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The X-BOLT® IM Hip Nailing System is intended for use in fracture fixation in adults with osteopenia or osteoporosis. The X-BOLT® IM Hip Nailing System is indicated for use in:

• · Intertrochanteric and subtrochanteric fractures
• Segmental fractures
• · Comminuted fractures
• · Pathological fractures
• Fractures with bone loss
• · Pseudoarthrosis, non-union, mal-union, and delayed union
• · Surgically created defects such as osteotomies

The X-BOLT® Dynamic Hip Plating System is intended for use in fracture fixation in the proximal femur in adults with osteopenia or osteoporosis. The X-BOLT® Dynamic Hip Plating System is indicated for use in:

• · Intracapsular and extracapsular fractures of the femoral neck
• · Trochanteric fractures of the proximal femur
• · Stable subtrochanteric fractures of the proximal femur

The X-BOLT® Hip Fracture Fixation System is a single use device intended for long-term (greater than 30 days) implantation into the femur or proximal femur. The system consists of two parts: the IM Hip Nailing System and the Dynamic Hip Plating System.

IM Hip Nailing System components:
A. X-BOLT®: An expanding hip bolt.
B. X-BOLT® IM Hip Nail: A metal nail used with the X-BOLT® for femur fracture fixation.
C. End-Cap: Prevents bone ingrowth into the proximal end of the nail.
D. Set Screw: Prevents X-BOLT® rotation while allowing dynamic movement.
E. X-BOLT® Distal Locking Screws: Bone fixation screws used with the IM Hip Nail for distal fixation.

Dynamic Hip Plating System components:
A. X-BOLT®: An expanding hip bolt.
B. X-BOLT® Dynamic Hip Plate: An angled metal plate used with the X-BOLT® for proximal femur fracture fixation.
C. X-BOLT® Cortical Screws: Bone fixation screws used with the Dynamic Hip Plate for proximal femur fracture fixation.

This document is a 510(k) premarket notification for the X-BOLT® Hip Fracture Fixation System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific acceptance criteria for AI/ML performance. Therefore, most of the requested information regarding AI/ML device testing, ground truth establishment, expert adjudication, and sample sizes for training/test sets is not available in this document.

The document describes a medical device, specifically orthopaedic implants for hip fracture fixation, not an AI/ML powered device. The "performance testing" detailed refers to biomechanical and material testing of the physical implant, not software or algorithmic performance.

However, based on the provided text, I can extract information related to the device and its testing as presented, which primarily supports its physical and material properties, rather than AI/ML performance.

Here's what can be gathered, addressing the questions to the extent possible, with many points being "Not Applicable" (N/A) or "Not Provided" due to the nature of the device and document:

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

The document does not present specific "acceptance criteria" in a quantitative table for device performance in the common sense of AI/ML evaluation (e.g., accuracy thresholds, sensitivity/specificity). Instead, performance is demonstrated through adherence to, and successful completion of, well-established ASTM and ISO standards for orthopedic implants. The "performance" reported is that the device "demonstrates that it performs comparably to predicate devices, thereby supporting its substantial equivalence."

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

• Test Set Sample Size: Not explicitly stated for each test. For biomechanical testing, often a defined number of samples (e.g., typically N=6 or more for each test condition) are required by the standards, but the exact numbers are not provided in this summary. Cadaver testing details are not quantified in terms of sample size.
• Data Provenance: Not specified. Standardized ASTM and ISO tests are laboratory-based. Cadaver testing would be conducted in a laboratory setting. No mention of geographical origin for data or if it's retrospective/prospective is relevant for this type of device.

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

• Number of Experts: N/A. Ground truth for mechanical and biocompatibility testing is established by adhering to widely accepted engineering and biological test standards (ASTM, ISO). These do not typically involve human expert consensus for "ground truth" in the way AI/ML models do.
• Qualifications of Experts: N/A. The "ground truth" is typically the physical and chemical properties of the materials and the mechanical performance defined by the test standards, measured by qualified laboratory personnel using calibrated equipment.

4. Adjudication method for the test set

• Adjudication Method: N/A. The testing described does not involve human interpretation or subjective assessment that would require an adjudication method. Results are quantitative measurements against defined standards.

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: N/A. This is a physical medical device (implant), not an AI/ML diagnostic or assistive tool. MRMC studies are specific to evaluating diagnostic imaging systems and reader performance.

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

• Standalone Performance: N/A. See above; this is not an algorithm or software device.

