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AltiVate Reverse® Shoulder System, Reverse® Shoulder Prosthesis (RSP®), SMR Shoulder System, PRIMA Humeral System, and PRIMA Glenoid System are intended for various forms of partial or total, primary or revision shoulder joint replacement. Specific indications depend on the system and configuration (modular, monoblock, anatomic, reverse), addressing conditions such as:

• Grossly rotator cuff deficient shoulder joint with severe arthropathy
• Previously failed joint replacement with a grossly rotator cuff deficient shoulder joint
• Functional deltoid muscle is necessary to use the device
• Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder (including humeral head fracture or displaced 3- or 4-part fractures of proximal humerus)
• Bone defect in proximal humerus
• Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid
• Inflammatory arthritis including rheumatoid arthritis
• Correction of functional deformity
• Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods
• Revision of a failed primary implant (if sufficient bone stock remains)
• 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)
• Massive irreparable rotator cuff tear

The patient's joint must be anatomically and structurally suited to receive the selected implant(s). Some components are intended for cemented and/or cementless application, often with the addition of screws for fixation. Revision surgery can include conversion from anatomic to reverse arthroplasty if the stem is stable, well positioned, and tissue integrated.

This 510(k) submission proposes updated labeling to reflect additional compatibility between previously cleared shoulder systems from Encore Medical, L.P. (AltiVate Reverse® Shoulder System) and LimaCorporate S.p.A. (SMR and PRIMA Shoulder Systems). The update allows for cross-system use of humeral and glenoid components for reverse total shoulder arthroplasty, where compatible sizes exist. There are no changes to the design, materials, function, or intended use of the devices, and no new implants or instruments are introduced. The proposed configurations include using an AltiVate Reverse® humeral stem and insert with SMR or PRIMA glenoid components, and vice versa.

It appears there might be a misunderstanding of the provided FDA 510(k) clearance letter. The document, K251184, is for orthopedic implants (shoulder prostheses, specifically reverse shoulder systems and related components), not for an AI/software as a medical device (SaMD) or diagnostic device that would typically have acceptance criteria, performance studies involving human readers, and ground truth establishment in the way described in your request.

The letter explicitly states:

• "Trade/Device Name: AltiVate Reverse® Shoulder System; Reverse® Shoulder Prosthesis (RSP®); SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System"
• "Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis"
• "Device Description: This 510(k) submission proposes updated labeling to reflect additional compatibility between previously cleared shoulder systems... The update allows for cross-system use of humeral and glenoid components for reverse total shoulder arthroplasty, where compatible sizes exist. There are no changes to the design, materials, function, or intended use of the devices, and no new implants or instruments are introduced."
• "Performance testing: Performance testing, including Wear Testing and Range of Motion Analysis, demonstrates substantial equivalence between the subject and predicate devices and did not raise different questions of safety and effectiveness."

This means the "device" in question is a physical medical implant, and the 510(k) is about demonstrating "substantial equivalence" to previously cleared implants, primarily regarding material compatibility and mechanical performance (wear, range of motion).

Therefore, the requested information about acceptance criteria for an AI/diagnostic device, sample sizes for test sets in medical imaging, number of experts for ground truth, MRMC studies, standalone algorithm performance, and training set details are not applicable to this specific 510(k) clearance letter. The testing mentioned ("Wear Testing and Range of Motion Analysis") would involve mechanical engineering and biomechanical testing, not clinical studies with human readers or AI performance metrics.

To answer your request based on the provided document would require fabricating information not present in the letter. If you have an FDA 510(k) clearance letter for an AI/SaMD or diagnostic device, I would be happy to analyze it against your criteria.

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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; in case of SMR Short Stems only if sufficient bone stock remains);
• . 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 ioint with severe arthropathy (disabled shoulder). The patient's ion t must be anatomically suited to receive the selected implants and a functional deltoid muscle is neces sary 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 SMR Shoulder System is a complete system intended to be used in primary or revision total shoulder joint replacement in either anatomic or reverse configurations. The SMR Shoulder System was cleared via several 510(k) submission, up to the latest approval under K220792.

