Search Results

The Shotel Ankle Arthrodesis Nail System is intended for the following:

• Charcot Foot
• Avascular necrosis of the talus
• Failed total ankle arthroplasty
• Trauma (malunited tibial pilon fracture)
• Severe deformity or instability as a result of talipes equinoivarus, cerebral vascular accident, paralysis or other neuromuscular disease
• Revision ankle arthrodesis
• Neuroarthropathy
• Rheumatoid arthritis
• Osteoarthritis
• Pseudoarthrosis
• Post-Traumatic arthrosis
• Previously infected arthrosis
• Severe end stage degenerative arthritis
• Severe defects after tumor resection
• Pantalar arthrodesis

The Shotel Ankle Arthrodesis Nail System is an implantable intramedullary system of fusion nails, bone screws, a nail cap and a set of instruments for primary ankle fusion. The curved fusion nail has 6 screw holes that can accommodate up to 6 bone screws and is available in seven (7) diameters in two configurations, left and right. The four (4) distal cross locking holes provide the surgeon with either a static or dynamic cross locking hole in alternative 90 degree orientation configurations. The 5mm fixation bone screws are offered in 27 lengths and the nail caps are available in two configurations; standard nail cap length and a plus 5 mm nail cap length affording the surgeon the ability to slightly adjust the final nail assembly length. All three implant components are manufactured from titanium Ti-6Al-4V and are single use only. Components are offered sterile and non-sterile.

This document is a 510(k) premarket notification for a medical device called the "Shotel Ankle Arthrodesis Nail System." It describes the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to legally marketed predicate devices.

Here's a breakdown of the requested information based on the provided text, with a strong caveat: This document is a regulatory submission for a medical implant (a nail system), not an AI/software as a medical device (SaMD) or diagnostic imaging device. Therefore, many of the requested elements (like acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable or not provided in the context of this type of device.

The "performance data" referred to in this document relates to mechanical and material performance of the implant, not diagnostic accuracy or AI performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. This is not a study assessing a diagnostic or AI device with a test set of data. The "testing" refers to physical and mechanical evaluation of the implant itself, not evaluation on patient data.
• Data Provenance: Not applicable in the context of diagnostic/AI data. The materials and mechanical tests were performed on the device components.

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 typically understood for diagnostic/AI studies (e.g., expert consensus on images, pathology results) is not relevant for this mechanical device submission.

4. Adjudication method for the test set

• Not applicable. There is no "test set" in the diagnostic/AI sense to adjudicate.

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 a study involving human readers or AI assistance.

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

• Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used

• Not applicable in the diagnostic/AI sense. The "ground truth" for this device's performance would be established through engineering standards (e.g., ASTM F1264) and measurements comparing the device's physical properties to those standards and predicate devices.

8. The sample size for the training set

• Not applicable. There is no training set as understood for AI/machine learning.

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

• Not applicable. There is no training set for this device.

Ask a specific question about this device

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.

Ask a specific question about this device

The BioPro - Infinity™ Plate Anchor System is indicated for ligament reattachment or fixation. The BioPro Infinity™ Plate and Screw(s) is supplied 'sterile' and intended for 'singleuse' only. The system is not intended for spinal use.

The BioPro- Infinity™ Plate Anchor System is a multiple plate system composed of a: 1). 2-hole Curved Plate, 2). 1-hole 10mm Plate, 3). 1-hole 12mm Plate, 4). 1-hole 14mm Plate, 5). 3-hole Flat Straight Plate, and 6). 3-hole T-Plate. Two(2) 3.0mm Cancellous Screws in a 15mm and 20mm length accompany the system for fixing the plate through soft-tissue to bone. Both the plates and screws are manufactured from 6-4 Alloyed Titanium to ASTM F136 with an anodize Type II surface treatment. Ancillary screwdriver and K-wire instrumentation is offered as 'sterile' and disposable and is made available for implantation and removal of the device. The plate and screw implant combination with instrumentation is sold in a 'sterile' condition for single-use. The sterilization method used is Ethylene Oxide.

