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The AltiVate Reverse® Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:

• Severe arthropathy with a grossly deficient rotator cuff;
• Previously failed joint replacement with a grossly deficient rotator cuff;
• Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
• 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.

The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures.

All RSP® Monoblock and AltiVate Reverse® humeral stems are intended for cemented or cementless use.

This 510(k) submission proposes updated Surgical Technique within labeling, to reflect alternative reaming method to prepare the glenoid surface for the AltiVate Reverse Glenoid wedge baseplate. The alternative technique does not replace the original technique; it adds a secondary method for the user. There are no changes to the design, materials, function, or intended use of the devices, and no new implants or instruments are introduced.

This 510(k) clearance letter is for a medical device (AltiVate Reverse® Glenoid), specifically a shoulder joint prosthesis, not an AI/ML-based device. The provided text details the regulatory clearance for the device itself and a minor update to its surgical technique within labeling.

Therefore, the input does not contain the information necessary to describe acceptance criteria and a study proving an AI/ML device meets them as requested in the prompt. The document describes a physical device, not a software or AI algorithm.

Here's why the prompt cannot be answered with the provided text:

• No mention of AI/ML or Software: The entire document refers to a "shoulder joint metal/polymer semi-constrained cemented prosthesis," a physical implant. There is no mention of algorithms, artificial intelligence, machine learning, image analysis, diagnostics, or any other software-based function.
• Performance Testing: The "Performance Testing" section states, "Design Control and Verification and Validation Activities performed, demonstrates substantial equivalence between the subject and predicate devices and did not raise different questions of safety and effectiveness." This refers to traditional engineering and biomechanical testing for a physical implant, not the evaluation of an AI model's performance on data.
• Acceptance Criteria for AI: The prompt specifically asks for acceptance criteria related to AI performance (e.g., sensitivity, specificity, AUC) and details about a study evaluating an AI model (test set size, ground truth, expert review, MRMC studies). None of this information is relevant or present in the provided 510(k) letter for a physical orthopedic implant.

In summary, the provided FDA 510(k) letter is for a physical medical device and does not contain any information about the acceptance criteria or study data for an AI/ML-based device.

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Joint replacement is indicated for patients suffering from disability due to:

• degenerative, post-traumatic or rheumatoid arthritis;
• avascular necrosis of the femoral condyle;
• post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
• moderate valgus, varus or flexion deformities;
• treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the EMPOWR Porous® Knee Femur, EMPOWR Porous® Knee Tibia, and Porous Patella which are intended for cementless applications.

While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

The EMPOWR Revision VVC+, e+™ Tibial Insert should be considered for use in total knee arthroplasty for patients under the following indications:

• Absence or loss of both cruciate ligaments
• Moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgment of the surgeon
• Bone loss that requires supplemental fixation in the clinical judgment of the surgeon

The EMPOWR Revision Knee™ system is intended for use in total knee arthroplasty. The system includes femoral components, tibial components, tibial inserts, cones, stems, stem extenders, and augments. Components are available in various sizes and configurations to accommodate a range of patient anatomies and surgeon preferences.

The purpose of this submission is to obtain clearance for using vaporized hydrogen peroxide (VHP) as a sterilization method for the EMPOWR VVC+, e+ Tibial Insert component. The subject device is identical in design, materials, and intended use to the predicate.

This FDA 510(k) clearance letter pertains to a medical device, the EMPOWR Revision Knee™ system, specifically focusing on the clearance for a new sterilization method (Vaporized Hydrogen Peroxide - VHP) for the EMPOWR Revision VVC+, e+ Tibial Insert component. The document explicitly states that no clinical data or animal studies were submitted for this clearance. Instead, the substantial equivalence to the predicate device is based on non-clinical performance data (verification and validation activities).

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance for a clinical or AI-based study cannot be extracted from this document, as it is not relevant to the type of submission described.

The document discusses the following non-clinical performance data:

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

   • This information is not explicitly presented in a table format within the provided document. However, the document states that "Verification and validation activities demonstrate substantial equivalence between the subject and predicate devices." and lists the types of tests conducted. To fully answer this, one would typically need access to the actual verification and validation reports.

