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The 2.4mm Secure Locking Variable Angle Distal Radius Plate and Ø2.4 mm Secure Locking Screws, Self-Tapping are intended for fixation of complex intra- and extra-articular fractures arid osteotomies of the distal radius.

The 2.7mm/3.5mm Secure Locking Distal Humerus Medial Plate, 2.7mm/3.5mm Secure Locking Distal Humerus, Dorsolateral Plate, and 2.7mm/3.5mm Secure Locking Distal Humerus Plate, Dorsolateral With Lateral Support are indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, and nonunions of the distal humerus.

The 3.5mm Secure Locking Small Plate, 3.5mm Secure Locking T-Plate, Small with 3 Head Holes, and Ø3.5 mm Secure Locking Screws, Self-Tapping, are indicated for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula.

The 3.5 mm Secure Locking Superior-Anterior Clavicle Plate and 3.5 mm Secure Locking Superior-Anterior Clavice Plate With Lateral Extension is indicated for fixation of fractures, malunions, and ostectornies of the clavice in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.

The 3.5mm Secure Locking Olecranon Plate is indicated for fractures, osteotomies, malunions and non-unions of the olecranon.

The 3.5 mm Secure Locking Philos Proximal Humeral Internal Plate is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

The 4.5/5.0mm Secure Locking Narrow LC Dynamic Compression Plate is indicated for fixation of various long bones, such as the humerus, femur and tibia and for use in fixation of peri-prosthetic fractures, and fixation of nonunions or malunions in adult patients.

The 4.5mm/5.0mm Secure Locking Distal Femoral Plate is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular condylar, periprosthetic fractures, nonunions and malunions, and osteotomies of the femur.

The 4.5mm/5.0mm Secure Locking Medial Proximal Tibia Plate is intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of nonunions of the medial proximal tibia and tibia shaft.

The 4.5mm/5.0mm Secure Locking L Buttress Plate and 4.5mm/5.0mm Secure Locking T Buttress Plate are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial tibia. Also, for use in fixation of non-unions and malunions.

The 3.5mm/4.5mm/5.0mm Secure Locking Distal Tibia Plates are intended treatment of non-unions, and fractures of the distal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.

The Ø3.5mm CORTICAL SCREW and Ø4.5mm CORTICAL SCREW are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The Ø2.7 mm Secure Locking Screws, Self Tapping, and Ø 2.7mm Cortical Screws are intended for fractures and osteotomies of small bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The Ø5.0mm Secure Locking Screws, Self-Tapping are intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or malunions.

The 6.5mm Cancellous Screw, 16mm Thread, 32 Thread, Ø4.0mm CANCELLOUS SCREW, Partial Thread, Full Thread, and Ø4.0mm SMALL CANCELLOUS CANNULATED SCREW, Partial Thread, Full Thread are indicated for use in hindfoot and midfoot fusions, subtalar fusions, calcaneal osteotomies, midfoot reconstruction, and ankle arthrodeses.

The 6.5mm Cancellous Cannulated Screw, 16mm Thread, 32 Thread, Full Thread, and 7.0mm Cancellous Cannulated Screw, 16mm Thread, 32 Thread, are indicated for fracture fixation of large bone fragments, such as tibial plateau fractures, ankle arthrodeses, intercondylar femur fractures; and subtalar arthrodeses.

HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System consists of various shapes and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking selftapping screws, compression and dynamic screws. The subject device system also consists of a variety of general use instruments (Class I), which include drill bits, forceps, plate benders, and drill guides.

The plates and screws are manufactured from Stainless Steel and Titanium alloy.

The system contains several models based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in many models available, such as:, Reconstruction Plates, T-Plates, Anatomical Plates, Clavicle Plates.

These all are mainly divided into:

• . Large Fragment Plates
• Small Fragment Plates ●
• Mini Fragment Plates .

The locking screw implants are offered in corresponding diameter ranges from 2.4mm, 2.7mm, 3.5mm, 5.0mm diameters with lengths varying from a minimum length of 6 mm to maximum length of 90mm.

The non-locking screw implants are offered in 2.7mm, 3.5mm and 4.5mm diameters, with lengths ranqing from 10mm to 80mm.

The cancellous screw implants are 4.0mm and 6.5mm in diameter, with lengths ranging from 10 to 120 mm. The cancellous cannulated screw implants are offered in 4.0mm. 6.5mm and 7.0mm diameters and lengths ranging from 16mm to 130 mm.

HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are provided non-sterile, the products must be sterilized prior to use. All implants are for single use only.

This document describes the 510(k) summary for the HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

The information provided pertains to the substantial equivalence of a medical implant (bone plates and screws) to predicate devices, focusing on material, design, and mechanical performance rather than AI/ML algorithm performance.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/ML device from the given text.

The document discusses the following:

• Device Name: HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System
• Intended Use: Fixation of various bone fractures and osteotomies.
• Predicate Devices: A list of Synthes Locking Compression Plate Systems and Screws.
• Non-Clinical Testing:
  • Material Standards: ASTM F136, ASTM F138, ASTM F139 (for Stainless Steel and Titanium alloy).
  • Performance Standards: ASTM F382 (Metallic Bone Plates), ASTM F384 (Metallic Angled Orthopedic Fracture Fixation Devices), ASTM F543 (Metallic Medical Bone Screws), and FDA guidance documents for orthopedic screws and fracture fixation plates.
  • Performance Results: Conforms to Static Four Point Bend Test, Dynamic Four Point Bend Test (for plates), Torsional Properties, Driving Torque, and Pull-out Test (for screws).
• Clinical Evaluation: Not necessary to demonstrate substantial equivalence, as the device is similar in design, pattern, and intended use to predicate devices.

In summary, the provided text does not describe an AI/ML device or its performance evaluation. It details the regulatory clearance process for a traditional medical implant based on substantial equivalence.

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InFix Cannulated Screw System is generally intended for fracture fixation of various bones and bone fragments, such as femoral neck, intercondylar femoral, malleolus, pilon tibial, calcaneus, talus, tibial plateau, tarsal, wrist, metacarpal, carpal, scaphoid and radius fracture. InFix Cannulated Screw System is also intended for fixation arthrodesis, iliosacral dislocations, and hallux valgus corrections.

Accessories implants:

The round washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone.

The InFix Cannulated Screw System includes eight cannulated screw specifications and associated washers, which are manufactured from stainless steel and titanium alloy. The cannulated screw is a self-tapping and self-drilling screw with a cancellous thread that can be guided into a position via a guided wire. They are used to aid in the alignment and stabilization of fractures to the skeletal system.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

This document is a 510(k) premarket notification for the InFix Cannulated Screw System, which is a Class II medical device. The primary purpose of this submission is to demonstrate substantial equivalence to existing predicate devices, rather than to prove de novo safety and effectiveness through extensive clinical trials.

1. Table of Acceptance Criteria and Reported Device Performance

Details Regarding the Study and Acceptance Criteria:

This submission relies heavily on non-clinical tests to demonstrate substantial equivalence. Clinical effectiveness studies as one might find for a novel AI device are not presented here because this is a hardware medical device for which the FDA determination is about substantial equivalence to already approved devices. Therefore, the "acceptance criteria" here are largely benchmarks against the performance of predicate devices and adherence to recognized standards.

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

• Biomechanical Test: The document states "The biomechanical tests ASTM F543 were performed". It does not specify the exact number of screws or test samples used for each performance metric (self-tapping, torsional, axial pullout, driving torque).
• Cleaning Validation & Sterilization Validation: Similarly, the document does not specify the number of samples used for these validation tests.
• Data Provenance: Not explicitly stated, but typically these tests would be conducted in a laboratory setting by the manufacturer or a contracted lab. The tests are non-clinical, so "country of origin of the data" in terms of patient demographics is not applicable. These are prospective tests performed to meet regulatory requirements.

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

• Not applicable in this context. For a hardware device demonstrating substantial equivalence through non-clinical testing, ground truth is established by objective engineering measurements against specified physical properties and performance standards (e.g., ASTM F543). There isn't a need for expert consensus on an interpretation of an output, as would be the case for an AI diagnostic device.

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

• Not applicable. Adjudication methods like 2+1 are used for expert review of images or data to establish a ground truth or resolve discrepancies in diagnostic labeling. This is not relevant for biomechanical or validation testing of a physical device.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices or software that assists human interpretation. The InFix Cannulated Screw System is a physical bone fixation device, not a diagnostic tool or AI-assisted product.

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

• Not applicable. This device is a physical implant. The concept of "standalone algorithm performance" does not apply.

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

• For the biomechanical tests (ASTM F543), the "ground truth" is established by engineering standards and direct physical measurements. The performance of the InFix Cannulated Screw System is compared against the known performance characteristics of the predicate devices and the requirements of the ASTM standard.
• For cleaning and sterilization validations, the "ground truth" is adherence to the specified industry standards (AAMI TIR30:2011 and ANSI/AAMI/ISO 17665-1).