The BioPro – Infinity™ Plate Anchor System is a medical device in the field of orthopedics, specifically designed for ligament reattachment or fixation.

Here's an analysis of its acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary does not explicitly list quantitative acceptance criteria in the typical format of metrics like accuracy, sensitivity, or specificity. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device.

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

The provided document does not contain information about a test set in the context of a clinical trial or performance study with human subjects or a defined dataset. The "study" for this device's acceptance is primarily a comparative analysis against a legally marketed predicate device (Synthes - Metallic Spiked Washers, K013806) to demonstrate substantial equivalence. Therefore, there is no explicit test set with a sample size or data provenance in the traditional sense of a performance study.

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

This information is not applicable as there was no test set in the context of diagnostic interpretation or a clinical performance study requiring expert ground truth establishment. The "ground truth" for demonstrating equivalence is based on engineering principles, material science, and regulatory evaluation by the FDA, correlating the new device's characteristics to those of the predicate.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. There was no test set requiring multi-reader adjudication.

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 done. This type of study is typically performed for diagnostic imaging devices to assess the impact of AI on human reader performance. The BioPro - Infinity™ Plate Anchor System is a surgical implant, not a diagnostic tool.

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

No, a standalone performance study was not done. This device is a passive surgical implant; it does not involve algorithms or AI, nor does it have a "standalone" operational mode in the way a diagnostic algorithm would. Its performance is tied to its mechanical properties and biocompatibility as an implant.

7. The Type of Ground Truth Used:

The "ground truth" used for the acceptance of this device is primarily regulatory precedent and engineering standards. The ground truth is that the predicate device (Synthes - Metallic Spiked Washers) is safe and effective and legally marketed. By demonstrating that the BioPro - Infinity™ Plate Anchor System is "substantially equivalent" in materials, design, and indications, the new device is then considered to share the safety and effectiveness profile of the predicate. This involves:

• Engineering specifications and material property verification: Ensuring the titanium alloy meets ASTM F136 and the anodization is Type II.
• Design comparison: Assessing the geometry and form factor against the predicate.
• Intended use comparison: Verifying the indications are the same or highly similar.
• Sterilization validation: Ensuring the Ethylene Oxide method is effective.

8. The Sample Size for the Training Set:

Not applicable. This device is a mechanical implant and does not involve machine learning or AI, and therefore does not have a "training set" in the computational sense.

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

Not applicable. As there is no training set for an AI/ML algorithm.

Ask a specific question about this device

The BioPro Kwick-Wire™ Universal Screw System is indicated for use in the internal fixation of fractures, fusions and revisions. The system is intended for but not limited to hand surgery, orthopedic surgery and podiatric surgery - but is not intended for Spinal Use.

The BioPro Kwick-Wire™ Universal Screw System comes in two diameter pin sizes of 2.5mm and 3.0mm and in a length of 4.0in. and is used for reduction and fixation of fractures appropriate for the size of the device. A mating compression nut of either the 2.5mm or 3.0mm size is mated with the proper pin size. Both the pin and nut are manufactured from either high strength 6-4 Alloyed Titanium to ASTM F136 or high strength 316 LVM Stainless Steel to ASTM F138. Ancillary instrumentation is available for device implantation and removal. The implant is sold in a 'sterile' condition for single-use. The sterilization method used is Ethylene Oxide.

The provided document is a 510(k) summary for the BioPro Kwick-Wire™ Universal Screw System, which is a medical device for internal fixation of fractures, fusions, and revisions. It is a regulatory submission for premarket notification to the FDA, not a study evaluating the device's performance against specific acceptance criteria.

Therefore, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria.