   Acceptance Criteria (Implied)	Reported Device Performance (Implied)
   Sterilization Efficacy	Validated for VHP
   Shelf-Life Stability	Demonstrated stability
   Packaging Integrity	Demonstrated integrity
   Biocompatibility (Cytotoxicity)	Met biocompatibility requirements
   Material Properties	Maintained material characteristics
   Wear Resistance	Comparable to predicate (Pin-on-disk)
   Fatigue Strength (Lock Detail)	Met strength requirements
   Fatigue Strength (Tibial Post)	Met strength requirements

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

   • Sample sizes: Not specified in the provided text. These would be detailed in the individual test reports for each verification and validation activity.
   • Data provenance: Not specified. This would typically come from internal laboratory testing or contract research organizations. The document indicates these are "Verification and validation activities," implying laboratory-based testing.

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

   • Not applicable. This is not a study assessing diagnostic performance or requiring expert ground truth in the traditional sense. The "ground truth" for non-clinical testing refers to established engineering or biological standards.

4. Adjudication method for the test set:

   • Not applicable. Adjudication is typically for clinical or interpretation-based studies. Non-clinical tests follow predefined protocols and acceptance limits.

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. The document explicitly states: "No clinical data submitted." This is not a study involving human readers or AI.

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

   • No. This is not an algorithm-based device.

7. The type of ground truth used:

   • For the non-clinical tests listed (Sterilization Validation, Shelf-Life Study, Packaging Testing, Cytotoxicity, Material Characterization, Pin-on-disk Wear, Lock Detail Fatigue, Tibial Post Fatigue), the "ground truth" would be established engineering standards, regulatory requirements, and validated testing methodologies.

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device requiring a training set.

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

   • Not applicable. This is not an AI/machine learning device requiring a training set.

In summary, the provided document is a 510(k) clearance letter for a medical device that highlights a change in sterilization method. The substantial equivalence argument is based entirely on non-clinical performance testing, not clinical trials or AI performance evaluations. Therefore, most of the requested information related to clinical studies, AI performance, expert ground truth, and sample sizes for such studies is not applicable to this specific submission.

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Intended Use:

The EMPOWR Revision Knee™ Symmetric 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 fixation in the clinical judgment of the surgeon. The EMPOWR Revision Knee™ Symmetric TT Cones are intended for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

Indications for Use:

The EMPOWR Revision Knee™:

Total joint replacement is indicated for patients suffering from disability due to:

• degenerative, post-traumatic or rheumatoid arthritis;
• avascular necrosis of the femoral condyle;
• post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
• moderate valgus, varus or flexion deformities;
• treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves cones or extensions.

The EMPOWR Revision Knee™ Symmetric TT Cones are indicated for the following conditions:

• EMPOWR Revision Knee™ Symmetric TT Cones are indicated for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental fixation in the clinical judgment of the surgeon.
• EMPOWR Revision Knee™ Symmetric TT Cones are indicated for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

The EMPOWR Revision Knee™ Symmetric TT (Trabecular Titanium) Cones are an optional accessory in primary or revision Total Knee Arthroplasty. The EMPOWR Symmetric TT Cones are sterile, single-use devices that are compatible for use with the EMPOWR Revision Knee™ components. The EMPOWR Symmetric TT Cones are composed of Ti6Al4V alloy (per ASTM F1472 and ISO 5832-3) and feature a porous Trabecular Titanium (TT) structure on the external surface of the implant. The EMPOWR Symmetric TT Cones are additively manufactured via Electron Beam Melting in the same manner as the reference AMF TT Cones device.

This document is an FDA 510(k) clearance letter for a medical device: the EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones).

It is crucial to understand that this document DOES NOT contain information about acceptance criteria or specific studies proving the device meets those criteria in the context of an AI/ML medical device.

The 510(k) clearance process for this orthopedic implant relies on demonstrating substantial equivalence to a previously cleared predicate device, primarily through bench testing (mechanical performance) and, in some cases, clinical data if significant differences exist. This is a very different type of clearance than for AI/ML devices, which require performance data related to algorithmic accuracy or clinical utility.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes for test/training sets, experts, adjudication, MRMC, standalone performance, ground truth establishment) because it is not present in this document.

The document states:

• "No animal data submitted."
• "No clinical data submitted."
• "All testing and evaluations demonstrate that the subject device is substantially equivalent to the primary predicate."

The performance testing listed focuses on mechanical properties (Dynamic Fatigue Testing, MR Conditional Labeling), which are relevant for an orthopedic implant but entirely different from the performance metrics and study designs expected for an AI/ML diagnostic or assistive device.

In summary, the provided document does not support a response to the prompt's specific questions regarding acceptance criteria and performance data for an AI/ML device.

