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The Linkt™ Compression Staple System is intended to be used for fracture and osteotomy fixation and joint arthrodesis of the hand and foot.

The Linkt Compression Staple System consists of individually packaged, sterile, bone staple implants and a separate single use, sterile instrument set. The implants are manufactured from a nickel titanium alloy (Nitinol) which meets the requirements of ASTM F2063. The staples utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. The staples are available in sizes ranging from 9mm x 9mm to 20mm x 20mm to allow the surgeon to select the appropriate device for the patient's anatomy.

The single use instruments are intended to prepare the site and deploy the staple. The instrument kit includes a drill, drill guide, locating pins and an insertion tool.

This FDA 510(k) clearance letter is for a physical medical device, the Linkt Compression Staple System, not a software or AI-based diagnostic device. Therefore, many of the typical acceptance criteria and study details relevant to AI/software (like sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable.

The clearance is based on non-clinical performance testing to demonstrate substantial equivalence to previously cleared predicate devices.

Here's a breakdown of the available information:

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

2. Sample size used for the test set and the data provenance:
This information is not provided as the evaluation was based on non-clinical, benchtop testing, not a dataset of patient cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as there was no test set requiring expert ground truth for diagnosis/interpretation. The device's performance was evaluated through standardized mechanical and material testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as there was no test set requiring adjudication.

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 surgical staple, not a diagnostic AI tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "ground truth" for this device's performance is established by its ability to meet specific engineering and material standards through validated testing methods (ASTM standards) and demonstrate mechanical properties equivalent to legally marketed predicate devices.

8. The sample size for the training set:
Not applicable. There is no "training set" for this physical device.

9. How the ground truth for the training set was established:
Not applicable.

Study/Evidence that Proves the Device Meets Acceptance Criteria:

The device claims to meet its acceptance criteria through non-clinical performance testing that demonstrates substantial equivalence to legally marketed predicate devices. The studies conducted were:

• Pull out Strength Testing according to ASTM F564.
• Static 4 Point Bend Testing according to ASTM F564.
• Dynamic 4 Point Bend Testing according to ASTM F564.
• Corrosion Susceptibility Testing according to ASTM F2129.
• Radio-Frequency Induced Heating according to ASTM F2182.

These tests are standard methods for evaluating the mechanical and material properties of bone fixation devices. The conclusion reached by Trax Surgical and accepted by the FDA is that based on the results of these tests, the Linkt Compression Staple System is substantially equivalent to the predicate devices and does not raise new questions of safety or effectiveness.

Key takeaway for this specific device: The FDA clearance is based on the device conforming to established engineering standards and demonstrating equivalent physical performance to existing devices, rather than clinical efficacy or diagnostic accuracy, which would involve different types of studies.

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The Medline UNITE® REFLEX® Hybrid Nitinol Implants are intended to provide fixation for fractures, fusions or osteotomies of the bones of short (tarsals) and long (metatarsals, phalanges, distal tibia and fibula) bones comprising the foot and ankle such as: First metatarsal-cuneiform arthrodesis, First metatarsophalangeal arthrodesis, Talo-Navicular Fusion, Lis-Franc arthrodesis, Scarf and Chevron osteotomies. Implants are intended for single use only.

The Medline UNITE® Locking and Non-Locking Cortical Screws are indicated for use with the Medline UNITE® REFLEX® Hybrid Nitinol Implant. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

The Medline UNITE® REFLEX® Hybrid Nitinol Implants are manufactured from nickel titanium alloy (nitinol). The implants utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. Chemical etching and passivation are common processes to create a uniform oxidation layer on the surface of the implant. The system includes implants offered in various styles, sizes, and options; each designed for specific anatomy and procedures. The implants can accommodate Ø2.7mm, Ø3.5mm, and Ø4.0mm locking and non-locking cortical screws to be used with the polyaxial locking holes and compression slots. The system also includes reusable and disposable instrumentation necessary for implantation of the REFLEX® Hybrid Nitinol Implant.