Specifically, the document states:

• "No nonclinical testing was used in the determination of substantial equivalence." (Page 1, Section "EQUIVALENCE")
• The determination of substantial equivalence is based on the device being "Similar in Material, Geometry Design/Markings, and Indications to other predicate system(s) currently sold in the U.S. market." (Page 1, Section "SUMMARY OF TECH-NOLOGICAL CHAR-ACTERISTICS")

This means the submission relies on the established safety and effectiveness of predicate devices, rather than presenting new performance data for the BioPro Kwick-Wire™ Universal Screw System.

As such, I cannot provide the requested information for the following points:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

Ask a specific question about this device

• A press fit implant for arthritic degradation of the metatarso-phalangeal joint that has resulted in disabling pain, limited motion and loss of the normal ambulatory function of the forefoot.
• Degenerative arthritis
• Rheumetoid arthritis
• Bunion deformity associated with arthritis of the metatarsal-phalangeal joint
• A titanium version is available for use only in patients susceptible to nickel-chromium allergies.
  The BioPro Hemi-Edge Toe System is not intended for spinal use.

The BioPro Hemi-Edge Toe System will be available in two material options: it can be manufactured from either Cobalt Chrome (ASTM F1537) or Titanium 6-4 (ASTM F1472). The system will be available in 5 sizes in both porous and non-porous coated versions as a press fit design. The basic implant design is unchanged to the original design which consists of a contoured articulating surface to simulate the normal concave articulation of the proximal phalanx in the toe. The current implant is a modification to the original implant design which includes a partial surrounding lip or rim adjacent the outer perimeter of the articulating surface. The purpose of the lip/rim is to prevent osteophyte bone on-growth to the articular surface that could inhibit function of the device. Two(2) small windows in opposite comers of the lip/rim allow either visual or needle verification in seating of the prosthesis on resected bone. The current implant design still includes the diamond shaped stem which provides a press-fit intra-medullary fixation. Ancillary instrumentation is available for device implantation and removal. The implant is sold in a 'sterile' condition for single-use. The sterilization method used is Ethylene Oxide.

The provided text describes the BioPro Hemi-Edge Toe System, a medical device for toe joint replacement. However, it does not contain any information about a study that establishes acceptance criteria or reports on device performance based on a study.

Instead, the document is a 510(k) Summary, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device). In this case, the manufacturer is claiming substantial equivalence to existing predicate devices based on material, geometry, design/markings, and indications for use.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study that proves the device meets those criteria, as this information is not present in the provided text.

Here's why each of your requested points cannot be addressed from the given document:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states "No nonclinical testing was used in the determination of substantial equivalence." This means no specific performance metrics or acceptance criteria derived from a study are presented.
2. Sample size used for the test set and the data provenance: Not applicable. No test set or data provenance is mentioned because no study was conducted to demonstrate performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication method 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: Not applicable. This device is a physical implant, not an AI-assisted diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth is established as no performance study is described.
8. The sample size for the training set: Not applicable. This device is a physical implant, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) document relies on demonstrating substantial equivalence to predicate devices rather than presenting data from a new performance study with specific acceptance criteria.

Ask a specific question about this device

The BioPro Bipolar Head is intended for use in combination with a BioPro PSL femoral stem for 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
• Revision procedures where other devices or treatments for this indications have failed

The BioPro Bipolar Head consist of a factory assembled Ultra High Molecular Weight Polyethylene (UHMWPE) liner in a cobalt chrome outer shell and UHMWPE retention ring with a Ti-6Al-4v spring. These bipolar heads include outer diameters ranging from 38-60mm, in 1mm increments, to properly fit the patient anatomy. The smaller bipolar heads (38-42 mm) have an inner diameter that mates with a 22mm diameter femoral head; the larger bipolar heads (43-60mm) have an inner diameter that mates with a 28mm diameter femoral head. The BioPro Bipolar Head may be used in conjunction with a BioPro PSL femoral stem (K872535 and K871462) for hemiarthroplasty.

This is a 510(k) summary for a medical device, specifically a hemi-hip prosthesis. The information provided heavily emphasizes that the device is "substantially equivalent" to predicate devices, and therefore no new clinical studies were performed to establish its performance or meet acceptance criteria derived from clinical data.