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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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Joint replacement is indicated for patients suffering from disability due to:

• · Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural head;
• Rheumatoid arthritis;
• · Correction of functional deformity;
• Femoral fracture

This device may also be indicated in the salvage of previously failed surgical attempts. The EMPOWR Dual Mobility™ system has the additional indication of joint replacement due to dislocation risks.

The constrained acetabular component is indicated for primary or revision at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for who all other options to constrained acetabular components have been considered.

The ceramys™ femoral head system represents the latest generation of prosthetic femoral heads used in hip arthroplasty.

The ceramys™ femoral head system is applicable for use in total hip arthroplasty and the prosthetic replacement of femoral neck fractures. It offers a femoral head design with a reproducible surgical technique carefully developed to enable consistent and accurate implantation.

The ceramys™ femoral head system is composed of ceramys™ femoral heads, ceramys™ choice sleeved femoral heads, and ceramys™ choice sleeves. The ceramys™ femoral head system consists of alumina toughened zirconia ceramic heads and titanium adapter sleeves that connect to femoral stems using a 12/14 taper. The ceramys™ choice femoral heads and sleeves can be used with a well fixed stem in revision hip arthroplasty. The femoral head spherical diameter will be offered as 28, 32, 36, 40, and 44 mm and the femoral head center is offered in 4 increments ranging from -4 to +8 mm.

The provided text describes a 510(k) premarket notification for the ceramys™ femoral head system. This notification is for a medical device and not an AI/ML software. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not explicitly present in the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Biocompatibility testing: Conducted according to FDA guidance and ISO standards for permanent implantation.
• Performance testing: A comprehensive list of tests performed to FDA recognized standards and internal protocols specific to the ceramys™ femoral head system. These tests cover mechanical properties, material composition, and other performance aspects relevant to the physical device.

Key points from the document regarding the device and its testing:

• Device Name: ceramys™ femoral head system
• Regulation Number: 21 CFR 888.3353 (Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis)
• Regulatory Class: Class II
• Intended Use/Indications for Use: Joint replacement for patients with noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, femoral fracture, and salvage of failed surgical attempts.
• Comparison to Predicate: The subject device is compared to the BIOLOX® delta Ceramic Femoral Head (K082844). While diameters and offsets are similar, the ceramic material formulation is different.
• No AI/ML Component: The submission does not mention any AI/ML components or software in the device description or testing.
• No Clinical Studies or Animal Studies: The document explicitly states "No animal data submitted" and "No clinical data submitted."

Therefore, it is not possible to extract the requested information about acceptance criteria or studies related to AI/ML device performance from this document. The acceptance criteria for this device would be embedded within the specific standards listed for performance testing (e.g., ISO 7206-10:2018, ASTM F1875-14) and would relate to the physical and mechanical properties of the femoral head system, not to an AI's diagnostic or predictive accuracy.

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The AltiVate Reverse® Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to: Severe arthropathy with a grossly deficient rotator cuff; Previously failed joint replacement with a grossly deficient rotator cuff; Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection; 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. The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures. All RSP® Monoblock and AltiVate Reverse® humeral stems are intended for cemented or cementless use.

The AltiVate Reverse® Glenoid is a line extension to the existing RSP Glenoid System consisting of additional size offerings, modularity, and augment/revision offerings for varying glenoid morphologies for use in reverse Total Shoulder Arthroplasty (TSA) applications. The new implants consist of modular neutral and augmented baseplates, Torx peripheral screws, porous coated pegs, and additional offsets of glenospheres. All of the subject device implants are manufactured from Ti-6Al-4V except the glenospheres, which are manufactured from CoCrMo. New device specific accessories/instruments have been developed and are intended to facilitate proper implantation of the glenoid shoulder system.

The provided text is an FDA 510(k) clearance letter for a medical device called the AltiVate Reverse® Glenoid. It explicitly states that "Clinical data was not required." This means that the device was cleared based on non-clinical performance testing and comparison to predicate devices, rather than through a clinical study involving human patients.

Therefore, I cannot provide the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, as no such clinical study was conducted or required for this 510(k) submission.

However, I can extract the information provided about the non-clinical performance testing and the basis for substantial equivalence.

