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The OIC Variable Angle Small Fragment Locking Plate System is indicated for the fixation of fractures, mal-unions, nonunions or osteolomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.

The OIC Variable Ande Small Fragment Locking Plate System consists of titanium plates for the Distal Radius. Clavice. Proximal Humerus, Tibia and Distal Fibula, bone screws and instruments for implantation. The platety of sizes and are pre-contoured to match the anatomy of the patient and 3.5mm bone screws. The bone screws are available in two diameters (2.5mm) and range in length from 6mm to 130mm. The bone screws are available with both threaded (locking) and non-threaded (non-locking) heads.

The OIC Variable Angle Small Fragment Locking Plate System implants are made of titanium alloy or cp titanium in compliance with ASTM F136 or ASTM F67.

The provided text describes a medical device submission (K140357) for the OIC Variable Angle Small Fragment Locking Plate System. However, it does not contain information regarding traditional acceptance criteria or a study proving the device meets said criteria in the context of clinical performance or diagnostic accuracy.

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed devices, primarily through engineering and material testing, rather than clinical trials with patient outcomes or AI-driven performance studies.

Therefore, many of the requested categories cannot be filled as the information is not present in the provided text.

Here's an attempt to answer based on the available information, with clear indications where the information is not present:

Acceptance Criteria and Device Performance Study for K140357: OIC Variable Angle Small Fragment Locking Plate System

The provided 510(k) summary for the OIC Variable Angle Small Fragment Locking Plate System does not detail specific acceptance criteria or clinical performance studies related to diagnostic accuracy or human-in-the-loop improvements for an AI device. Instead, the document focuses on demonstrating substantial equivalence through mechanical testing and material compliance.

The "acceptance criteria" can be inferred from the standards the device conforms to and the evaluation methods used to demonstrate substantial equivalence, which are primarily related to mechanical properties and materials.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable/not provided. The evaluation was primarily based on engineering analyses (FEA) and literature review, not a test set of data in the context of AI or clinical outcomes.
• Data Provenance: Not applicable/not provided. The document refers to "literature review" for comparative mechanical performance, but does not specify the origin of this literature.

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

• Not applicable. The ground truth for mechanical performance was established via engineering analyses and comparisons to published standards and literature, not expert consensus on a test set of cases.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring expert adjudication is described.

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 typically performed for diagnostic devices or AI-assisted interpretation, which is not the nature of this orthopedic implant submission.

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

• No, a standalone algorithm performance study was not done. This device is a physical orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

• The 'ground truth' for this 510(k) submission relates to engineering standards, material specifications, and documented mechanical performance characteristics established through finite element analysis and literature review. It is not clinical pathology, outcomes data, or expert consensus on patient cases.

8. The Sample Size for the Training Set

• Not applicable. This device is an orthopedic implant, not an AI algorithm requiring a training set. The "training" for its design and evaluation would come from established engineering principles, material science, and the design of predicate devices.

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

• Not applicable, as there is no "training set" in the context of this orthopedic implant. The benchmarks for performance (comparable mechanical properties, material compliance, etc.) were established through recognized ASTM standards, the performance of predicate devices, and engineering analyses (FEA).

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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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The Suspension™ Clavicle Fracture Fixation System can be used for adult patients. The Suspension™ Clavicle Fracture Fixation plates and screws are indicated for fixation of clavicle fractures. For lateral clavicle fractures, the Suspension™ Clavicle Fracture Fixation System may also be used with the Suspension™ Acromioclavicular (AC) Repair System.

The subject device consists of the following implantable components:

1. Three sizes of clavicle fracture plate for each shoulder (i.e. small, medium, and large; each with Left & Right configurations)
2. Eight 2.7mm lengths of non-locking & locking bone screws
3. Eight 3.5mm lengths of non-locking & locking bone screws
   Implantable components are included in a carrier case and must be steam sterilized by the hospital or surgical center. These components are intended for re-sterilization, but are for singleuse only. All implantable components are composed of stainless steel.
   The optionally accompanying Suspension™ Acromioclavicular (AC) Repair System is an internal fixation system consisting of a non-absorbable suture anchor with pre-threaded suture. The metallic suture anchor and metallic accessories are fabricated from 316L stainless steel. Implantable portions of the device are: USP size 5 braided polyethylene suture, coracoid anchor, clavicle set screw, clavicle sleeve extension washer, clavicle sleeve.