Here's a breakdown based on your request, highlighting the relevant sections and the absence of clinical data:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission relying on predicate devices, there aren't explicit "acceptance criteria" for a new study to meet, nor "reported device performance" in terms of clinical outcomes. Instead, the "acceptance criteria" are implied by the performance of the predicate devices and the successful completion of specific non-clinical tests.

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

• Sample Size: Not applicable in the context of clinical data. For the non-clinical tests (push-out, lever-out, heat tolerance, sterilization), the specific sample sizes are not provided in this summary.
• Data Provenance: The "study" here is a series of non-clinical, benchtop tests. The data provenance is from laboratory testing conducted by or for the device manufacturer, BioPro, Inc. There is no clinical data provenance from human subjects.

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

Not applicable. No clinical test set with ground truth established by experts was used. The evaluation relies on engineering principles and comparison to predicate device specifications.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

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 device is a physical implant (hemi-hip prosthesis), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study involving human readers or AI was performed or is relevant.

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

Not applicable. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). For the non-clinical tests, the "ground truth" would be established engineering standards, material specifications, and the performance characteristics of the legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. There was no "training set" in the context of clinical data or machine learning for this device. The device design and testing are based on established engineering principles and comparison to predicate devices.

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

Not applicable. As there was no training set, there was no ground truth for it to be established. The basis for the device's design and assessment is its substantial equivalence to previously cleared devices, supported by non-clinical testing demonstrating comparable mechanical and material properties.

Ask a specific question about this device

The BioPro HBS screw is designed for hand, foot and small bone fragment repairs or fusions. Uses include osteotomy fixation, joint arthrodesis or post traumatic fragment repair. The BioPro HBS screw is made of titanium in compliance with ASTM F136-02a. The screw is similar to other screws available on the market. The HBS screw is cannulated and comes in two diameters, 2.5mm and 3.0mm. Each screw is available in several lengths ranging from 6mm up to 40mm in length. The screws have a Torx driving head. The new versions of the screw will be provided sterile.

The provided text describes a 510(k) submission for a medical device (HBS Headless Bone Screw) and primarily focuses on proving substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study designed to prove the device meets specific performance metrics in the way that would typically be described for a diagnostic or AI-driven medical device.

The "performance testing" mentioned refers to engineering rationale regarding the screw's material and design, particularly torsional strength, in relation to ASTM F-543 ("Standard Specification and Test Methods for Metallic Medical Bone Screw"). The primary "studies" described relate to sterilization validation.

Therefore, many of the requested elements for describing acceptance criteria and a study cannot be directly extracted from the provided document.

However, I can extract and interpret the information that is present regarding the device's characteristics and the rationale for its approval.

Here's a breakdown based on the categories you provided, indicating where information is present versus not present:

Acceptance Criteria and Device Performance Study (Based on Submitted Information)

The document's primary "study" is a demonstration of substantial equivalence, with particular focus on the unchanged design (except for length), material, and sterilization process. It does not present specific quantitative performance metrics or acceptance criteria for clinical efficacy or diagnostic accuracy, as it is a bone screw and its performance is more related to mechanical properties and sterilization.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the context of a clinical performance study as defined for AI or diagnostic devices. Performance is largely based on engineering testing and sterilization validation. Specific sample sizes for engineering tests (e.g., how many screws tested for torsional strength, or how many sterilization cycles validated) are not provided in this summary.
• Data Provenance: Not applicable in the context of clinical data for software. The "data" pertains to engineering specifications, material compliance, and sterilization validation results, which would be generated internally from laboratory testing.

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 would relate to objective measurements of mechanical properties or sterility, not expert interpretation of clinical data.

4. Adjudication Method for the Test Set

• Not applicable.