This 510(k) clearance letter is for a medical implant system, not an AI/software device, so the typical AI-related acceptance criteria and study details (like sample size for test set, experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this document. The provided text describes the regulatory clearance process for a physical medical device.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, the Medline UNITE® REFLEX® Nitinol Staple System (K231885). This is achieved primarily through non-clinical (bench) testing and engineering analysis, not clinical trials or AI performance evaluations.

Here's a breakdown of the requested information based on the provided document, noting where specific AI-related questions are not applicable:

Acceptance Criteria and Device Performance (for a physical medical implant)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set:
  • For Corrosion Susceptibility: Mentioned "not all samples," implying multiple samples were tested, but an exact number for the "test set" is not specified for the initial pass/fail.
  • For Nickel-ion Release: "three (3) samples tested over 60-days."
  • For Galvanic Corrosion: "all three (3) test samples."
• Data Provenance: The testing was non-clinical (bench testing) and performed according to ASTM standards and FDA guidance documents. There is no mention of country of origin of data as it's not human or patient data. It is inherently "prospective" in the sense that the tests were conducted specifically for this submission.

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. This is a physical medical device. Ground truth as typically defined in AI/software evaluations (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for the device's performance is established by standardized material and mechanical testing specifications (ASTM standards and FDA guidance).

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

• Not Applicable. This is a physical medical device. Adjudication methods are typically used for expert consensus on challenging cases in AI/software evaluations.

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 is a physical medical device, not an AI-assisted diagnostic tool. No MRMC study was performed.

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" for this physical device is defined by established engineering and material science standards (ASTM F2129, ASTM F3306, ASTM F3044) and FDA guidance on biocompatibility and material safety (specifically for Nitinol implants and nickel release). Device performance is measured against these quantitative and qualitative benchmarks.

8. The sample size for the training set

• Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning.

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

• Not Applicable. This is a physical medical device. There is no "training set" or corresponding ground truth establishment process in the context of machine learning.

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The Arthrex DynaNite Nitinol Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

The Arthrex DynaNite Nitinol Staples are indicated for:
• Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
• Fixation of proximal tibial metaphysis osteotomy.
• Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
• Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.
• When used with Arthrex FiberTape Cerclage System, the Arthrex DynaNite Nitinol Staple (sizes 13x10 and 15x12 only) is intended for sternotomy indications including the "rewiring" of osteotomized sternums.

The Arthrex DynaNite Nitinol Staples are Nickel Titanium (Nitinol) bone fixation devices intended to be permanently implanted. The implant is formed with two legs connected by a bridge and is offered in multiple combinations of bridge widths, leg lengths, and cross sections to accommodate various anatomy.

This document is a 510(k) Summary for the Arthrex DynaNite Nitinol Staples, which is a medical device. It describes the device's indications for use and states that the submission is to expand these indications. The document mainly focuses on proving substantial equivalence to a predicate device rather than presenting a study to meet specific performance acceptance criteria for a new device.

Therefore, the information provided does not directly describe a study that sets acceptance criteria for device performance in the sense of accuracy or efficacy (as would be typical for an AI/CADe device). Instead, it describes performance testing conducted to demonstrate safety and substantial equivalence for an implantable medical device.

Based on the provided text, here’s an extraction of the requested information, adapted for a medical device rather than an AI/CADe system:

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

The document does not explicitly state numerical acceptance criteria in a table format for specific performance metrics in the way one would for an AI model (e.g., sensitivity, specificity thresholds). Instead, it describes types of performance tests and implies the acceptance criterion is "perform substantially equivalent" or "meets specifications" for safety parameters.

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

The document does not specify sample sizes or data provenance for the performance tests conducted. These tests are typically biomechanical or material tests performed in a lab setting, not clinical studies with human data.

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)

This is not applicable as the studies described are laboratory performance tests for a physical implant, not diagnostic assessments requiring expert interpretation or ground truth establishment in a clinical sense.

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

This is not applicable for the types of engineering and material performance tests described.

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

This is not applicable, as the device is a physical bone fixation staple, not an AI/CADe system for diagnostic imaging.

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

This is not applicable, as the device is a physical bone fixation staple, not an algorithm. Performance tests are inherently "standalone" in this context, evaluating the physical properties of the device.

