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Advanced Intramedullary Nail System is intended to be implanted into the medullary canal of limbs for alignment. stabilization, fixation of fractures caused by trauma or diseases.

Indications:

1. Ulna Nail: Indicated for the fixation of fractures and osteotomies of the ulna.

2.Fibular Nail: Indicated for fixation of fractures and osteotomies of the fibula.

3. Ankle Fusion Nail: Indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot: tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and subtalar joints; avascular necrosis of the ankle and subtalar joints; failed total ankle replacement with subtalar intrusion;failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the subtalar joints.

The method of intramedullary nail fixation is symmetrical central splint fixation; central fixati on is theoretically superior to cortical external fixation, which can reduce the moment arm, re duce the incidence of varus and valgus angulation and internal fixation failure. Intramedullary nail fixation of fractures is stress-distributed fixation rather than stress-shielded fixation, whi ch is beneficial to the plasticity of callus. Advanced Intramedullary Nail System are made of Ti-6Al-4V ELI following ASTM F136. Advanced Intramedullary Nail System is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.

This document is a 510(k) Pre-market Notification for a medical device called "Advanced Intramedullary Nail System." It is a submission to the FDA seeking clearance to market the device based on its substantial equivalence to previously cleared predicate devices.

Based on the provided text, there is no study conducted to prove the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device performance study.

The document describes a medical implant device, not an AI or software algorithm. The "Advanced Intramedullary Nail System" is a physical device used for fixation of fractures. The information provided is typical for a 510(k) submission for a physical medical device, focusing on material equivalence, design features, biocompatibility, and mechanical testing.

Therefore, many of the questions asked cannot be answered because they pertain to performance studies of AI/algorithmic devices, which are not relevant to this submission.

Let's break down why and what information is available:

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

• Not applicable in the context of an AI/algorithmic device. The document discusses the device's physical properties and its equivalence to predicate devices.
• The "acceptance criteria" here would be related to the mechanical performance standards (e.g., specific loads the nails can withstand, or how well the screws perform under torsion), which are tested against ASTM standards (F543-17 and F1264-16). However, specific numerical acceptance criteria and reported performance values are not explicitly stated in a table format in this summary. The summary only lists the types of tests performed.

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

• Not applicable in the context of an AI/algorithmic device. For mechanical testing, the "sample size" would refer to the number of physical nails and screws tested. This information is not provided in the summary.
• There's no data provenance in the sense of patient data because this is a physical device, not an AI output.

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. There is no "ground truth" in the diagnostic or clinical sense for this physical device as it's not an AI evaluating patient data.

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

• Not applicable. There is no clinical "test set" requiring adjudication for a physical device like an intramedullary nail.

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 study design is relevant for AI image analysis or diagnostic support systems, not for a physical orthopedic implant.

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

• Not applicable. This refers to AI algorithm performance.

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

• Not applicable. The "ground truth" for this device's safety and effectiveness relies on its mechanical properties (meeting ASTM standards) and biocompatibility with human tissue, demonstrating equivalence to already cleared devices.

8. The sample size for the training set:

• 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:

• Not applicable.

Summary of relevant information from the document related to "acceptance criteria" (understood as compliance with standards) and "study" (understood as non-clinical testing):

Acceptance Criteria (Implicit via Standards Compliance):

• Biocompatibility: The device should be biocompatible according to the FDA Guidance "Use of International Standard ISO 10993-1." Specific pass/fail criteria are not detailed in this summary but are inherent in the standard.
• Mechanical Performance: The device materials and mechanical properties should meet the requirements of:
  • ASTM F543-17 (Standard Specification and Test Methods for Metallic Medical Bone Screws) for the locking screws.
  • ASTM F1264-16 (Standard Specification and Test Methods for Intramedullary Fixation Devices) for the intramedullary nail.
  • Specific acceptance values (e.g., minimum torque, maximum deflection) are not listed in this summary but would have been presented in the full 510(k) submission.

The Study that Proves the Device Meets the Acceptance Criteria:

The document refers to "Non-Clinical Performance Data" as the study justifying the device's safety and effectiveness and its substantial equivalence.

