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HBS2 Headless Bone Screw is used for the treatment of intraarticular fractures and pseudoarthroses of smaller bones and bone fragments as well as for arthrodeses on small joints, especially in the scope of:

HBS2 MIDI: Scaphoid fractures, Scaphoid pseudoarthroses, Proximal pole fractures of the scaphoid, DIP arthrodeses, Metacarpal fractures, Metatarsal fractures of the processus styloideus ulnae, Proximal radial head fractures

HBS2 MINI: Scaphoid fractures, Scaphoid pseudoarthroses, Proximal pole fractures of the scaphoid, DIP arthrodeses, Metacarpal fractures, Fractures of the processus styloideus ulnae, Proximal radial head fractures of the processus styloideus radii

The HBS2 Headless Bone Screws are used in the field of hand surgery, accident surgery and reconstructive surgery, and in orthopedics for the treatment of intraarticular and extra articular fractures and pseudo arthroses of small bone fragments, and for arthrodesis on small joints.

The system consists of various screws and instruments for different treatment options.

HBS2 screws are cannulated, self-drilling, self-cutting, have a reversing thread and are available in two diameters with different thread lengths.

HBS2 MIDI screws (magenta) are available with a diameter of 2.0 mm (shaft) and in different lengths. HBS2 MINI screws (green) are available with a diameter of 1.7 mm (shaft) and in different lengths too.

These devices are delivered in non-sterile condition and must be reprocessed before use. All implants are made out of Ti6Al4V 3.7165.

The provided text is a 510(k) summary for the HBS2 Headless Bone Screw. It details the device's indications for use, description, classification, and comparison to predicate devices. It explicitly states that no clinical studies were performed for this device, and therefore, an AI/ML-based study with acceptance criteria, ground truth, and expert evaluation as described in the prompt is not applicable to this document.

The document primarily focuses on non-clinical tests to demonstrate substantial equivalence to legally marketed predicate devices. The non-clinical tests are summarized in a table, which includes standards for biological safety (cytotoxicity, chemical analysis, characterization of organic extractable, bioburden, LAL endotoxin, particle) and mechanical safety (torsional properties, driving torque, axial pullout strength, static and dynamic 3-point bending).

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML-based device and its study, as this document pertains to a medical device that was evaluated through non-clinical testing and substantial equivalence, not through AI/ML performance studies.

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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.

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KLS Martin Cannulated Headless Screws are intended for the treatment of fractures, osteotomies, and nonunions of small bones in the hand, wrist, foot, and ankle.

The KLS Martin Cannulated Headless Screws (CHS) system is comprised of headless cannulated screws intended for bone fixation in the treatment of fractures, non-unions, osteotomies, or to aid in small joint fusions of the hand, wrist, foot, and ankle. Bone fixation is achieved by proximal and distal threads designed with different pitches that, when inserted into the bone, cause compression of the bone fragments for bone reduction, stability, and healing. Cannulation of the screws is designed to allow the user to insert the screw over the guide wire for proper placement prior to compression. The CHS system offers screws in various diameters, overall lengths, and thread lengths to accommodate different sizes and types of bone reduction, such as scaphoid fractures and non-unions. The screws are self-drilling and self-tapping to eliminate the need for drilling a pilot hole prior to implantation. All screws are manufactured from Ti-6Al-4V (ASTM F136:2013). This system also includes the necessary and appropriate instrumentation to facilitate implantation of the screws by qualified and trained physicians.

The provided text describes a 510(k) premarket notification for a medical device, the KLS Martin Cannulated Headless Screws. This document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data, primarily mechanical and pyrogenicity testing.

Therefore, the requested information regarding acceptance criteria and studies focused on AI/algorithm performance, human reader studies, and training/test set details is not applicable to this document. This is a traditional medical device approval, not an AI/software as a medical device (SaMD) submission.

