Search Results

The Intended Use of the Cannulated Screw and Kirschner (Kwire) System is for the treatment and fixation of bone fractures and osteotomies of various bones including the clavicle, acetabulum, pelvis, scapula, humerus, radius, ulna, femur, tibia, phalanges, carpals, metacarpals, tarsals, metatarsals and fibula.

Cannulated Screws and Kwires are a self-tapping, self-drilling screw with a cortico/cancellous or cancellous thread that can be guided into position by Kwire placement. Partial or fully threaded screws are available in various different lengths and diameters to provide fixation in various size bones. The screws are made of Titanium Alloy or Stainless Steel. The Kirschner Wires (Kwires) are threaded, spaded or blunt ranging from 0.8 to 1.4mm in diameter and ranging from 100 to 200mm in length and made of 316L Stainless Steel.

N/A

Ask a specific question about this device

The 4.0 mm Cannulated Screws and associated washers are indicated for arthrodesis and osteotomies of small bones and small joints, and ankle fracture.

The 5.5 mm. 6.5 mm. 7.0 mm. and 8.0 mm Cannulated Screws. Cannulated Hip Pins and associated washers are indicated for fracture fixation, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device.

The Smith & Nephew 2.5 mm, 3.0 mm Headless Compression Screws are indicated for fixation of fractures, bunionectomies and osteotomies of small bones, and arthrodesis of small joints.

The Smith & Nephew 2.0 mm QFX Screw is indicated for osteotomies of the lesser metatarsals, and osteotomies and fractures of the phalanges.

The subject Cannulated Screw System includes the 2.0 QFX Screw, 2.5mm and 3.0mm Headless Compression Screws, 4.0mm, 5.5mm, 6.5mm, 7.0mm, and 8.0mm Cannulated Screws and associated Washers (K090675, K111994, K213126).

The Smith & Nephew Cannulated Screw System consists of stainless steel (316L conforming to ASTM F139 and ISO 5832-1 or titanium (Ti-6Al-4V conforming to ASTM F1472/SO 5832-3) implantable devices of many styles for use in fracture fixation. The Smith & Nephew Cannulated Screws product family includes Large Cannulated Screws, Cannulated Hip Pins, Hip Screws, QFX Screws, and associated Washers. The components are available in various diameters, thread options, and lengths. All screws are designed with a self-drilling, self-tapping tip to facilitate easy implantion with a reverse cutting flute design to assist with implant removal. Select screws are designed with low-profile screw heads for reduced soft tissue irritation, and 3.0mm and 7.0mm screws are available headless.

The implants within this system are single-use and are Gamma sterilized.

The provided text is a 510(k) summary for a "Cannulated Screw System" and details that the submission is for labeling updates, specifically updated indications for use. The critical information here is that there are no changes to the device's design, technological characteristics, function, sterilization, or packaging.

Therefore, the submission explicitly states: "no performance testing (bench, animal, clinical) was required." This means there is no study described in this document that proves the device meets specific acceptance criteria based on performance. The clearance is based on the substantial equivalence of the device itself (which was previously cleared) and the fact that the labeling changes do not impact safety or effectiveness.

Because no performance study was conducted for this specific submission, I cannot fill in the requested table and information points.

Here's a breakdown of why based on the input:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. No performance study was conducted.
• 2. Sample size used for the test set and the data provenance: Not applicable. No performance study was conducted.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No performance study was conducted.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No performance study was conducted.
• 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 screw system, not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a screw system, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No performance study was conducted.
• 8. The sample size for the training set: Not applicable. No machine learning training was performed.
• 9. How the ground truth for the training set was established: Not applicable. No machine learning training was performed.

The core of this 510(k) submission is to update the indications for use based on existing, cleared devices, implying that the safety and effectiveness have already been established through prior submissions for functionally identical devices. The changes are specifically for "user clarification" of the indications.

Ask a specific question about this device

Cannulated Screw and Double Compression Cannulated Screw are intended for the treatment of fractures, and arthrodesis of bones with the appropriate screw size.

The Cannulated Compression Taper Screw (2.5-3.0 mm 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 Cannulated Compression Taper Screw (3.5 mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, ostectomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, femur, and fibula.

Cannulated Screws are implantable medical devices developed for application in osteosynthesis, with the purpose of reducing, compressing, aligning, stabilizing, and fixing different types of fractures, in small, medium, and large bones, of lower and upper limbs, and can be used in isolated form or associated with washers. This submission also includes the corresponding washers for Cannulated Screws.