• Biocompatibility Testing: Conducted in accordance with FDA Guidance and ISO 10993-1. (No further details on methods or results are provided in this summary).
• Mechanical Testing: Performed on the Advanced Intramedullary Nail System.
  • Locking Screw Tests: Torsion Test, Insertion/Removal Test, Self-tapping Test, Pullout Test, Bending Test. (These tests implicitly compare the device's performance to the predicate device and relevant ASTM standards).
  • Intramedullary Nail Tests: Four-Point Bend Test, Static Torsion Test. (These tests implicitly compare the device's performance to the predicate device and relevant ASTM standards).

Conclusion: The supplied document is a 510(k) summary for a physical medical implant. It does not contain information about acceptance criteria or studies related to AI/algorithmic performance. The "studies" conducted are non-clinical (biocompatibility and mechanical testing) to demonstrate substantial equivalence to predicate devices by meeting recognized industry standards.

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Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction following tumor resection and grafting; supracondylar fractures; bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures, intertrochanteric fractures, and ipsilateral femoral shaft/neck fractures.

In addition to the indications for interlocking intramedullary nails, devices that use a retrograde femoral surgical approach (e.g. Knee Nail, Retrograde and Supracondylar Nails) are indicated for the following: comminuted supracondylar fractures with or without intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants (periprosthetic fractures).

Indications for the TRIGEN Hindfoot Fusion Nail (HFN) include the following: degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations of the hindfoot; tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and sub-talar joints; avascular necrosis of the ankle and sub-talar joints; failed total ankle replacement with sub-talar intrusion; failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the sub-talar joint.

The TRIGEN Humeral Nail System is indicated for proximal and/or diaphyseal fractures of the humerus, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures.

The TRIGEN InterTAN nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures.

Knee Fusion Nails are intended for intramedullary knee arthrodesis.

The purpose of this Traditional 510(k) is to add the MR safety information to the labeling and update the information within the package insert for the Smith & Nephew Intramedullary Nail Systems. The Smith & Nephew Intramedullary Nail Systems consist of the following previously cleared devices:

• Trigen Antegrade Tibial/Retrograde Femoral Nailing System (K981529 S.E. . 7/9/1998, K051557 S.E. 6/30/2005 and K061019 S.E. 6/6/2006)
• Trigen Tan/Fan Nailing System (K981529 S.E. 7/9/1998, , K040929 S.E. 5/25/2004, ● and K111025 S.E. 7/1/2011)
• Trigen Hindfoot Fusion Nail System (K043052 S.E. 11/24/2004) .
• . Trigen Humeral Nail System (K032722 S.E. 10/1/2003)
• Trigen Intertan Intertrochanteric Antegrade Nail System (K040212 S.E. 2/20/2004) ●
• . Trigen Knee Fusion Nail System (K050938 S.E. 5/4/2005)
  The technological characteristics, function of the devices, packaging and sterilization remain unchanged. No modifications have been made to the device design, material, sterilization and the manufacturing processes of the previously cleared devices as a part of this subject 510(k).

The provided text describes a 510(k) premarket notification for Smith & Nephew Intramedullary Nail Systems. The primary purpose of this submission is to add MR safety information to the labeling and update the information within the package insert for existing, previously cleared devices. This means the device itself has not changed in design, material, sterilization, or manufacturing processes. Therefore, the "study that proves the device meets the acceptance criteria" is focused on Magnetic Resonance Imaging (MRI) compatibility testing.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a tabular format with specific performance metrics for the device itself (e.g., fracture healing rates, strength). Instead, the acceptance criteria relate to MRI compatibility, which is assessed against established standards and guidance documents. The "reported device performance" in this context refers to the successful completion of these tests.

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

The document does not detail the specific sample size of devices tested for MRI compatibility. The testing information is generic, referring to "MRI compatibility testing was conducted." Given the nature of medical device MR safety testing, it typically involves a representative sample of device configurations (e.g., different sizes, materials, locking mechanisms) rather than a large "dataset" of patient data.

