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The S-Core® Implant System (6.0 mm - 10.0 mm diameter) is intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction,

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collament Reconstruction,

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.

Hip: Capsular repair, acetabular labral repair, gluteus medius repair.

The S-Core® Implant System consists of screws and is generally intended for fixation of fracture, fusion and osteotomies of large and small bones appropriate for the size of device. These large and small bones may include the following:

Fixation of small bone fragments, such as apical fragments (patellar), minimally invasive reconstruction of fractures and joints, adjuvant for osteosynthesis in complex joint fractures, multifragment joint fractures, simple metaphyseal fractures fractures of the wrist, ankle, elbow, and shoulder, condylar fractures, osteochrondritis dissecans, osteochondral fixation, fractures, and fragments (talar, vault, femoral condyle), intra-articular fractures, ligament avulsion injuries, ligament fixation, other small fragments, cancellous bone fragments (talus) or fractures, areas where accurate screw placement is vital, metatarsal and phalangeal osteotomies, fractures of the tarsals, and other fractures of the foot, avulsion fractures of metatarsal V, tarso-metatarsal and metatarso-phalangeal arthrodesis, fractures of small joints, such as: ankle fractures, fractures of the fibula, malleolus, and calcaneus, distal tibia and pilon fractures, acetabular fractures, calcaneal and talar fractures, subtalar arthrodesis, ankle arthrodesis, other fractures of the pelvic ring, fractures of the femoral head and neck, supracondylar femoral fracture, slipped capital femoral epiphyses, an adjunct to DHIS in basilar neck fractures, intercondylar femur fractures, intracapsular fractures of the distal femur and proximal tibia, patellar fractures, tibial plateau fractures, small fragments of the hand wrist, fractures of the carpals and metacarpal arthrodesis, scaphoid fractures of the hand, phalangeal and interphalangeal fractures, fractures of the ulna and radius, radial head fractures of the olecranon and distal humerus, humeral head fractures, ligament fixation at the proximal humerus, glenoid fractures.

The S-Core® Implants are titanium screws that are threaded, headless, cannulated devices offered in diameters ranging from 4mm to 10mm. Each diameter size offers three length options; the shortest being 7mm for the 4mm diameter screw to the longest at 14mm for the 10mm diameter screw. Each screw body incorporates 0.8mm fenestrations on the screw head surface and in a helical pattern within the thread pitch. All screws are offered with the option of an hydroxyapatite (HA) coating. The system also includes stainless steel screw instruments for implantation.

The S-Core® Implant System may be used as a stand-alone screw for the fixation of fracture, fusion, and osteotomies. The S-Core Implant System may also be used with the S-Fibre Suture when used as a suture anchor for the attachment of soft tissue to bone.

The S-Fibre Suture is a non-absorbable, sterile, surgical suture composed of high molecular weight polyethylene (UHMWPE). It is available in white, size 3-0, meeting USP requirements except for oversize diameter. The S-Fibre Suture was originally cleared as the Force Fiber® Polyethylene Non-Absorbable Suture (K063778).

The S-Core® Implant suture anchor includes the S-Fibre Suture (prepackaged) with the titanium screw.

This document is an FDA 510(k) clearance letter for the S-Core® Implant System. It does not describe acceptance criteria for an AI/software device or a study proving an AI/software device meets acceptance criteria. The device is a physical bone fixation fastener (screws and suture anchors) and the testing described is mechanical and biocompatibility testing for this physical device.

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

The closest relevant sections in the document are:

• Summary of Non-Clinical Performance Testing Bench Test: This section mentions mechanical testing (Torsional Properties, Insertion and Removal Torque, Pullout Strength, Fatigue testing) and bacterial endotoxin testing performed on the physical implant system. These are acceptance criteria for a physical medical device, not for an AI/software.
• Statement of Equivalence: This section states that the device is substantially equivalent to predicate devices based on indications for use and technological characteristics, and that "The submitted test data demonstrates that the proposed device is substantially equivalent to the predicates." This refers to the mechanical and biocompatibility testing mentioned, not an AI performance study.

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Minimally invasive reconstruction of fractures and joints; Adjuvant for osteosynthesis in complex joint fractures; Multifragment joint fractures; Simple metaphyseal fractures of the wrist, ankle, elbow, and shoulder, Condylar fractures; Osteochrondriis dissecans, Ostero-Chondral Fractures, Ligament avulsion injuries, Ligament fixation, Other small fragment, cancellous bone fractures, Small joint fusion. Areas where accurate sorew placement is vital. Metatarsal and phalangeal osteotomies; Fractures of the tarsals, metatarsals and other fractures of the foot; Avulsion fractures and fractures of metatarsal V; Tarso-metatarso-phalangeal arthrodesis; Tarsal Fusions; Calcaneal and talar fractures, Subtalar arthrodesis. Ankle arthrodesis. Fractures of small joints, such as: Ankle fractures, Fractures of the fibula, malleolus, and calcaneus, Distal tibia and pilon fractures, Acetabular fractures of the pelvic ring; Fractures of the femoral head and neck, Supracondylar femoral fractures, Slipped capital femoral epiphyses, An adjunct to DHIS in basilar neck fractures, Intractures, Intracapsular fractures of the hip, Fractures of the distal femur and proximal tibia, Patellar fractures. Small fragments of the hand and wrist, Fractures of the carpals and metacarpals, Carnal and metacarpal arthrodesis. Scaphoid fracture and other fractures of the hand, Phalangeal and interphalangeal fractures of the ulna and radius. Radial head fractures. Fractures of the olecranon and distal humeral head fractures, Ligament fixation at the proximal humerus, Glenoid fractures.

