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ArTT Augments and Buttresses are indicated to be used, in combination with EMPOWR Acetabular Cup System, as an alternative to structural allograft in skeletally mature patients in cases of segmental acetabular deficiencies.

ArTT Augments and Buttresses are indicated for cementless use to the bone interface; and are affixed to the mating acetabular cup using bone cement.

This 510(k) submission aims at introducing new device components, the ArTT Augments and Buttresses and Bone Screws (Revision Bone Screws (Dia. 6.5mm), Locking Bone Screws (Dia. 6.5mm), Locking Bone Screws (Dia. 4mm), Bone Screws (Dia. 4mm)) to be used in combination with the EMPOWR Acetabular Cup System (K190057) manufactured by Encore Medical, L.P.

ArTT Augments and Buttresses are manufactured from Ti6Al4V 3D printed (ISO 5832-3) and are indicated for cementless use to the bone interface; they are affixed to the mating acetabular cup using bone cement. ArTT Augments are available in 9 diameters (Dia. 50mm to 66mm) and 3 eccentricities (Ecc. 10mm, Ecc. 15mm, Ecc. 20mm), while ArTT Buttresses are available in 3 diameters (Dia.50mm, Dia.56mm, Dia.62mm), 3 heights (H. 15mm, H. 30mm, H. 60mm) and 3 configurations (Neutral, Left, Right).

Bone Screws are manufactured from Ti6Al4V (ISO 5832-3 - ASTM F1472); they are intended for cancellous or cortical bone and are available in several lengths.

This FDA 510(k) clearance letter pertains to
"ArTT Augments and Buttresses and Bone Screws" for orthopedic use. It's important to note that this document is a clearance letter, not a detailed scientific study publication. As such, it provides summary information about the device and the types of testing performed to demonstrate substantial equivalence, rather than a deep dive into specific study methodologies or acceptance criteria with detailed performance metrics.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum wear rate, specific pull-out force thresholds) or precise numerical performance results for the ArTT Augments and Buttresses and Bone Screws.

Instead, it states:

• "Mechanical tests demonstrated that the device performance fulfilled the intended use, and that the device is substantially equivalent to the predicate device."
• "Other performance requirements were fulfilled through rationales and comparisons with previously cleared components (K210717, latest 510(k) approval)."

This implies that the acceptance criteria were based on:

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

• Sample Size for Test Set: The document states that mechanical testing was performed on "worst case components or constructs." However, it does not specify the exact number of samples or specimens used for each test (e.g., how many augments, how many screws of each type).
• Data Provenance: The studies were "Non-clinical testing" conducted by the manufacturer, Limacorporate S.p.A. The location of the testing laboratories or specific origin of data (e.g., retrospective/prospective in a clinical sense) is not described, as these are non-clinical (mechanical) tests.

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

This section is not applicable as the studies described are non-clinical (mechanical) tests. The "ground truth" for mechanical testing is typically established by engineering standards (e.g., ASTM F543) and internal protocols, not by expert consensus from medical professionals.

4. Adjudication Method for the Test Set:

This section is not applicable for non-clinical mechanical testing, where adjudication methods like 2+1 or 3+1 by human experts are not used. Performance is measured against engineering specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not done. The clearance is for a physical orthopedic implant system, not an AI software/diagnostic device that would involve human readers interpreting cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

No, a standalone (algorithm only) performance study was not done. This device is a physical implant system, not an algorithm or AI.

7. The Type of Ground Truth Used:

For the mechanical tests conducted, the "ground truth" implicitly refers to:

• Engineering Standards: Specifically mentioned is ASTM F543 for torsional properties, driving torque, and pull-out load of bone screws.
• Internal Protocols: Used for fretting fatigue testing.
• Performance of Predicate Devices: The measured performance of the ArTT Augments and Buttresses was deemed "substantially equivalent" to that of the predicate devices. This means the performance of the predicate likely served as a benchmark or reference point for establishing acceptable performance.

8. The Sample Size for the Training Set:

This section is not applicable as this is a physical medical device, not an AI/machine learning model that requires a training set.

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

This section is not applicable for the same reason as above (physical medical device, no training set).