The new compatibilities introduced with this 510(k) are related to the system when used in reverse shoulder configuration 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 Shoulder System in reverse configuration consists of humeral stems, reverse humeral bodies, reverse liners, glenospheres, metal back glenoid components and pegs. The metal back glenoid component, when used as part of a reverse shoulder replacement, is intended for cementless fixation with bone screws.

Glenoid components of the SMR Shoulder System are cleared for use also with the humeral components of the PRIMA Humeral System (K212800). When used in combination with the PRIMA Humeral System, the device consists of a humeral stem, tray, reverse insert, glenospheres, metal back glenoid components and pegs.

With this Traditional 510(k) submission, new compatibilities between already cleared devices of the SMR Shoulder System are introduced:

• Bone Screws dia. 5.0 mm (K210717) compatible with SMR Metal Back Glenoid -(K113254) and SMR TT Baseplate (K133349);
• -SMR TT Hybrid Glenoid Reverse Baseplate (K163397) compatible with SMR Glenosphere dia. 42 mm (K212800).

No changes in indications for use, materials, manufacturing processes, packaging and sterilization are introduced with this 510(k) on already cleared devices.

The provided document is a 510(k) summary for the SMR Shoulder System, a medical device. It focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and comparison of technological characteristics. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML device.

This document specifically states: "Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Shoulder System to the predicate device." This indicates that the device's performance was evaluated through non-clinical means (mechanical tests), not through studies involving clinical data or AI performance metrics.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving those criteria, as the document does not describe such a study for an AI/ML device.

However, I can extract the information related to the device and its testing as presented:

Device: SMR Shoulder System

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

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 mechanical testing. The phrase "worst case components" suggests a targeted selection rather than a large statistical sample.
• Data Provenance: Not applicable. The testing was non-clinical (mechanical).

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

• Not applicable. This was a non-clinical mechanical test, not an evaluation requiring expert-established ground truth for an AI/ML device.

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

• Not applicable. This was a non-clinical mechanical test, not an evaluation requiring adjudication for an AI/ML device.

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:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence." This type of study is relevant for AI/ML devices involving human readers interpreting clinical data, which is not the case here.

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

• Not applicable. This device is a shoulder implant system, not a software algorithm or AI. The testing was on the physical components.

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

• Not applicable in the context of clinical or AI/ML ground truth. The "ground truth" for non-clinical mechanical testing would be the engineering specifications and performance standards (e.g., ASTM F2028).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device; therefore, there is no training set.

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

• Not applicable. This is not an AI/ML device; therefore, there is no training set or associated ground truth establishment.

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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).

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 Shoulder System in Anatomic configuration usually consists of a humeral stem, a humeral body, an adaptor taper, a humeral head and a glenoid component. Components are offered for hemi or total shoulder joint arthroplasty, in primary trauma surgery. SMR Shoulder System components are provided in different designs and are intended for cemented or cementless use.

Humeral stems are connected with humeral bodies trough taper coupling. The humeral body is then coupled with the humeral heads, directly (only for some sizes of the heads) or through adaptor tapers. Adaptor tapers are made of Ti6A14V. They are neutral or with eccentricities and in different offsets to allow the adjustment of the centre of rotation of the joint, to provide the required offset to the humeral head and to achieve the correct balancing to the soft tissues, optimizing joint stability. The humeral heads are made of CoCrMo. They are intended to articulate with the glenoid bone in hemi-arthroplasty or with the glenoid component in total shoulder joint arthroplasty.

The current submission is for the extension of the available heights for each diameter of the humeral heads and for the introduction of a new eccentricity (+6 mm) for the adaptor tapers.

This document is a 510(k) Pre-Market Notification from the FDA regarding the "SMR Shoulder System". It's a regulatory approval document for a medical device, specifically shoulder joint prostheses.

