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ArTT Augments and Buttresses are indicated to be used, in combination with EMPOWR Acetabular Cup System, as an alternative to structural allograft in skeletally mature patients in cases of segmental acetabular deficiencies.

ArTT Augments and Buttresses are indicated for cementless use to the bone interface; and are affixed to the mating acetabular cup using bone cement.

This 510(k) submission aims at introducing new device components, the ArTT Augments and Buttresses and Bone Screws (Revision Bone Screws (Dia. 6.5mm), Locking Bone Screws (Dia. 6.5mm), Locking Bone Screws (Dia. 4mm), Bone Screws (Dia. 4mm)) to be used in combination with the EMPOWR Acetabular Cup System (K190057) manufactured by Encore Medical, L.P.

ArTT Augments and Buttresses are manufactured from Ti6Al4V 3D printed (ISO 5832-3) and are indicated for cementless use to the bone interface; they are affixed to the mating acetabular cup using bone cement. ArTT Augments are available in 9 diameters (Dia. 50mm to 66mm) and 3 eccentricities (Ecc. 10mm, Ecc. 15mm, Ecc. 20mm), while ArTT Buttresses are available in 3 diameters (Dia.50mm, Dia.56mm, Dia.62mm), 3 heights (H. 15mm, H. 30mm, H. 60mm) and 3 configurations (Neutral, Left, Right).

Bone Screws are manufactured from Ti6Al4V (ISO 5832-3 - ASTM F1472); they are intended for cancellous or cortical bone and are available in several lengths.

This FDA 510(k) clearance letter pertains to
"ArTT Augments and Buttresses and Bone Screws" for orthopedic use. It's important to note that this document is a clearance letter, not a detailed scientific study publication. As such, it provides summary information about the device and the types of testing performed to demonstrate substantial equivalence, rather than a deep dive into specific study methodologies or acceptance criteria with detailed performance metrics.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum wear rate, specific pull-out force thresholds) or precise numerical performance results for the ArTT Augments and Buttresses and Bone Screws.

Instead, it states:

• "Mechanical tests demonstrated that the device performance fulfilled the intended use, and that the device is substantially equivalent to the predicate device."
• "Other performance requirements were fulfilled through rationales and comparisons with previously cleared components (K210717, latest 510(k) approval)."

This implies that the acceptance criteria were based on:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: The document states that mechanical testing was performed on "worst case components or constructs." However, it does not specify the exact number of samples or specimens used for each test (e.g., how many augments, how many screws of each type).
• Data Provenance: The studies were "Non-clinical testing" conducted by the manufacturer, Limacorporate S.p.A. The location of the testing laboratories or specific origin of data (e.g., retrospective/prospective in a clinical sense) is not described, as these are non-clinical (mechanical) tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

This section is not applicable as the studies described are non-clinical (mechanical) tests. The "ground truth" for mechanical testing is typically established by engineering standards (e.g., ASTM F543) and internal protocols, not by expert consensus from medical professionals.

4. Adjudication Method for the Test Set:

This section is not applicable for non-clinical mechanical testing, where adjudication methods like 2+1 or 3+1 by human experts are not used. Performance is measured against engineering specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not done. The clearance is for a physical orthopedic implant system, not an AI software/diagnostic device that would involve human readers interpreting cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

No, a standalone (algorithm only) performance study was not done. This device is a physical implant system, not an algorithm or AI.

7. The Type of Ground Truth Used:

For the mechanical tests conducted, the "ground truth" implicitly refers to:

• Engineering Standards: Specifically mentioned is ASTM F543 for torsional properties, driving torque, and pull-out load of bone screws.
• Internal Protocols: Used for fretting fatigue testing.
• Performance of Predicate Devices: The measured performance of the ArTT Augments and Buttresses was deemed "substantially equivalent" to that of the predicate devices. This means the performance of the predicate likely served as a benchmark or reference point for establishing acceptable performance.

8. The Sample Size for the Training Set:

This section is not applicable as this is a physical medical device, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This section is not applicable for the same reason as above (physical medical device, no training set).

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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 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 Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.

The subject SMR Reverse HP Shoulder System is a line extension to the predicate SMR Shoulder System (K223876) consisting of Reverse HP crosslinked UHMWPE glenospheres and Co-Cr-Mo liners. The components are available in one diameter with various options to accommodate varying patient anatomy.