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The aap Cannulated Headless Bone Screws are indicated for use in non-spinal fragment fixation, osteotomy and arthrodesis of human bones appropriate for the size of the screw. The devices are intended for single use only. The aap Cannulated Headless Bone Screws are indicated for adults, and children (2 years to less than 12 years) and adolescents (aged 12 through 21, up to but not including the 22nd birthday) in which growth plates have fused or in which growth plates will not be crossed by fixation.

K-Wires are indicated for use as guide wire for osteosynthesis implants and for application as implant according to the AO/ASIF principles of fracture management.

The K-Wires are indicated for adults, and children (2 years to less than 12 years) and adolescents (aged 12 through 21, up to but not including the 22nd birthday) in which growth plates have fused or in which growth plates will not be crossed by fixation.

The subject device Cannulated Headless Bone Screws are cannulated at both the leading end (tip) and at the trailing end. The leading/trailing diameters are: 2.5/3.4 mm. 3.5/4.5 mm. 4.0/4.8 mm. 4.5/5.3 mm, 5.5/6.2 mm, 6.5/7.2 mm, and 7.5/7.9 mm., The leading thread have different pitches which facilitates closure of any fracture gap and generates compression across the bone fragments. The subject screws are provided in overall lengths ranging from 12 mm, and with threaded lengths (at the leading end or tip) ranging from 4 mm to 40 mm. The subject screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and ISO 5832-3.

The subject K-Wire is provided in one size with a diameter of 2.4 mm and a length of 250 mm. The subject K-Wire has a trocar point, is threaded, and is manufactured from stainless steel conforming to ASTM F138 and ISO 5832-1.

This document describes the aap Cannulated Headless Bone Screws, a medical device for bone fixation. Since this is a 510(k) summary, the core of the submission is to demonstrate substantial equivalence to existing legally marketed devices, rather than establishing brand-new performance criteria for a novel device. Therefore, the "acceptance criteria" here are largely defined by demonstrating that the new device performs at least as well as and shares similar characteristics with the predicate devices.

Here's an analysis of the provided information based on your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of explicit acceptance criteria with numerical targets as one might see for a novel device, the "acceptance criteria" here are met by demonstrating similarity and comparable performance to the predicate devices.

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

• Sample Size: Not explicitly stated as a number of devices or clinical cases for this submission's testing. The non-clinical performance data mentions "mechanical testing of the subject device screws according to ASTM F543." ASTM F543 outlines test methods, but the specific number of screws tested is not provided in this summary.
• Data Provenance: The data is primarily non-clinical performance data which includes mechanical testing, sterilization validation, and references to previous submissions (K111316, K130590, K131459, K161616) for biocompatibility, packaging, and shelf-life. There is no clinical data included in this submission. The origin of the reference data for predicate devices is not specified, but previous 510(k) submissions would have their own established provenance.

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

Not applicable. This submission relies on non-clinical performance testing and substantial equivalence to predicate devices, not on establishing ground truth via expert review of clinical cases.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. There's no test set requiring human adjudication for diagnostic or interpretive tasks. The evaluation is based on engineering specifications, material standards, and mechanical test results.

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 medical device (bone screws and K-wires), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation 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 or software.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established through:

• Engineering Specifications and Material Standards: Compliance with recognized standards like ASTM F136, ISO 5832-3, ASTM F138, ISO 5832-1, ASTM F543, ISO 17665-1, ISO 10993-1. These standards define the acceptable properties and performance for such devices.
• Bench Testing: Mechanical testing data according to ASTM F543.
• Referencing Predicate Devices: The established regulatory clearances and performance data of the cited predicate devices (K111316, K130590, K131459, K161616) serve as a de-facto "ground truth" for comparison under the substantial equivalence pathway.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model, so there is no training set.

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

Not applicable, as there is no training set.

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The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.

The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:

• . non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis:
• inflammatory degenerative joint disease such as rheumatoid arthritis; ●
• . treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
• revision of a failed primary implant;
• . cuff tear arthropathy (CTA Heads only);
• . glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only).

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.

In the Anatomic shoulder the humeral construct consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.

The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists or of a peg/baseplate/glenosphere construct.

On the glenoid side, the fixation of the all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.

Bone Screws are characterized by a 5,0 mm diameter (new device) and they are used in combination with SMR TT Augmented 360 Baseplate (K191746/K200171) to fix the baseplate to the glenoid bone.