The data provenance is implied to be laboratory testing conducted according to the listed ASTM and IEC standards. There is no mention of patient data (retrospective or prospective) from any specific country of origin, as the submission is about changes to labeling based on technical testing, not clinical performance.

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

This question is not applicable to this submission. The "ground truth" for MRI compatibility testing is established by the scientific principles and methodologies outlined in the referenced international standards (ASTM, IEC, ISO/TS) and FDA guidance documents, not by expert consensus on clinical cases. Testing engineers and MR safety specialists would be involved in conducting and interpreting these tests, but they are not "experts establishing ground truth" in the way radiologists might for diagnostic imaging.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human reviewers assess the same case and discrepancies need to be resolved. This submission is about technical testing of device properties, not clinical assessment by human readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC comparative effectiveness study involves human readers (e.g., radiologists) assessing cases, often with and without AI assistance, to measure the impact of AI on their performance. This submission does not involve an AI component or the assessment of human reader performance.

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

No. This submission is for physical intramedullary nail systems, not a software algorithm or AI device.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is derived from the established physical and electromagnetic principles and measurement standards for MRI compatibility. The tests measure physical parameters like temperature rise, displacement force, torque, and artifact generation under defined MR conditions, with the standards themselves defining acceptable limits and testing methodologies.

8. The Sample Size for the Training Set:

Not applicable. This submission does not involve a training set as it pertains to physical devices and their MRI compatibility testing, not machine learning algorithms.

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

Not applicable, as there is no training set.

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Smith & Nephew IM Nail Systems Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew IM Nail Systems and their cleared Indications for Use.

Trigen Adolescent TAN Nail System and Trigen 130° TAN Nail System Instruments are accessory devices and are intended to be used to assist in the implantation of the Smith & Nephew Trigen Adolescent TAN Nail System and the Smith & Nephew Trigen 130° TAN Nail System and their cleared indications for use. Indications for interlocking intramedullary nails include: Simple long bone fractures, Severely comminuted, spiral, large oblique and segmental fractures, Nonunions and malunions, Poly trauma and multiple fractures, Prophylactic nailing of impending pathologic fractures, Reconstruction following tumor resection and grafting, Supracondylar fractures, Bone lengthening and shortening, Fractures that occur in and between the proximal and distal third of the long bones being treated. In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability are indicated for the following: Subtrochanteric fractures with lesser trochanteric involvement, Ipsilateral femoral shaft/neck fractures, Intertrochanteric fractures.

Trigen Humeral Nail System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Trigen System and its cleared indications for use. TRIGEN Humeral Nail System is indicated for: Proximal and/or diaphyseal fractures of the humerus, Nonunions, Malalignments, Pathological humeral fractures, Impending pathological fractures.

Trigen InterTAN Nail System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Trigen InterTAN Nail System and its cleared indications for use. TRIGEN InterTAN Nails are indicated for: Simple long bone fractures, Severely comminuted spiral, long oblique, and segmental shaft, Nonunions and malunions, Poly trauma and multiple fractures, Prophylactic nailing of impending pathologic fractures, Reconstruction, following tumor resection and grafting, Bone lengthening and shortening, Subtrochanteric fractures, Ipsilateral femoral shaft/neck fractures, Intertrochanteric fractures, Intracapsular fractures.

Intramedullary Nail Systems Instruments are accessory devices and are intended to be used to assist in the implantation.of Smith & Nephew Intramedullary Nail Systems and their cleared indications for use. The Short Knee Nail, REVISION Nail and Hindfoot Fusion Nail (HFN) are indicated for: Degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations of the hindfoot, Tibiocalcaneal arthrodesis, Combined arthrodesis of the ankle and sub-talar joints, Avascular necrosis of the ankle and sub-talar joints, Failed total ankle replacement with sub-talar intrusion, Failed ankle arthrodesis with insufficient talar body, Rheumatoid arthritis, Severe deformity secondary to untreated talipes equinovarus or neuromuscular disease, Severe pilon fractures with trauma to the subtalar joint.