Based on the provided FDA 510(k) clearance letter for the SMR Reverse HP Shoulder System, here's an analysis of the acceptance criteria and the study proving the device meets them:

It's important to note that this document is a 510(k) clearance, which is primarily a declaration of substantial equivalence to a previously cleared predicate device, rather than a full, de novo approval that would detail extensive clinical performance studies with specific statistical acceptance criteria for novel claims. The focus here is on demonstrating that the new device (SMR Reverse HP Shoulder System) is as safe and effective as existing legally marketed devices, rather than proving a new level of clinical efficacy.

Therefore, many of the specific details you've asked for, such as precise quantitative acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity, or effect size for AI assistance), adjudication methods, or detailed expert qualifications for ground truth establishment, are typically not found in a 510(k) summary, as they are not generally required for demonstrating substantial equivalence for an orthopedic implant.

The "acceptance criteria" for a 510(k) device primarily revolve around demonstrating that the new device performs as intended and is as safe and effective as its predicate. This is primarily done through non-clinical (mechanical) testing and reference to the predicate's established clinical history.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SMR Reverse HP Shoulder System are implicit in the demonstration of substantial equivalence to its predicate devices. The performance testing aims to show that the new components function equivalently to, or better than, the predicate components within the intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

The study described is primarily a non-clinical performance study combined with a post-market clinical data review for demonstrating substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set (Non-clinical): The document states "Mechanical testing was performed on worst case components or constructs." This implies a limited sample size based on engineering principles (e.g., statistical power calculations for specific test types or industry standards for mechanical testing). Specific numbers are not provided, as is typical for 510(k) engineering tests.
• Data Provenance (Clinical): "Post-market clinical data from outside the United States on the subject and predicate device were provided in this submission." This indicates a retrospective collection of data from clinical use, not a prospective, controlled clinical trial specifically designed for this submission. The exact country of origin within "outside the United States" is not specified, nor is the specific sample size, though it is described as "patient-level radiographs, outcome measures, and safety data."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Non-clinical: Ground truth is established by engineering standards and specifications (e.g., ISO, ASTM). The "experts" would be the engineers and technicians performing and assessing the mechanical tests against these predefined standards. Their qualifications are implicit in their ability to conduct and interpret these tests, but not explicitly stated in terms terms like "mechanical engineer with 10 years experience."
• Clinical: For the post-market clinical data, the "ground truth" refers to patient outcomes and safety information. This data is observed in real-world clinical practice, typically by treating physicians. There is no mention of a separate panel of experts specifically adjudicating this post-market data for "ground truth" purposes in the context described.

4. Adjudication Method for the Test Set:

• Non-clinical: The "adjudication" is against the pre-defined engineering standards and performance specifications for each mechanical test. This is typically a pass/fail determination based on quantitative measurements. No human-expert consensus "adjudication method" (like 2+1, 3+1) is described or typically applicable to component mechanical testing.
• Clinical: For the post-market clinical data, there's no mention of an adjudication method by external experts. The data would have been collected as part of routine clinical care or existing registries, and then compiled and analyzed by the manufacturer for the submission.

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 MRMC study was done. This device is an orthopedic implant, not a diagnostic imaging AI algorithm. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are not applicable to the SMR Reverse HP Shoulder System.

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

• Not applicable. As stated above, this is an orthopedic implant, not an AI algorithm.

7. The Type of Ground Truth Used:

• Non-clinical: The ground truth for mechanical testing is based on established engineering principles and international standards (ISO, ASTM) for orthopedic implants. These standards define the expected performance and limits for various mechanical properties.
• Clinical: The "ground truth" for the clinical data is real-world patient outcomes, safety events, and radiographic assessments collected during post-market use of the predicate device and the subject device (where applicable) outside the US. These are actual clinical observations rather than expert consensus on a test set.

8. The Sample Size for the Training Set:

• Not applicable for a 510(k) orthopedic implant. Training sets are relevant for machine learning algorithms. The design and validation of this mechanical implant do not involve "training sets" in this context. The "training" for the device would be the iterative design and development process, informed by biomechanical principles and material science, leading up to the final testing.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. See point 8.

In summary, the FDA 510(k) clearance for the SMR Reverse HP Shoulder System relies heavily on demonstrating engineering equivalence and material compliance through non-clinical testing, supplemented by a review of existing post-market clinical data for the predicate and related devices. It is a process focused on showing that the new device is "substantially equivalent" to an already cleared device, rather than a de novo approval process that would require extensive novel clinical efficacy studies with sophisticated statistical methodologies often seen for new drug or AI algorithm approvals.

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Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

• Non-inflammatory degenerative joint disease including
  • osteoarthritis
  • traumatic arthritis, and
  • avascular necrosis (not applicable to Physica TT Tibial Plate);
• Inflammatory degenerative joint disease including rheumatoid arthritis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and
• Treatment of fractures that are unmanageable using other techniques.