7. The type of ground truth used

• Type of Ground Truth: For the mechanical and biocompatibility testing, the "ground truth" is defined by the requirements and methodologies outlined in the referenced ISO and ASTM standards. For example, for mechanical tests, the ground truth is the measured force, displacement, or fatigue life against the specified limits. For biocompatibility, it's the biological response (or lack thereof) according to the ISO 10993 series.

8. The sample size for the training set

• Training Set Sample Size: N/A. This device is not an AI/ML product; therefore, there is no "training set."

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

• Ground Truth for Training Set: N/A. As there is no AI/ML component, there is no training set or associated ground truth establishment process.

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Smith & Nephew Plate and Screw Systems Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Plate and Screw Systems and their cleared Indications for Use.

PERI-LOC Locking Bone Plates, Locking Hole Inserts and Cable Accessories:
Smith & Nephew PERI-LOC Locking Bone Plates, Locking Hole Inserts and Cable Accessories Instruments are accessory devices and are intended to assist in the implantation of Smith & Nephew Periarticular Locked Plating Systems and their cleared indications for use.
The PERI-LOC Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws, Locking Hole Inserts and Cable Accessories are indicated for:

• fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multi-fragmentary, and fractures with the medial cortex instability
• proximal femur fractures combined with ipsilateral shaft fractures
• pathological fractures of the proximal femur including metastatic fractures
• proximal femur osteotomies
• fixation of fractures in osteopenic bone
• fixation of nonunions and malunions
• basi/transcervical femoral neck fractures
• subcapital femoral neck fractures
• subtrochanteric femur fractures.
  In addition, the PERI-LOC Periarticular Locked Plating System including Locking Hole Inserts and Cable Accessories can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bone plates and screws are indicated for:
• fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.

Smith & Nephew VLP FOOT Plating System, Screw System and Accessories:
Smith & Nephew VLP FOOT Plating System, Screw System and Accessories Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew VLP FOOT Plating System and Screw Systems and their cleared indications for use.
The Smith & Nephew VLP FOOT Plating System is indicated for:

• the treatment of fracture fixation, reconstruction or arthrodesis of small bones, including those in the forefoot, midfoot and hindfoot.
  The Smith & Nephew Screw Systems, containing 2.5mm, 3.0mm Cannulated and 3.0mm Headless Compression Screws, are indicated for:
• fixation of interarticular and extra-articular fractures and non-unions of small bones and small bone fragments;
• arthrodesis of small joints;
• bunionectomies and osteotomies;
• scraphold and other carpal bones;
• metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
  The Smith & Nephew 2.0mm QFX Screw is indicated for:
• osteotomies of the lesser metatarsals, such as Weil osteotomies, osteotomies, fusions and fractures of the phalanges, metacarpals and carpals of the hand.
  Smith & Nephew Accessories, such as pins and wires, are indicated for:
• pelvic, small and long bone fracture fixation.

Smith & Nephew InterTAN CHS Limited Collapse Set Screw:
Smith & Nephew InterTAN CHS Limited Collapse Set Screw Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew InterTAN CHS Limited Collapse Set Screw Systems and their cleared indications for use.
InterTAN CHS Limited Collapse Set Screw is indicated for:

• Intracapsular fractures of the proximal femur (For certain high subcapsular fractures, it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of nonunion or AVN of the femoral head).
• Intertrochanteric fractures.
• Stable and unstable fractuers of the proximal femur in which medial cortex stability can be restored.
• Hip osteotomy

PERI-LOC Periarticular Locked Plating System- VLP Locking Bone Plates and Locking/Non-Locking Bone Screws:
Smith & Nephew VLP Locking Bone Plates and Locking/Non-Locking Bone Screws Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew PERI-LOC Periarticular Locked Plating Systems and their cleared indications for use.
PERI-LOC contoured VLP Plates and Screws are indicated for:

• partial articular fractures (AO/OTA Fracture Classification Type B) of the distal and proximal tibia and for fracture fixation of the fibula
  PERI-LOC VLP One-Third Tubular Locking Plates are indicated for:
• fixation of fractures, non-unions, and osteotomies of the medial malleolus, fibula, distal ulna, olecranon, calcaneus and metatarsals.

Smith & Nephew 6.5mm and 8.0mm Cannulated Screws:
Smith & Nephew 6.5mm and 8.0mm Cannulated Screw Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew 6.5mm and 8.0mm Cannulated Screw Systems and their cleared indications for use.
Smith & Nephew 6.5mm and 8.0mm Cannulated Screws are indicated for:

• fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones;
• treatment of the calcaneal
• hip arthrodesis
• provisional bone fixation.

