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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 implants of the Foot and Hand Motion are intended for the fixation of bone fractures and for arthrodeses of the foot and hand in adults.

The Foot and Hand Motion consists of screws designed for the fixation of bone fractures, for arthrodeses and for osteotomies of foot and hand in adults. The implants of the Foot and Hand Motion will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. The instruments of the Foot and Hand Motion will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization (Initial S single use kits).

This document is a 510(k) summary for a medical device called "Foot and Hand Motion" by NEWCLIP TECHNICS. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with performance metrics. Therefore, many of the requested elements for describing acceptance criteria and a study are not directly available in the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in a quantitative format within the document. The document primarily focuses on establishing substantial equivalence through non-clinical testing and similarity to predicate devices. There are no explicit performance acceptance criteria (e.g., minimum pullout strength in Newtons) or reported device performance values in a table.

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

• Sample Size for Test Set: Not specified in terms of number of screws tested. The non-clinical tests mention "Comparative pullout tests," "Torsional tests," and "Driving torque tests," but the number of samples used for these tests is not quantified.
• Data Provenance: The tests are non-clinical (laboratory tests). There is no mention of country of origin of data or whether it's retrospective or prospective, as these terms typically apply to clinical studies.

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

Not applicable. The tests mentioned are non-clinical engineering and material tests (e.g., pullout, torsional strength), not diagnostic or clinical studies that would require expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable, as there is no human-involved "test set" requiring adjudication in the context of this 510(k) summary.

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

No. The document explicitly states: "No clinical studies were performed." Therefore, an MRMC study was not conducted.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. The device is a physical bone fixation system (screws), not an algorithm or AI system.

7. Type of Ground Truth Used

Not applicable. For the non-clinical tests mentioned, the "ground truth" would be established by the testing protocols and measurements of physical properties (e.g., force, torque) of the device.

8. Sample Size for the Training Set

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

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

Not applicable. There is no training set mentioned.

Summary of Available Information from the Document:

The document establishes that the "Foot and Hand Motion" device is substantially equivalent to predicate devices based on:

• Intended Use: Fixation of bone fractures and arthrodeses of the foot and hand in adults.
• Design, Materials, Mechanical Safety, and Performance.
• Materials: Titanium alloy Ti-6Al-4V (conform to ASTM F 136 and/or ISO 5832-3).
• Non-Clinical Tests Conducted:
  • Comparative pullout tests
  • Torsional tests
  • Driving torque tests
  • Engineering analyses
  • Endotoxins testing using LAL quantitative kinetic chromogenic method.
• Clinical Studies: None were performed.

The conclusion is that the device is equivalent based on similarities in principles of operation, technology, materials, and indications for use with the listed predicate devices. The "acceptance criteria" appear to be implicit in the demonstration of substantial equivalence through these non-clinical tests and comparison to the predicate devices, rather than explicit numerical performance targets.

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