Additional indications for Physica LMC component are:

• Moderate varus, valgus, or flexion deformities.

In patients with preserved and well functioning collateral ligaments, Physica PS, PS Pro and HPS components are also indicated for:

• Absent or not-functioning posterior cruciate ligament;
• Severe antero-posterior instability of the knee joint.

Additional indications for Physica HPS component are:

• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Moderate varus, valgus, or flexion deformities.

Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of Physica Porous Femoral components and Physica TT Tibial Plates that are intended for uncemented use.

Tibial liners can be used with cemented or uncemented tibial or femoral components.

This 510(k) submission aims at introducing the Physica CR Porous Femoral components as part of the subject Physica system. The subject device components are intended to be used without cement, articulating with other components of the cleared Physica system. The Physica system (including subject Physica CR Porous Femoral components) is intended for a total knee replacement.

Physica CR Porous Femoral components are designed based on the cemented Physica CR Femoral components already cleared (K151266). They are made of CoCrMo (ISO 5832-4 / ASTM F75) and are intended to replace the condyles of the distal femur. The femoral components are available in ten sizes (left and right) and are intended to replace the condyles of the distal femur. The femoral components are available in left and right versions and have an asymmetric anterior flange (to adapt left and right knees) with symmetric condyles for the articulation with the tibial liner.

This FDA 510(k) clearance letter pertains to a medical device, specifically the Physica CR Porous Femoral components for total knee replacement, not an AI/Software as a Medical Device (SaMD).

Therefore, the requested information (acceptance criteria and study that proves the device meets the acceptance criteria), which is typically associated with the validation of AI/SaMD, is not directly applicable to this document. The document describes the device, its intended use, and indicates that substantial equivalence to predicate devices was demonstrated through non-clinical mechanical testing and comparisons.

Here's how I can describe the information requested if this were an AI/SaMD, and then explain what the provided document does say in terms of device performance:

As this document describes a physical medical device (knee implant) and not an AI/SaMD, the requested information regarding acceptance criteria and studies for AI/SaMD performance validation (e.g., sample size for test set, expert qualifications, MRMC studies, standalone performance, training set details) is not present in the provided text.

However, I can interpret your request in the context of the provided document by outlining the performance evaluation conducted for this physical device as presented in the 510(k) summary.

Acceptance Criteria and Study for Physica CR Porous Femoral Components (Non-AI/SaMD Context)

The primary method to demonstrate "acceptance criteria" and "device performance" for this type of medical device in a 510(k) submission is through substantial equivalence to legally marketed predicate devices, supported by non-clinical (mechanical) testing and material characterization.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document mentions "worst case components or constructs" were used for mechanical testing. It does not specify a numerical sample size for these tests.
• Data Provenance: The data comes from non-clinical mechanical testing conducted on physical components of the device, likely performed in a laboratory setting by the manufacturer (Limacorporate S.p.A. in Italy). It is not retrospective or prospective patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• This question is not applicable as the ground truth for a physical medical device like a knee implant is established through objective engineering standards and mechanical test results, not through expert consensus on diagnostic images or clinical outcomes in the same way as an AI/SaMD. The "experts" involved would be engineering and material science professionals conducting and interpreting the tests.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in evaluating subjective assessments (e.g., image interpretation). Mechanical testing results are objective measurements against defined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not applicable. This device is a physical knee implant, not an AI or a system that assists human readers. Therefore, no MRMC study or AI-related comparative effectiveness was conducted or reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

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

7. The Type of Ground Truth Used

• For mechanical performance: The ground truth is defined by established engineering standards (e.g., ASTM F3210-22e1 for fatigue testing) and material specifications (e.g., ISO 5832-4 / ASTM F75 for CoCrMo, FDA Guidelines for PoroTi coating). The "ground truth" is that the device must meet these predetermined, objectively measurable criteria.
• For substantial equivalence: The ground truth is the performance and characteristics of the legally marketed predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This device does not use a "training set" in the context of machine learning or AI. Its design is based on established engineering principles and prior device designs.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. See point 8. The design and development process for a physical implant involves engineering principles, CAD, materials science, and testing against known biomechanical principles, rather than AI training data.

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LimaCorporate Femoral modular heads are intended to be used in Total Hip arthroplasty with compatible femoral and acetabular components.

• Coupling of femoral modular heads with DELTA Acetabular System is indicated for use 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.
• · Revision of previously failed total hip arthroplasty (DELTA Multihole TT Pro only)

The components are intended for use in cementless (press-fit) applications.