The SMR TT Augmented 360 Baseplate is a metal back glenoid component coupled to a peg made of Trabecular Titanium, intended for uncemented use with the addition of bone screws for fixation to the bone. This glenoid component is part of the SMR TT Augmented Glenoid System (K191746/K200171) that is a modular system intended to be used in combination with previously cleared components of the SMR Reverse Shoulder System. The system consists of a modular glenoid component to be used in total shoulder replacement in a reverse shoulder configuration.

This document is a 510(k) premarket notification decision letter from the FDA regarding Bone Screws dia. 5,0 mm manufactured by LimaCorporate S.p.A. The letter states that the device is substantially equivalent to legally marketed predicate devices.

The information provided does not contain details about acceptance criteria, device performance tables, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, as these elements are typically associated with the evaluation of AI/ML-driven medical devices or diagnostic tools. This document pertains to the substantial equivalence determination of a bone screw, which is a mechanical implant, and its evaluation relies on mechanical testing and comparison to predicate devices, not data-driven performance metrics for an algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the provided text, as this information is not present. The document explicitly states:

• "Clinical testing was not necessary to demonstrate substantial equivalence of Bone Screws dia. 5,0 mm to the predicate device." This confirms that there was no clinical study with a test set of patient data, human readers, or ground truth as you described.
• The testing performed was "Mechanical testing" which demonstrated the device's ability to perform substantially equivalent to the predicate device in:
  • Torsional test, driving torque test, pull-out test for bone screws (ASTM F543)
  • Dynamic Evaluation of the Glenoid Loosening or Disassociation (ASTM F2028)

In summary, the provided document is for a mechanical orthopedic implant, not an AI/ML-driven device. Therefore, the questions regarding acceptance criteria, test sets, training sets, expert consensus, MRMC studies, and ground truth are not applicable to the content of this FDA 510(k) premarket notification.

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General Indications:
The MobileLink® Acetabular Cup System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.
Indications:

• 1. Primary and secondary osteoarthritis
• 2. Rheumatoid arthritis
• 3. Correction of functional deformities
• 4. Avascular necrosis
• 5. Femoral neck fractures

6. Revision after implant loosening dependent on bone mass and quality

The subject devices are 6.5mm diameter acetabular bone screws in various lengths manufactured from Ti6Al4V alloy. They are accessories to the predicate MobileLink® Acetabular Cup System (K182321).

This document (K192559) describes the 510(k) premarket notification for "Acetabular Bone Screws (for MobileLink Acetabular Cup System)". It's important to note that this document is for a medical device (bone screws), not an AI or software device. Therefore, the requested information regarding acceptance criteria and studies for an AI/software device does not apply to this submission.

The document discusses the substantial equivalence of the bone screws to predicate devices based on:

• Device Description: 6.5mm diameter acetabular bone screws in various lengths manufactured from Ti6Al4V alloy. They are accessories to the MobileLink® Acetabular Cup System.
• Intended Use: The MobileLink® Acetabular Cup System (with which these screws are used) is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures, including primary and secondary osteoarthritis, rheumatoid arthritis, correction of functional deformities, avascular necrosis, femoral neck fractures, and revision after implant loosening.
• Comparison to Predicate Device: The subject screws provide supplemental screw fixation for acetabular shells, are manufactured from the same Ti6Al4V alloy as the predicate, are available in Ø 6.5mm and various lengths, and minor technological differences do not raise new questions of safety or effectiveness.
• Performance Testing (Non-Clinical):
  • Bone screw testing according to ASTM F543.
  • Endotoxin testing.
  • Biocompatibility evaluation.
• Clinical Testing: "Clinical performance testing was not required to demonstrate the substantial equivalence of this device."

Therefore, I cannot provide the requested information related to AI/software device acceptance criteria and study details because this document does not pertain to such a device.

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The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or posttraumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

All TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only, except the TRULIANT Porous Tibial Trays, which are indicated for cemented or cementless use.