SURESHOT TAN Nail Systems Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew SURESHOT TAN Nail Systems and their cleared indications for use. SURESHOT TAN Nails are indicated for: Fractures of the femur including: simple long bone fractures, severely comminuted, spiral, large oblique and segmental fractures, Non unions and malunions, Poly trauma and multiple fractures, Prophylactic nailing of impending pathologic fractures, Reconstruction, following tumor resection and grafting, Supracondylar fractures, Bone lengthening and shortening, Fixation of fractures that occur in and between the proximal third and distal fourth of the femur. In addition, SURESHOT TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: Subtrochanteric fractures;, Intertrochanteric fractures;, Ipsilateral femoral shaft/neck fractures;, Intracapsular fractures.

Intramedullary Hip Screw System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Intramedullary Hip Screw Systems and their cleared indications for use. Intramedullary Hip Screws are indicated for: Intracapsular fractures of the femoral neck;, Trochanteric or subtrochanteric fractures;, Osteotomies for patients with diseases or deformities of the hip;, Hip arthrodesis;, Supracondylar fractures and distal femoral fractures using a supracondylar plate;, Ipsilateral femoral shaft/neck fractures;, Intertrochanteric fractures;, Femoral neck fractures;, Subcapital fractures;, Comminuted neck and shaft fractures;, Femur reconstruction following tumor resection;, Leg length discrepancies secondary to femoral inequality;, Prophylactic nailing of impending pathologic fractures.

Ender Nail System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Ender Nail Systems and their cleared indications for use. ENDER Nails are indicated for: Fracture of the neck, trochanteric, and subtrochanteric region of the femur;, Distal femoral fractures with a distal fragment 10cm or longer, Tibial shaft fractures, Proximal humeral fractures.

TriMax Nail System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew TriMax Nail Systems and their cleared indications for use. Femoral/Recon antegrade nails and retrograde nails are indicated for: Shaft fractures including severely comminuted, spiral, large oblique and segmental fractures, Non-unions and malunions, Bone lengthening/shortening, Severely comminuted shaft fractures, Pathologic fractures, pseudoarthrosis, failed osteosynthesis, Closed supracondylar fractures, Prophylactic nailing of impeding pathologic fractures. Additonal indications for the femoral/recon antegrade include: Subtrochanteric fractures with lesser trochanteric involvement, Ipsilateral femoral shaft/neck fractures. Additonal indications for retrograde nails include: Severly comminuted supracondylar fractures with or without difficult intra-articular extension, Fractures that require opening the knee joint to stabilize the femoral condylar segmarnt, Fractures above total knee implants. The TriMax Nail System is intended to be removed upon fracture healing.

Indications for interlocking intramedullary nails include: Simple long bone fractures, Severely comminuted, spiral, large oblique and segmental fractures, Nonunions and malunions, Poly trauma and multiple fractures, Prophylactic nailing of impending pathologic fractures, Reconstruction following tumor resection and grafting, Supracondylar fractures, Bone lengthening and shortening, Fractures that occur in and between the proximal and distal third of the long bones being treated. In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: Subtrochanteric fractures, Intertrochanteric fractures, Ipsilateral femoral shaft/neck fractures. In addition to the indications for interlocking intramedullary nails, devices that use a retrograde femoral surgical approach (e.g. Knee Nail, Retrograde and Supracondylar Nails) are indicated for: Comminuted supracondylar fractures with or without intra-articular extension, Fractures that require opening the knee joint to stabilize the femoral condylar segment, Fractures above total knee implants (peri-prosthetic fractures).

Knee Fusion Nail Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Knee Fusion Nails and their cleared indications for use. Knee Fusion Nails are indicated for: Intramedullary Knee Arthrodesis.

IP-XS Compression Nail System Instruments are accessory devices and are intended to be used to assist in the implantation of the Smith & Nephew IP-XS Compression Nail System and its cleared indications for use. The IP-XS Compression Nail System is inserted into the medullary canal of long bones for the : Alignment, stabilization, and fixation of fractures caused by disease or trauma, The fixation of long bones that have been surgically prepared {osteotomy) for correction of deformity, Arthrodesis.