Based on the provided document:

Accepted Basis for Clearance (Non-Clinical/Bench Testing):

Regarding the other requested information (which is not applicable to a non-clinical 510(k) clearance):

1. Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test set was used. The performance testing was non-clinical (bench testing).
2. Number of experts used to establish the ground truth... and qualifications: Not applicable, as no human expert-driven ground truth was established from clinical data.
3. Adjudication method for the test set: Not applicable, as no clinical test set was used.
4. 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, not an AI or imaging diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical implant, not an AI or imaging diagnostic tool.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical testing, the "ground truth" was established by adherence to ASTM standards and demonstrated mechanical/material equivalence to the predicate device.
7. The sample size for the training set: Not applicable, as no clinical training set was used.
8. How the ground truth for the training set was established: Not applicable, as no clinical training set was used.

Conclusion stated in the document: "All testing and evaluations demonstrate that the subject device is substantially equivalent to the predicate device identified." This means the device met the acceptance criteria by demonstrating equivalence to a legally marketed predicate device through non-clinical performance testing.

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Total joint replacement is indicated for patients suffering from disability due to:

-degenerative, post-traumatic or rheumatoid arthritis;

-avascular necrosis of the femoral condyle;

-post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion,

dysfunction or prior patellectomy;

-moderate valgus, varus or flexion deformities;

This device may also be indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves cones or extensions.

The EMPOWR Revision Knee™ Symmetric Cones are indicated for the following conditions:

EMPOWR™ Revision Knee™ Symmetric Cones are indicated for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental fixation in the clinical judgment of the surgeon.

EMPOWR™ Revision Knee™ Symmetric Cones are indicated for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

Envois is adding a non-mating modular component accessory to the EMPOWR™ Knee product line and is compatible with the EMPOWR Revision Knee™ Femur (K213793), the EMPOWR PS Knee® Femur (K160342), the EMPOWR ™ Universal Tibial Baseplate (K173723), and the EMPOWR™ Knee Cemented Stems and Extender Accessories (K173723, K213793, and K230441).

The EMPOWR Revision Knee™ Symmetric Cone implants (also known as Cones) are an optional accessory in primary or revision Total Knee Arthroplasty. The Cones are sterile, single-use device that are compatible for use with the EMPOWR Revision Knee™ components. The EMPOWR™ Cones are composed of Ti6Al4V alloy per ASTM F1472 and contain a modified surface composed of commercially pure titanium per ASTM F67. This modified surface (i.e. porous coating) is exactly the same as applied to existing FMP™ Porous Coated Acetabular Shells (K072888).

The EMPOWR Revision Knee™ Symmetric Cones are intended to the mating femoral and/or tibial component using bone cement. The cones are intended for fixation as an assembled construct in the distal femur and/or proximal tibia, without bone cement.

The provided text describes a 510(k) premarket notification for a medical device, EMPOWR Revision Symmetric Knee Cones. It details the device's indications for use, comparison to predicate devices, and the types of testing performed to demonstrate substantial equivalence.

However, the document does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML medical device. The product is a physical knee implant accessory, not an AI/ML software device. Therefore, the questions related to AI/ML device performance (such as sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, training set details, etc.) are not applicable to this submission.

The document states:

• "No animal data submitted."
• "No clinical data submitted."

Instead, substantial equivalence is demonstrated through:

• Biocompatibility testing: In accordance with FDA guidance and ISO 10993 standards.
• Performance Testing:
  • Dynamic Fatigue Testing: ASTM F1800-19e1 (modified)
  • MR Conditional Labeling: ASTM F2052 -21, ASTM F2213-17, ASTM F2119-07(2013), ASTM F2182-10e2, ASTM F2503-20

Therefore, I cannot provide the requested information regarding acceptance criteria and study details relevant to an AI/ML medical device based on the provided text.

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The AltiVate® Anatomic Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:

· Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis

• · Rheumatoid and other inflammatory arthritis
• · Correction of functional deformity, including fracture malunion
• · Humeral head fracture
• · Revision of other devices if sufficient bone stock remains

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for a total shoulder arthroplasty.

Humeral components with a porous coated surface are indicated for either cemented or uncemented applications. Glenoid components are indicated for cemented use only.

This application is to include the AltiVate® Anatomic Shoulder AG e+™ with Markers (Full-Wedge), as a component of the AltiVate® Anatomic Shoulder System. The AltiVate® Anatomic Shoulder AG e+™ with Markers are manufactured from ultra-high molecular weight polyethylene with vitamin E. The articulating surface has a radius of curvature greater than the compatible humeral heads to allow translation in the superior/inferior and anterior/posterior directions. The back surface(s) of the component is spherical in geometry and has four pegs for fixation in the glenoid. The central peg has three annular barbs and the peripheral pegs have machined fixation features, referred to as Tri-lobes, to provide immediate fixation to the patient's glenoid when inserted. Radiographic markers are found in all three peripheral pegs.