Based on the provided text, the device is the "SMR Shoulder System". This document is a "Special 510(k) - Device Modification" focusing on the extension of available heights for humeral heads and the introduction of a new eccentricity (+6 mm) for adaptor tapers for the shoulder system.

The core of the request is to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove the device meets acceptance criteria through a new study. Therefore, the information you're asking for regarding acceptance criteria and a study to prove it is largely not present in this document for the specific modifications.

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

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

• Acceptance Criteria: Not explicitly stated as pass/fail criteria in this document for the specific modifications. The FDA's acceptance is based on demonstrating "substantial equivalence" to a legally marketed predicate device. This typically involves showing that the device has the same intended use, similar technological characteristics, and does not raise different questions of safety and effectiveness.
• Reported Device Performance: The document states that the new components (Variable-Height Humeral Heads and 6mm Eccentricity Adaptor Tapers) do not represent worst cases for mechanical testing. Therefore, the performance is assumed to be equivalent to the predicate device in terms of mechanical properties.

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

• Not applicable / Not provided for the current modification. The submission states "no additional testing was required to demonstrate substantial equivalency" for these modifications. This implies that no new test set was generated or analyzed for these specific changes.

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 / Not provided. Since no new testing was conducted for these modifications, there's no mention of experts establishing a ground truth for a test set. This type of information would be relevant for studies involving diagnostic accuracy or clinical outcomes, which are not the focus of this particular 510(k) modification.

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

• Not applicable / Not provided. No test set for ground truth establishment.

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 document is for a shoulder prosthesis, not an AI-powered diagnostic tool. Therefore, MRMC studies ("human readers improve with AI") are entirely irrelevant and not mentioned.

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

• Not applicable. This device is a physical implant, not an algorithm.

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

• Not applicable. For this specific 510(k) modification, the "ground truth" to establishing substantial equivalence relies on the established safety and effectiveness of the predicate device (K100858) and the argument that the changes do not introduce new safety or effectiveness concerns. There isn't a "ground truth" in the sense of clinical outcomes or expert labels being evaluated for the modified device itself in this submission.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. See point 8.

Summary of available information related to "acceptance criteria" and "study" for this specific 510(k) modification:

The "study" performed here is a demonstration of substantial equivalence to a predicate device already on the market (SMR Shoulder System cleared via K100858).

Table of "Acceptance Criteria" and "Reported Device Performance" (as interpreted from the document):

In essence, for this specific 510(k) submission, the "study" demonstrating the device meets "acceptance criteria" is a determination by the manufacturer (and accepted by the FDA) that the modified components are substantially equivalent to a previously cleared device (K100858) through a comparison of technological characteristics and a rationale for why new mechanical or clinical testing is not necessary due to the nature of the modification.

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The SMR Revision Stems are indicated for the treatment of fractures or revision of a failed primary component in total or hemi-shoulder replacement.

The components are intended for use in cemented applications according to their labeled indication.

Total or hemi-shoulder replacement is indicated for 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
• Cuff tear arthropathy; .
• Revision of a failed primary component. .

The SMR Revision Stems are made from Ti6Al4V (ISO 5832-3 / ASTM F1472). They are available in two versions: cemented and uncemented.

SMR Revision cemented stems are characterized by a cylindrical shape in the distal region while the proximal part is tapered and fluted. The whole surface of the stem is polished.

SMR Revision uncemented stems are characterized by a cylindrical shape in the distal region while the proximal part is tapered and finned. The whole surface of the stem is sand-blasted.

Both the stems are provided with a male taper for the coupling with the humeral bodies and a safety screw is used to help initially seat the body on the stem taper. SMR Revision Stems can be used for anatomical (when coupled with trauma and election humeral bodies, cleared via K100858 and K101263) shoulder replacements.

SMR Revision cemented stems are intended to be used with bone cement: SMR Revision uncemented stems are intended for press-fit applications.

This document describes a medical device, the SMR Revision Stems, and its substantial equivalence to predicate devices, focusing on non-clinical testing. It explicitly states that clinical testing was not necessary. Therefore, many of the requested elements pertaining to acceptance criteria and clinical study performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from the provided text.