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

• No. This is a medical device (bone screw), not a diagnostic tool or AI software. Therefore, an MRMC study is not relevant.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Engineering Specifications: Compliance with ASTM F136-02a for material and, by engineering rationale, maintenance of torsional strength based on unchanged diameter.
• Sterilization Validation Standards: Compliance with ANSI/AAMI/ISO 10933-7 and ANSI/AAMI ST 27-1988 for sterility assurance and residuals.
• Predicate Device Equivalence: The ultimate "ground truth" for the 510(k) submission is demonstrating substantial equivalence to the legally marketed predicate device (K020791 for the original design, and K991197 for additional lengths) in terms of safety and effectiveness, given the minor modifications (sterilization and increased length).

8. The Sample Size for the Training Set

• Not applicable. This is not an AI or machine learning device requiring a training set.

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

• Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" described in the 510(k) summary is not a single, comprehensive clinical trial for performance metrics typical of AI or diagnostic devices. Instead, it comprises several components:

• Engineering Rationale: An engineering rationale was provided to demonstrate that because the screw diameters remain unchanged, there is no change to the torsional strength from the predicate device, which is made of the same ASTM-compliant titanium (F136-02a). This addresses the mechanical performance aspect.
• Sterilization Validation Study: A complete summary of studies related to sterilization (Attachment "B" of the submission) was included. This validation was performed using the Ethylene Oxide (EtO) method with an AAMI Overkill Method to achieve a Sterility Assurance Level (SAL) of 10^-6. EtO and ECH residuals were tested to meet ANSI/AAMI/ISO 10933-7 standards.
• Packaging Validation: Packaging (double blister system with Tyvek® Lids) was certified and tested according to current medical packaging requirements.
• Risk Analysis: A complete risk analysis for sterilization and packaging (Attachment "A" of the submission) was provided.
• Device Comparison: A tabular comparison highlighting the similarities in material and design, and the modifications (sterilization, length increase) relative to predicate devices (Vilex 510k 991197, Osteomed K010783, and the original HBS 510k 020791).

The conclusion of the submission states that "Based on these studies we believe the subject device is safe and effective" and that the device is "substantially equivalent to the predicate devices" due to the unchanged design (except for length), material, and new sterilization. The FDA's 510(k) clearance (K101030) confirmed this substantial equivalence.

Ask a specific question about this device

The BioPro Femoral Heads are indicated for use for significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis; revision of failed femoral head replacement, cup arthroplasty, or other hip procedures; proximal femoral fractures, avascular necrosis of the femoral head; non-union of proximal femoral neck fractures; other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities. The BioPro hip system (PSL) is for cemented and non-cemented use.

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the "Biopro Femoral Heads," indicating that the device is substantially equivalent to legally marketed predicate devices.

The text specifies:

• Trade/Device Name: Biopro Femoral Heads
• Regulation Number: 21 CFR 888.3358
• Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
• Regulatory Class: II
• Product Code: LPH, JDI
• 510(k) Number: K090208
• Indications For Use: For significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis; revision of failed femoral head replacement, cup arthroplasty, or other hip procedures; proximal femoral fractures, avascular necrosis of the femoral head; non-union of proximal femoral neck fractures; other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities. The BioPro hip system (PSL) is for cemented and non-cemented use.

However, it does not include any details on:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory approval letter, not a study report or a summary of performance data.

Ask a specific question about this device

Indications For Use: The BioPro K-Wire is indicated for use in fixation of bone fractures, for bone reconstructions, and as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a device called "K-Wire," detailing its regulation, product code, and intended use. It does not include any performance data, study designs, or ground truth information.

Ask a specific question about this device

The BioPro Bipolar Head is intended for use in combination with a BioPro femoral stem for uncemented primary or revision arthroplasty 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;
• Revision procedures where other devices or treatments for these indications . have failed.

The BioPro Bipolar Head consists of a factory assembled UHMWPE liner in a cobalt chrome outer shell, and UHMWPE retention ring. 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 42 mm) have an inner diameter that mates with a 22 mm diameter femoral head; the larger bipolar heads (43 mm to 60 mm) have with a iiim ater that mates with a 28 mm diameter femoral head. The BioPro Bipolar an infor diamotor that may be a BioPro femoral stem (K882146) for arthroplasty.