This FDA 510(k) summary is for the AltiVate® Anatomic Shoulder AG e+™ with Markers. It is a premarket notification, not a study report. Therefore, it does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and a study proving device performance in the way a clinical trial report would.

However, based on the provided text, I can infer some aspects and directly state where information is not available.

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

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

The document does not provide a table of acceptance criteria or reported device performance in the sense of clinical metrics (e.g., pain reduction, range of motion improvement). Instead, it discusses the substantial equivalence to a predicate device based on material, design, and manufacturing standards.

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 in the context of the testing performed for this 510(k). The mechanical testing mentioned (ASTM F2028-17) would have a sample size of components, but it is not specified here. There was no clinical study.
• Data Provenance: Not applicable as a clinical test set. The mechanical testing would have been conducted in a lab.

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 with human interpretation requiring ground truth by experts was conducted or needed for this 510(k) submission.

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

Not applicable. No clinical test set requiring adjudication was conducted.

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 shoulder 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 shoulder implant, not an algorithm.

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

Not applicable. The "ground truth" for this device's regulatory clearance is established through demonstrating substantial equivalence to a legally marketed predicate device, primarily through engineering principles, material science, and adherence to relevant ASTM standards for mechanical performance.

8. The sample size for the training set

Not applicable. The device is a mechanical implant; there is no "training set" in the context of machine learning or algorithms.

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

Not applicable. See point 8.

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Joint replacement is indicated for patients suffering from disability due to:

• · degenerative, post-traumatic or rheumatoid arthritis;
• · avascular necrosis of the femoral condyle;
• · post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
• · moderate valgus, varus or flexion deformities;
• · treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the 3DKNEE™ Porous Coated Femur, EMPOWR 3DKNEE™ POROUS Femur, and EMPOWR POROUS Tibia which are intended for cementless applications.

While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

The EMPOWR Revision VVC+, e+ Tibial Insert should be considered for use in total knee arthroplasty for patients under the following indications:

· absence or loss of both cruciate ligaments

• · moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgement of the surgeon
• · bone loss that requires supplemental fixation in the clinical judgement of the surgeon

The EMPOWR Revision VVC+ (Varus / Valgus Constrained) e+ Tibial Insert Implant is a line extension that offers an increased level of femoral / tibial constraint over the EMPOWR VVC Tibial Insert. This tibial insert implant provides additional internal / external and varus / valgus rotational stability.

The sizing architecture for the insert includes 14 sizes (2-11, 4BU, 5BU, 6BD, 7BD) and thicknesses of 10mm, 12mm, 14mm, 16mm, 19mm, 22mm and 25mm with post medial/lateral width of 0.5520 inches for sizes 2-5 and 0.7080 inches for sizes 6 - 11. Along with the post width, the articulating geometry of the proximal side of the tibial insert accommodates an additional amount of internal / external (I/E), varus / valgus (V/V) constraint, and tibial post / femoral cam jump height when interfacing with the EMPOWR Revision Femoral implant. The material (highly crosslinked 75kGy UHMWPE with vitamin E per ASTM F2695/F2565) and distal locking mechanism geometry with the mating tibial baseplate are identical to the predicate.

All tibial insert thickness options are configured to interface with a reinforcement pin accessory made of Wrought CoCr per ASTM F1537. This accessory is configured with a taper interface on the distal end to mate with the EMPOWR UNIVERSAL TIBIAL BASEPLATE, has a diameter and length configured to reinforce the post and thickness for the EMPOWR Revision VVC+ e+ tibial insert, and contains barbs to prevent the pin from backout when fully seated within the post of the EMPOWR Revision VVC+, e+ tibial insert.

This document is a marketing clearance letter from the FDA for a medical device, specifically a knee joint prosthesis. It does not contain information about the acceptance criteria and study proving the device meets those criteria in the context of an AI/ML medical device.