Exactech Alteon Bone Screws are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Exactech Alteon Bone Screws are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

The Exactech Alteon Bone Screws are also indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The tibial tray implant and its porous structure is manufactured from Ti-6Al-4V titanium alloy using electron beam melting (EBM) technology. This product line represents a scope extension of the Truliant knee implant system. The previously cleared Alteon Bone Screws are now cleared for use with the TRULIANT Porous Tibial Trays.

This document does not describe a study involving an algorithm or AI. It is a 510(k) summary for a medical device (TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws), which means it focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance data from non-clinical (mechanical) testing.

Therefore, many of the requested categories, such as "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this type of submission.

Here's an analysis based on the information provided, focusing on the mechanical performance data:

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

Note: The document states that "The results of this non-clinical testing show that the strength of the TRULIANT Porous Tibial Tray is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." The specific numerical acceptance criteria (e.g., minimum load or cycles) and quantitative results for the mechanical tests are not provided in this 510(k) summary, but are implicitly met as per the FDA's clearance.

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

This information is not provided in the given text. For mechanical testing, sample sizes are typically determined by the relevant ASTM standards, but the exact numbers are not mentioned here. The data provenance is also not specified, as this is non-clinical lab testing rather than patient 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 document describes mechanical and pyrogenicity testing, not studies requiring expert review for ground truth in the context of medical image analysis or clinical outcomes.

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

This is not applicable for the type of testing described. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, not for standardized mechanical tests.

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. This document describes the clearance of a physical medical device (tibial tray and bone screws) through non-clinical testing, not an AI-powered diagnostic or assistive tool.

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

This is not applicable. This document does not pertain to an algorithm.

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

For the mechanical tests, the "ground truth" would be the physical properties and performance of the device under controlled laboratory conditions as measured against established ASTM standards. For pyrogenicity, it's the measured endotoxin level. This is not "expert consensus", "pathology," or "outcomes data" in the clinical sense.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable. There is no "training set" and thus no ground truth to establish for it in this context.

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The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement. The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:

• non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• inflammatory degenerative joint disease such as rheumatoid arthritis;
• treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
• revision of a failed primary implant;
• cuff tear arthropathy (CTA Heads only);
• glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR Hybrid Glenoid only).

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The Hybrid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.

In the Anatomic shoulder the humeral consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.

The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.

On the glenoid side, the fixation of the all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.

The Delta TT Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
• Rheumatoid arthritis;
• Post-traumatic arthritis,
• Correction of functional deformity;
• Fractures, dislocation of the hip and unsuccessful cup arthroplasty.
• Revisions in cases of good remaining bone stock.

Bone screws are used to provide further stability to the Delta TT acetabular cups and to the metal back glenoid of the SMR Shoulder System in reverse shoulder configuration.

The Delta TT acetabular cups (K112898, K141395) are acetabular components intended for uncemented fixation; screw holes present in the Delta TT cups allow optional additional fixation of the cup to the bone using 6.5mm diameter bone screws.

The SMR Shoulder System metal back glenoids (K110598, K113254, K133349, K161120, K163397) are components intended to be implanted into a hole drilled in the glenoid cavity. The metal back glenoid can be used in both anatomic and reverse shoulder configuration; when used in reverse shoulder configuration, the metal back glenoid are intended for uncemented use and are fixed to the glenoid bone through the use of 6.5mm bone screws.

The current submission is for additional lengths of 6.5mm diameter bone screws:

• the proposed range of bone screws used in combination with the SMR Shoulder System is 20mm to 55mm in length;
• the proposed range of bone screws used in combination with the Delta TT Acetabular System is 15mm to 90mm in length.

Design, material, manufacturing process and intended use of the new 6.5mm diameter bone screws are the same as those for the 6.5mm bone screws cleared in the previous 510(k)s.

The provided document is a 510(k) premarket notification decision letter and accompanying information for Bone Screws 6.5mm by LimaCorporate S.p.A.

This document describes a submission for a medical device (bone screws), not an AI/ML-enabled diagnostic or therapeutic device that would typically undergo the kind of acceptance criteria, standalone performance studies, and human-in-the-loop studies involving expert readers, ground truth establishment, and large image datasets as outlined in your request.

Therefore, the information required to answer your prompt, such as acceptance criteria based on performance metrics (e.g., accuracy, sensitivity, specificity), sample sizes for test sets of images, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and training set details, is not present in this document.