The provided text describes a 510(k) premarket notification for the BioPro Bipolar Head, a medical device. This type of notification focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the way a new, high-risk device might.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance
   As a 510(k) submission, the primary "acceptance criterion" is demonstrations of substantial equivalence to predicate devices, not performance against specific clinical or technical benchmarks (beyond material properties and design specifications). The document provides a detailed comparison table (Table 1 in section 5. Predicate Device Comparison) between the BioPro Bipolar Head and predicate devices (Ortho Development Pivot Bipolar Head and PLUS Orthopedics PLUS Bipolar Prosthesis).

   Feature	BioPro Bipolar Head	Ortho Development Pivot Bipolar Head	PLUS Orthopedics PLUS Bipolar Prosthesis
   510(k) Number	Pending	K050966	K982447
   FDA Product Code	KWY	KWY	KWY
   DESIGN: Head-Liner-Shell	CoCr-UHMWPE-CoCr	CoCr-UHMWPE-CoCr	CoCr-UHMWPE-CoCr
   DESIGN: Head Outer Diameter	38 to 60 mm in 1 mm increments	38 to 60 mm in 1 mm increments	43 to 60 mm in 1 mm increments
   DESIGN: Self-aligning	Yes	Yes	Yes
   DESIGN: Liner Inner Diameter	22.225 or 28 mm	22.225 or 28 mm	28 mm
   DESIGN: Liner-Head Assembly	Head snap-fit into bipolar liner	Head snap-fit into bipolar liner	Head held in by retention ring
   DESIGN: UHMWPE retention ring	Yes	Yes	Yes
   MATERIALS: Outer shell	Cobalt chromium (ASTM F75)	Cobalt chromium (ASTM F75)	Cobalt chromium (ASTM F75)
   MATERIALS: Liner & retention ring	UHMWPE (ASTM F648), EtO sterilized (not highly crosslinked)	UHMWPE (ASTM F648), gamma sterilized (not highly crosslinked)	UHMWPE (ASTM F648), EtO sterilized (not highly crosslinked)

   Acceptance Criteria Implied: The device is considered to meet "acceptance criteria" if its design, materials, and intended use are substantially equivalent to the predicate devices. The table above shows that the BioPro Bipolar Head is largely identical in design and materials to its predicates, with minor differences (e.g., sterilization method for UHMWPE, range of outer diameters compared to one predicate), which were presumably deemed not to raise new questions of safety or effectiveness.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
   This document describes a 510(k) submission, which is typically based on mechanical testing, material characterization, and comparison to predicate devices, rather than a clinical "test set" from patient data. There is no mention of a clinical study or a "test set" in the context of patient data for performance evaluation in this document. The data provenance would be laboratory testing data for material properties and design specifications, not patient data.

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. As this is a 510(k) submission for a physical medical device, there is no "ground truth" establishment by experts in the context of interpreting medical images or clinical outcomes from a test set of data. The "experts" involved would be engineers and material scientists validating the device's physical properties and designers ensuring substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   Not applicable. There is no clinical "test set" and therefore no adjudication method 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
   Not applicable. This device is a hip implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   Not applicable. This device is a hip implant, not an algorithm. Its performance is evaluated through material testing and mechanical simulations if needed, and comparison to predicate devices.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
   Not applicable in the AI/diagnostic sense. For a device like this, "ground truth" relates to compliance with material standards (e.g., ASTM F75 for Cobalt chromium, ASTM F648 for UHMWPE) and design specifications, established through laboratory testing and engineering principles. The "truth" is that the materials meet stated specifications and the device performs its intended mechanical function in a manner equivalent to previously approved devices.

8. The sample size for the training set
   Not applicable. This document does not describe a clinical study or an AI algorithm that would require a training set.

9. How the ground truth for the training set was established
   Not applicable. No training set is mentioned in the document.

Ask a specific question about this device