The screws have a hexagonal connection for a wrench and can be found in three different models: Cannulated Screw, Double Compression Cannulated Screw and Cannulated Compression Taper Screw. These devices are found in a variety of diameters to meet the range of anatomies of the patients, are presented in Titanium Alloy according to the standard ASTM F136, being provided in non-sterile condition.

The provided text is a 510(k) Premarket Notification from the FDA regarding "Cannulated Screws." It details the device's indications for use, technological characteristics, and performance data. However, this document does not contain information about an AI/ML-driven medical device, a study involving human readers or expert ground truth, or an AI algorithm's performance.

The "Performance Data" section discusses mechanical properties testing of the physical screws (torsional properties, driving torque, axial pullout strength, chemical and mechanical properties) against ASTM standards. It concludes that the device presents safety and efficacy in terms of its mechanical properties, but this pertains to the physical product, not a diagnostic or AI-assisted system.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-driven device, as the provided document does not pertain to such a device.

Ask a specific question about this device

The Cannulated Screw Internal Fixation System is intended to be used for alignment and stabilization of small bone fractures. Specifically:

· Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand for treatment of fractures, or mal-unions

• Ligament reconstruction

• · Osteochondritis dissecans
  · Arthrodesis of the foot, ankle, wrist, elbow and hand

· Small bone osteotomies, including first metatarsal head osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies

These procedures may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.

The Life Spine Cannulated Screw Internal Fixation System is comprised of Cannulated Headed and Headless Screws intended to align and stabilize small bone fragments around articular regions. It is fabricated and manufactured from titanium alloy (Ti 6A1-4V-ELI per ASTM F 136). Screws offer a variety of sizes of non-sterile, single-use implantable components. Longer pitched threads on the distal tip of the screw penetrates bone at a faster rate than the shorter trailing threads for headless screws, allowing interfragmentary compression as the screw is advanced and countersunk. The nonthreaded portion facilitates compression of the joint surfaces through a lag technique.

All implants are provided non-sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the Cannulated Screw Internal Fixation System components with components from any other system or manufacturer. The Cannulated Screw Internal Fixation System components should never be reused under any circumstances.

The provided text is a 510(k) premarket notification for a medical device called the "Cannulated Screw Internal Fixation System." This type of document focuses on demonstrating that a new device is "substantially equivalent" to predicate devices already on the market, rather than proving that the device meets specific acceptance criteria through a clinical study or performance evaluation with AI.

Therefore, the document does not contain the information requested regarding:

• Acceptance criteria and reported device performance (in the context of AI or clinical efficacy). The performance data presented is mechanical testing to demonstrate substantial equivalence, not clinical performance.
• Sample size and data provenance for a test set.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily addresses the regulatory path for a traditional medical device (implantable screws) and emphasizes physical and material properties, along with manufacturing standards, to establish substantial equivalence to existing devices. There is no mention of artificial intelligence (AI) or machine learning (ML) in this submission.

Ask a specific question about this device

The Cannulated Screws Neoortho are generally intended for fracture fixation of various bones and bone fragments, such as femoral neck, intercondylar femoral, malleolus, pilon tibial, calcaneus, talus, tibial plateau, tarsal, metatarsal, wrist, metacarpal, carpal, scaphoid and radius fracture. The Cannulated Screws Neoortho are also intended for fixation arthrodesis, iliosacral dislocations, and hallux valgus corrections. Accessories implants: The washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone.

The Neoortho Cannulated Screws include nine cannulated screw specifications and associated washers, which are manufactured from stainless steel and titanium alloy. The cannulated screw is a self-tapping screw with a cancellous or cortical thread that can be guided into a position via a guided wire. They are used to aid in the alignment and stabilization of fractures to the skeletal system.

The technological characteristic of the Neoortho Cannulated Screws are similar to the predicate devices including design, dimensions, and materials. The Neoortho cannulated screws and washers are fabricated from stainless steel per ASTM F138 and Ti-6Al-4V alloy per ASTM F136. The stainless steel and Ti-6Al-4V are commonly used material in orthopedic implants.

The provided text describes a 510(k) premarket notification for "Cannulated Screws Neoortho" and details the non-clinical tests performed to demonstrate substantial equivalence to predicate devices. It does not contain information about an AI device or details relating to acceptance criteria and studies typically associated with AI/ML medical devices. The document focuses on mechanical and sterilization properties for an orthopedic implant.