The S4 Screw System is collection of cannulated, headless screws having fenestrations on the head and within the thread pitch.

This document, a 510(k) Summary for the S4 Screw System, does not describe a study that uses AI or machine learning technology. It pertains to a physical medical device (bone screws) and its mechanical properties.

Therefore, many of the requested elements regarding acceptance criteria for an AI/ML device and the details of a study proving its performance (e.g., sample size for test/training sets, expert ground truth, MRMC studies) are not applicable to the content provided.

The document focuses on non-clinical performance testing (bench tests) and comparisons to predicate devices for substantial equivalence, which is typical for Class II devices like bone screws.

Here's an analysis based on the information provided in the document, framed by what would be relevant if it were an AI/ML device, to highlight why the full set of questions cannot be answered:

Based on the provided FDA 510(k) Summary for the S4 Screw System (K191995), the following information can be extracted regarding its acceptance criteria and the study proving it meets them:

Note: This submission does not involve an AI/ML device. Therefore, the concepts of a "test set," "training set," "ground truth experts," "adjudication methods," or "MRMC studies" as they apply to software-based diagnostic or prognostic devices are not relevant or described in this document. The "study" mentioned refers to non-clinical bench testing of the physical screw system.

1. Table of Acceptance Criteria and Reported Device Performance:

For a physical device like a bone screw, "acceptance criteria" are typically defined by engineering standards to ensure its mechanical integrity and safety. "Performance" refers to the results of tests against these standards.

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

• Sample Size (Test Set): Not explicitly stated in terms of number of screws tested for each mechanical property. For bench testing, samples are typically specific numbers of manufactured devices.
• Data Provenance: The studies are non-clinical, bench-top laboratory tests conducted by the manufacturer, Subchondral Solutions, Inc. No information regarding country of origin of data (beyond the company's US location) or retrospective/prospective nature is applicable in the context of human clinical data.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

• Not applicable. For a physical device, "ground truth" is established through adherence to national/international engineering standards and validated test methods, not by expert interpretation of data or images.

4. Adjudication Method for the Test Set:

• Not applicable. This concept relates to resolving disagreements among human readers or annotators for ground truth in AI/ML performance studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, this was not done. MRMC studies are specific to evaluating the clinical performance of diagnostic or screening devices, often involving human readers and potentially AI assistance. This submission is for a physical orthopedic implant.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This refers to the performance of an AI algorithm without human intervention. The S4 Screw System is a physical device, not an algorithm.

7. Type of Ground Truth Used:

• For this physical device, "ground truth" is defined by engineering specifications, material science standards, and established mechanical test methodologies (e.g., ASTM F543). It is not derived from expert consensus, pathology, or outcomes data in the way an AI/ML diagnostic would be.

8. Sample Size for the Training Set:

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. No training set exists for this type of device.

In summary, the provided document details the mechanical, material, and sterilization validation of a bone screw system (S4 Screw System) through non-clinical bench testing against established industry standards for similar devices. It does not contain any information relevant to the development, validation, or performance of an AI/ML driven medical device.

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The S4 Screw System™ is indicated for fixation of small bone fragments, osteochondral fragments and cancellous fragments, appropriate for the device which may include the following: simple metaphyseal fractures; condylar fractures; osteochondritis dissecans; areas where accurate screw placement is vital; apical fragments (patellar); cancellous fragments (talus); osteochondral fragments (talar vault, femoral condyle); intra-articular fractures and osteochondral fixation and fractures.

The S4 Screw System™ is collection of cannulated, headless screws having fenestrations on the head and within the thread pitch.

The provided text describes a 510(k) premarket notification for the "S4 Screw System™". This document is an FDA submission for a medical device, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as one might find for an AI/ML device.

Based on the information provided, here's a breakdown regarding your request:

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

The document does not explicitly state "acceptance criteria" in the way one might for a diagnostic test with metrics like sensitivity, specificity, accuracy, etc. Instead, performance is demonstrated through mechanical testing against a recognized standard (ASTM F543) and comparison to predicate devices. The acceptance criteria are implicitly that the device's mechanical performance should be substantially equivalent to the predicate devices and meet the requirements of ASTM F543.

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

The document mentions "mechanical testing of the worst case S4 Screw System™ and a predicate component." It does not specify the exact sample size (i.e., number of screws or components tested) for this mechanical testing. There is no information regarding data provenance in terms of country of origin or whether it was retrospective/prospective, as this applies more to clinical data which is not the primary focus of this type of submission for a bone fixation device.

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 question is not applicable to the S4 Screw System™ submission. This is a physical medical device (bone screw), and its performance is evaluated through mechanical testing, not a diagnostic or AI-driven assessment requiring expert interpretation to establish ground truth.

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

This question is not applicable. Adjudication methods are typically used in clinical studies, especially for diagnostic devices, to resolve disagreements among experts in establishing ground truth. Mechanical testing of a physical device does not involve this type of adjudication.

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 question is not applicable. An MRMC study is relevant for diagnostic devices (often AI-assisted) where human readers interpret medical images or data. The S4 Screw System™ is a hardware device for bone fixation.

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

This question is not applicable. The S4 Screw System™ is a physical screw system, not an algorithm or AI.

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

For the mechanical testing, the "ground truth" is defined by the objective measurements obtained from the ASTM F543 standard tests (torsion, insertion, pushout) and the specified pyrogenicity limit for bacterial endotoxin testing. This is not "expert consensus", "pathology", or "outcomes data" in the typical sense; rather, it's adherence to established engineering and biological standards.

8. The sample size for the training set

This question is not applicable. There is no "training set" for a physical medical device like the S4 Screw System™. Training sets are relevant for AI/ML algorithms.

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

This question is not applicable for the same reason as #8.

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