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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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The D-RAD SMART PACK is intended for the fixation of fractures involving the distal radius.

The D-RAD SMART PACK is a cost-effective sterile procedural kit that contains an anatomically contoured volar distal radius plate and single-use instruments to treat extra-articular and intra-articular distal radius fractures. The Kit consists of an anatomically shaped distal radius fixation plate, associated locking and non-locking screws and pegs, and instrumentation to assist in implantation of the fixation construct.

The provided document, K132296, for the Smith & Nephew D-RAD SMART PACK is a 510(k) Premarket Notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than on proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information (like acceptance criteria, specific device performance metrics beyond mechanical testing, sample sizes for test/training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment) is not typically found or required in a 510(k) submission for this type of device.

The document explicitly states: "Mechanical testing and analysis has been conducted on the devices to ensure that they meet or exceed predicate standards in terms of fatigue, material strength, and biocompatibility." This indicates that mechanical testing was the primary method used to demonstrate that the device performs equivalently to the predicate devices.

Here's an attempt to answer the questions based on the available information, noting where information is not present in the document:

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

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

• Sample Size for Test Set: Not applicable or not specified for a clinical study. The "test set" here refers to the actual device components undergoing mechanical testing. The exact number of samples tested is not provided in this summary.
• Data Provenance: Not applicable for a clinical study. Data would be generated from laboratory mechanical testing. The country of origin for this testing is not specified. It is laboratory data, not patient data (retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Ground truth as typically understood in AI/imaging studies (e.g., expert consensus on diagnoses) is not relevant for this type of medical device submission. The "ground truth" for mechanical performance is established by standardized material and mechanical testing protocols, interpreted by engineers and regulatory experts.

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

• Not applicable. This is not a study involving human interpretation or adjudication of cases. Mechanical testing results are typically evaluated against pre-defined engineering specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This device is a bone plate and screw system, not an AI-assisted diagnostic or therapeutic device. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance was not conducted.

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

• No. This device is a physical implant and surgical instrumentation, not an algorithm.

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

• For mechanical performance: Compliance with established industry standards and engineering specifications for fatigue, material strength, and biocompatibility. These standards themselves are developed from extensive research and clinical experience.
• For substantial equivalence: Comparison against the design, materials, and mechanical properties of the predicate devices.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. No training set for an algorithm was used.

Summary of the Study (Mechanical Testing for Substantial Equivalence):

The "study" referenced in this 510(k) submission is primarily a series of mechanical tests and analyses designed to demonstrate that the D-RAD SMART PACK meets or exceeds the performance standards of its predicate devices in terms of fatigue, material strength, and biocompatibility. This type of testing is standard for orthopedic implants. The document indicates that the device's functional characteristics, intended use, and materials were also compared directly to three predicate devices previously cleared by the FDA (K993106, K051735, K083032). The conclusion is based on this direct comparison and mechanical data rather than a clinical trial or AI performance study.

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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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OsteoMed Wrist Plating System is intended for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures.

OsteoMed Wrist Plating System implants are intended for single use only.

The OsteoMed Wrist Plating System is a rigid fixation and fusion system , consisting of plates and screws in various configurations along with the appropriate instrumentation to facilitate modification, implantation, or removal of the implants. Plates are anatomically pre-contoured in various shapes and sizes. Screws are provided with variable angle locking or non-locking head in various lengths. These screws are either solid core or cannulated and can be used with or without plates.

Plates and screws are supplied in a variety of configurations. The plates and screws are made of titanium alloy (ASTM F136). K-wires are made of titanium alloy (ASTM F136) or stainless steel (ASTM F138). The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymers.

The provided text describes a 510(k) summary for the OsteoMed Wrist Plating System. This document focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than conducting a de novo clinical study with specific acceptance criteria, sample sizes, and ground truth establishment for novel device performance.

Therefore, the requested information regarding acceptance criteria, a study proving device meeting these criteria, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for the training set is not applicable or available within this 510(k) submission.

The document states:

• "Analyses of plate and screw strength were conducted to compare the OsteoMed Wrist Plating system components to predicate devices." This implies mechanical bench testing for equivalence, not a clinical study with performance metrics like sensitivity, specificity, or accuracy.
• "Equivalence for OsteoMed Wrist Plating system is based on similarities in intended use, design and operational principle to the referenced predicates. Based on the similarities, we believe that the OsteoMed Wrist Plating System does not raise any new safety or effectiveness issues." This is the core argument for a 510(k) submission.

Without a clinical study explicitly designed to measure performance against predefined acceptance criteria, it's impossible to populate the requested table and answer many of the questions.

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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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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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