• Coupling of femoral modular heads with H-MAX S, Minima S, Master SL, C2, MODULUS femoral stems is indicated 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;
• · osteoarthritis after femoral heads fractures (H-MAX S and Modulus stem);
• · treatment of femoral head and neck fractures (Minima S and MasterSL stems)
• · correction of functional deformity (MODULUS stems);
• · revisions in cases of good remaining femoral bone stock.

The components are intended for use in cementless (press-fit) applications.

• Coupling of femoral modular heads with Revision Femoral Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. The components are intended for use in cementless (press-fit) applications.

• Coupling of femoral modular heads with Cemented Cup is intended applications in hip arthroplasty where the acetabular socket needs reconstruction.

LimaCorporate Lock Bipolar femoral heads are intended to be used in Partial Hip replacement with compatible femoral components (Minima S, Master SL, C2, MODULUS femoral stems) for cementless applications.

This procedure is intended for redict of pain and/or improved hip function in skeletally mature patients with the following conditions: treatment of non-union, femoral neck fracture and intertrochanteric fractures unmanageable by other techniques.

Biolox® Delta Revision heads consist of a Biolox® Delta ball head and a titanium sleeve (Ti6Al4V). The ball heads are made of the Biolox® Delta ceramic material (K141327, K182099) and come in various outer diameters. The ceramic Biolox® Delta ball head is assembled with the corresponding titanium sleeve and is then placed over the taper of an in-situ hip stem prosthesis, during revision of a previously implanted femoral head:

K170473, K112091, K160011, K140975, K151739, K161226, K141327, K143509, K150855

The titanium sleeve has an inner 12/14 taper which fits the dimensions of a metallic hip stem prosthesis, and the Biolox® Delta ball head has a 16/18 taper which fits to the dimensions of the outer diameter of the titanium sleeve. The ball head then articulates against an acetabular insert:

K112898, K141395, K182099, K181491, K191622, K200656

The titanium sleeves are available in sizes -3, 0, +4, and +7 (S, M, L, XL) and the ball heads of the Biolox® Delta Revision heads are available with outer diameters ranging from 28mm - 40 mm.

Based on the provided text, the device in question is Biolox® Delta Revision heads, which are components of hip joint prostheses. The document is a 510(k) summary from the FDA, indicating a premarket notification for a medical device.

It's important to clarify that this document describes the substantial equivalence of a physical medical device (hip joint components), not a software-based or AI-driven diagnostic device. Therefore, the questions related to AI performance, ground truth establishment for AI, human reader improvement with AI assistance, and specific AI-related acceptance criteria are not applicable to this submission.

The "study that proves the device meets the acceptance criteria" in this context refers to mechanical testing of the physical hip replacement components to demonstrate their performance and substantial equivalence to predicate devices, rather than a clinical study evaluating an AI algorithm's diagnostic accuracy.

Here's an analysis of the provided text in relation to your questions:

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

The document does not present performance in a typical "acceptance criteria vs. reported performance" table format for a diagnostic device. Instead, it states that "Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices are substantially equivalent to the predicate devices."

The acceptance criteria are implied by the standards chosen for testing, and the performance is implicitly meeting those standards.

2. Sample size used for the test set and the data provenance

The document states, "Mechanical testing was performed on worst case components or constructs." It does not specify the exact number of samples tested (e.g., how many heads or constructs were subjected to each test). This is typical for mechanical testing where a representative "worst case" sample or a small batch is tested to ensure compliance with engineering standards.

• Sample Size: Not explicitly stated as a number of units, but "worst case components or constructs."
• Data Provenance: Not specified (e.g., country of origin). The mechanical testing is conducted by the manufacturer, Limacorporate S.p.A., based in Italy. The data is generated from laboratory testing of manufactured components, not patient data.
• Retrospective or Prospective: Not applicable in the context of mechanical testing of physical devices.

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

This question is not applicable as the device is a physical hip implant component, not an AI or diagnostic software. Ground truth in this context would be related to material properties and mechanical integrity, established by engineering specifications and physical testing methods, not expert human interpretation.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on image interpretation or clinical diagnoses, which is not relevant for mechanical testing of a medical device component. The "ground truth" for mechanical testing is derived from the physical properties and performance of the device under stress, measured by instruments according to established standards.

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 physical medical implant (hip replacement component), not an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant.

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

Not applicable. This question refers to AI algorithm performance. The device is a physical hip implant component, not an algorithm.

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

The "ground truth" for this device's performance is based on engineering standards and specifications for mechanical integrity and durability. This is established by:

• Physical measurements and material properties of the components.
• Performance of the components when subjected to standardized mechanical loading (e.g., burst, fatigue, pull-off, fretting, torque-off tests) as defined by ISO and ASTM standards.
• Comparison to the performance of legally marketed predicate devices, which have a history of safe and effective use.