8. The sample size for the training set:

• Not applicable. This device is hardware and does not involve machine learning or AI, and therefore has no "training set."

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

• Not applicable. As there is no training set for this hardware device, there is no ground truth to be established for it.

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APTUS® Cannulated Compression Screws 5.0, 7.0 are intended for the treatment of fractures, osteotomies and arthrodeses of bones with the appropriate screw size.

APTUS® Cannulated Compression Screws 5.0, 7.0 are headless screws intended for the treatment of fractures, osteotomies and arthrodeses of bones. The design of the screw, incorporating various diameters, threads on the head and tip, provides compression of the bone segments upon insertion of the screw. The submission includes the associated Kwires, intended to be used for internal fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of the implants.

APTUS Cannulated Compression Screws 5.0, 7.0 are available in two diameters (5.0 mm and 7.0 mm) and come in partially-threaded or fully-threaded designs. The 5.0 mm screws are provided in overall lengths ranging from 30 to 70 mm. The 7.0 mm screws are provided in overall lengths ranging from 40 to 140 mm. The 5.0 and 7.0 mm screws are used with the 1.6 and 2.2 mm diameter K-wires, respectively.

APTUS® Cannulated Compression Screws 5.0, 7.0 are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and the K-wires are made of stainless steel conforming to ASTM F138 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673).

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and study proving device performance:

This 510(k) summary is for a medical device (APTUS® Cannulated Compression Screws 5.0, 7.0), not an AI/software device. Therefore, many of the typical acceptance criteria and study aspects related to AI (e.g., sample size for test set, data provenance, ground truth experts, MRMC studies, standalone performance, training set) are not applicable.

The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical data, primarily engineering and mechanical testing. Clinical data was explicitly not submitted.

1. Table of Acceptance Criteria and Reported Device Performance

Note: Since this is a hardware device submission, the "acceptance criteria" are related to mechanical performance and regulatory standards, not diagnostic accuracy or AI model performance.

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

• Test set sample size: Not applicable in the context of AI/software performance. For mechanical testing, the specific number of screws tested is not detailed in this summary, but it would typically involve a statistically relevant number of samples to demonstrate compliance with ASTM F543.
• Data provenance: Not applicable in the context of data used for AI training/testing. The tests were performed on the physical device.

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

• Not applicable. Ground truth as typically defined for AI (e.g., expert consensus on medical images) is not relevant for mechanical testing of bone screws. The "ground truth" here is compliance with established engineering and material standards.

4. Adjudication method for the test set

• Not applicable. No expert adjudication process as understood in AI performance evaluations. Mechanical tests have pass/fail criteria based on standards.

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

• No. This is a hardware device, not an AI-assisted diagnostic tool.

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

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

7. The type of ground truth used

• Engineering and material standards compliance: The "ground truth" for this device revolves around its conformance to established material specifications (e.g., ASTM F136 for titanium alloy, ASTM F138 for stainless steel) and mechanical performance standards (ASTM F543 for metallic bone screws). The tests demonstrated that the device performs equivalently to previously cleared predicate devices when subjected to these standards.

8. The sample size for the training set

• Not applicable. This is a hardware device; there is no "training set" in the AI sense.

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

• Not applicable. This is a hardware device.

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Cortical Screws are intended for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula.

Large Cannulated Screws (4.5mm diameter and larger) are intended for fracture fixation of large bones and large bone fragments. Diameters 6.5mm and larger are intended for large bones and large bone fragments such as femoral neck fractures; slipped capital femoral epiphyses; tibial plateau fractures; ankle arthrodeses; pediatric femoral neck fractures; intercondylar femur fractures; and subtalar arthrodeses.

Small Cannulated Screws (4.0mm diameter and smaller) are intended for fixation of fractures and non-unions of small bones and small bone arthrodeses. Examples include scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.

Cannulated screws are machined, metallic screws with a cannulation that are self drilling and self tapping, which can be guided into position by a guide wire.

Cortical and cancellous screws are machined, metallic screws and are self tapping.

All screws utilize a hex shaped recess that accepts a standard hex drive. Each type is offered in a variety of diameters and lengths, as well as short, medium, and fully threaded options.

Materials: The devices are manufactured from 316L Stainless Steel which meets ASTM F138 standards.