The document explicitly states under "Non-Clinical Testing" and "Clinical Testing":

• Non-Clinical Testing: "The additional lengths of 6.5mm bone screws use the same fundamental scientific technology and device design concepts, are made from the same materials utilizing the same manufacturing processes, utilize the same packaging and sterilization processes, and have the same indications for use as the predicate devices; the new lengths of 6.5mm diameter bone screws therefore do not require any testing to determine substantial equivalency."
• Clinical Testing: "Clinical testing was not necessary to demonstrate substantial equivalence of the new sizes of bone screws to the predicate devices."

This indicates that the FDA's substantial equivalence determination for these bone screws was based on their similarity to existing predicate devices in terms of design, materials, manufacturing, intended use, and indications, rather than requiring performance studies against specific acceptance criteria for diagnostic accuracy or clinical outcomes that would involve the elements you've listed.

In essence, the "study" proving the device meets acceptance criteria was a comparison to legally marketed predicate devices, demonstrating that the new bone screw lengths do not raise different questions of safety and effectiveness. The acceptance criteria for this type of device would primarily revolve around material compatibility, mechanical properties (which were not explicitly detailed as new testing data, given the stated substantial equivalence), manufacturing quality, and intended use as compared to the predicates, rather than the performance metrics of an AI/ML system.

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The Arthrosurface Bone Screws (2.0-3.0 mm solid and cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist.

The Arthrosurface Bone Screws (3.5 mm and larger, solid and cannulated) are intended to be used as stand-alone bone screws for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, shoulder, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula.

The Arthrosurface Bone Screws have diameters ranging from 2.0 mm to 4.0 mm and lengths ranging from 8 mm to 50 mm. The screws are either partially or fully threaded, solid or cannulated, self-tapping or self-drilling and are manufactured from implant grade stainless steel or titanium alloy. Depending on their size, these bone screws are intended to be used for different indications for use.

Here's a breakdown of the acceptance criteria and the study information based on the provided FDA 510(k) summary for the Arthrosurface Bone Screws:

It's important to note that this document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to existing devices, rather than proving a new device meets specific, novel acceptance criteria through a clinical trial. Therefore, the "study" described is primarily non-clinical testing to show equivalence in performance and safety.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for bone screws, the "acceptance criteria" are generally derived from recognized industry standards for mechanical performance and safety, and the "reported device performance" are the results demonstrating compliance with these standards.

Note: The document states "demonstrated that the Arthrosurface Bone Screws are substantially equivalent to the predicate devices" and "The safety and effectiveness... is adequately supported by the substantial equivalence and performance testing information," implying that the device met the established criteria within these standards.

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

• Test Set Sample Size: The document does not specify the exact number of screws or tests performed for each non-clinical test (torque, pullout, LAL). It typically refers to "the Arthrosurface Bone Screws" as a general product line being tested.
• Data Provenance: The data is generated from non-clinical laboratory testing conducted by the manufacturer, Arthrosurface, Inc. The location of the testing is not specified beyond the company's address in Franklin, Massachusetts. This is prospective testing conducted specifically for the 510(k) submission.

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

This section is not applicable in the context of this 510(k) submission for bone screws.

• Ground truth is typically established through expert consensus or clinical outcomes for diagnostic or AI-driven devices. For implantable mechanical devices like bone screws, "ground truth" is determined by objective physical and chemical testing against established engineering and biocompatibility standards (e.g., ASTM, USP). There are no human experts "establishing ground truth" in the way one would for image interpretation.

4. Adjudication Method for the Test Set

This section is not applicable. As described above, the "test set" involves physical and chemical property measurements against predefined international standards, not subjective assessments requiring adjudication among human experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done.

• MRMC studies are typically used for diagnostic devices (e.g., imaging AI) to compare the performance of human readers with and without AI assistance. This device is a mechanical bone fixation fastener, not a diagnostic tool.

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

No, this concept is not applicable.

• This question pertains to AI/software as a medical device (SaMD). The Arthrosurface Bone Screw is a physical implantable device. There is no "algorithm" or standalone software performance to evaluate in this context.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance testing is based on:

• Established engineering standards: Specifically, ASTM F543 for mechanical properties (torque to failure, insertion/removal torque, axial pullout force).
• Biocompatibility and sterility standards: United States Pharmacopeia (USP) Chapter Bacterial Endotoxins Test, USP Chapter Transfusion and Infusion Assemblies and Similar Medical Devices, and AAMI ST72:2002/R2010, Bacterial Endotoxins-Test Methodologies.

