new device itself.

8. The sample size for the training set:

• Not applicable. There is no concept of a "training set" for physical surgical instruments in this type of 510(k) submission. Training sets are relevant for machine learning algorithms.

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

• Not applicable, as there is no training set.

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