8. The sample size for the training set

Not applicable. This question refers to machine learning. This device does not involve a training set for an AI algorithm.

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

Not applicable. As above, no AI "training set" is involved. The "ground truth" for the device's design and mechanical properties is based on established biomechanical and material science principles, engineering design standards, and the performance characteristics of previously cleared predicate devices.

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Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

• · Non-inflammatory degenerative joint disease including
  o osteoarthritis
  o traumatic arthritis, and
  o avascular necrosis (not applicable to Physica TT Tibial Plate);
• · Inflammatory degenerative joint disease including rheumatoid arthritis;
• · Correction of functional deformity:
• · Revision procedures where other treatments or devices have failed; and
• · Treatment of fractures that are unmanageable using other techniques.

Additional indications for Physica LMC component are:

• · Moderate varus, valqus, or flexion deformities.
  In patients with preserved and well functioning collateral ligaments, Physica PS, PS Pro and HPS components are also indicated for:
• · Absent or not-functioning posterior cruciate ligament;
• · Severe antero-posterior instability of the knee joint.

Additional indications for Physica HPS component are:
· Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.

• · The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
• · Collagen disorders, and/or avascular necrosis of the femoral condyle.
• · Moderate varus, valgus, or flexion deformities.

AMF Revision TT Cones are intended for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental metaphyseal fixation in the clinical judgment of the surgeon.

Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of Physica Porous Femoral components and Physica TT Tibial Plates that are intended for uncemented use, and tibial and femoral cones that are intended for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

Tibial liners can be used with cemented or uncemented tibial or femoral components.

Physica Porous Femoral Components have been cleared via K210554 with a Porous coating performed by a supplier. With this 510(k) submission, Limacorporate intends to add an additional coating vendor for these components. No other change is introduced on the Physica Porous Femoral Components: Intended use, design, material, sterilization, packaging and principle of operation are unchanged compared to the information approved in K210554.

The provided text is a 510(k) premarket notification for a medical device called "Physica Porous Femoral Components." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific performance acceptance criteria via a clinical study with a detailed test set, ground truth, or expert review.

Therefore, the document does not contain the information requested regarding acceptance criteria met by a study that proves the device meets them. Specifically:

• No table of acceptance criteria and reported device performance: The document does not define specific performance metrics or acceptance thresholds that the device was tested against in a clinical setting.
• No sample size used for the test set or data provenance: There is no clinical test set described.
• No number of experts or their qualifications for ground truth: Since no clinical test set is described, there's no mention of experts establishing ground truth for it.
• No adjudication method for the test set: Not applicable as there's no clinical test set.
• No multi-reader multi-case (MRMC) comparative effectiveness study: The document explicitly states "Clinical testing was not necessary to demonstrate substantial equivalence of the new Physica Porous Femoral components to the predicate devices." This means no human-in-the-loop study was conducted.
• No standalone (algorithm only) performance study: This is not an AI/algorithm-based device; it's a knee prosthesis component.
• No type of ground truth used: Not applicable as there's no clinical test.
• No sample size for the training set: Not applicable as this is a physical device and not an AI/ML model.
• No description of how ground truth for the training set was established: Not applicable.

What the document does state regarding demonstrating equivalence:

The submission for the Physica Porous Femoral Components focuses on demonstrating substantial equivalence primarily through non-clinical testing and comparison of technological characteristics.

• Non-clinical testing: "Mechanical and morphological characteristics of the coating of the subject cementless Physica Porous Femoral components were confirmed through a comparison with previously cleared (K210554) cementless Physica Porous Femoral components. The PoroTi coating of subject Porous Femoral components fulfills the conformity to the FDA guidelines and referenced standards and the analysis was performed on worst case components or constructs."
• Comparison of technological characteristics: The document asserts that "The intended use, design, and materials of the subject Physica Porous Femoral components (part of Physica system) are substantially equivalent to those of the predicate devices."

In essence, the "study" proving the device meets requirements for market clearance in this case is a non-clinical bench testing and design control process to ensure the new manufacturing of the porous coating is equivalent to a previously cleared version, which itself would have established safety and effectiveness through its own predicate or data. No new clinical or human performance data was required for this specific 510(k) submission.

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AMF TT Cones are intended for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental metaphyseal fixation in the clinical judgment of the surgeon. Tibial and femoral cones are intended for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

The AMF TT Cones are intended to be used as an optional accessory component in total knee arthroplasty. The AMF TT Cones are one-piece devices, made from Ti6A14V alloy, conically shaped with cannulation all the way through the cone.