Function: Bone screws functions are to provide immediate stability and temporary fixation during the natural healing process.

The provided text is a 510(k) premarket notification for OrthoPediatrics Bone Screws. It primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than presenting a study against specific acceptance criteria for the new device's performance.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria.

Key reasons for this include:

• 510(k) Premarket Notification Focus: A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device) and does not require premarket approval (PMA). This is typically achieved by demonstrating "substantial equivalence," not by conducting new clinical studies or setting and meeting new performance acceptance criteria for the device itself.
• Lack of Performance Data: The document describes the device, its materials, function, and indications for use. It lists predicate devices. However, there is no mention of specific performance metrics (e.g., strength, durability, fatigue life, accuracy) for the OrthoPediatrics Bone Screws, nor any study data (sample sizes, ground truth, expert opinions) that would demonstrate the device meets such criteria.
• No Mention of AI/Algorithm: The context of "AI," "test set," "training set," "experts," "adjudication," "MRMC," and "standalone algorithm performance" strongly suggests a request related to an AI/Machine Learning device. The OrthoPediatrics Bone Screws are described as machined, metallic screws, which are physical hardware devices, not software or AI-driven systems.

In summary, this document is for a medical device (bone screws) seeking market clearance through substantial equivalence, and as such, it does not include performance studies with acceptance criteria in the manner described for software or AI-based diagnostic/assistive devices.

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The QWIX Positioning Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

• Mono or Bi-cortical osteotomies in the foot or hand (including Hallux Valgus treatment)
• Fractures management in the foot or hand -
• Fixation of bone fragments in long bones or small bones fractures -
• Arthrodesis in hand, foot or ankle surgery -

The size of the chosen screw should be adapted to the specific indication.

The QWIX® Positioning Screw is a cannulated fully threaded screw. It also has a self-tapping screw tip. It is provided in diameters 5.5 mm and 7.5 mm and in length from 30 mm to 80 mm for the 5.5 mm and from 40 mm to 120 mm for the 7.5 m. The QWIX® Positioning Screw is made from Titanium alloy (Ti-6Al-4V ELI).

The provided text describes a 510(k) premarket notification for the QWIX® Positioning Screw. This document focuses on demonstrating substantial equivalence to an existing predicate device rather than establishing new performance criteria through efficacy studies with acceptance criteria.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, and ground truth establishment cannot be fully provided from the given text.

Here's an analysis of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criterion	Reported Device Performance
   Mechanical Properties	"Mechanical tests have been carried out. Results have shown that the mechanical properties of the QWIX® Positioning Screw staples have similar to properties of predicate devices, such as Newdeal ICOS screws (K011821) and Synthes 7.3 screw (K962011)."
   Substantial Equivalence	"The new QWIX® Positioning Screws are substantially equivalent to the commercially marketed device, Stabilization Screw, K050346."

   Note: The document states "similar to properties" and "substantially equivalent" rather than specific quantitative acceptance criteria or numerical performance metrics. The 510(k) process is about demonstrating equivalence, not necessarily meeting a predefined performance target in the same way a de novo or PMA would require.

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

   • No specific sample size for a "test set" (in the context of clinical or algorithmic performance evaluation) is mentioned.
   • The study referenced is "Mechanical tests," which typically involves material and component testing, not human or patient data. Therefore, data provenance relevant to clinical outcomes is not applicable here.

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

   • Not applicable. Ground truth in a clinical or diagnostic sense is not established for this type of submission. The comparison is mechanical properties against existing devices.

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

   • Not applicable. There is no "test set" requiring expert adjudication in this context.

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

   • Not applicable. This device is a bone fixation screw, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant.

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

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

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

   • The "ground truth" or reference for the mechanical tests would be the established mechanical properties of the predicate devices (Newdeal ICOS screws (K011821) and Synthes 7.3 screw (K962011)) and relevant material standards. This is not "expert consensus, pathology, or outcomes data" in a clinical sense.

8. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/ML device.

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

   • Not applicable.

Summary of what the document does provide:

• Device: QWIX® Positioning Screw, a cannulated fully threaded screw for bone fixation.
• Indicated Use: Fixation of bone fractures or bone reconstruction in the foot or hand, including osteotomies, Hallux Valgus treatment, fracture management, fixation of bone fragments, and arthrodesis.
• Basis for Approval: Substantial equivalence to predicate device Stabilization Screw, K050346.
• Supporting Evidence for Equivalence: Mechanical tests showing "similar" mechanical properties to other predicate devices (Newdeal ICOS screws K011821 and Synthes 7.3 screw K962011). The submission also asserts same intended use, materials, basic design, instructions for use, and manufacturing process as previously cleared devices.