The provided text discusses:

• The FDA's decision regarding substantial equivalence for the EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert.
• Regulatory information about the device (product code, regulation number, class).
• General controls provisions and additional controls that may apply.
• Indications for Use for the device, which describe the patient conditions for which the device is intended.
• A brief description of the device as a line extension offering increased constraint.
• Comparison of technological characteristics with a predicate device.
• Performance testing: This section lists types of performance tests conducted (e.g., CAD Based Range of Motion (ROM), Femoral – Tibial Contact Area Assessment, Femur - Tibial Intrinsic Stability, Femur - Tibial Varus / Valgus Constraint Testing, MR Conditional Labeling), but it does not provide acceptance criteria or the reported results of these tests. It merely states that "The following testing was performed to FDA recognized standards and internal protocols."
• Absence of animal or clinical studies: The document explicitly states "No animal data submitted" and "No clinical data submitted." This indicates that the substantial equivalence determination was based on non-clinical data, likely bench testing and comparisons to the predicate device.

Therefore, based solely on the provided text, it is not possible to answer the detailed questions about acceptance criteria, study methodologies, sample sizes, expert involvement, and ground truth establishment, as these pertain to performance studies that would typically be conducted for AI/ML medical devices or devices requiring clinical evidence for efficacy/safety.

The provided document is a 510(k) clearance letter, which often relies on demonstrating substantial equivalence to a predicate device through non-clinical performance and material characterization, rather than extensive clinical trials or AI/ML specific performance studies. This specific device is a mechanical implant, not an AI/ML-driven diagnostic or therapeutic device.

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Joint replacement is indicated for patients suffering from disability due to:

• · degenerative, post-traumatic or rheumatoid arthritis;
• · avascular necrosis of the femoral condyle;
• · post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
• · moderate valgus, varus or flexion deformities;
• · treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the 3DKNEE™ Porous Coated Femur, EMPOWR 3DKNEE™ POROUS Femur, 3DKNEE™ Porous Coated Tibia, and EMPOWR POROUS Tibia which are intended for cementless applications.

While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

The EMPOWR Stem Extender, 50mm implant is a modular accessory of the EMPOWR Revision Knee (K213793). When coupled with the EMPOWR Revision Knee, the Stem Extender is intended to be fixed to the bone by cement. The extender is connected to the mating implant, Revision Femur, by 7/16-20 UNF-2A male threaded connection on the implant, and 7/16-20 UNF-2B female threaded connection on the other side that is used to "extend" the length of cemented stem accessories (K173723) in an identical way as the EMPOWR Stem Extender, 25mm (K213793).

The Stem Extender is also compatible with the EMPOWR Universal Tibial Baseplate (K173723) and will be offered for use as an accessory with the baseplate.

The EMPOWR Stem 50mm Extender comes in a single diameter of 15mm and is offered a length of 50mm (Refer to Figure 1). The EMPOWR Stem Extender, 50mm is made of wrought CoCr alloy per ASTM F1537, which is identical to the material used in the 25mm extender included in the EMPOWR Revision Knee (K213793).

The provided text is a 510(k) summary for the EMPOWR™ Stem Extender, 50mm, which is a medical device. This type of submission is for clearance of a device that is substantially equivalent to a legally marketed predicate device. The document states that no clinical studies or animal studies were submitted to demonstrate the device meets acceptance criteria. Instead, substantial equivalence is claimed based on similar materials, manufacturing, sterilization processes, and performance testing against a recommended consensus standard.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth for the specific device performance study cannot be extracted from this document, as such a study was not presented.

However, I can extract information about the performance testing conducted to demonstrate substantial equivalence, which serves a similar role to proving a device meets acceptance criteria in a 510(k) context.

Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "An evaluation was performed against the recommended consensus standards for knee implants per the product codes assigned to the subject device. Of those standards, it was determined for this line extension that these additional components should be evaluated against ASTM F2083-21 (Standard Specification for Knee Replacement Prosthesis)." This implies the acceptance criteria are the specifications within ASTM F2083-21, and the reported performance is that the device met these specifications, leading to a conclusion of substantial equivalence.

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

• Sample size for the test set: Not specified in the provided text.
• Data provenance: Not explicitly stated, but assumed to be laboratory testing conducted by the manufacturer, Encore Medical, L.P.

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

• Not applicable, as this was mechanical performance testing against a standard, not a clinical study requiring expert consensus for ground truth.

4. Adjudication method for the test set

• Not applicable, as this was mechanical performance testing.

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 not an AI diagnostic or imaging device, and no clinical studies were performed.

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

• Not applicable. This device is not an algorithm or AI.

7. The type of ground truth used

• For mechanical performance: The technical specifications and requirements outlined in the ASTM F2083-21 standard.

8. The sample size for the training set

• Not applicable. No clinical or AI-related training was mentioned.

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

• Not applicable. No clinical or AI-related training was mentioned.

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