Therefore, I cannot provide an answer based on the prompt's request for AI device acceptance criteria, performance, and study details like sample size for test/training sets, expert qualifications, or MRMC studies.

Ask a specific question about this device

The Cannulated Screw for the Proximal Humerus Plating System is indicated for internal fixation of fractures of the proximal humerus.

The Miami Device Solutions (MDS) Cannulated Screw is a cannulated bone screw intended for use with the MDS Proximal Humerus Plating System cleared in K141493. The MDS cannulated bone screw is 3.5 mm in diameter, 30 to 60 mm in length in 3 mm increments, fully cannulated and threaded, and can interface with MDS Proximal Humerus Plates and Locking Caps cleared in K141493. The MDS device is supplied not sterile and is single-use only.

Materials: Ti-6Al-4V ELI alloy conforming to ASTM F136.

The provided document describes a 510(k) premarket notification for a medical device called the "Cannulated Screw." This document focuses on demonstrating the substantial equivalence of the new device to legally marketed predicate devices, primarily through performance testing. However, it does not describe a study that involves an AI algorithm, human readers, or image analysis for diagnosis.

Therefore, I cannot fill in any details for the following requested information, as the document does not contain them:

• Acceptance Criteria and Reported Device Performance (as typically defined for AI/diagnostic devices)
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and qualifications
• Adjudication method for the test set
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone (algorithm-only) performance
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set
• How the ground truth for the training set was established

However, I can extract information related to the device's performance testing for its substantial equivalence claim:

Device: Cannulated Screw (intended for internal fixation of fractures of the proximal humerus)

Type of Study Conducted: Performance testing against consensus standard ASTM F543 to demonstrate substantial equivalence to predicate devices (Zimmer cannulated screw and Arthrex screw). This testing is for the physical and mechanical properties of the screw, not for diagnostic performance.

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

The document states that the acceptance criterion was that the MDS device possess "similar strength and performance characteristics" as the predicate devices. The reported performance was that "the results of these tests showed the MDS device to possess similar performance properties as the Zimmer predicate device, and the Arthrex predicate device (K041965), and therefore do not raise new questions of safety when used per the products labeling."

Note: The document only provides a qualitative statement of "similar performance properties" and does not list specific numerical thresholds or results for these tests.

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

• Sample Size: Not explicitly stated for the performance tests. The testing was done on the physical devices themselves (MDS Cannulated Screw and predicate Zimmer Cannulated Screw).
• Data Provenance: Not applicable in the traditional sense of human patient data. This refers to in-vitro mechanical testing of manufactured medical devices.

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 performance testing is established by the specifications defined in the ASTM F543 consensus standard, not by human experts interpreting clinical data.

4. Adjudication method for the test set

• Not applicable.

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

• No. This is a medical device (screw) clearance, not an AI diagnostic software.

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

• No. This is a medical device (screw) clearance.

7. The type of ground truth used

• The "ground truth" for the performance testing was the established performance characteristics and specifications outlined in the ASTM F543 consensus standard for bone screws, and the performance observed from the legally marketed predicate devices (Zimmer and Arthrex cannulated screws). This is a technical performance ground truth, not a clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

• Not applicable. This is a device clearance for a physical medical implant, not an AI algorithm.

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

• Not applicable.

Ask a specific question about this device

The CSS cannulated bone screw is indicated for bone fractures, arthodeses, osteochronditis and tendon reattachment. These screws are not intended for attachment or fixation to the posterior elements (pedicles) of cervical, thoracic, or lumbar spine.

The Cannulated Screw System is designed for bone fracture, osteotomies, arthrodesis, osteochronditis and tendon reattachment. These screws are not intended for attachment or fixation to the posterior elements (pedicles) of cervical, thoracic, or lumbar spine.

The Cannulated Screw System implants are partially threaded devices offered in multiple lengths and diameter. The implants have a cruciate driver head. The implants are cylindrical in shape and incorporate a center cannula designed for use with a guide wire to facilitate proper placement of the implant. These screws are of self-tapping.

The provided document is a 510(k) premarket notification for a medical device called the "Cannulated Screw System". This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a study. Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for a study cannot be found in this document.

Here's an explanation based on the document's content:

• Substantial Equivalence: The FDA's 510(k) pathway is for devices that are "substantially equivalent" to a legally marketed predicate device. This means the new device has the same intended use as the predicate and either has the same technological characteristics or, if it has different technological characteristics, the differences do not raise new questions of safety or effectiveness and performance data demonstrates that the device is as safe and effective as the predicate.