Here is the information that can be extracted:

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

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 for Test Set: Not applicable. No clinical test set.
• Data Provenance: Not applicable. Non-clinical testing was conducted, but details on data provenance (e.g., country of origin, retrospective/prospective) for this type of testing are not typically included in these summaries, nor are they provided here.

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. No clinical test set.

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

Not applicable. No clinical test set.

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. No clinical testing, and this device is a physical implant, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical implant, not an algorithm.

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

For non-clinical testing, the "ground truth" would be established by engineering standards and validated testing protocols. The text states: "Where possible, standard test methods were used to allow comparison to testing of the predicate devices."

8. The sample size for the training set

Not applicable. No training set for an AI/algorithm is mentioned. For the non-clinical mechanical testing, "worst case components or constructs" were used, but a specific "sample size" in terms of number of units tested is not provided.

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

Not applicable. No training set for an AI/algorithm. For non-clinical testing, the "ground truth" would be the expected performance based on relevant engineering standards and predicate device performance.

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The SMR CTA Humeral Heads are intended for use with cemented and uncemented SMR humeral body - humeral stem assemblies in total or hemi- shoulder joint arthroplasty. The Glenoid is intended for cemented use only.

Total and hemi-shoulder replacement utilizing the CTA head is indicated for 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;
• Cuff tear arthropathy. .

The SMR CTA Humeral Heads are made from CoCrMo (ISO 5832-12 / ASTM F1537). They are intended to articulate with the glenoid bone (in hemi-arthroplasty) or with the glenoid component (total arthroplasty). The articulating surface is polished. The only difference between the SMR CTA Humeral Heads and the humeral heads cleared in K100858 is the addition of a lateral flange to better accommodate the rotator cuff tear arthropaty patient.

The SMR CTA Humeral Heads are intended to be coupled to the humeral body by means of specific adaptor tapers. Humeral bodies are then assembled by taper coupling with humeral stems. When used in total shoulder replacement. the SMR CTA Humeral Heads are coupled with glenoid components. Humeral stems, humeral bodies, adaptor tapers and glenoid components are the same cleared in K100858 and K101263.

SMR CTA Humeral Heads can be used with both cemented and uncemented stems. Glenoid components are intended for cemented use only.

The device descriptions for the adaptor tapers, humeral bodies, humeral stems and glenoid components cleared via K100858 and K101263 are repeated here in italic typing for an understanding of the complete system.

Two designs of humeral stems are available: the first one is intended for uncemented use while the second one is intended for cemented use only.

Two lengths of uncemented humeral stems are available: 60 and 80 mm. The 60 mm stems are characterized by an outline with a double conicity and they are finned to provide optimal proximal fixation. The stem is sand-blasted. The 80 mm stems are characterized by an outline with a triple conicity and are also finned to provide optimal proximal fixation. The proximal part is sand-blasted while the distal part is polished. All stems are made from Ti6A14V (ISO 5832-3, ASTM F1472). The stems are provided with a male Morse taper (identical to that described in K100858) to allow coupling with the humeral bodies.

Humeral bodies are available in two designs. The first one is characterized by holes for humeral bone reconstruction as a consequence of trauma while the second one is finned to allow proximal press-fit fixation of the humeral system. Both designs of humeral bodies can be used in cemented and in uncemented applications. Humeral bodies are made from Ti6Al4V (ISO 5832-3, ASTM F1472).

They are coupled with the humeral stem via a female Morse-taper connection stabilized with a locking screw. Cylindrical marks are designed at the base of this Morse-taper to provide correct alignment of the eccentricity of the humeral head during surgery. A male Morse-taper connection is designed for the coupling between the humeral body and the humeral head by means of specific adaptor tapers: an angle of 45° between the axis of this Morse-taper and the axis of the stem gives the correct varus-valgus alignment to the joint.