With this 510(k) submission, the compatibility of the AMF Revision TT Cones (K200653) with the EMPOWR Revision Knee (K230169) manufactured by Encore Medical, L.P. is introduced.

I am sorry, but the provided text does not contain information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or multi-reader multi-case studies for a device.

The document is a 510(k) premarket notification letter from the FDA to LimaCorporate S.p.A. concerning the AMF TT Cones. It confirms the substantial equivalence of the device to a legally marketed predicate device.

The key points from the provided text are:

• Device: AMF TT Cones
• Purpose of filing: Introducing compatibility of the AMF Revision TT Cones (K200653) with the EMPOWR Revision Knee (K230169).
• Substantial Equivalence: The FDA found the device substantially equivalent to its predicate.
• Non-clinical testing: The document states that the new compatibility does not introduce a worst-case for mechanical testing and that test results of mechanical testing submitted in K200653 are applicable. It explicitly says, "Additional testing to demonstrate substantial equivalence to predicate devices is thus not required."
• Clinical testing: The document explicitly states, "Clinical testing was not necessary to demonstrate substantial equivalence of the new AMF TT Cones to the predicate device."

Therefore, without any clinical or non-clinical studies conducted specifically for this 510(k) submission to demonstrate new performance criteria, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance details.
7. Type of ground truth used.
8. Training set sample size.
9. Ground truth establishment for the training set.

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The PRIMA Humeral System is intended for partial or total, primary or revision, shoulder joint replacement in skeletally mature 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 PRIMA Short Stem and PRIMA Short Stem Plus are intended for use in cementless and cemented applications, at the discretion of the surgeon.

The PRIMA Anatomic implant is indicated for partial or total, primary or revision shoulder joint replacement, in patients suffering from pain and disability due to:

• . Non-inflammatory degenerative joint disease (i.e. osteoarthritis),
• Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis, .
• Avascular necrosis of the humeral head, ●
• . Traumatic/post-traumatic arthritis,
• Fractures of the humeral head where adequate fixation can be achieved and adequate bone . stock remains,
• . Post-fracture deformity with intact rotator cuff, where adequate fixation can be achieved and adequate bone stock remains,
• . Cuff tear arthropathy (CTA Heads only).

The PRIMA Reverse implant is indicated for primary reverse total shoulder replacement or for revision when converting an anatomic PRIMA arthroplasty to a reverse total shoulder arthroplasty (i.e. in case of cuff tear arthropathy or in a grossly rotator cuff deficiency joint with severe arthropathy).

Revision surgery with retention of the PRIMA Short Stem and PRIMA Short Stem Plus are intended as conversion surgery from anatomic to reverse, where the stem is stable, well positioned and tissue integrated. Other revisions of the humeral prosthesis part should be treated with traditional shoulder prostheses.

The PRIMA reverse implant is indicated for patients suffering from pain and disability due to:

• Rotator cuff tear arthropathy,
• Osteoarthritis with rotator cuff tear,
• Rheumatoid arthritis with rotator cuff tear,
• Massive irreparable rotator cuff tear,
• Avascular necrosis of the humeral head,
• Correction of functional deformity, where adequate fixation can be achieved and adequate bone stock remains,

The PRIMA Glenoid 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 PRIMA Glenoid System components are intended for uncemented use with the addition of screw fixation.

This 510(k) submission aims at introducing new components to the previously cleared PRIMA Humeral (K212800) and Glenoid (K222427) systems.

The PRIMA Short Stem Plus is introduced as part of the PRIMA Humeral System. As the already cleared PRIMA Short Stem, the PRIMA Short Stem Plus is a convertible short stem component with proximal (metaphyseal) fixation with Trabecular Titanium to be used in both anatomic and reverse configurations. Depending on the configuration, the stem component can be coupled with an Adaptor for the humeral heads for the anatomic configuration and with a Reverse Tray and Reverse Insert in reverse configuration.

The PRIMA Short Stem Plus is intended for use in cementless and cemented applications.

The PRIMA Short Stem Plus is made of Ti6A14V (ISO 5832-3) and is available in two different lengths: 86 mm and 96 mm. Each length is available in seven different sizes, varying from 28mm to 40mm in the proximal diameter.

The PRIMA TT Glenoid Central Compressive Cortical and Cancellous Screws in length 20mm are introduced as part of the PRIMA Glenoid System, as an additional option to the already available sizes (length 25 to 50mm), cleared via K222427. The PRIMA TT Glenoid Central Compressive Cortical and Cancellous Screws are intended to be inserted in the central hole of the glenoid baseplate and are used to fix the PRIMA TT Glenoid baseplates to the glenoid bone.