The document states:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent..." (Page 1)
• "The Cannulated Screw System is technologically substantially equivalent to the predicate devices." (Page 3)
• "Testing rationales related to pull out, insertion, removal and ultimate torque were provided to support the substantial equivalence of the subject device and show that no new worst-case devices are introduced in this system." (Page 4)
• "The safety and effectiveness of the Cannulated Screw System is adequately supported within this premarket notification. Through the analysis of technical characteristics the new devices are substantially equivalent to the predicate devices." (Page 4)
• "(b)(2). Substantial Equivalence - Clinical Evidence N/A" (Page 4) - This explicitly states no clinical evidence (which would typically involve large-scale studies with acceptance criteria) was provided or deemed necessary for this submission.

The "testing rationales" mentioned for pull-out, insertion, removal, and ultimate torque are benchtop (non-clinical) tests used to show that the new device performs at least as well as the predicate devices in these specific mechanical properties, thereby supporting substantial equivalence. They are not framed as meeting specific clinical "acceptance criteria" through a clinical study as your request implies.

In summary, this document does not contain the details of a study that proves the device meets specific acceptance criteria in the way you've outlined because it's a 510(k) submission focused on demonstrating substantial equivalence through technical characteristics and bench testing, not clinical performance against defined acceptance metrics.

Ask a specific question about this device

The Intended Use of the Cannulated Screw and Kirschner (Kwire) System is for the treatment and fixation of bone fractures and osteotomies of various bones including the, acetabulum, pelvis, humerus, radius, ulna, femur, tibia, phalanges, carpals, metacarpals, tarsals, metatarsals and fibula

Cannulated Screws and Kwires are a self-tapping, self-drilling screw with a cortico/cancellous or cancellous thread that can be guided into position by Kwire placement. Partial or fully threaded screws are available in various different lengths and diameters to provide fixation in various size bones. The screws are made of Stainless Steel. The Kirschner Wires (Kwires) are threaded, spaded or blunt ranging from 0.8mm to 1.4mm of an inch in diameter and 150mm in length and made of 316L Stainless Steel.

The provided text is a 510(k) Premarket Notification for a Cannulated Screw and Kirschner (K-wire) System, a type of orthopedic implant used for bone fixation. For this type of device, the "acceptance criteria" and "study" are not typically presented in the same way as for diagnostic AI software. Instead, the performance is demonstrated through substantial equivalence to predicate devices, focusing on design, materials, and dimensional comparisons rather than a clinical performance study with specific metrics like sensitivity or specificity.

Therefore, many of the requested sections (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of medical device submission.

Here's the information parsed from the document based on your request, with a clear indication of sections that are not applicable:

Acceptance Criteria and Device Performance Study for the Cannulated Screw and Kirschner (K-wire) System

For the Cannulated Screw and Kirschner (K-wire) System (K130613), acceptance criteria and performance were established through demonstrating substantial equivalence to legally marketed predicate devices, as is common for Class II medical devices of this nature. The "study" in this context refers to the comparison of design and material specifications rather than a clinical trial or AI performance study.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable. This device demonstrated substantial equivalence through comparison of design, materials, and dimensions to predicate devices, not through a "test set" of patient data in the manner of AI or diagnostic devices.

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

• Not applicable. Ground truth in the context of expert consensus or pathological findings is not relevant for demonstrating substantial equivalence for this orthopedic implant. The "ground truth" here is the established safety and effectiveness of the predicate devices.

4. Adjudication Method for the Test Set

• Not applicable. No formal adjudication method was used for a "test set" as described for AI or diagnostic performance studies. The FDA reviewed the comparison presented by the manufacturer.

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

• Not applicable. This type of study is not relevant for an orthopedic implant device seeking substantial equivalence based on design and material comparisons.

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

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

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the predicate devices themselves, confirmed through their prior clearance by the FDA. The manufacturer provided a detailed comparison of the new device to these predicates based on:

• Design characteristics: How the screws and K-wires are constructed, their features (self-tapping, self-drilling, cannulated, thread types).
• Material composition: Type of Stainless Steel used.
• Dimensional specifications: Ranges of diameters and lengths available.

The predicate devices cited are:

• Internal Fixation Systems, Inc. Bone Fixation Devices (K071035)
• Internal Fixation Systems, Inc Cannulated Bone Screw (K061620)

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of an AI algorithm for this orthopedic implant. The "training" for the device design would implicitly come from general engineering principles and existing knowledge of bone fixation.