Here's a breakdown of the parts that are directly addressed by the provided text, and clarification for those that are not applicable:

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

The document does not provide a formal table of acceptance criteria with reported performance in a pass/fail format, as might be seen for a software algorithm. Instead, it describes mechanical property tests and pyrogenicity testing, stating they were "successfully completed without any signs of device failure" and that "endotoxin levels [are] below the USP allowed limit."

• Mechanical Properties Testing:
  • Acceptance Criteria Implied: Meeting the requirements of ASTM F543-13:2013 for torsional properties, driving torque, and axial pullout strength.
  • Reported Device Performance: Tests were "successfully completed without any signs of device failure." Comparative testing to the Synthes 3.0 mm cannulated screw "demonstrates substantial equivalence in performance testing."
• Pyrogenicity Testing:
  • Acceptance Criteria Implied: Endotoxin levels below the USP allowed limit for medical devices and meeting pyrogen limit specifications, as per AAMI ANSI ST72.
  • Reported Device Performance: "Endotoxin levels below the USP allowed limit for medical devices and meet pyrogen limit specifications."

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 does not specify the sample size for the mechanical and pyrogenicity tests. Data provenance (country, retrospective/prospective) is not mentioned as these are laboratory tests of the physical device, not human 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 in this context refers to defined physical standards outlined in ASTM F543-13:2013 and AAMI ANSI ST72, not expert human interpretation.

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

Not applicable. Adjudication methods are relevant for human-interpreted data, not for laboratory physical property 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/software device.

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

Not applicable. This is not an AI/software device.

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

The "ground truth" for this device's performance is based on established industry standards and test methods:

• For mechanical properties: ASTM F543-13:2013 Standard Specification and Test Methods for Metallic Medical Bone Screws.
• For pyrogenicity: AAMI ANSI ST72.

8. The sample size for the training set

Not applicable. There is no training set for this type of medical device assessment.

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

Not applicable.

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The Extremity Medical Compression Screw is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures and nonunions of the small bones and joints of the foot and hand. Examples include scaphoid fractures, tarsal and metatarsal fracture, hand, wrist, foot and ankle arthrodeses, metacarpal and metatarsal arthrodeses, distal radius fractures.

The EXTREMITY MEDICAL Compression Screw

This 510(k) Premarket Notification for the EXTREMITY MEDICAL Compression Screw does not contain information about acceptance criteria or a study proving the device meets them.

The provided document is a summary of safety and effectiveness, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than independent performance testing against predefined acceptance criteria. This type of submission relies on the fact that similar, legally marketed devices (predicates) have already met regulatory requirements.

Therefore, I cannot fulfill the request to provide the acceptance criteria and study details based on the information given.

Here's a breakdown of why and what information is missing:

1. Acceptance Criteria and Reported Device Performance: This document does not specify any quantitative acceptance criteria (e.g., tensile strength, fatigue life, screw pull-out force thresholds) or report specific performance metrics of the EXTREMITY MEDICAL Compression Screw against such criteria. The "Statement of Technological Comparison" only broadly states similarity in design and materials to predicate devices.

2. Sample Sized used for the test set and the data provenance: Not applicable, as no performance study data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance study data is presented.

4. Adjudication method for the test set: Not applicable, as no performance study data is presented.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is a medical implant, not an imaging or diagnostic AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is a medical implant, not an AI algorithm.

7. The type of ground truth used: Not applicable, as no performance study data is presented.

8. The sample size for the training set: Not applicable, as no AI/algorithm training set is involved.

9. How the ground truth for the training set was established: Not applicable, as no AI/algorithm training set is involved.

Conclusion from the document:

The conclusion states: "The EXTREMITY MEDICAL Compression Screw is substantially equivalent to its predicate devices. This conclusion is based upon the fact that this device is substantially equivalent in terms of indications for use, materials, design and principles of operation."

This indicates that the regulatory pathway chosen here (510(k)) relies on demonstrating similarity to existing, legally marketed devices, rather than comprehensive de novo performance testing against specific acceptance criteria.

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