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Duet™ and Impact™ Suture Anchors are intended for use to reattach soft tissue to bone in orthopaedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The Duet™ and Impact™ Suture Anchors are contraindicated in 1) Surgical procedures other than those listed, 2) Conditions that may compromise Anchor fixation (osteopenic, comminuted bone, pathologic conditions in the soft tissues to be attached, etc., 3) Conditions that may retard healing (poor blood supply, past or potential infection, etc), 4) Active infection, 5) Conditions that may limit the patients ability or willingness to restrict activities or follow directions during the healing period, 6) Foreign body sensitivity to materials, 7) Patients with suspected or known allergy with implant or suture materials.

Duet™ Suture Anchor and Impact™ Suture Anchors are bioabsorbale suture anchors that are preloaded on a disposable inserter device with two non-absorbable sutures. Originally they were preloaded with non-absorbable, braided, polyester #2 sutures, one of them is green and another one is white.

Purpose of this special 510(k) premarket notification is amendment of new preloaded suture material into Duet™ and Impact™ suture anchor product lines. The new suture, Herculine is non-absorbable, braided, ultra-high molecular weight polyethylene #2 suture. In coloured version 2 filaments are replaced by blue polypropylene monofilaments Herculine suture meets USP requirements for knot tensile strength and needle attachment strength.

The provided text is a 510(k) summary for a medical device (Duet™ and Impact™ Suture Anchor) and a letter from the FDA regarding its clearance. It does not contain information about acceptance criteria, device performance, study design details (sample size, data provenance, expert consensus, adjudication, MRMC, or standalone studies), or ground truth establishment for either training or test sets.

The document primarily describes a special 510(k) premarket notification for an amendment to the existing suture anchors, specifically changing the preloaded suture material from polyester to ultra-high molecular weight polyethylene (Herculine). The core argument for substantial equivalence is that this change has no effect on the intended use, principles of operation, production, raw materials, or sterilization of the device, and that the new suture meets USP requirements for knot tensile strength and needle attachment strength.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about the study that proves the device meets the acceptance criteria, as this information is not present in the given text.

The text focuses on demonstrating substantial equivalence to a predicate device based on material change and compliance with general standards rather than presenting a performance study against specific acceptance criteria.

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Ø 1.5 and 2.0mm screw models of BioSorb™ FX and BioSorb™ PDX are used for plate fixation fasteners in trauma and constructive procedures in the midface and craniofacial skeleton. Specifically, the device is indicated for use in treating fractures of the craniofacial skeleton, including, but not limited to, comminuted fractures of the nasoethmoidal and infraorbital areas; comminuted fractures of the frontal sinus wall; orbital floor fractures; trauma of the midface or craniofacial skeleton and reconstructive procedures of the midface or craniofacial skeleton.

Ø 2.0 mm screw models of BioSorb™ FX can be used for plate fixation fasteners with BioSorb™ 2.0/2.4 O/M plates in trauma and reconstructive procedures in the midface, maxilla and mandible. Especially in mandible BioSorb™ FX 2.0/2.4 O/M System must be used in conjunction of appropriate maxillomandibular fixation (MMF).

Ø 1.5mm and 2.0mm screw models of BioSorb™ FX and BioSorb™ PDX product families. Originally the screw head design of Ø 1.5 and 2.0mm screw models of BioSorb™ FX and BioSorb™ PDX product families was designed as a crosshead screw. Further development of head design for easier insertion of 0 1.5mm and 2.0mm screw models continued and finally new head design with outer attachment of screw driver was finalized. The main purposes were improvement of installation properties without sacrificing torsion properties of the screw model. The revision of head design has no effect on intended use, principles of operation, production methods, raw material or sterilization. The screw drivers are revised accordingly, but other parts of instrumentation are remaining unchanged.

This 510(k) summary describes a modification to an existing medical device, specifically screw head redesigns for bioabsorbable fixation fasteners. As such, the submission focuses on demonstrating substantial equivalence to the predicate devices rather than proving a new device meets specific acceptance criteria through a clinical study. The provided text does not include the information requested regarding conventional acceptance criteria and a study proving those criteria are met, as this type of submission is for device modification and substantial equivalence.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document focuses on explaining that the new screw head design has no effect on intended use, operating principles, production methods, raw materials, or sterilization, and thus is substantially equivalent to the previously cleared devices. It lists contraindications and indications for use, but these are for the device family as a whole and not specific to demonstrating performance of the new head design against defined acceptance criteria.

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SmartScrew® II is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses of cancellous bone with the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and 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SmartScrew® II is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses of cancellous bone with the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and 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This 510(k) premarket notification for the SmartScrew II is a Special 510(k), meaning it is for a modification to a previously cleared device (the SmartScrew/NuGenFX Screw, K012001). As such, the submission focuses on demonstrating that the revised device is substantially equivalent to the predicate device, especially regarding the modification, rather than proving performance against novel acceptance criteria through extensive clinical studies like a de novo device might require.

