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The Arthrex VAL KreuLock™ Compression Screws (2.0-3.0 mm solid) are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, radius, ulna, calcaneus, clavicle and scapula. When used with a plate, the screw may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Distal Extremity Plates, Mesh Plates (2.7-3.0) and Distal Radius Plates.

The Arthrex Hybrid KreuLock™ Compression Screws (3.5 mm and larger, solid) are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, Osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, pelvis, acetabulum, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.

The Arthrex Hybrid Low Profile VAL Screws (3.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, pelvis, acetabulum, metacarpals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.

The Arthrex VAL and VAL KreuLock™ Compression Screw System is a fracture fixation device system comprised of titanium (Titanium Ti-6AL-4V per ASTM F1472) self-tapping, solid, fully threaded, variable angle locking (VAL) screws that are offered in standard and hybrid configurations. The Arthrex VAL KreuLock™ Compression Screws are offered in 2.0, 2.7 and 3.0 diameters and range in lengths from 6 mm to 80 mm. The Arthrex Hybrid KreuLock™ Compression Screws and Hybrid Low Profile VAL Screws consist of line extension screws with the locking head geometry of the existing 2.7 mm screws and a shaft geometry of the existing 3.5 mm screws. The Arthrex Hybrid KreuLock™ Compression Screws range in lengths from 12 mm to 80 mm and the Arthrex Hybrid Low Profile VAL Screws range in lengths from 10 mm to 80 mm. Arthrex VAL and VAL KreuLock™ Compression Screw System consist of single-use, non-sterile devices intended for end-user sterilization.

The provided text describes a 510(k) premarket notification for the Arthrex VAL and VAL KreuLock™ Compression Screw System. This is a medical device submission, and the information is primarily focused on demonstrating substantial equivalence to previously cleared predicate devices, rather than an AI/ML algorithm's performance study with acceptance criteria and ground truth.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for an AI/ML model, are not applicable to this document.

However, I can extract information related to the performance data and the conclusion regarding substantial equivalence.

Here's a summary of the available information:

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

Since this is a mechanical fixation device, the "acceptance criteria" are not framed in terms of metrics like sensitivity or specificity, but rather in terms of compliance with established ASTM standards for mechanical properties. The reported performance is that the device meets these standards.

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

• Sample Size for Test Set: Not explicitly stated in terms of the number of screws or test repetitions. Testing was conducted "on the proposed Arthrex VAL and VAL KreuLock™ Compression Screw Systems."
• Data Provenance: Not applicable in the context of clinical data provenance. The data comes from mechanical and MRI compatibility testing of the physical device.

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

• Not Applicable. This is a mechanical device, not an AI/ML diagnostic system requiring expert interpretation for ground truth. The "ground truth" is adherence to established engineering and safety standards.

4. Adjudication method for the test set:

• Not Applicable. Mechanical testing to standards does not typically involve adjudication in the clinical sense. Results are measured against predefined engineering specifications.

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 implant, not an AI/ML diagnostic or assistive technology.

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

• Not Applicable. This is a medical implant, not an AI/ML algorithm.

7. The type of ground truth used:

• The "ground truth" for this device's performance is adherence to recognized ASTM International standards and FDA guidance documents for mechanical properties (e.g., pull-out strength, torsional strength, driving torque) and MRI compatibility (e.g., force, torque, image artifact, heating).

8. The sample size for the training set:

• Not Applicable. This is a medical implant, not an AI/ML algorithm.

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

• Not Applicable. This is a medical implant, not an AI/ML algorithm.

In summary: The provided document is a 510(k) clearance letter for a traditional medical device (bone screws), not an AI/ML software device. Therefore, most of the requested information pertinent to AI/ML model validation is not found here and is not relevant to this type of device submission. The study described focuses on demonstrating the physical and mechanical properties of the screws meet established industry standards and are substantially equivalent to predicate devices.

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The Arthrex Pilon Fusion Plates are intended to be internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, tibia, and calcaneous.

The Arthrex Low Profile Screws (3.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Distal Extremity Plates, Humeral Fracture Plates and Osteotomy Plates.

The Arthrex Pilon Fusion Plate System are a family of contoured plates and screws. The Arthrex Pilon Fusion Plates are manufactured from Titanium conforming to ASTM F136 and are available in a variety of configurations. The Arthrex Pilon Fusion Plates are intended to be used with solid locking and non-locking Low Profile Screws. The proposed plates are sold sterile or non-sterile and single use.

The proposed Arthrex Low Profile Screws are offered in a 3.5mm diameter, length range of 85 to 120 mm, in a solid and fully threaded design. The screws are manufactured from Titanium conforming to ASTM F136 and are sold sterile or non-sterile and single-use.

The provided FDA 510(k) clearance letter and summary for the Arthrex Pilon Fusion System do not contain information about a study proving that a device meets acceptance criteria related to artificial intelligence (AI) or software performance.