Adaptor tapers (neutral and eccentrical with different heights), are made from Ti6Al4V (ISO 5832-3, ASTM F1472). They allow coupling between the humeral body and the humeral head. These devices are designed to adjust the centre of rotation of the joint and to give the required offset to the humeral head in order to achieve the correct tensioning to the soft tissues, optimizing joint stability.

The humeral heads are made from CoCrMo (ISO 5832-12, ASTM F1537). They are intended to articulate with the glenoid bone (in hemi-arthroplasty) or with the glenoid component (total arthroplasty). The surface is polished in order to reduce wear.

Glenoids are manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE ISO 5834-2, ASTM F648). The articulating surface has a radius of curvature greater than the corresponding humeral head. This allows translation in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has a single central peg which is inserted in the hole drilled in the glenoid cavity during surgery. The peg surface has three grooves to provide enhanced cement fixation. Six cement pockets are also incorporated on the back surface of the glenoid to enhance cement fixation.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary for the SMR CTA Humeral Heads, detailing its description, intended use, comparison to predicate devices, and non-clinical testing performed. It explicitly states that "Clinical testing was not necessary to demonstrate substantial equivalence of the SMR CTA Humeral Heads to the predicate device(s)."

Therefore, I cannot fulfill your request for the table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information. This information simply is not present in the provided text.

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The SMR Shoulder system is intended for partial or total primary shoulder joint replacement. The components are intended for use in cemented and uncemented applications, as specified in the following table:

Total or hemi-shoulder replacement is indicated for 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

The SMR Shoulder System consists of a humeral stem, a humeral body, an adaptor taper, a humeral head and a glenoid components are offered for hemi or total shoulder joint arthroplasty, in primary trauma surgery. Humeral components are provided in different designs and are intended for cementless use while glenoid components are intended for cemented use only.

Two designs of humeral stems are available: the first one (object of this submission) is intended for uncemented use while the second one (submitted in 510(k): K100858) is intended for cemented use only.

Two lengths of uncemented humeral stems are available: 60 and 80 mm. The 60 mm stems are characterized by an outline with a double conicity and they are finned to provide optimal proximal fixation. The stem is sand-blasted. The 80 mm stems are characterized by an outline with a triple conicity and are also finned to provide optimal fixation. The proximal part is sand-blasted while the distal part is polished. All stems are made from Ti6Al4V (ISO 5832-3, ASTM F1472). The stems are provided with a male Morse taper (identical to that described in K100858) to allow coupling with the humeral bodies.

Humeral bodies are available in two designs. The first one (submitted in 510(k): K100858) is characterized by holes for humeral bone reconstruction as a consequence of trauma while the second one (object of this 510(k)) is finned to allow proximal press-fit fixation of the humeral system. Both designs of humeral bodies can be used in cemented (with cemented stems submitted in 510(k): K100858) and in uncemented applications (with uncemented stems submitted in this 510(k). Humeral bodies are made from Ti6Al4V (ISO 5832-3, ASTM F1472).

They are coupled with the humeral stem via a female Morse-taper connection; a locking screw is provided to aid in initial mating of the stem / body assembly.. Cylindrical marks are designed at the base of this Morse-taper to provide correct alignment of the eccentricity of the humeral head during surgery. A male Morse-taper connection is designed for the coupling between the humeral body and the humeral head by means of specific adaptor tapers: an angle of 45° between the axis of this Morse-taper and the axis of the stem gives the correct varus-valgus alignment to the joint.

The device descriptions for the adaptor tapers, humeral heads and glenoid components submitted in K100858 are repeated here in italic typing for a better understanding of the complete system.

Adaptor tapers (neutral and eccentrical with different heights), are made from Ti6Al4V. They allow coupling between the humeral body and the humeral head. These devices are designed to adjust the centre of rotation of the joint and provide the required offset to the humeral head to achieve the correct tensioning to the soft tissues, optimizing joint stability.