Therefore, the provided document does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria in the way a new device would. Instead, the "study" is more accurately a comparison to the predicate device focusing on the impact of the design change.

Here's how to address your request based on the provided text, recognizing the nature of a Special 510(k):

Acceptance Criteria and Reported Device Performance

The acceptance criteria for a Special 510(k) revolve around demonstrating that the modifications do not negatively impact the safety and effectiveness of the device and that it remains substantially equivalent to the predicate. The performance is assessed by comparing the new design feature (screw head) against the predicate.

Study Information (Based on Special 510(k) Context)

1. Sample size 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 a Special 510(k) focused on a design change like this, the "test set" would typically involve bench testing of the new screw head design and the predicate design for properties like torsional strength, insertion torque, and perhaps pull-out strength. The sample size for such bench tests would likely involve a statistically significant number of screws of each type, but this is not detailed in the summary.
   • Data Provenance: Not stated. Given the manufacturer is based in Finland, the testing would likely have been conducted in Europe or by contractors. It would be prospective bench testing designed specifically to compare the new and predicate designs.

2. 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):

   • This is not applicable in the context of this 510(k). "Ground truth" established by experts (like radiologists for imaging devices) is relevant for diagnostic devices or those requiring subjective clinical assessment. For a mechanical fixation device undergoing a minor design change evaluated by substantial equivalence, "ground truth" is typically established through objective engineering tests (bench testing) and comparison against established performance criteria of the predicate. Engineers and biomechanical specialists would design and execute these tests.

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

   • Not applicable. Adjudication methods (like 2+1 for discordant expert reads) are used in studies involving human interpretation or clinical outcomes where subjectivity might exist. For objective engineering bench tests, results are typically quantitative and directly compared, not "adjudicated."

4. 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 is a mechanical orthopedic fixation device, not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic performance, particularly with AI assistance in image interpretation.

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

   • Not applicable. This device does not involve an algorithm or AI.

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

   • The "ground truth" for this type of device, especially for a special 510(k), is primarily objective engineering and biomechanical data (e.g., torsional strength, insertion torque, material properties) derived from bench testing comparing the modified device to the predicate device and ensuring it meets its original performance specifications and does not introduce new risks.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device, so there is no "training set" in that sense. If referring to product development testing, materials were iterated and developed, but not as a "training set" for an algorithm.

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

   • Not applicable. See point 7.

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The Cannulated NuGen™ FX Screw is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts within the condylar aspects of the upper extremity, ankle and foot, in the presence of appropriate brace and/or immobilization. Specifically, it is intended for phalangeal fusion and fracture, metacarpal fusion and fracture, carpal fusion and fracture, wrist arthrodesis, Distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies and correction of hallux valgus.

The Cannulated NuGen™ FX Screw is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except those in the hand and foot) and proximal femoral fractures. 2) Situations where internal fixation is otherwise contraindicated, e.g.. active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism). 3) Highly comminuted fractures, which would not be appropriate for fixation with metallic screws. 4) Patients with suspected or known allergy to the implant material.

The device description of the Cannulated NuGen™ FX Screw biodegradable bone fixation screw is as follows.

• Composed of poly-L/D-lactide copolymer
• Lengths 14 70mm
• Diameters 3.5mm with cannulation for 1.2mm K-wire and 4.5 mm with cannulation for 1.6mm K-wire.
• Fully and partly threaded models

The only modifications that were made are:

• Amendment of screw models with cannulation
• Amendment of suitable instruments into instrumentation accordingly.

This submission is a 510(k) premarket notification for a medical device called the Cannulated NuGen™ FX Screw. As such, it focuses on demonstrating substantial equivalence to previously cleared devices rather than robust clinical studies with acceptance criteria and detailed performance reporting as would be seen in a PMA (Premarket Approval) application.

Therefore, many of the requested categories of information for a study and acceptance criteria are not applicable or available within this 510(k) submission. 510(k)s typically rely on design principles, material equivalence, and potentially limited bench testing rather than extensive clinical trials.

Here's the breakdown of what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable/Available: This document does not present formal acceptance criteria or detailed device performance metrics from a study in the way a clinical trial would. The basis of this 510(k) is substantial equivalence to predicate devices rather than meeting specific performance thresholds in a de novo study. The "performance" demonstrated here is the similarity to the predicate devices.

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

• Not Applicable/Available: No test set in the sense of a clinical trial or large-scale performance evaluation is described. The submission focuses on product modifications and demonstrating equivalence to existing cleared devices. Data provenance is not relevant as no specific patient data is analyzed or referenced for a test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable/Available: Ground truth is not established in this context. The submission relies on regulatory judgment of substantial equivalence based on device design, materials, and intended use, not expert consensus on diagnostic or prognostic outcomes.