SLIM (Friedl) Gliding Nail Systems Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew SLIM (Fried), Gliding Nails and their cleared indications for use. The SLIM (Friedl) Gliding Nail System is an all-purpose locking nail system for ensuring primary load stability in: Petrochanteric femoral fractures, Subtrochanteric femoral fractures, Lateral femoral neck fractures. Internal fixation with the SLIM (Friedl) Gliding Nail System is indicated in all combination injuries involving the lateral femoral neck or trochanter region and femoral shaft fractures. Thanks to its biomechanical characteristics, the SLM (Friedl) Gliding Nail System is also suitable for medical femoral neck fractures with retention of the head and simple femoral shaft factures down to the distal metaphysis. Gliding nail fixation can also be used to secure pathological fractures or to provide weight-bearing stability after varus and valgus revision osteotomies of the proximal femur.

TriGen Low Profile Bone Screw Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew TriGen Low Profile Bone Screws and their cleared indications for use. The TRIGEN Low Profile Bone Screw can be used with several types of nails in Smith & Nephew's (TRIGEN) Titanium Nail System. The TRIGEN Low Profile Bone Screw therefore has the following indications: Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures, intertrochanteric fractures, and ipsilateral femoral shaft/neck fractures. In addition to the indications for interlocking intramedullary nails, devices that use a retrograde femoral surgical approach (e.g. Knee Nail, Retrograde and Supracondylar Nails) are indicated for the following: comminuted supracondylar fractures with or without intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants (peri-prosthetic fractures). The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fractures; subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; intracapsular fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening. SURESHOT TAN Nails are indicated for fractures of the femur including simple long bone fractures, severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; and for fixation of fractures that occur in and between the proximal third and distal fourth of the femur. In addition, SURESHOT TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; and intracapsular fractures.

Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. intramedullary (IM) Nail Systems Instruments. The subject devices are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew IM Nails and their cleared Indications for Use. Smith & Nephew IM Nail Systems Instruments can be organized into instrument families which are categorized as follows: Torque/Tightening, trials, drills, extractors, impactors, replacements, alignment, other guides and gauges, and bone preparation.

The provided document is a 510(k) Premarket Notification for Intramedullary Nail Systems Instruments, which are accessory devices used to assist in the implantation of various Smith & Nephew IM Nails. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study with specific acceptance criteria and performance metrics for a novel device. Therefore, much of the requested information regarding acceptance criteria, performance, and detailed study methodologies for an AI/CADe device cannot be extracted directly.

This document describes the equivalence of the instruments used for implantation of nails, not the nails themselves or a diagnostic AI/CADe system.

However, I can extract the information that is present and highlight what is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document as it is a 510(k) for accessory instruments, relying on substantial equivalence to predicate devices rather than demonstrating performance against specific clinical acceptance criteria. The "performance" described is the instruments' ability to assist in the implantation of already cleared nails, which is assessed through comparisons of materials, manufacturing, sterilization, and body contact.

• Share the same raw materials as predicate instruments.
• Be manufactured through the same processes as predicate instruments.
• Utilize the same sterilization procedures as predicate instruments.
• Have a similar nature of body contact as predicate instruments.
• Be similar in design and function to competing IM nail instrumentation on the market. |

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 applicable as there is no test set or clinical study conducted in the context of a new diagnostic algorithm or device requiring such data. The premarket notification relies on substantial equivalence.

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 information is not applicable as there is no test set or ground truth to establish for this type of device (surgical instruments).

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

This information is 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

This information is not applicable as no MRMC study, or any study involving human readers and AI assistance, was conducted or described. The device consists of surgical instruments, not an AI/CADe system.

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

This information is not applicable as the device is surgical instrumentation, not an algorithm or AI system.

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

This information is not applicable as no ground truth is required for demonstrating substantial equivalence of surgical instruments. The equivalence is based on physical characteristics and intended use.

8. The sample size for the training set

This information is not applicable as there is no training set mentioned or relevant for this type of device.

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

This information is not applicable as there is no training set or ground truth mentioned or relevant for this type of device.

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