Smith & Nephew Bone Plate System:
Smith & Nephew Bone Plate System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Bone Plate Systems and their cleared indications for use.
Smith & Nephew Bone Plates, Bone Screws, and Accessories are indicated for:

• pelvic fracture fixation
• small bone fracture fixation
• long bone fracture fixation.

Titanium Classic Compression Hip Screw System:
Smith & Nephew Titanium Classic Compression Hip Screw System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Titanium Classic Compression Hip Screw Systems and their cleared indications for use.
The Titanium Classic Compression Hip Screw System is indicated for:

• Pelvic Radius Plate- general fractures of the pelvis and acetabulum
• Tibial Plateau Plate- fractures of the proximal tibia with or without diaphyseal involvement
• One Third Tubular Plate- fractures of the fibula, lateral malleolus, metacarpals, metatarsals, olecranon, and distal ulna
• Small Auto-Compression Plate- fracture fixation of metatarsals, metacarpals, radius, and ulna
• Titanium Cortical Bone Screw- small and long bone fracture fixation

Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. Plate and Screw Systems Instruments. The subject devices are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Plates and Screws and their cleared Indications for Use. Smith & Nephew Plate and Screw Systems Instruments can be organized into instrument families which are categorized as follows: Templates, Reamers, Handles, Bases, Pins, Taps, Drill Guides, Insertion or Removal, and Other Guides.

This document describes a 510(k) premarket notification for "Plate and Screw Instruments" by Smith & Nephew, Inc. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML medical device.

The document pertains to orthopedic surgical instrumentation, which are physical tools (templates, reamers, handles, pins, taps, drill guides, etc.) used to assist in the implantation of bone plates and screws. These are accessory devices to existing cleared bone fixation systems.

The submission is for substantial equivalence to previously cleared predicate devices, not for a novel device requiring performance studies or clinical trials to establish new safety and effectiveness claims based on specific acceptance criteria. The basis for substantial equivalence is listed as:

• Sharing the same raw materials
• Manufactured through the same processes
• Utilizing the same sterilization procedures
• Having a similar nature of body contact
• Similar in design and function to competing surgical instrumentation on the market.

Therefore, the requested information points, which are typically relevant for AI/ML device submissions involving performance benchmarks and clinical studies, are not applicable to this document. There are no acceptance criteria related to a model's performance, no data sets (training or test), no ground truth establishment, and no mention of human-in-the-loop studies or standalone algorithm performance.

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PERI-LOC™ Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. PERI-LOC™ Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multi-fragmentary, and fractures with medial cortex instability; proximal femur fractures combined with ipsilateral shaft fractures; pathological fractures of the proximal femur including metastatic fractures; proximal femur osteotomies; fixation of fractures in osteopenic bone; fixation of nonunions; basiltranscervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures.

The subject PERI-LOC™ Periarticular Locked Plating System – Proximal Femur Locking Bone Plates manufactured from titanium material have undergone a design modification when compared to devices cleared under K072818. Like the predicate devices include various lengths of contoured, locking bone plates made from titanium material. PERI-LOC™ Proximal Femur locking bone plates incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.

The provided text is a 510(k) summary for the PERI-LOC™ Periarticular Locked Plating System - Proximal Femur Locking Bone Plates. It describes a medical device, specifically bone plates, and discusses its substantial equivalence to previously cleared devices.

However, the document does not contain information about acceptance criteria or a study that uses terms like sensitivity, specificity, or any form of diagnostic performance metrics typically associated with AI/ML device evaluations. The study mentioned is a "pre-clinical bench testing" focused on "Construct fatigue testing of bone plate (and screw) constructs." This is a mechanical engineering test, not a clinical study involving human or image data.

Therefore, I cannot populate the requested table and answer the study-related questions (2-9) because the provided text describes a hardware medical device (bone plates) and its mechanical testing for substantial equivalence, not an AI/ML-based diagnostic or assistive device that would have such performance criteria and studies.