4. Adjudication Method for the Test Set:

• Not Applicable/Available: No test set means no adjudication method.

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

• Not Applicable/Available: This type of study is for evaluating human performance, often in diagnostic imaging, with and without AI assistance. This device is an orthopedic implant, so an MRMC study is entirely irrelevant.

6. Standalone (Algorithm Only) Performance:

• Not Applicable/Available: This device is a physical implant, not an algorithm, so standalone performance is not applicable.

7. Type of Ground Truth Used:

• Not Applicable/Available: As mentioned, no ground truth is established as part of this submission. The "truth" in a 510(k) is whether the new device is substantially equivalent to existing, legally marketed predicate devices.

8. Sample Size for the Training Set:

• Not Applicable/Available: This device is not an AI/ML algorithm or a diagnostic tool that relies on a training set.

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

• Not Applicable/Available: As above, no training set.

Summary of Relevant Information from the K033447 Submission:

This 510(k) submission (K033447) by Linvatec Biomaterials Ltd. for the Cannulated NuGen™ FX Screw seeks to demonstrate substantial equivalence to several predicate devices, primarily existing NuGen™ FX Screw models (K012001, K023022) and other Bionx Implants Inc. Biofix® and SmartScrew™ products.

The core argument for equivalence is based on the following similarities to the cleared predicate NuGen FX Screw models:

• Same indicated use
• Same operating principle
• Same basic design of thread
• Same basic dimensions
• Manufactured by machining
• Packaged and sterilized using the same materials and processes
• Same shelf life

The only modifications introduced in this new device are:

• Amendment of screw models with cannulation
• Amendment of suitable instruments into instrumentation accordingly

The FDA's review letter (pages 2-3 of the provided text) confirms that they found the device substantially equivalent for the stated indications for use. This means FDA determined that the device is as safe and effective as a legally marketed device that does not require premarket approval (PMA).

In essence, the "acceptance criteria" here implicitly revolve around demonstrating that the new device, despite minor modifications (cannulation), does not raise new questions of safety or effectiveness when compared to its existing, predicate counterparts. The "study" is the submission's argument and evidence of this substantial equivalence based on design, materials (poly-L/D-lactide copolymer), and manufacturing processes.

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2.4 SmartNail is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.

2.4 SmartNail is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection; patient conditions, including blood supply limitations, insufficient quantity or quality of bone; and where patient cooperation cannot be guaranteed, (e.g., alcoholism) 4) Treatment of physeal fractures in children, because the effect of 2.4 SmartNail upon the healing of growth plate has not been tested clinically.

The device description of the 2.4mm SmartNail implant is as follows.

• The implant is composed of poly-96L/4D-lactide copolymer. This is the very same implant raw material with SmartNail (K993074) and 1.5mm Bone Fixation Kit (K012000, K013546)
• Lengths of implant are 16, 25, 35 and 45 mm. The current product selection of SmartNail products contains 16, 20 and 25 mm long implants. The current product selection of 1.5mm Bone Fixation Kit contains 14, 16, 18, 20 and 25mm long implants
• Diameter of implant is 2.4 mm.
• Shelf life is same with SmartNail™ and 1.5mm Bone Fixation Kit (K012000, -K013546), 3 years.
• Our current packaging style of SmartNail is that aluminium pouch is inner and tyvek®-pouch is outer pouch, implant is placed into cardboard holder. This packaging method is identical for 1.5mm and 2.4 SmartNail implants.

The only modifications that were made are:

• Amendment of one new sizes, 2.4mm in diameter and lengths of 16, 25, 35 and 45 mm
• Revision of design accordingly in longer lengths, more rows of barbs than in shorter nails
• Reference numbers for new sizes. These changes are updated in labelling.
• Revision of instrumentation accordingly
• Amendment of optional silicone cover for improvement of arthroscopic surgical technique

The provided text describes a 510(k) premarket notification for a medical device (2.4 SmartNail) and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a regulatory submission for premarket clearance, focusing on demonstrating substantial equivalence to existing devices rather than presenting detailed performance studies against defined acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on:

• Device Description: Material, dimensions, shelf life, packaging, and modifications compared to predicate devices.
• Intended Use and Contraindications: What the device is designed for and situations where it should not be used.
• Predicate Devices: Identifying similar devices already on the market.
• Substantial Equivalence Claim: Stating that the modifications do not raise new safety or efficacy concerns and do not affect pull-out properties (though no specific data proving this is provided in the excerpt).
• FDA Clearance Letter: Confirming the substantial equivalence determination and allowing marketing.

To answer your questions, a different type of document, such as a detailed technical report, clinical study protocol, or performance testing summary, would be needed.

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