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

For the performance tests described:

• Cyclic/Fatigue Testing: The "ground truth" or reference is the performance of the predicate device/construct (Arthrex Cerclage Suture construct).
• MRI Compatibility: The "ground truth" is established by relevant national and international standards (FDA guidance, ASTM standards).
• Bacterial Endotoxin: The "ground truth" is established by pharmacopeial standards (EP 2.6.14/USP pyrogen limit specifications).

8. The sample size for the training set

This is not applicable, as the device is a physical bone fixation staple and does not involve AI model training.

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

This is not applicable for the reasons mentioned above.

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The system is intended to be used for fracture fixation, and joint arthrodesis of the foot and ankle.

TMC Compression Implant System is comprised of staple implants and related instrumentation for implantation. The implants are offered in multiple combinations of bridge lengths, leg lengths, cross sections, and cannulated versions to accommodate various anatomies. This includes two (2x1) or four (2x2, 4x1) legged implants. It also includes locking screws for additional fixation. All implantable components are manufactured from implant grade titanium alloy (Ti-6A1-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

The provided document, a 510(k) Premarket Notification for the "TMC Compression Implant System," primarily focuses on establishing substantial equivalence to previously cleared predicate devices for a physical medical device (bone fixation implants). It does not describe a study involving an AI or software-based device that would require the detailed acceptance criteria and performance study information typically requested for AI/ML-based medical devices.

Therefore, I cannot extract the information required to answer your prompt, such as:

• A table of acceptance criteria and reported device performance: This document does not present performance data in this format for AI/ML metrics (e.g., sensitivity, specificity, AUC). It discusses mechanical testing for the implants.
• Sample size for the test set and data provenance: Not applicable in the context of an AI/ML study.
• Number of experts used to establish ground truth and their qualifications: Not applicable.
• Adjudication method for the test set: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable for AI/ML ground truth; it refers to mechanical testing standards for implants.
• Sample size for the training set: Not applicable.
• How ground truth for the training set was established: Not applicable.

The document states the following regarding performance testing for the physical device:

• Acceptance Criteria Mentioned (Implicit for Mechanical Testing): "The analysis demonstrated that the subject devices met all acceptance criteria..." This refers to mechanical performance criteria outlined in the standards, specifically:
  • ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples for dynamic fatigue strength (four-point bending test, Annex A1)
  • ASTM F564-17 for pull-out strength (Annex A2)
  • ASTM F543-17 for the added screw options.
• Reported Device Performance: The document only states that the devices met these acceptance criteria, rather than providing specific numerical performance results. It concludes that the devices are "substantially equivalent" to predicate devices based on these tests and other factors (materials, design, intended use).
• Study Type: Mechanical testing.
• Ground Truth: The "ground truth" in this context is the performance standard established by ASTM (American Society for Testing and Materials) for metallic bone staples and screws.
• Sample Size: The document does not specify the number of implants tested, but rather refers to meeting the requirements of the ASTM standards.

In summary, this document describes a traditional medical device submission for physical implants, not an AI/ML-driven device. The elements you're asking for are specific to the validation of AI/ML algorithms and are not present in this regulatory submission for the TMC Compression Implant System.

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The Ortho Solutions COGNITiON™ Staple System is indicated for hand and foot bone fragments, osteotomy, fixation and joint arthrodesis. The COGNiTiON™ Staple System is not intended for spinal use.

The COGNITION Staple System is comprised of a set of implantable metallic (Superelastic NiTi Alloy per ASTM F2063) staples and accessory instrumentation. The system consists of a series of two and four-leg staples of various bridge and leg lengths. Each staple is provided to the user in a relaxed state with the staple legs in a converging position. During the staple insertion step, the provided staple driver is used to splay the staple legs, allowing for implantation across the fracture, fusion, or osteotomy site. The staple legs then have the inherent propensity to converge due to the superelastic nature of the NiTi material. This stability is intended to allow for bone healing to occur.

This document is a 510(k) premarket notification for the COGNITION™ Staple System, a medical device for bone fixation. It details the device's characteristics, intended use, and comparison to a predicate device to establish substantial equivalence.

Based on the provided text, there is no information related to an AI/ML-driven device or an AI performance study. The document describes a traditional medical device (a staple system) and its mechanical and non-clinical testing.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving the device meets the acceptance criteria in the context of an AI/ML system, as this information is not present in the provided text.