8. The Sample Size for the Training Set

This section is not applicable.

• There is no "training set" in the context of a 510(k) submission for a mechanical bone screw. Training sets are used for machine learning algorithms.

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

This section is not applicable for the same reason as point 8.

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The DRACO Locking Screws are intended to be used in combination with DRACO Locking plates for adult and pediatric patients as indicated for small bone fracture fixations for use include fixation of fractures, osteotomies, nonunions of the clavicle, scapula, olecranon, radius, metacarpals, metatarsals, Hallux Valgus osteotomy corrections, middle hand and middle foot bones, particular in osteopenic bone.

The DRACO Compression Screws are indicated for fracture fixation of various bones, including, osteotomies in the foot (as Hallux Valgus treatment) or hand, foot or ankle surgery, fixation of bone fragments in long bones or small bone fractures. The size of the chosen screw should be adapted to the specific indication.

The DRACO MetaFuse L Plates and the DRACO MetaFuse BLP Plates are used for adult and pediatric patients as indicated for small bone fracture fixations for use include fixation of fractures, ostectornies, non-unions of the clavicle, scapula, olecranon, radius, ulna, metacarpals, Hallux Valgus osteotomy corrections, middle hand and middle foot bones, particular in osteopenic bone.

The DRACO MetaFuse MTP Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, and toes.

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I am sorry, but the provided text from the FDA 510(k) K163486 document for DRACO Locking Screws, DRACO Compression Screws, and various DRACO MetaFuse Plates does not contain any information about acceptance criteria or performance study results for a medical device that uses artificial intelligence (AI).

The document is a clearance letter and the "Indications for Use" for a range of metallic bone fixation appliances and accessories. It details:

• The 510(k) clearance number (K163486).
• The trade/device names (DRACO Locking Screws, DRACO Compression Screws, DRACO MetaFuse L Plates and BLP Plates, DRACO MetaFuse MTP Plates, Takú Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates).
• The regulation number and name (21 CFR 888.3030, Single/Multiple Component Metallic Bone Fixation Appliances And Accessories).
• The regulatory class (Class II).
• Product codes (KTT, HWC, HRS, HTY).
• Dates of submission and review.
• The FDA's determination of substantial equivalence to predicate devices.
• General controls provisions and other regulatory requirements.
• Specific indications for use for each device type (e.g., fixation of fractures, osteotomies, non-unions in various small bones for adult and pediatric patients).
• Confirmation that these are Prescription Use devices.
• Information related to the Paperwork Reduction Act.

The document does not describe:

• Any AI functionality.
• Performance metrics (e.g., sensitivity, specificity, accuracy).
• A test set, training set, or data provenance.
• Experts used for ground truth or adjudication methods.
• MRMC studies, standalone AI performance, or types of ground truth used in a study.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance in the context of an AI-powered device based on the provided text. The textual content is solely about the regulatory clearance of bone fixation hardware.

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ALLY™ Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

The ALL Y™ Bone Screws are fully threaded cortical screws offered in various diameters and lengths. All screws are manufactured from titanium alloy. The implants are single use only.

The provided text describes the 510(k) submission for the ALLY™ Bone Screws, a Class II medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its performance in a clinical setting against specific acceptance criteria in the way an AI/ML device would.

Therefore, many of the requested categories are not applicable to this submission. This device is a bone screw, not an AI/ML algorithm or software device.

Here's a breakdown of the available information based on your request:

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

For a traditional medical device like a bone screw, acceptance criteria typically refer to engineering specifications and performance testing results against established industry standards.

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

This information is not provided in the document. For engineering tests of a medical device, the sample size would typically refer to the number of screws tested for each mechanical property. The data provenance would be that the tests were conducted in a lab setting, not from clinical 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)

Not applicable. For a bone screw, "ground truth" is established through standardized mechanical testing and engineering analysis rather than expert consensus on clinical data.