The document describes a medical device, which is a system of plates and screws for internal bone fixation. The performance data presented refers to mechanical testing of the plates and screws (e.g., insertion torque, failure torque, 4-point bend testing, pull-out testing) to demonstrate substantial equivalence to predicate devices. There is also mention of MR compatibility testing.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving an AI/software device meets acceptance criteria from the provided text.

Based on the nature of the document (510(k) for orthopedic implants), it is highly unlikely to contain such information. This type of submission focuses on the physical and mechanical properties of the device, biocompatibility, and substantial equivalence to existing predicate devices, not AI or software performance.

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The In2Bones USA LLC, Fracture and Correction System plates and screws are intended to treat fractures and non-unions of the 5th metatarsal.

The Fracture and Correction System lag screws are intended to be used as screws, or in a plate-screw system for internal bone fraction for bone fractures, fusionies and non-unions of various bones, including humerus, radius, uha, tibia, calcaneus, fibula, and small bones (metacarpals, metatarsals, and phalanges).

The In2Bones Fracture and Correction System is a system of plates, screws and washers used to treat fracture and reconstruction of the bones of the extremities.

The provided text describes the regulatory clearance for the "In2Bones Fracture and Correction System," a medical device consisting of plates, screws, and washers used for bone fixation. However, the document does not contain information about acceptance criteria, device performance metrics, or study design details in the way requested by the prompt (e.g., sample size, expert qualifications, adjudication method, MRMC studies, standalone performance, ground truth establishment, or training set details).

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, primarily through performance data confirming the mechanical properties of the device rather than clinical or AI algorithm performance.

Here's what can be extracted from the document regarding "performance data," albeit not in the format of AI algorithm acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

As per the document, the device underwent various mechanical tests to demonstrate its substantial equivalence to predicate devices. The specific acceptance criteria (e.g., minimum torque values, maximum displacement under load) are not explicitly stated in this summary but are implied by the statement that the testing "demonstrate[s] that the device is substantially equivalent to the predicate devices identified."

Missing Information (Regarding the original prompt's questions):

The document does not provide details for the following requested items as they are not relevant to a 510(k) submission for a mechanical bone fixation system:

2. Sample size used for the test set and the data provenance: Not applicable in the context of mechanical testing. "Test set" here refers to physical device samples, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical properties is established by engineering standards and measurements, not medical expert consensus.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an AI-assisted diagnostic device, but a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is not an AI algorithm.
7. The type of ground truth used: For mechanical tests, the ground truth is derived from engineering measurements and established standards.
8. The sample size for the training set: Not applicable. This is not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.

Summary from the provided text:

The In2Bones Fracture and Correction System demonstrated "substantial equivalence" to identified predicate devices (K123241, K983495, K131920, K160174) by undergoing mechanical performance testing, including pyrogenicity, static driving torque, static pullout, static torsion, static bending, and fatigue bending tests. The results of these tests (namely, that the device performed adequately to be deemed substantially equivalent) are reported, but the specific numerical acceptance criteria or detailed outcomes of each test are not provided in this 510(k) summary. The device's "acceptance criteria" were met by establishing that its technological characteristics and performance were comparable to legally marketed predicate devices, ensuring its safety and effectiveness.

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The Arthrex Compression Screws are intended for fixation of fractures, osteotomies and arthrodesis in:

• carpal, metacarpal and small hand bones .
• . tarsal and metatarsals
• . phalanges
• . intra-articular fractures
• . ankle
• . proximal and distal humerus
• . proximal and distal radius
• . proximal and distal ulna
• . osteochondral fixation and fractures
• . osteochondritis dissecans
• . fixation of fractures and osteotomies about the knee
• . oblique fractures of the fibula
• . reconstructive surgeries of the foot
• malleolar fixation

where size of offered implant is patient appropriate.

The Arthrex Compression Screws are a family of titanium, cannulated, compression screws that are offered in a diameter range of 5.0 to 7.0mm, length range of 20 to 140mm, in a fully threaded design.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Arthrex Compression Screws, formatted as requested:

This document is a 510(k) premarket notification for Arthrex Compression Screws. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device requiring extensive clinical trials with human readers or AI. Therefore, many of the requested fields related to AI performance, human reader studies, and large-scale ground truth establishment are not applicable.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • The document mentions "Shear, push-out, torque, and compression testing" which are mechanical tests performed on the devices themselves, not tests involving human anatomical samples or patient data.
   • The specific sample sizes for these mechanical tests are not provided in the summary.
   • Data provenance is not applicable as it's not clinical data or images.

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

   • Not applicable. The "ground truth" here refers to the performance of the predicate device for comparison in mechanical testing. Expert consensus related to diagnostic imaging or clinical outcomes is not involved.

