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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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BRM TOOL Screws
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.

BIOPLAN Subtalar Implants
The BIOPLAN Subtalar Implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

• Flat foot treatment in children and adolescents
• Congenital flat foot
• Non successful long term orthopaedic treatment (shoes, insoles ...)
• Tarsal coalitions
• Painfully flat foot
• Supple deformity in posterior tibial tendon dysfunction
• Paralytic flat foot
• Subtalar instabilitv

The BRM TOOL Screws are interfragmentary compression osteosynthesis screws, i.e., devices used in surgical orthopedic interventions to provide support to the bone 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 BIOPLAN Subtalar Implants are used for the correction of the flatfoot pathology. The BIOPLAN Subtalar Implants are available in Titanium alloy and PEEK options.

This document is an FDA 510(k) clearance letter and summary for a medical device (BRM Screw Family). It does not contain any information about a study proving the device meets acceptance criteria related to AI or algorithmic performance.

The "Performance Testing" section states: "Testing included static strength and fatigue strength testing, pushout and pull-out testing, as well as insertion and extraction torque testing. Results were determined to meet the pre-defined acceptance criteria per ASTM F543 and ASTM F1264."

This refers to mechanical and material performance of the screws themselves, not the performance of an AI algorithm. Therefore, the requested information (acceptance criteria for an AI device, sample sizes, expert qualifications, MRMC studies, etc.) is not present in the provided text.

To answer your request, I would need a document describing the clinical or algorithmic performance study of a device, rather than a 510(k) clearance for a physical medical device like bone screws.

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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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The BRM Extremities NewPrim device is intended for use in:

• Hallux rigidus or hallux limitus;
• Painful rheumatoid arthritis;
• Hallux abducto valgus associated with arthritis;
• Unstable or painful joint from previous surgery

The NewPrim system is a double-stemmed, constrained, silicone prosthesis, intended to be implanted to replace the osteo-cartilaginous heads of the first metatarsophalangeal joint. The implant is designed to act as a joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.

The provided text is a 510(k) summary for the BRM Extremities NewPrim System, a toe joint polymer constrained prosthesis. This document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for medical devices in the US.

The document does not contain information about a clinical study with acceptance criteria, human readers, or ground truth for evaluating the device's performance in the context of diagnostic accuracy or clinical outcomes. Instead, it describes bench testing conducted to support substantial equivalence.

Therefore, many of your requested points cannot be answered based on the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

The document mentions two types of bench testing:

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

• Sample Size: Not specified for any of the bench tests.
• Data Provenance: This is bench testing, not clinical data from patients. The manufacturer is BRM Extremities, located in Milano, Italy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study assessing diagnostic accuracy or clinical outcomes requiring human expert ground truth.

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

Not applicable. This is not a study assessing diagnostic accuracy or clinical outcomes requiring human expert ground truth.

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 device is a prosthesis, not an AI diagnostic tool.

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

Not applicable. This device is a prosthesis, not an AI diagnostic tool.

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

For the bench tests, the "ground truth" would be the predefined engineering specifications and comparison to the predicate device's measured performance for mechanical characteristics and compliance with a standard for LAL testing. It's not a clinical "ground truth."

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device that requires a training set.

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