Here's a breakdown of why this information is not available in the provided text:

• Acceptance Criteria & Device Performance (Table 1): The document doesn't define acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy). The "performance" mentioned relates to mechanical properties (fatigue testing), not clinical diagnostic outcomes.
• Sample Size (Test Set) & Data Provenance (Question 2): Not applicable. The "test set" for a mechanical fatigue test would involve physical constructs, not a dataset of patient information.
• Number of Experts & Qualifications (Question 3): Not applicable. This relates to establishing ground truth for clinical diagnoses, which is not what this document describes.
• Adjudication Method (Question 4): Not applicable.
• Multi-Reader Multi-Case (MRMC) Study (Question 5): Not applicable. This is completely irrelevant to a bone plate's mechanical performance.
• Standalone Performance (Question 6): Not applicable. "Algorithm only" performance refers to AI, which is absent here.
• Type of Ground Truth (Question 7): Not applicable. For mechanical testing, the "ground truth" would be the physical properties measured in a lab.
• Sample Size for Training Set (Question 8): Not applicable. This is not an AI/ML device.
• Ground Truth for Training Set (Question 9): Not applicable.

In summary, the provided document describes a traditional medical device (bone plates) and its mechanical testing for regulatory clearance based on substantial equivalence, not an AI/ML diagnostic device.

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PERI-LOC Locking Hole Inserts and Cable Accessories are intended for use with existing PERI-LOC Periarticular Locked Plating Systems and their cleared indications for use as listed below:

The PERI-LOC Periarticular Locked Plating System including Locking Hole Inserts and Cable Accessories can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bone plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.

PERI-LOC Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws, Locking Hole Inserts and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. PERI-LOC Proximal Femur Locking Bone Plates, Bone Screws, Locking Hole Inserts and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multi-fragmentary, and fractures with medial cortex instability: proximal femur fractures combined with ipsilateral shaft fractures; pathological fractures of the proximal femur including metastatic fractures; proximal femur osteotomies; fixation of fractures in osteopenic bone; fixation of nonunions and malunions; basi/transcervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures.

Components in the PERI-LOC Periarticular Locked Plating System are for single use only.

Subject of this premarket notification are PERI-LOC™ Locking Hole Inserts and Cable Accessories. The PERI-LOC Locking Hole Inserts and Cable Accessories are line additions to the PERI-LOC Periaticular Locked Plating System cleared under K033669, K051735, K072818, and K082516. The subject Locking Hole Inserts and Cable Saddles are accessory components that may be used in coniunction with various PERI-LOC locking bone plates for the upper and lower extremities. The subject devices are made from 316L stainless steel.

When compared to the predicate PERI-LOC Screw Hole Plug and Cable Saddles, the subject PERI-LOC Locking Hole Inserts and Cable Saddles have been modified as follows:

• Designed to be used independently or in conjunction with one another .
• Addition of a Hexalobular drive feature .
• Addition of a 3.5mm Locking Hole Insert .

The subject devices are available in the following size ranges:

The provided document, K100325, describes a 510(k) premarket notification for PERI-LOC™ Locking Hole Inserts and Cable Accessories. This document is a regulatory submission for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical study results.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document explicitly states "Performance Data" and then details "Pre-clinical testing included four point bend fatigue testing of plate constructs with appropriate accessory devices." It then states that "Substantial equivalence is based on similarities in design features and overall indications for use" with the predicate devices. This implies that the acceptance criteria for these accessory devices revolved around demonstrating sufficient mechanical strength for their intended orthopedic application and proving they are functionally similar to previously cleared devices.

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

• Sample Size: Not specified. The document only mentions "plate constructs" without providing the number of samples tested for the four-point bend fatigue tests.
• Data Provenance: Not explicitly stated, but it's a pre-clinical study, meaning it was conducted in a lab setting by the manufacturer (Smith & Nephew, Inc.). It is retrospective in the sense that the testing was completed before the submission to FDA.

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

Not applicable. This is a pre-clinical, mechanical performance study, not a study involving human interpretation or clinical outcomes data that would require expert ground truth establishment.

4. Adjudication method for the test set

Not applicable. There was no human interpretation or decision-making in the testing that would require adjudication. The testing involved mechanical measurements.

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 document pertains to a medical device (orthopedic fixation accessories), not an AI/software device that would involve human readers or AI assistance.

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

Not applicable. This is a physical medical device; there is no algorithm involved.

7. The type of ground truth used

For the pre-clinical performance testing, the "ground truth" would be the engineering specifications and industry standards for mechanical strength and fatigue resistance for orthopedic implants. The failure modes and stress limits observed during the four-point bend fatigue testing would be compared against these established benchmarks.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable. As above, there is no training set for this type of device.

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