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The EVOS Small Fragment Plating System is indicated for adult and pediatric patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, metatarsals, and clavicle.

The EVOS Partial Articular and Anti-Glide plates are indicated for the treatment of partial articular fractures of the distal and proximal tibia (AO/OTA Fracture Classification Type B), and for fracture fixation of the fibula.

Subject of this premarket notification is an extension of the EVOS Small Fragment Plating System, the EVOS Small Fragment Lower Extremity Plates. The subject plates feature similarities to existing Smith & Nephew small fragment plates (TC-100 Small Bone Plating System, PERI-LOC and PERI-LOC VLP Plating Systems, EVOS Small Fragment Plating System Straight Plates) and also share some instruments and compatible implants from the existing EVOS MINI Plating System and EVOS Small Fragment Plating System. EVOS Small Fragment Lower Extremity Plates are available in a variety of plate designs for specific anatomical areas. These plate designs include plates with 2.7mm holes or 3.5mm holes only, or with a combination of 2.7mm and 3.5mm holes. Plate designs may include threaded holes, nonthreaded holes, and variable-angle locking holes. The subject plates are offered in "thick" and "thin" varieties. The "thin" plates are the partial articular/antiglide plates.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EVOS Small Fragment Lower Extremity Plates, presented in the requested format:

It's important to note that the provided document is a 510(k) clearance letter and an associated summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical performance acceptance criteria through a clinical study in the way an AI/ML device would. Therefore, much of the requested information for AI/ML device studies (like sample sizes for test/training sets, ground truth establishment, MRMC studies, etc.) is not applicable to this traditional medical device clearance.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a traditional medical device (bone plates) seeking 510(k) clearance by demonstrating substantial equivalence, the "acceptance criteria" are not based on clinical performance metrics like sensitivity/specificity but rather on engineering and material performance compared to predicate devices.

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

• Sample Size for Test Set: Not applicable. For traditional medical device clearances based on substantial equivalence, mechanical and materials testing are typically performed on a subset of product configurations or representative samples, not on a "test set" in the context of clinical data. The document mentions "worst case plates" identified by FEA for mechanical testing. The specific number of plates or trials is not provided within this summary.
• Data Provenance: Not applicable in the sense of patient data. The provenance for the testing data would be Smith & Nephew's internal labs or authorized testing facilities performing controlled laboratory experiments.

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

• Not applicable. This device is cleared based on engineering and performance testing, not on interpretation of clinical images or data by experts to establish a "ground truth."

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" in the sense of data requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. This is not an AI/ML device, and thus MRMC studies are not performed for its clearance.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

• Not applicable. This is a physical medical device (bone plates), not a software algorithm.

7. Type of Ground Truth Used

• Not applicable in the context of clinical "ground truth." The "ground truth" for this device's clearance would be established engineering principles, material science standards (e.g., ASTM standards for mechanical testing), and regulatory guidance regarding sterility and biocompatibility.

8. Sample Size for the Training Set

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

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

• Not applicable. This is not an AI/ML device, and therefore no training set or its ground truth establishment is relevant.

Summary Conclusion from the Document:

The EVOS Small Fragment Lower Extremity Plates received 510(k) clearance (K170457) based on demonstrating substantial equivalence to legally marketed predicate devices (Smith & Nephew Bone Plate System K993106, K033669, K062216, K071563, and K162078). This was achieved through:

• Technological Characteristics: Showing similarities to predicate devices in design, materials, and hole configurations (locking and non-locking).
• Pre-Clinical Testing:
  • Finite Element Analysis (FEA) to identify worst-case configurations.
  • Mechanical bending tests proving performance "similar or superior" to predicates.
  • Packaging verification to ensure sterility and prevent damage.
  • Bacterial endotoxin testing meeting established standards.
• Intended Use and Indications: The indications for use are consistent with those of predicate devices, covering adult and pediatric patients with osteopenic bone for fixation of various small and long bone fractures, including partial articular and anti-glide plates for specific tibia and fibula fractures.

The regulatory conclusion is that, "Based on similarities to the predicate plating systems and a review of the mechanical testing performed, the subject devices are substantially equivalent to the predicate devices."

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The EVOS Small Fragment Plating System is indicated for adult and pediatric patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, metatarsals, and clavicle.

Subject of this premarket notification is an extension to the EVOS family of plates and screws, the EVOS Small Fragment Plating System. This system features similarities to existing Smith & Nephew small fragment plates (TC-100 Small Bone Plating System, PERI-LOC Plating System) and also shares some instruments and implants from the existing EVOS MINI Plating System. It is comprised of a variety of locking and non-locking 2.7mm and 3.5mm straight plates as well as 3.5mm locking and non-locking screws and 4.7mm non-locking osteopenia screws.

The provided document is a 510(k) premarket notification for a medical device (EVOS Small Fragment Plating System), not a study analyzing AI performance. Therefore, I cannot extract information related to AI acceptance criteria, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance.

However, I can extract the acceptance criteria and study descriptions for the mechanical performance of the physical EVOS Small Fragment Plating System, as detailed in the document.