The document discusses:

• Device Name: COGNITION™ Staple System
• Intended Use: Hand and foot bone fragments, osteotomy, fixation, and joint arthrodesis. Not for spinal use.
• Device Description: Comprised of implantable metallic (Superelastic NiTi Alloy) staples and accessory instrumentation.
• Predicate Device: K111678 Ortho Solutions Extremity Fixation Implants for Osteosynthesis.
• Technological Comparison: The new device is stated to have the same materials, chemical composition, manufacturing methods, austenite finish temperature, similar size range, and sterilization methods as the predicate.
• Non-Clinical Tests: Mechanical testing per ASTM F564 Annex A1 and A4, and corrosion testing per ASTM F2129-19a.
• Conclusions: The COGNITION device was found to be superior in static bending strength, constant amplitude bending resistance, and corrosion resistance compared to the predicate.

The document does not contain any details about:

• AI/ML algorithms
• Test sets, training sets, or data provenance for AI models
• Expert involvement for establishing ground truth in an AI context
• Adjudication methods for AI performance
• MRMC comparative effectiveness studies (AI vs. human)
• Standalone AI algorithm performance
• Types of ground truth for AI
• Sample sizes for training or test sets in an AI context
• Ground truth establishment for training sets in an AI context

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The A'TOMIC™ Nitinol Fixation System is indicated for use in fracture, osteotomy fixation and joint arthrodesis as well as fixation of bone fragments (i.e., small fragments of bone which are not comminuted to the extent that preclude staple placement). The device is intended for use in short, long, or flat bones. The A'TOMIC Nitinol Fixation System is intended for single use only.

The A TOMICTM Nitinol Fixation System, which consists of the A TOMIC™ Nitinol Fixation System implant and associated instruments, is intended for use for fixation and compression and supports several surgical techniques (e.g., fracture, osteotomy, joint arthrodesis, and fixation of bone fragments). The staples are made of implant-grade Nitinol (ASTM F2063-18) and are designed to exhibit superelastic properties at room temperature. This allows for continued compression to be applied across bone segments, thus enhancing long-term stability, and promoting fusion. Implants are passivated per ASTM F86 following machining to create a surface oxide layer that is resistant to corrosion which ensures the biocompatibility of the implant. Each staple is pre-loaded on an inserter for implantation and sterile packed. The staples are available in multiple sizes, varying by bridge length and leg length, to accommodate individual patient anatomy. Single-use disposable instrumentation is provided to assist in the surgical placement of the A TOMICTM Nitinol Fixation System implant. Reusable instrumentation will also be available as an option for the surgeon and facility.

This FDA 510(k) premarket notification describes the A'TOMIC™ Nitinol Fixation System, a medical device for bone fixation. However, it does not contain a study that proves the device meets specific acceptance criteria in the context of diagnostic accuracy or clinical performance with human readers and AI.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (BME Speed™ Implant) through a comparison of technological characteristics and non-clinical mechanical performance testing.

Therefore, many of the requested details such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets are not applicable to this type of regulatory submission. The information provided is primarily related to the device's physical and mechanical properties.

Here's an breakdown of the information that is available in the document, tailored to your request, with an emphasis on what is missing or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for diagnostic performance (e.g., sensitivity, specificity, AUC) and "reported device performance" are not directly addressed in this 510(k) for a fixation system. Instead, the "acceptance criteria" are implied by the standards and the performance of the predicate device for mechanical and material properties. The "reported device performance" refers to the results of the non-clinical mechanical tests demonstrating it meets these standards and is comparable to the predicate.

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arcad® 2.0 Duo & Quadro osteosynthesis compressive staples are indicated for foot bone fragments osteotomy fixation and joint arthrodesis.

arcad® 2.0 Duo & Quadro osteosynthesis compressive staple implants with two-leg and four-leg configurations with multiple bridge and leg lengths. The implants are manufactured from nickel-titanium alloy (ASTM F2063). The system is provided as a single-use sterile pack comprising of a bone staple implant ready to implant assembled in open legs position on its dedicated disposable insertor forceps and instruments for implantation. The implant is designed to facilitate bone fusion with Nitinol pseudoelastic behavior.

