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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.

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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.

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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.

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