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

• Not applicable. As there is no training set, this question does not apply.

Ask a specific question about this device

The screws are used to fix bone fragments of the foot together for osteosynthesis.

This range of screws for foot includes several types of cannulated screws made of titanium alloy (according to ISO 5832/3 and ASTM F 136) with an hexagonal head.

• The cannulated self-compression screw, and
• The cannulated arthrodesis screw.
  A specifical guide pin is used for implant placement.

The provided text describes a 510(k) premarket notification for "CANNULATED SCREWS" (K070617), which are cannulated screws for foot osteosynthesis. The device is compared to predicate devices to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of a clinical performance study. The performance testing described is mechanical testing.

• Test Set Description: Not applicable for a clinical test set. The testing was mechanical.
• Sample Size: Not explicitly stated for the rupture torque test, but "our cannulated screws" implies a sample of the manufactured screws.
• Data Provenance: Not applicable as it's mechanical testing, not human data.

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

This information is not applicable. The ground truth for mechanical testing is established by compliance with a specific industry standard (NF F 90-414), not by expert medical review.

4. Adjudication Method for the Test Set

This information is not applicable as it's mechanical testing, not a clinical study involving human judgment.

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

No, an MRMC comparative effectiveness study was not done. This device is a medical implant (screws), and the performance evaluation focused on mechanical properties and substantial equivalence to existing predicate devices, not on human reader interpretation of images.

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

This question is not applicable. The device is a physical medical implant, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for demonstrating performances was a recognized industry standard: the French Standard NF F 90-414 for resistance to torsion.

8. The Sample Size for the Training Set

This information is not applicable. There is no concept of a "training set" in the context of mechanical testing for this type of medical device submission.

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

This information is not applicable. There is no training set mentioned or implied.

Ask a specific question about this device

The Cannulated Screw System by Pioneer will be indicated for use in long and small bone fracture fixation, which may include the following:

• 1. Fractures of the tarsals and metatarsals;
• 2. Metatarsal and phalangeal osteotomies;
• 3. Fractures of the carpals and metacarpals;
• 4. Carpal and metacarpal arthrodesis;
• 5. Small fragments of the hand and wrist;
• 6. Ligament fixation as appropriate;
• 7. Sacroiliac joint disruptions;
• 8. Fractures of the distal femur and proximal tibia;
• 9. Intracapsular fractures of the hip;
• 10. Ankle arthrodesis; and
• 11. Pelvis and acetabulum fractures;

This system is not indicated for use in the spine. The Cannulated Screw System by Pioneer will be offered both sterile and non-sterile and is a single use device.

The Cannulated Screw System by Pioneer consists of cannulated screws of varying diameters, lengths and thread configurations to accommodate variations in surgical technique and severity level of fracture. The system includes correspondingly sized washers, the use of which is optional. The cannulated screws are self-cutting and self-tapping in appropriate bone stock, which maximizes OR efficiency. The threads are reverse batting, facilitating of engle use and will be offered both sterile and nonsterile.

The provided document is a 510(k) summary for the Pioneer Surgical Technology Cannulated Screw System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than performing clinical studies to establish novel performance criteria or the effectiveness of an AI algorithm.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not applicable to this document.

The document describes the device, its intended use, and states that substantial equivalence is claimed based on existing predicate devices (Zimmer MAGNA-Fx, Zimmer Mini MAGNA-Fx, and Synthes Cannulated Screw System). The performance evaluation relies on demonstrating equivalence in material and adherence to established ASTM standards relevant to bone screws, rather than a clinical study or AI performance evaluation.

Summary of relevant information from the document:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The performance evaluation is based on in-vitro testing against ASTM standards for medical devices, not a test set derived from 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):
Not applicable. Ground truth for a clinical or AI study is not relevant here. The "ground truth" in this context would be the adherence to validated ASTM standards and material equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for clinical or AI studies involving human interpretation, not for mechanical device 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:
Not applicable. This is not an AI 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 device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the device's safety and effectiveness determination in this 510(k): The ground truth utilized is the established performance characteristics of legally marketed predicate devices (Zimmer MAGNA-Fx, Zimmer Mini MAGNA-Fx, and Synthes Cannulated Screw System) as demonstrated through compliance with recognized ASTM standards (F 1691, F 117, F 1622) for metallic bone screws.

8. The sample size for the training set:
Not applicable. This is not an AI device, and thus no training set was used.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI device.

Ask a specific question about this device