The humeral heads are made from CoCrMo (ISO 5832-12, ASTM F1537). They are intended to articulate with the glenoid bone in hemi-arthroplasty or with the glenoid component in total shoulder arthroplasty. The surface is polished to aid in the reduction of wear.

The glenoid components are manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE ISO 5834-2, ASTM F648). The articulating surface has a radius of curvature greater than the corresponding humeral head, which allows translation in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has a single central peg which is inserted in the hole drilled in the glenoid cavity during surgery. The peg surface has three grooves to provide enhanced cement fixation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SMR Uncemented Shoulder System:

Based on the document K101263, the SMR Uncemented Shoulder System is a medical device (shoulder prosthesis). The submission is a 510(k) premarket notification, which means the manufacturer is asserting substantial equivalence to existing legally marketed predicate devices, rather than proving safety and effectiveness through extensive clinical trials.

The provided document does not describe a study involving a particular "device" that makes predictions against a "ground truth" using metrics, nor does it provide acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or F1-score. This type of information is typically associated with AI/ML-driven or diagnostic devices.

Instead, this document describes a traditional medical device (implantable prosthesis) and its premarket submission. The "acceptance criteria" and "study" are interpreted here in the context of device design verification and validation, demonstrating substantial equivalence to predicate devices, focusing on mechanical performance and material compatibility.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a mechanical device submission and not an AI/ML or diagnostic device, the "acceptance criteria" relate to mechanical performance and material compatibility, demonstrated through non-clinical testing. The document states that a detailed table or specific quantitative acceptance criteria and their corresponding results are not provided in this summary. Instead, a general statement of compliance is made.

Regarding the other requested points (2-9), these are typically relevant for AI/ML or diagnostic device studies, and are not applicable to this traditional mechanical medical device submission.

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This refers to non-clinical mechanical testing, not a data-driven test set.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineering standards and measurements, not expert consensus on diagnostic images or clinical outcomes.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 an implant, not a diagnostic tool or an AI-assisted device for human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For non-clinical tests, the "ground truth" is defined by established engineering principles, material science, and physical measurement standards (e.g., ASTM, ISO).
• 8. The sample size for the training set: Not applicable. There is no "training set" in the context of this traditional device submission.
• 9. How the ground truth for the training set was established: Not applicable.

Study that proves the device meets the acceptance criteria:

The study proving the device meets the acceptance criteria is detailed in the "Non-Clinical Testing" section of the document.

• Type of Study: Non-Clinical Mechanical Testing.
• Tests Performed:
  • Static pull-out testing of all modular connections.
  • Torsional testing of all modular connections.
  • Fatigue testing to demonstrate humeral stem strength and post-fatigue strength of modular connections.
  • Static shear testing of the glenoid component.
  • Torsional testing of the glenoid component.
  • Fatigue testing of the glenoid component.
• Test Conditions: Testing was performed on "worst case components or constructs."
• Methodology: "Where possible, standard test methods were used to allow comparison to testing of the predicate devices." (Specific standards like ISO or ASTM are not explicitly named in this summary but are commonly used for such tests).
• Results/Conclusion: "The testing results demonstrated the device's ability to perform under expected clinical conditions."
• Clinical Testing: The document explicitly states: "Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Shoulder System to the predicate device(s)." This reinforces that the primary evidence for this 510(k) submission comes from non-clinical mechanical testing and comparison to predicate devices, rather than human trials for safety and effectiveness.

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The SMR Shoulder system is intended for partial or total primary shoulder joint replacement. The components are intended for use in cemented applications.

Total or hemi-shoulder replacement is indicated for 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

The SMR Shoulder System consists of a humeral stem, a humeral body, an adaptor taper, a humeral head and a glenoid component. Components are offered for cemented use for hemi or total shoulder joint arthroplasty, in primary trauma surgery.