As for the already cleared central compressive screws of PRIMA TT Glenoid, the PRIMA TT Glenoid Central Compressive Cortical and Cancellous Screws in length 20 mm are manufactured from Ti6A14V (ASTM F1472, ISO 5832-3) and have respectively diameter 5mm (cortical) and 6.5mm (cancellous).

The provided document is a 510(k) Premarket Notification from the FDA, which assesses the substantial equivalence of medical devices to legally marketed predicate devices. It does not contain information about acceptance criteria or a study proving that a device meets specific performance criteria related to AI or diagnostic accuracy.

The document describes the PRIMA Humeral System and PRIMA TT Glenoid devices, which are shoulder joint replacement prostheses. The review focuses on their substantial equivalence in terms of intended use, design, materials, and mechanical non-clinical testing to previously cleared devices.

Therefore, I cannot provide an answer based on the given prompt about acceptance criteria and a study proving device performance in the context of diagnostic accuracy or AI assistance, as this information is not present in the provided text.

Specifically, the document states:

• "Clinical testing was not necessary to demonstrate substantial equivalence of PRIMA Humeral System and PRIMA TT Glenoid to the predicate devices." (Page 8)

This confirms that no clinical study for performance (like diagnostic accuracy, AI assistance, or human reader improvement) was conducted or needed for this particular 510(k) clearance.

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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 joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically 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.

The SMR Hybrid Glenoid System (K223876) is a modular system intended to be used in combination with previously cleared devices of the SMR Shoulder System. The system consists of a SMR Hybrid Glenoid component to be used in anatomical shoulder configuration and a reverse baseplate with screws and glenosphere that are used in reverse shoulders.

The SMR Hybrid Glenoid is a cemented glenoid component composed of a polyethylene baseplate connected to a central peg made of Trabecular Titanium. The baseplate has two peripheral pegs intended to be cemented into the native glenoid with the central peg being uncemented. The SMR Hybrid Glenoid is available in different sizes of baseplate and peg.

If a SMR Hybrid Glenoid is in place and revision to a reverse prosthesis is required, the patient can be revised by removing the anatomic polyethylene baseplate and leaving the metal peg in place. A metal SMR Hybrid Glenoid Reverse Baseplate is then connected to the central peg and a SMR Glenosphere coupled to the metal SMR Hybrid Glenoid Reverse Baseplate to articulate with a SMR Reverse Shoulder humeral liner, body and stem assembly on the humeral side. The metal SMR Hybrid Glenoid Reverse Baseplate and central porous peg assembly is intended for uncemented use with the addition of screws for fixation in reverse shoulder reconstructions.

This 510(k) is to introduce Selective Laser Melting (SLM) as a manufacturing option for central peg comprised of Trabecular Titanium. The subject device peg, made by SLM, has the same design of the predicate SMR Hybrid Glenoid System (K223876) and features the same net on the external surface.

This document is a 510(k) Premarket Notification from the FDA regarding the "SMR Hybrid Glenoid System." It primarily concerns the substantial equivalence of a new manufacturing method (Selective Laser Melting - SLM) for a component (central TT peg) of an already cleared medical device, rather than the initial clearance of an AI/ML medical device.

Therefore, many of the typical acceptance criteria and study elements associated with AI/ML device clearances (like those relating to diagnostic accuracy, human-in-the-loop performance, ground truth establishment by experts, etc.) are not applicable to this specific submission. This submission focuses on demonstrating that the new manufacturing process for a physical implant component does not change the core safety and effectiveness of the device as previously cleared.

Here's an analysis based on the provided text, addressing the points where information is available and explaining why other points are not relevant to this type of submission:

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

The acceptance criteria for this 510(k) are based on demonstrating that the SLM manufactured central TT peg performs equivalently to the peg made by the previous manufacturing method of the predicate device (K223876). This is primarily established through non-clinical testing.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the text. For non-clinical (mechanical) testing, sample sizes are typically determined by relevant ASTM/ISO standards to achieve statistical significance for the properties being measured.
• Data Provenance: The testing was "conducted according to the following test standards," implying laboratory testing. The specific country of origin for the lab data is not stated, but the manufacturer is based in Italy. This is retrospective in the sense that the testing was performed, and the results were subsequently submitted to the FDA. It is not human subject data (clinical data).

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

Not applicable. This submission is not for an AI/ML device requiring human expert annotation or ground truth for diagnostic accuracy. The "ground truth" here is the performance of the predicate device's component and the established engineering standards for orthopedic implants.