This is a medical device submission, not a submission for an AI-powered device or software. Therefore, the provided information does not contain the details typically associated with acceptance criteria and study designs for AI systems. The document describes a traditional medical device, specifically osteosynthesis compressive staples.

However, I can extract the acceptance criteria related to the device's performance as tested and the general approach to proving substantial equivalence.

Acceptance Criteria and Device Performance (based on non-clinical testing for substantial equivalence):

Study Information (Non-Clinical Performance Testing):

The device is a physical medical implant (osteosynthesis compressive staples), not an AI system. Therefore, the questions related to AI-specific study design (test set size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set) are not applicable.

Here's the relevant information based on the provided text:

• Sample size used for the test set and data provenance: The document does not specify exact sample sizes for each non-clinical test conducted (static bending, fatigue, pullout, corrosion, thermal analysis). The testing was conducted by the manufacturer, Novastep SAS, in France.
• Number of experts used to establish the ground truth and qualifications: Not applicable. Ground truth for mechanical and material properties of an implant is established through standardized testing methodologies, not expert consensus as in AI image interpretation.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not applicable to a physical implant.
• If a standalone performance study was done: The "standalone" performance here refers to the device's intrinsic mechanical and material properties. The non-clinical tests (bending, fatigue, pullout, corrosion, thermal analysis) are essentially standalone performance evaluations against established standards and comparison to a predicate device.
• The type of ground truth used: The ground truth is defined by recognized industry standards (e.g., ASTM F564-17 for mechanical properties, ASTM F2129-19a for corrosion, ASTM F2004-17 for thermal analysis) and comparison to the performance of a legally marketed predicate device (ARCAD compressive osteosynthesis staple, K142111).
• The sample size for the training set: Not applicable (no training set for a physical implant).
• How the ground truth for the training set was established: Not applicable.

Summary of Non-Clinical Performance Testing Approach:

The manufacturer conducted functional testing to demonstrate that the arcad® 2.0 Duo & Quadro osteosynthesis compressive staples are substantially equivalent to their predicate device (ARCAD compressive osteosynthesis staple, K142111). This was done by evaluating the device's properties against relevant FDA guidance for Nitinol products ("Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol") and established ASTM standards. The tests covered:

• Mechanical properties: Static bending, bending fatigue, and pullout strength (referencing ASTM F564-17).
• Material properties: Corrosion resistance (referencing ASTM F2129-19a) and thermal analysis by Differential Scanning Calorimetry (referencing ASTM F2004-17).

The document explicitly states: "Performance testing and engineering analysis demonstrated substantial equivalence to the predicate device in the following..." meaning the device met the criteria for similarity in performance to the predicate device under these tests.

Clinical Study Information:

The document explicitly states: "Not applicable. Clinical studies were not required for this submission." This means that the FDA determined that the non-clinical testing was sufficient to establish substantial equivalence for the device.

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The Medline UNITE® REFLEX® Nitinol Staples are intended to provide fixation for fractures of the bones of the hand and foot such as: First metatarsalcunerform arthrodesis, First metatarsophalangeal arthrodesis, Talo-Navicular Fusion, LisFranc arthrodesis, Akin osteotomy, Scarf and Chevron osteotomies. Staples are intended for single use only.

The Medline UNITE® REFLEX™ Nitinol Staples are manufactured from nickel titanium alloy (Nitinol). The staples utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. Chemical etching and passivation are common processes to create a uniform oxidation layer on the surface of the implant. The kits includes staples offered in a range of sizes from 8mm x 8mm to 25mm x 25mm. The Medline UNITE® REFLEX® Nitinol Staples are offered in three different bridge widths. The MINI features a 1.5mm bridge width, the MAX has a 4.0mm bridge width and the ULTRA has a 5.0mm bridge width. The MAX and ULTRA staples have a chamfer on the bridge that is not present on the MINI version of the staples.

The requested information about the acceptance criteria and study proving the device meets them is not available in the provided text. The document is an FDA 510(k) clearance letter for a medical device (Medline UNITE® REFLEX® Nitinol Staple Kit), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for clinical or standalone performance.