Humeral stems are designed for cemented use and are characterized by an outline with a triple conicity to provide optimal fixation and fit independent of canal morphology. The stems are made from Ti6Al4V (ISO 5832-3, ASTM F1472). The surface in contact with cement is polished to reduce shear stresses on the cement mantle and avoid abrasion resulting from micromovements at the stem-cement interface. The distal part of the stems is characterized by a cylindrical cross-section while the proximal part is fluted to prevent rotation of the component relative to bone. The stems are provided with a male Morse taper in the proximal part for coupling with the humeral body.

Humeral bodies are made from Ti6Al4V and are coupled with the humeral stem via a female Morse-taper connection; a locking screw is provided to aid in initial mating of the stem / body assembly. Cylindrical marks are designed at the base of the Morse-taper to provide correct alignment of the eccentricity of the humeral head during surgery. A male Morsetaper connection is designed for the coupling between the humeral body and the humeral head by means of specific adaptor tapers: an angle of 45° between the axis of this Morsetaper and the axis of the stem gives the correct varus-valgus alignment to the joint. A system of holes on the external surface allows anatomical attachment of tuberosities using sutures or wires in trauma applications.

Adaptor tapers (neutral and eccentrical with different heights), are made from Ti6Al4V. They allow coupling between the humeral body and the humeral head. These devices are designed to adjust the centre of rotation of the joint and provide the required offset to the humeral head to achieve the correct tensioning to the soft tissues, optimizing joint stability.

The humeral heads are made from CoCrMo (ISO 5832-12, ASTM F1537). They are intended to articulate with the glenoid bone in hemi-arthroplasty or with the glenoid component in total shoulder joint arthroplasty. The surface is polished to aid in the reduction of wear.

The glenoid components are manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE ISO 5834-2, ASTM F648). The articulating surface has a radius of curvature greater than the corresponding humeral head, which allows translation in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has a single central peg which is inserted in the hole drilled in the glenoid cavity during surgery. The peg surface has three grooves to provide enhanced cement fixation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SMR Shoulder System:

The provided document, K100858 for the SMR Shoulder System, is a Traditional 510(k) premarket notification. Traditional 510(k)s typically demonstrate substantial equivalence to a predicate device through non-clinical performance data. They generally do not require extensive clinical studies with specified acceptance criteria in the same way a PMA (Pre-Market Approval) or certain De Novo applications might.

Based on the provided text, the "acceptance criteria" are implicitly met by demonstrating that the device performs comparably to the predicate devices and meets established performance standards for orthopedic implants.

Here's a breakdown of the information requested, based solely on the provided document:

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

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

• Test Set Sample Size: The document only mentions "worst case components or constructs" were used for non-clinical (mechanical) testing. It does not specify the exact number of samples for each test.
• Data Provenance: The document does not explicitly state the country of origin for the non-clinical test data. The manufacturer is Lima-Lto S.p.A. in Italy, suggesting the testing may have been conducted in Italy or by a contracted lab. The testing is prospective in nature, as it involves physical testing of newly manufactured components.

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. This information is relevant for studies involving human interpretation (e.g., image analysis, diagnostic algorithms). The provided document describes non-clinical mechanical testing of an orthopedic implant. Ground truth for mechanical tests is established by physical measurement against engineering specifications and industry standards, not by expert consensus in the diagnostic sense.

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

• Not Applicable. As explained above, this document describes non-clinical mechanical testing, not a study requiring human adjudication of results.

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 document describes a medical device (shoulder implant), not an AI-assisted diagnostic tool. No MRMC study was performed, and thus no effect size related to AI assistance is mentioned.

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

• Not Applicable. This document describes a medical device (shoulder implant), not an algorithm or AI system. Therefore, no standalone algorithm performance study was relevant or conducted.

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

• The "ground truth" for the non-clinical testing appears to be engineering specifications, established industry standards (ISO, ASTM), and historical performance data of predicate devices. The tests (static pull-out, torsional, fatigue, shear) are designed to assess physical properties and durability against these benchmarks.

8. The sample size for the training set

• Not Applicable. This document describes a device, not an AI or machine learning model that would require a training set.

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

• Not Applicable. As per point 8, there is no training set for an AI/ML model described in this document.

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