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

Not applicable. No expert adjudication process similar to those used for clinical image review or diagnostic ground truth was performed or required.

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 a physical implant, not an AI/ML diagnostic or assistive device. No MRMC study was conducted.

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

Not applicable. This is a physical implant, not a software algorithm.

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

The "ground truth" for this engineering submission is based on:

• Established Material and Mechanical Standards: Such as ISO 5832-3 for Ti6Al4V, and various ASTM standards for tensile strength, shear, fatigue, and abrasion (e.g., ASTM E8, F1044, F1147, F1160, F1978). These standards define the expected performance benchmarks for the material and component.
• Performance of the Predicate Device Component: The existing SMR Hybrid Glenoid System (K223876) serves as the benchmark, demonstrating that the new manufacturing process yields an equivalent product.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device requiring a training set. If referring to the manufacturing process, the "training" involves optimizing the SLM parameters, though "sample size" in a machine learning context is irrelevant here.

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

Not applicable. As above, no training set in the AI/ML sense was used. For the manufacturing process, "ground truth" would relate to achieving desired material properties and geometric accuracy, established through quality control, material characterization, and metrology.

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The MINIMA S System stems are indicated for use in partial or total hip arthroplasty and are intended for press-fit (uncemented) use. When used in total hip arthroplasty, the MINIMA S Stems are intended for use with compatible femoral heads and acetabular components. When used in partial hip arthroplasty, the MINIMA S stems are intended for use with Lock Bipolar Heads. Hip arthroplasty is intended 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 dvsplasia:
· rheumatoid arthritis;
· treatment of femoral head and neck fracture;
· revisions in cases of good remaining femoral bone stock.

The MINIMA S System is intended for partial or total hip arthroplasty in cementless use. It is a monolithic collarless stem currently available in 9 sizes (sizes from 4 to 12) in standard and lateralized versions. This Special 510(k) is to introduce Size 3 of the stem. Also this size comes in a standard and a lateralized version.
The Minima S stem is made of Ti6Al4V, and it has a plasma sprayed titanium coating in the proximal area (ASTM F1472, ISO 5832-3). The stem is characterized by a 12/14 conical taper to be coupled to LimaCorporate Femoral Heads, Biolox Delta femoral heads or Lock Bipolar Heads.

The provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria, as it relates to AI/ML or diagnostic performance.

The document is a 510(k) premarket notification for a hip joint prosthesis (MINIMA S System) and primarily focuses on establishing substantial equivalence to previously cleared predicate devices. It states that:

• No clinical testing was necessary to support equivalence.
• No additional preclinical testing was required for the new Size 3 of the stem because it does not represent a "worst-case" for mechanical testing, and results from previously cleared sizes (K141327) are applicable.

Therefore, none of the requested information (acceptance criteria table, sample size for test set, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth type, training set size, or training set ground truth establishment) is available in the provided text.

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

· non-inflammatory degenerative joint disease including osteoarthritis;

• revision of previous surgeries of the shoulder that do not compromise the fixation (such as a failed SMR resurfacing implant);

· glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only).

The SMR Stemless Anatomic is intended for uncemented use.

The SMR Stemless Anatomic is a modular system comprised of a stemless core and humeral head adaptor taper. The modular components are available in various sizes and are interchangeable allowing for independent sizing and positioning. The SMR humeral heads were previously cleared (K161476, K100858), and the SMR Stemless Anatomic is compatible with the previously cleared Cemented SMR metal back Glenoid Components (K113254, K133349, K143256), Cemented SMR all polyethylene glenoid components (K100858, K130642, K153722), and SMR TT Hybrid Glenoid System (K163397).

This document is a 510(k) clearance letter from the FDA for a medical device called the "SMR Stemless Anatomic." It's not a study report of an AI/ML powered medical device, and therefore does not contain the information requested in the prompt regarding acceptance criteria, study methodologies for AI performance, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML product.

The document discusses performance testing for a mechanical orthopedic implant, specifically a shoulder joint prosthesis, covering aspects like fatigue, micromotion, and pull-out strength. It also mentions "Clinical Data" related to the device's success in patients, comparing it to a predicate device. This is a traditional medical device clearance, not an AI/ML software as a medical device (SaMD) or AI-powered medical device.

Therefore, I cannot extract the requested information (table of acceptance criteria with AI performance, sample sizes for AI test sets, expert details for AI ground truth, MRMC studies, etc.) from this document. The concepts and methodologies described in the prompt are specific to the evaluation and clearance of AI/ML-driven medical devices, which this document does not concern.

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