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

   • Not applicable, as there's no clinical test set requiring adjudication.

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:

   • No MRMC study was done. This is a medical device (bone fixation screw) and the submission is for its substantial equivalence, not an AI-powered diagnostic or assistive tool.

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

   • Not applicable. This is not an algorithm or AI device.

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

   • The "ground truth" for comparison was the performance characteristics of the legally marketed predicate device (K132217: Arthrex Compression FT Screws) as measured through mechanical testing. This is a benchmark against a predicate device's established mechanical properties.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning device, so there is no "training set."

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

   • Not applicable, as there is no training set.

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The Arthrex Fracture Plates are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, and fibula.

The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates.

The Arthrex Fracture Plates are a family of flat and contoured plates and screws. The plates are comprised of stainless steel and come in a variety of configurations. The Arthrex Fracture Plates are intended to be used with solid locking and non-locking Low Profile Screws. The proposed Low Profile Screws, in this submission, are comprised of Stainless Steel and are 2.7mm in diameter and range from 32mm to 60mm in length.

The provided text is a 510(k) premarket notification for the Arthrex Fracture Plates and accompanying screws. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study proving a device meets specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, many of the requested categories for AI/ML study description (like sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this document. The document describes a mechanical performance study to demonstrate substantial equivalence.

Here's the information that can be extracted relevant to acceptance criteria and the "study" conducted for this type of device:

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

The document describes material and mechanical testing to demonstrate substantial equivalence. It implies that the acceptance criteria for these tests were met by being comparable to the predicate devices. The specific raw data or numerical acceptance limits are not provided in this summary, but the conclusion of meeting them is stated.

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

• Sample size: Not explicitly stated for the mechanical tests in this summary. Mechanical tests typically involve a small number of samples of the device and predicate.
• Data provenance: The tests were "in-vitro testing" conducted by the manufacturer, Arthrex, Inc., in the USA (Naples, FL).

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

• Not applicable. This pertains to mechanical testing, not expert-based evaluation of medical images.

4. Adjudication method for the test set:

• Not applicable. This pertains to mechanical testing.

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

• No. This is not an AI/ML device, and 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 not an AI/ML device.

7. The type of ground truth used:

• Mechanical properties comparison to predicate devices. The "ground truth" here is the established mechanical performance of legally marketed predicate devices, against which the new device's performance is compared.

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not an AI/ML algorithm requiring a training set.

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

• Not applicable.

Summary of what the document does say about the "study":

The study conducted was in-vitro mechanical testing (4-point bend, section modulus comparison, torque) to compare the performance of the Arthrex Fracture Plates and screws to their predicate devices. The conclusion was that the "performance of the proposed devices is substantially equivalent to that of the predicate devices" and that "The mechanical data indicate that the Arthrex Fracture Plates are adequate for their intended use." The document explicitly states: "Clinical data and conclusions are not needed for this device."

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The Instratek 4.5mm, 5.5mm, and 6.5mm screws are indicated for fixation of bone fractures, osteotomies, non-unions and mal-unions in bone reconstruction. These devices are not intended for use in the spine.

The Instratek 4.5mm, 5.5mm, and 6.5mm screws are intended for the following surgical indications:

• Metatarsal fractures
• Fixation of malunions and nonunions
• Acute fractures
• Avulsion fractures
• Repetitive stress fractures
• Malleolar fractures
• Talus fractures
• Greater tuberosity fractures
• Small joint fusion
• Jones fractures
• Osteotomies and non-unions in the foot and ankle

The Instratek Jones-FX System is comprised of screws in diameters 4.5mm, 5.5mm and 6.5mm. The screws are available in cannulated and non-cannulated versions and are constructed of TI-6AL-4V anodized titanium alloy conforming to ASTM F136. The screws have Torx heads. Instruments provided in the set include: Tissue protector K-wire guides Drill guide inserts (3.1mm, 4.0mm and 4.9mm) Tap Guide inserts (4.5mm, 5.5mm and 6.5mm) K-wire (1.7mm x 230mm) Cannulated drill bits (3.1mm, 4.0mm and 4.9mm) Screw Taps, Cannulated (4.5mm, 5.5mm, 6.5mm) Depth gauge Driver blade Fixed and Rachet Quick Connect Drivers Countersink Tray with Caddy

The provided text is for a 510(k) summary for a bone screw system (Instratek Jones-FX System). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving new clinical efficacy or performance through extensive studies with acceptance criteria as one might see for novel diagnostic AI devices.

Based on the provided information, no study was conducted to prove the device meets acceptance criteria. The submission explicitly states:

"No testing was conducted for inclusion with this submission."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because the submission does not contain such a study. The basis for substantial equivalence is the similarity in design, materials, intended use, and technological characteristics to predicate devices, not through performance testing against specific acceptance criteria.

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