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

Not applicable. Adjudication methods are relevant for studies involving human interpretation (e.g., image reading) to establish ground truth, not for mechanical testing of a 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

Not applicable. This device is a bone screw, not an AI/ML diagnostic tool requiring MRMC studies.

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

Not applicable. This device is a bone screw, not an AI/ML algorithm.

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

The "ground truth" for this device's performance is established by objective mechanical testing against ASTM F543 standards and engineering analysis. It is not based on expert consensus, pathology, or outcomes data in the traditional sense.

8. The sample size for the training set

Not applicable. This device is a bone screw, not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is a bone screw, not an AI/ML algorithm.

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The OrthoSolutions 'System26' cannulated screws (headed and headless compression) and washers are indicated for use over a guide pin or wire for aligned bone fracture repair and arthrodesis, osteotomy, joint fusion and bone fragment fixation appropriate with the size of the screw. Washers of matching size to the headed cannulated bone screw may be used in certain applications for deficient osteopenic bone. The non-cannulated 2.0 (headed, headless compression and Twist-Off) bone screws are applicable, as well, for bone fracture repair and arthrodesis, osteotomy, joint fusion and bone fragment fixation appropriate with the size of the screw.

'System26' non-cannulated 2.0mm (headed, headless compression and Twist-Off) bone screws and cannulated (headed and headless compression) bone screw sizes of 2.0mm, 2.5mm 3.0mm are indicated for treating small bone fractures as well as performing osteotomies, arthrodesis and joining cancellous bone fragments in the upper and lower limb and extremities.

'System26' cannulated bone screw sizes (headless compression and headed with optional matching washer) of 4.0mm, 5.0mm, 6.5mm, and 8.0mm are indicated to be used with large and long bones. Specific indications, which are dependent in part on the diameter of the screw include: Minimally invasive bone fracture/joint reconstructions; Additive osteosynthesis for complex joint fractures; Multiple-fragment joint fractures; Femoral neck and femoral head fractures; Femoral supracondylar fractures; Tibial plateau fractures; Fractures of the head of the humerus; Fractures of the tibia; Cooper fractures of the tibia; Bone fractures of the radius, wrist, ankle, elbow, and shoulder; Ligament fixation of the proximal humerus; Bone fractures of the acetabulum and dorsal pelvic ring; Condylar fractures; Ligament avulsion injuries; Malleolar and navicular fractures; Bone fractures of the calcaneus and talus; Arthrodesis of the ankle joint; Arthrodesis of foot joints and; Avulsion fractures.

The OrthoSolutions ‘System26’ Bone Screws are not intended for spinal use.

OrthoSolutions 'System26' Bone Screws are comprised of noncannulated/cannulated bone screws and washers manufactured from Titanium Alloy (to ISO 5832-3/ASTM F136) for implantation within the human body. The instrumentation is made from medical grades of stainless steel and silicon. The 'System26' implants are threaded screws offered in both a 'headed' and 'headless compression' design. The implant screws are available in a range of diameter sizes between 2mm thru 8mm, (each identified with a Type III color anodising) with lengths between 10mm (shortest length) and 120mm (longest length). The implant screw devices (headed with washers and headless compression) and associated instrumentation are available in specifically designed, modular trays and are provided 'Non-sterile' to the end user for 'Single Use'. The 'System26' instruments include guide wires and size specific guides, drill bits and size specific guides, tissue protectors, depth gauges, countersinks, screw driver shafts, ratcheting screw driver handles and bone distractors. These instruments are used to ensure correct positioning and placement of the screws.

The provided text is a 510(k) Summary for the OrthoSolutions 'System26' Bone Screws. It describes the device, its intended use, and argues for its substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance.

The document is for a traditional medical device (bone screws), not an AI/ML-driven device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test/training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, are not applicable to this submission.

The "study that proves the device meets the acceptance criteria" mentioned in the document is an "Engineering Analysis" to demonstrate "Substantial Equivalence (SE)" to predicate devices. This type of analysis typically involves comparing material properties, geometric dimensions, mechanical testing results (if applicable), and intended use of the new device against the predicate devices. It does not involve performance metrics like sensitivity, specificity, or AUC that would be seen in an AI/ML device study.

Therefore, I cannot provide the requested information for an AI/ML device based on the provided text.

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