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The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.

The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:

• . non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis:
• inflammatory degenerative joint disease such as rheumatoid arthritis; ●
• . treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
• revision of a failed primary implant;
• . cuff tear arthropathy (CTA Heads only);
• . glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only).

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.

In the Anatomic shoulder the humeral construct consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.

The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists or of a peg/baseplate/glenosphere construct.

On the glenoid side, the fixation of the all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.

Bone Screws are characterized by a 5,0 mm diameter (new device) and they are used in combination with SMR TT Augmented 360 Baseplate (K191746/K200171) to fix the baseplate to the glenoid bone.

The SMR TT Augmented 360 Baseplate is a metal back glenoid component coupled to a peg made of Trabecular Titanium, intended for uncemented use with the addition of bone screws for fixation to the bone. This glenoid component is part of the SMR TT Augmented Glenoid System (K191746/K200171) that is a modular system intended to be used in combination with previously cleared components of the SMR Reverse Shoulder System. The system consists of a modular glenoid component to be used in total shoulder replacement in a reverse shoulder configuration.

This document is a 510(k) premarket notification decision letter from the FDA regarding Bone Screws dia. 5,0 mm manufactured by LimaCorporate S.p.A. The letter states that the device is substantially equivalent to legally marketed predicate devices.

The information provided does not contain details about acceptance criteria, device performance tables, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, as these elements are typically associated with the evaluation of AI/ML-driven medical devices or diagnostic tools. This document pertains to the substantial equivalence determination of a bone screw, which is a mechanical implant, and its evaluation relies on mechanical testing and comparison to predicate devices, not data-driven performance metrics for an algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the provided text, as this information is not present. The document explicitly states:

• "Clinical testing was not necessary to demonstrate substantial equivalence of Bone Screws dia. 5,0 mm to the predicate device." This confirms that there was no clinical study with a test set of patient data, human readers, or ground truth as you described.
• The testing performed was "Mechanical testing" which demonstrated the device's ability to perform substantially equivalent to the predicate device in:
  • Torsional test, driving torque test, pull-out test for bone screws (ASTM F543)
  • Dynamic Evaluation of the Glenoid Loosening or Disassociation (ASTM F2028)

In summary, the provided document is for a mechanical orthopedic implant, not an AI/ML-driven device. Therefore, the questions regarding acceptance criteria, test sets, training sets, expert consensus, MRMC studies, and ground truth are not applicable to the content of this FDA 510(k) premarket notification.

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The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement. The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:

• non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• inflammatory degenerative joint disease such as rheumatoid arthritis;
• treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
• revision of a failed primary implant;
• cuff tear arthropathy (CTA Heads only);
• glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR Hybrid Glenoid only).

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The Hybrid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.

In the Anatomic shoulder the humeral consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.

The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.

On the glenoid side, the fixation of the all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.

The Delta TT Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
• Rheumatoid arthritis;
• Post-traumatic arthritis,
• Correction of functional deformity;
• Fractures, dislocation of the hip and unsuccessful cup arthroplasty.
• Revisions in cases of good remaining bone stock.

Bone screws are used to provide further stability to the Delta TT acetabular cups and to the metal back glenoid of the SMR Shoulder System in reverse shoulder configuration.

The Delta TT acetabular cups (K112898, K141395) are acetabular components intended for uncemented fixation; screw holes present in the Delta TT cups allow optional additional fixation of the cup to the bone using 6.5mm diameter bone screws.

The SMR Shoulder System metal back glenoids (K110598, K113254, K133349, K161120, K163397) are components intended to be implanted into a hole drilled in the glenoid cavity. The metal back glenoid can be used in both anatomic and reverse shoulder configuration; when used in reverse shoulder configuration, the metal back glenoid are intended for uncemented use and are fixed to the glenoid bone through the use of 6.5mm bone screws.

The current submission is for additional lengths of 6.5mm diameter bone screws:

• the proposed range of bone screws used in combination with the SMR Shoulder System is 20mm to 55mm in length;
• the proposed range of bone screws used in combination with the Delta TT Acetabular System is 15mm to 90mm in length.

Design, material, manufacturing process and intended use of the new 6.5mm diameter bone screws are the same as those for the 6.5mm bone screws cleared in the previous 510(k)s.

The provided document is a 510(k) premarket notification decision letter and accompanying information for Bone Screws 6.5mm by LimaCorporate S.p.A.

This document describes a submission for a medical device (bone screws), not an AI/ML-enabled diagnostic or therapeutic device that would typically undergo the kind of acceptance criteria, standalone performance studies, and human-in-the-loop studies involving expert readers, ground truth establishment, and large image datasets as outlined in your request.

Therefore, the information required to answer your prompt, such as acceptance criteria based on performance metrics (e.g., accuracy, sensitivity, specificity), sample sizes for test sets of images, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and training set details, is not present in this document.

The document explicitly states under "Non-Clinical Testing" and "Clinical Testing":

• Non-Clinical Testing: "The additional lengths of 6.5mm bone screws use the same fundamental scientific technology and device design concepts, are made from the same materials utilizing the same manufacturing processes, utilize the same packaging and sterilization processes, and have the same indications for use as the predicate devices; the new lengths of 6.5mm diameter bone screws therefore do not require any testing to determine substantial equivalency."
• Clinical Testing: "Clinical testing was not necessary to demonstrate substantial equivalence of the new sizes of bone screws to the predicate devices."

This indicates that the FDA's substantial equivalence determination for these bone screws was based on their similarity to existing predicate devices in terms of design, materials, manufacturing, intended use, and indications, rather than requiring performance studies against specific acceptance criteria for diagnostic accuracy or clinical outcomes that would involve the elements you've listed.

In essence, the "study" proving the device meets acceptance criteria was a comparison to legally marketed predicate devices, demonstrating that the new bone screw lengths do not raise different questions of safety and effectiveness. The acceptance criteria for this type of device would primarily revolve around material compatibility, mechanical properties (which were not explicitly detailed as new testing data, given the stated substantial equivalence), manufacturing quality, and intended use as compared to the predicates, rather than the performance metrics of an AI/ML system.

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Bone screws are used to fix fractured long and short bones. They are also used to fasten bone plates. Bregma International manufactures three kinds of bonc screws, Aach with its own intended use. Cortical bone screws are used to augment compact and hard bones (diaphyseal reglons of the bones). Cancelluus bone screws are used in the epiphyseal and metaphyseal reglons of the bones which are largely soft and spongy. Cannulated bone screws, are used in situations where surgical wire is required to pass through the central axis of the screw, along which a holes has been drilled.

Not Found

The provided text is a 510(k) clearance letter from the FDA for Bone Screws, Kirschner Wire, and Steinman Pins. It states that these devices are substantially equivalent to devices marketed prior to May 28, 1976. This type of clearance does not involve the kind of detailed study data and acceptance criteria that would be found for a novel medical device requiring de novo classification or PMA.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as such studies were not required for this specific 510(k) clearance. The FDA's determination here is based on the devices being "substantially equivalent" to existing, legally marketed predicate devices, not on new performance data demonstrating meeting specific, novel acceptance criteria through a clinical or performance study of the type usually associated with AI/software devices.

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