Here's the information based on the provided text, focusing on the mechanical testing of the device itself:

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

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

• Sample Size: Not explicitly stated for each mechanical test. The document mentions "worst-case designs" for FEA and fatigue testing, and specific sizes of screws (3.5mm, 4.7mm) for others. Typically, mechanical testing involves a limited number of samples (e.g., 5-10 per test condition) to satisfy a statistical confidence level or regulatory requirement, but the exact numbers are not provided here.
• Data Provenance: Not applicable as these are pre-clinical (benchtop) tests of the device's physical properties, not clinical data from patients. The testing was conducted by Smith & Nephew, Inc.

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. These are engineering and mechanical tests, not analyses requiring expert human interpretation or ground truth establishment in a clinical sense. The "ground truth" is defined by the objective measurement of mechanical properties against predetermined performance standards, often based on existing predicate devices or industry standards like ASTM.

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. The results are quantitative measurements against objective criteria.

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 describes the mechanical testing of a medical implant, not an AI or diagnostic imaging device.

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

Not applicable. This document describes the mechanical testing of a medical implant, not an AI algorithm.

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

The "ground truth" for the mechanical testing is based on:

• Performance of legally marketed predicate devices. The acceptance criteria consistently refer to being "similar or superior" to predicates.
• Adherence to industry standards (e.g., ASTM F543 for screw testing).
• Compliance with FDA Guidance documents for sterility and endotoxin testing.

8. The sample size for the training set

Not applicable. This is not an AI study requiring a training set.

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

Not applicable. This is not an AI study requiring a training set or its associated ground truth establishment.

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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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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 Merete BLP™ Small Fragment Locking Bone Plate System is used for adult and pediatric patients as indicated for small bone fracture fixation. Indications for use include fixation of fractures, osteotomies, non unions of the clavicle, scapula. olecranon, radius, ulner, fibula, metacarpals, metatarsals, Hallux Valgus osteotomy corrections, middle hand and middle foot bones, particular in osteopenic bone.

The Merete BLP™ Small Fragment Locking Bone Plate System consists of anatomically shaped U-oblique plates, right or left in the length of 33, 35 and 37 mm and 3.0 mm locking screws. The system is available in titanium (ASTM F-136), Locking plates/screws incorporate a screw-to-plate locking feature which creates a locked, fixed angle construction to hold fracture or osteotomy reduction.

This is a 510(k) premarket notification for a medical device (Merete BLP™ Small Fragment Locking Bone Plate System), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and AI/ML specific evaluations (like MRMC studies, standalone performance, training sets) is not applicable or present in the provided document.

A 510(k) submission demonstrates substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria for AI algorithms. The document confirms that the device is "substantially equivalent" to predicate devices, meaning it has similar indications for use, materials, and technological characteristics.

Therefore, I cannot populate the requested tables and sections as the information is not relevant to this type of regulatory submission.

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PERI-LOC Periarticular Locked Plating System B-Plates and Screws can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC contoured B-Plates and Screws are indicated for partial articular fractures of the distal fibula, distal tibia, and proximal tibia. PERI-LOC Locking Tubular Plates are indicated for fracture fixation of the tibia, fibula, femur, metacarpals, humerus, ulna, radius, calcaneus, and clavicle.

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

PERI-LOC* Periarticular Locked Plating System - B-Plates are line additions to the PERI-LOC* Periarticular Locked Plating System cleared under K033669. Like the predicate devices listed below, the subject components include various sizes of contoured and straight, locking bone plates and locking/non-locking bone screws made from stainless steel. PERI-LOC B-Plate locking bone plates and locking/non-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 - B-Plate Locking Bone Plates and Locking/Non-locking Bone Screws. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study or standalone algorithm performance.

Therefore, the following information about acceptance criteria and studies is not available in the provided text:

• A table of acceptance criteria and the reported device performance: The document does not define specific performance metrics or acceptance criteria for the device itself. The focus is on demonstrating equivalence to existing devices.
• Sample size used for the test set and the data provenance: No test set is described, as the evaluation is based on comparison to predicate devices, not on a new performance study.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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: This is a medical device for bone plating, not an AI or imaging diagnostic device. MRMC studies are not relevant here.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no new performance study generating "ground truth" data is described.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

What the document does state about the device's "study" and "criteria":

The "study" in this context is the 510(k) substantial equivalence submission process. The "acceptance criteria" are implicitly met by demonstrating that the new device is "substantially equivalent" to legally marketed predicate devices.

The document explicitly states:

• Substantial Equivalence Information: "When compared to the predicate devices listed below, substantial equivalence is based on similarities in design features, overall indications for use, and material composition."
• Predicate Devices:
  • PERI-LOC Periarticular Locked Plating System K033669
  • Smith & Nephew Bone Plate System (TC-100 Plating and Screw System) K993106

Essentially, the device "meets acceptance criteria" by being sufficiently similar in its technological characteristics, intended use, and materials to devices already cleared by the FDA, without requiring new clinical performance data.

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