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The IXOS Radius Plate System is intended for surgical procedures in which internal fixation by implants is required for aligning, reconstruction and stabilizing bone tissue.

It is used in particular for fixing intra- and extra articular acute fractures of the distal radius, in particularly

• · Type A2 Colles fractures
• · Type A3 fractures
• · Type B1 fractures
• · Type B2 Barton fractures
• · Type B3 Smith or reversed Barton fractures
• · Type C1 fractures
• · Type C2 fractures
• · Type C3 fractures

and in osteotomies of the distal radius.

The IXOS Radius Plate System is used for aligning, reconstructing and stabilizing bone tissue. It is used in the field of hand, accident and reconstructive surgery and orthopedics especially for the fixation of acute distal intra- and extra-articular fractures of the radius.

I am sorry, but the provided text is a summary of an FDA 510(k) clearance for a physical medical device (IXOS Radius Plate System), not an AI/ML-driven software as a medical device.

Therefore, the input does not contain information about:

• Acceptance criteria and reported device performance related to an AI/ML algorithm.
• Sample sizes, data provenance, ground truth establishment, or expert involvement for an AI/ML model.
• Any AI-related studies such as MRMC comparative effectiveness or standalone algorithm performance.

The document discusses the substantial equivalence of a bone fixation plate system to predicate devices based on material, design, and mechanical testing (static and dynamic 4-point bending tests), and biocompatibility.

As such, I cannot fulfill your request for information about the acceptance criteria and studies for an AI/ML device based on the given text.

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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 Herbert Ulnar Head Prosthesis System is indicated for ulnar head and stem replacement necessitated by: 1) Failed operative procedures such as Darrach, Bowers, or Sauve-Kapandji, 2) Primary osteoarthritis, 3) Post -traumatic osteoarthritis as a result of radial fractures, TFCC tears, ulnar impingement, 4) Rheumatoid arthritis, and 5) Tumors.

The Herbert Ulnar Head Prosthesis System consists of an intramedullary ulnar stem made of titanium, a Co/Cr or Zirconia ulnar head, and a surgical instrumentation set.

The provided text describes a 510(k) premarket notification for the "Herbert Ulnar Head Prosthesis System." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo clinical study with specific acceptance criteria and performance metrics against those criteria. Therefore, much of the requested information regarding detailed acceptance criteria and a study proving device performance in the context of AI/software device evaluation is not directly applicable to this document.

However, I can extract the relevant information from the document to address as many of your points as possible within the context of a 510(k) submission for a physical medical device.

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

For a 510(k) for a physical implant, "acceptance criteria" are typically related to meeting recognized standards and demonstrating equivalence to a predicate device in terms of design, materials, and intended use. Performance is demonstrated through comparison with the predicate and compliance with these standards.

• ISO 5832-2:1999 (Unalloyed Titanium)
• ISO 5832-3:1996 (Wrought titanium 6-aluminium 4-vanadium alloy)
• ISO 5832-12:1996 (Wrought cobalt-chromium-molybdenum alloy)
• ISO 7153-1:1991/Amd. 1:1999 (Surgical instruments Metallic materials - Stainless steel)
• ASTM F899 95 (Stainless Steel Billet, Bar and Wire for Surgical Instruments)
• ASTM F138 97 (Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants) |
  | Sterilization Process Compliance: Ensure the sterilization method meets recognized standards. | The device complies with:
• AAMI/ANSI/ ISO 11134:1993 (Sterilization of health care products - industrial moist heat sterilization)
• AAMI/ANSI ST46:2002 (Steam Sterilization and Sterility Assurance in Health Care Facilities) |
  | Technological Equivalence to Predicate Device: Demonstrate that the design and features are substantially equivalent to a legally marketed predicate device. | An "8-point comparison of technological characteristics" was performed between the Herbert Ulnar Head Prosthesis System and the predicate device (uHead Ulnar Implant System, K010786). The devices were found to be substantially equivalent based on this comparison. |
  | Intended Use Equivalence: Ensure the indications for use are the same or subset of the predicate device. | The indications for use match the predicate: for ulnar head and stem replacement necessitated by: 1) Failed operative procedures (Darrach, Bowers, Sauve-Kapandji), 2) Primary osteoarthritis, 3) Post-traumatic osteoarthritis, 4) Rheumatoid arthritis, and 5) Tumors. |
  | Manufacturing Standards: Adherence to good manufacturing practices. | The device "will be manufactured per specifications using good manufacturing practices that ensure the device is safe and effective for its intended use." |

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 to this 510(k) submission. A test set in the context of device performance studies (like for AI/software) was not used. The clearance is based on comparison to a predicate device and adherence to recognized standards for materials and manufacturing.

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 was no "test set" and thus no ground truth established by experts in the sense of a clinical performance study for this type of device submission.

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

Not applicable. No test set requiring adjudication was used.

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 for a physical prosthetic implant, not an AI/software medical device.

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

Not applicable. This is for a physical prosthetic implant, not an AI/software medical device.

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

Not applicable. For this 510(k), the "ground truth" for clearance is the established performance and safety of the legally marketed predicate device and the recognized standards for materials and manufacturing, not a clinical ground truth established for a test set.

8. The sample size for the training set

Not applicable. This is for a physical prosthetic implant, not an AI/software medical device that uses a training set.

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

Not applicable. This is for a physical prosthetic implant, not an AI/software medical device that uses a training set.

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