The provided text describes a 510(k) summary for the Suspension™ Clavicle Fracture Fixation System, a medical device, and not an AI/ML-based diagnostic or prognostic device. Therefore, the traditional "acceptance criteria" and "study" questions related to AI/ML device performance (e.g., sensitivity, specificity, human-in-the-loop studies, ground truth establishment by experts) are not applicable in this context.

Instead, the "acceptance criteria" for a medical device like this, under a 510(k) pathway, revolve around substantial equivalence to a predicate device. This is demonstrated primarily through performance testing, safety testing (biocompatibility, sterility), and engineering analysis to show that the device meets its intended use and does not raise new questions of safety or effectiveness.

Here's how to reframe the information based on the provided text, focusing on the substantial equivalence criteria for this mechanical device:

Device Acceptance Criteria and Supporting Study

Device Name: Suspension™ Clavicle Fracture Fixation System
Premarket Notification Number: K112923
Predicate Device: Smith & Nephew (K061352) and K102095 (previous version of the subject device) for components.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Description: Multiple cadaver shoulders and simulated bone.
• Sample Size: Not explicitly stated as a number of samples or cases. The document uses phrases like "multiple cadaver shoulders" and "in all instances" for simulated bone testing, suggesting sufficient samples were tested to draw conclusions.
• Data Provenance: The cadaver and simulated bone testing was conducted specifically for this submission to support the device's performance. The location of the test facility is not explicitly mentioned, but it's part of a US FDA 510(k) submission. It is a prospective set of tests conducted for regulatory submission.

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

Not Applicable (N/A). This is a mechanical device, not an AI/ML diagnostic. The "ground truth" is established by physical measurement of mechanical properties (yield load, stiffness, ultimate load) using an Instron™ device and observation of failure modes, not by expert interpretation of images or clinical data.

4. Adjudication Method for the Test Set

Not Applicable (N/A). As this is mechanical testing, there is no human "adjudication" in the sense of consensus reading or clinical judgment. The results are quantitative measurements from the Instron™ device.

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

Not Applicable (N/A). This type of study is relevant for diagnostic performance, typically for image-based AI/ML systems where human reader performance is being evaluated with and without AI assistance. This device is an orthopedic implant.

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

Not Applicable (N/A). This question applies to AI/ML algorithms. The device is a physical implant.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance was established through biomechanical testing data obtained from:

• Measurements using an Instron™ device (for yield load, stiffness, ultimate load).
• Observation of failure modes during testing.
• Engineering analysis for specific concerns like fretting/corrosion.
• Reference to previously established biocompatibility and sterility validation data from predicate devices/prior submissions.

8. The Sample Size for the Training Set

Not Applicable (N/A). There is no "training set" in the context of a physical medical device like an orthopedic implant. Training sets are relevant for AI/ML models.

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

Not Applicable (N/A). As there is no training set, this question is not applicable.

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The PERI-LOC™ Periarticular Locked Plating System 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.

The subject devices are design modifications to PERI-LOC™ Periarticular Locked Plating System devices previously cleared under K033669, K051735 and K061352. Like the predicate devices listed below, the subject components include various sizes of contoured, locking bone plates made from stainless steel. PERI-LOC™ 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 a medical device (PERI-LOC™ Locking Bone Plates). It describes design modifications to an existing device and asserts substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for assessing performance.

Therefore, I cannot populate the requested table or answer most of the questions based on the provided input.

Here's a breakdown of what can be inferred:

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

• Not available in the provided text. The document focuses on demonstrating substantial equivalence through design modifications, material composition, and intended use, rather than presenting new performance data against specific acceptance criteria.

