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The iNSitu Bipolar Hip System is intended for use in combination with the iNSitu Total Hip System Femoral Stems for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

• Femoral neck and trochanteric fractures of the proximal femur;
• . Osteonecrosis of the femoral head;
• . Revisions procedures where other devices or treatments for these indications have failed

The iNSitu Bipolar Hip System consists of a factory assembled UHMWPE (ASTM F648) liner in a cobalt chrome (ASTM F75) outer shell, and UHMWPE (ASTM F648) retention ring with a Ti-6Al-4V ELI (ASTM F136) spring. These Bipolar Heads include outer diameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the patient anatomy. The smaller Bipolar Heads (38 to 43 mm) have an inner diameter that mates with the subject 22mm diameter Femoral Head; the larger Bipolar Heads (44 to 60 mm) have an inner diameter that mates with the previously cleared 28 mm diameter Femoral Head. The iNSitu Bipolar Hip System may be used in conjunction with an iNSitu Total Hip System Femoral Stem (K161184/K172501) for hemiarthroplasty.

This document describes the regulatory clearance of a medical device, specifically the iNSitu Bipolar Hip System. It refers to performance testing done for a predicate device to establish substantial equivalence. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device.

The provided text is a 510(k) summary for a traditional medical device (a hip prosthesis), not an AI/ML device. Therefore, the questions related to AI/ML device performance (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (the BioPro Bipolar Head) based on identical design, materials, indications for use, and manufacturing methods.

Here's a breakdown of the relevant information provided, adapted to the context of a traditional device:

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

The document does not explicitly state "acceptance criteria" in the way one would for an AI/ML algorithm's performance metrics (e.g., sensitivity, specificity). Instead, it relies on the mechanical and functional equivalence to a predicate device.

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

• Test set sample size: Not specified. The "testing" refers to mechanical and functional tests of the physical device components, not a "test set" of data as in AI/ML.
• Data provenance: Not applicable in the context of mechanical device testing.

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. Ground truth as typically defined for AI/ML (e.g., expert consensus on medical images) is not relevant for the mechanical testing of a hip prosthesis. The "ground truth" here is adherence to mechanical and material standards and performance comparable to a predicate device.

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

Not applicable. This concept is for resolving disagreements in expert labeling of data, which is not part of this device's evaluation.

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 not an AI/ML device, so no MRMC study would be conducted for human reader improvement with AI assistance.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" for this medical device's performance is adherence to established material specifications (e.g., ASTM F75 for cobalt chromium, ASTM F648 for UHMWPE, ASTM F136 for Ti-6Al-4V) and demonstrated mechanical performance comparable to a legally marketed predicate device as determined through physical testing.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. There is no training set for this type of device.

In summary: The provided document is for a traditional hip implant, not an AI/ML powered device. The "acceptance criteria" are implied to be the successful demonstration of mechanical and material properties that are substantially equivalent to a cleared predicate device, as confirmed by physical performance testing. The questions regarding AI/ML specific aspects (sample sizes, experts, adjudication, MRMC, standalone performance, training sets, etc.) do not apply to this submission.

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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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