The provided text only mentions:

• Summary of Non-Clinical Testing (Bench):
  • Elastic Static Bend and Constant Amplitude Bending Fatigue Testing per ASTM F564
  • Pullout Strength Testing per ASTM F564
  • Corrosion Susceptibility Testing per ASTM F2129
  • Bacterial endotoxin testing using the Limulus Amebocyte Lysate (LAL) kinetic chromogenic assay, demonstrating the device meets the recommended maximum endotoxin level of 20 EU per device.
• Performance Testing (Animal): This section does not apply. No animal testing was performed.
• Performance Testing (Clinical): This section does not apply. No clinical testing was performed.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the given document.

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The StealthFix Intraosseous Fixation System is indicated for fixation of bone fractures, fusions, or for bone reconstructions, including:

• · Arthrodesis in hand or foot surgery
• · Mono or bi-cortical osteotomies in the foot or hand
• · Fracture management in the foot or hand
• · Distal or proximal metatarsal or metacarpal osteotomies
• · Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc.

The StealthFix Intraosseous Fixation System is an orthopedic intraosseous staple system consisting of staple and screw implants. The staples consist of two legs or posts connected by a bridge. The staples are available in post diameters of 2.5mm(mini), and 4.5mm(standard). The 2.5mm staples are provided with a bridge span of 10mm and range in post length from 8mm to 12mm. The 3.5mm staples are provided with a bridge span of 15mm and range in post length from 14mm to 20mm. The 4.5mm staples are available in bridge spans of 15mm and range in post length from 14mm to 32mm. The system provides crossing screws for optional fixation with the standard staple implants. Standard staples are designed with a screw slot to accept a crossing screw. The screws are available partially and fully threaded and are 3.5mm in diameter with lengths ranging from 16mm to 38mm in 2mm increments. The partially threaded screws are headed. The fully threaded and headless. The system provides accessory instruments designed for preparation of the and insertion of implants into bone, including implant specific inserters and targeting arms. The implants of the system are available packaged both sterile for single use. The instruments are provided non-sterile, reusable or single be cleaned and sterilized by the end user prior to use. The system also provides some instruments sterile packaged, individually and in sets. Sterile instruments are for single use only.

This document describes the 510(k) summary for the StealthFix Intraosseous Fixation System. It outlines the device, its intended use, and its substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to a legally marketed predicate device (K220181). This typically means showing that the new device is as safe and effective as the predicate and does not raise new questions of safety or effectiveness.

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

• Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of clinical or performance data for a diagnostic device. The evaluation primarily relied on engineering analysis, materials comparison, and cadaveric testing.
• Data Provenance:
  • Engineering Analysis: Based on design comparisons and calculations.
  • Cadaveric Testing: Implied to be prospective testing carried out for usability evaluation.
  • Endotoxin Testing: Laboratory testing on device samples.

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

• Number of Experts: Not applicable in the context of this 510(k) summary, as it does not involve a diagnostic algorithm requiring expert-established ground truth on a test set. The assessment is based on physical and engineering properties, and direct comparison to a predicate device.
• Qualifications of Experts: Not specified or relevant for this type of submission.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The evaluation is not based on interpreting results from a test set that requires expert adjudication.

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

• MRMC Study: Not applicable. This is a medical device (intraosseous fixation system), not a diagnostic artificial intelligence (AI) device.

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

• Standalone Performance: Not applicable. This is a medical device (intraosseous fixation system), not a diagnostic artificial intelligence (AI) device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Type of Ground Truth: The "ground truth" in this context is established through:
  • Material Specifications: Conformance to ASTM standards for Ti-6Al-4V alloy and Stainless Steel.
  • Design Documentation: Verification of identical staple designs and comparison of screw designs to the predicate device.
  • Engineering Principles: Analysis demonstrating mechanical equivalence or non-inferiority of new screw designs.
  • Performance Standards: Meeting endotoxin limits.
  • Functional Assessment: Cadaveric testing for usability.
  • Predicate Device Performance: The safety and effectiveness of the predicate device (K220181) serves as the benchmark.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Ground Truth Establishment for Training Set: Not applicable. This device does not involve a "training set."

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