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The Digitalis Spacer MCP implants are intended for replacement of the metacarpophalangeal joint of the hand which has been damaged by:

• Osteoarthrosis;
• Rheumatoid arthritis;
• Post traumatic arthritis.
  The Digitalis Spacer PIP implants are intended for replacement of the proximal interphalangeal joint of the hand which has been damaged by:
• Rheumatoid arthritis;
• Osteoarthritis;
• Ankylosed joints or those with limited range of motion which have not responded to conservative treatment;
• Non-functional joint due to inadequate bony alignment and joint space which cannot be restored by soft tissue reconstruction alone;
• Destroyed articular surface(s).

The Digitalis Spacer is a double-stemmed, constrained, silicone prosthesis with a hinge joint. The subject device is available in two options, one intended for use in the metacarpophalangeal (MCP) and the other for use in the proximal interphalangeal joints (PIP). The implant MCP option is intended to be implanted to replace the osteo-cartilaginous heads of the metacarpophalangeal joint an act as a joint spacer between the resected head of the metacarpal at the distal head and the base of the proximal phalanx. The implant PIP option is intended to be implanted to replace the osteo-cartilaginous heads of the proximal interphalangeal joint and act as a joint spacer between the head of proximal phalanx and base of the medial phalanx.

This FDA 510(k) summary does not contain the information required to populate the table and answer the study-related questions. Specifically, it discusses mechanical performance testing of the device itself (BRM Digitalis Spacer) but not a clinical study evaluating the device's performance against pre-defined acceptance criteria.

The summary references:

• Mechanical testing: "Mechanical testing included evaluation of static strength of the silicone material as well as fatigue strength testing of the worst-case construct." and "Fatigue testing performed on the subject device... was performed according to ASTM F1781 (2021). Additionally, crack propagation was specifically analyzed as well as wear particle analysis."
• LAL testing: "Additionally, the Digitalis Spacer is in compliance with LAL testing requirements for orthopedic devices per AAMI ST-72 testing."

These are tests to ensure the physical properties and safety of the implant, not its clinical effectiveness in patients. An "acceptance criteria" table and details about a "study that proves the device meets the acceptance criteria" would typically refer to a clinical study (e.g., comparing outcomes like pain reduction, range of motion, revision rates) and the statistical methods used to demonstrate non-inferiority or superiority to existing treatments/devices, or to show a certain level of performance against a pre-defined threshold.

Therefore, I cannot extract the requested information from the provided document. The document describes non-clinical performance data for the device's material and mechanical integrity, not clinical performance or acceptance criteria related to patient outcomes.

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The BRM TOOL Screws are indicated for use for aligned bone fracture repair and arthrodesis, osteotomy, joint fusion and bone fragment fixation appropriate with the size of the screw.

The BRM TOOL Screws are interfragmentary compression osteosynthesis screws, i.e., devices used in surgical orthopedic interventions to provide support to the bone, ligament, tendon or cartilage structure, with the aim to reduce fractures in several parts of the skeleton, particularly of bone epiphyses. The application field excludes spinal, rib cage and skull bones. The BRM TOOL Screws are available in Titanium alloy.

The provided document is a 510(k) summary for the BRM TOOL Screws, a medical device for bone fixation. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about an AI/ML device or a study involving human readers or AI assistance.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance of an AI/ML device because the document does not describe such a device or study.

The document discusses mechanical testing of the screws (torsional yield strength, driving torque, and pullout strength) and mentions that results met predefined acceptance criteria per ASTM F543 and ASTM F1264, and LAL testing, but this relates to the physical characteristics of the screws, not an AI/ML system.

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