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

• Not available in the provided text. No performance testing data is presented.

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 available in the provided text. No performance testing data is presented.

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

• Not available in the provided text. No performance testing data is presented.

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 / Not available in the provided text. This device is a mechanical bone plate system, not an AI-assisted diagnostic tool.

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

• Not applicable / Not available in the provided text. This device is a mechanical bone plate system, not an algorithm.

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

• Not available in the provided text. No performance testing data is presented. The "ground truth" for this type of device would typically involve mechanical testing (e.g., fatigue, static strength) and biocompatibility, but no such details are provided for this specific submission beyond asserting similarity to predicates.

8. The sample size for the training set

• Not applicable / Not available in the provided text. This is not an AI device, so there is no "training set."

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

• Not applicable / Not available in the provided text. This is not an AI device, so there is no "training set" or its associated ground truth establishment.

Summary of what the document does provide:

The document describes design modifications to existing PERI-LOC™ Periarticular Locked Plating System devices. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (K033669, K051735, and K061352) based on:

• Identical indications for use.
• Identical material (stainless steel).
• Very similar technological design characteristics.

The modifications are described as minor (e.g., removal of tunnels, chamfers, tabs, or slots) and do not appear to fundamentally change the intended mechanical function or safety profile in a way that would necessitate new, extensive clinical or performance studies for this 510(k) submission. The FDA clearance letter confirms the substantial equivalence determination.

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The PERI-LOC Periarticular Locked Plating System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bones 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.

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

Volar Distal Radius Locking Plates for the Upper Extremity manufactured from ASTM F139 material are line additions to the PERI-LOC™ Periarticular Locked Plating System cleared under K051735 and K061352. Like the predicate devices listed below, the subject components include various sizes of contoured locking bone plates and locking/non-locking bone screws made from stainless steel. PERI-LOC™ locking bone plates and locking bone screws incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.

The provided text describes a 510(k) summary for the PERI-LOC™ Periarticular Locked Plating System – Volar Distal Radius Locking Plate for the Upper Extremity – ASTM F139 Material Change. This is a medical device submission, and the content focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study demonstrating performance against specific acceptance criteria for a new AI or diagnostic algorithm.

Therefore, many of the requested categories for AI/diagnostic studies, such as acceptance criteria, reported device performance, sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this type of submission.

The document primarily addresses the following aspects:

1. Device Description: It describes the Volar Distal Radius Locking Plates as line additions to an existing system, made from ASTM F139 material, and incorporating a screw-to-plate locking feature.
2. Intended Use: Specifies that the system is for adult patients with osteopenic bone and is indicated for fixation of various bone fractures.
3. Technological Characteristics: States that the device is similar to legally marketed devices in terms of indications, materials, and technological characteristics.
4. Substantial Equivalence Information: Compares the device to several predicate devices based on design features, indications, and material composition.

Key points from the document regarding the device's assessment:

• No specific acceptance criteria for a new performance metric are listed. The approval is based on demonstrating "substantial equivalence" to existing, legally marketed predicate devices. This means the new device is considered as safe and effective as the predicate devices, without needing to prove new performance thresholds.
• No explicit study proving specific performance metrics is included. The 510(k) summary relies on comparison to predicate devices, implying that the established performance and safety of the predicates serve as the benchmark.
• No sample sizes for test sets, data provenance, expert numbers, adjudication, MRMC studies, or standalone performance are mentioned. These are typically associated with studies evaluating diagnostic or AI-driven devices, which this orthopedic implant is not.
• The "ground truth" for this type of device is implicitly the clinical performance and history of the predicate devices. Its substantial equivalence implies it should perform similarly in a clinical setting.
• No training set or ground truth establishment for a training set is relevant as this is not an AI/machine learning device.

In summary, based on the provided text, the device approval is based on substantial equivalence, not on meeting specific quantitative acceptance criteria through a performance study. The document does not contain the information required to populate the requested table or answer the specific questions about an AI/diagnostic study.

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