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Synthes Large Fragment DCL is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of osteopenic bone and fixation of non-unions or malunions.

The Large Fragment DCL system consists of limited-contact profile plates in broad and narrow sizes, which include combination dynamic compression/locking screw holes. The plates accept 4.5 mm cortex, 6.5 mm cancellous, 4.5 mm cannulated, 7.0 mm cannulated, and 5.0 mm locking screws. This device is manufactured in either stainless steel or titanium.

Synthes DCL System is a plate and screw system intended to treat fractures of various long bones. The primary feature of this system is limited-contact profile and the combination dynamic compression/locking screw holes. The standard screws facilitate reduction and create compression between the plate and bone, while the locking screws form a locked, fixed angle construct with the plate.

The DCL System includes both broad and narrow straight plates. The broad plates are 5.2 mm thick, 17.5 mm wide and are available in lengths ranging from 121 mm - 409 mm (6 - 22 screw holes). The narrow plates are 4.2 mm thick, 13.5 mm wide and are available in lengths ranging from 49 mm - 409 mm (2 - 22 screw holes). The screw holes are combined to allow placement of standard 4.5 mm cortex, 6.5 mm cancellous and 4.5 mm and 7.0 mm cannulated screws on one side of each hole, or 5.0 mm threaded conical, locking screws on the opposite side. The holes are uniformly spaced along the length of the plate. The holes are oriented so that the compression component of the holes is always directed towards the middle of the plate.

The DCL System utilizes a locking feature that screw to the plate, enabling unicortical or bicortical screw purchase. This feature consists of conical shaped, threaded locking screw holes in the plates that correspond with the conical- shaped, threaded head of the screw.

The 5.0 mm locking screws feature self-tapping tips, flat head profiles with rounded edges, and are available in lengths from 14mm to 90mm. The threads just below the head of each locking screw engages with the threaded side of the holes in the DCL plate. The engagement of these screws to the plate creates a locked, fixed angle construct.

The provided document is a 510(k) premarket notification for a medical device, the Synthes Large Fragment Dynamic Compression Locking (DCL) System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and detailed study results as one might find for novel devices or drugs.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is provided:

• Acceptance Criteria and Reported Performance: The document does not specify quantitative acceptance criteria or a study designed to measure the device's performance against such criteria (e.g., a specific threshold for bone healing rates, reduction in non-union incidence, or mechanical stability in a clinical setting). Instead, it focuses on demonstrating that the device is

  • Identical or similar in intended use: "fixation of various long bones..."
  • Identical or similar in technological characteristics: "limited-contact profile plates... combination dynamic compression/locking screw holes... manufactured in either stainless steel or titanium... utilizes a locking feature that screw to the plate..."
  • Raises no new questions of safety or effectiveness: This is implied by the comparison to predicate devices and adherence to material standards.

• Study That Proves the Device Meets Acceptance Criteria: There is no description of such a study. The 510(k) process relies heavily on:

  1. Comparison to Predicate Devices: The document explicitly lists "Synthes Broad and Narrow Dynamic Compression Plates" and "Synthes Anatomical Locking Plate System" as predicate devices (Page 0, Section Predicate Device). On Page 3, Section 12.0, it states: "A comparison of Synthes' DCL System to Synthes Broad and Narrow Dynamic Compression Plates and Synthes Anatomical Locking Plate System follows." This comparison is the primary "proof" of substantial equivalence.
  2. Material Standards: The device is manufactured from 316L stainless steel, commercially pure titanium, and Titanium - 6% Aluminum - 7% Niobium (Ti-6Al-7Nb), all of which adhere to specific American Society for Testing and Materials (ASTM) standards (F 139, F67, F 1295, respectively) (Page 1, Section 7.0). Adherence to these standards is intended to ensure biocompatibility and mechanical properties similar to already approved devices.
  3. Sterilization Validation: Moist heat sterilization parameters have been validated using AAMI guidelines to provide a sterility assurance level (SAL) of 10^-6 (Page 1, Section 8.0). This addresses a critical safety aspect.

In summary, the provided text describes a regulatory submission (510(k)) that does not include the detailed clinical study information you are asking for. It focuses on demonstrating substantial equivalence to existing devices rather than presenting novel performance data against pre-defined acceptance criteria.

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