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All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

Exactech Alteon HA femoral stems are intended for press-fit fixation.

The proposed Exactech Alteon HA Femoral Stems are intended for press-fit hip arthroplasty.

The Exactech Alteon HA Femoral Stems are manufactured from Ti-6A1-4V ELI (per ASTM F136, ASTM F620) with a grit blast surface and HA coating (per ISO 13779-2). The stem has a 12/14 taper. The Alteon HA Femoral Stems are available in various lengths with standard and extended neck offset configurations, and collarless configurations. The stem has a trapezoidal cross-sectional stem geometry with a distal taper, and it contains vertical and horizontal grooves along its bone contacting surfaces.

The Alteon HA Femoral Stems are compatible with the same femoral components as the predicate:

• Exactech Cobalt Chromium Alloy Femoral Heads (K041906, K121392)

• Exactech Ziramic Zirconia Femoral Heads (K050398, K060107)

• Exactech BIOLOX forte Alumina Femoral Heads (K032964, K051682)

• Exactech BioloxDelta and DeltaOption Femoral Heads and Adapters (K103012,K121392)

• AcuMatch L-series Unipolar endoprostheses (K010081)

• AcuMatch L-Series Bipolar Endoprostheses (K013211) .
  The Alteon HA Femoral Stems are compatible with the same acetabular components as the predicate:

• AcuMatch A-Series Acetabular Shells and Liners (K993082, K042906)

• AcuMatch A-Series Acetabular GXL Liners (K051556)

• AcuMatch A-Series Acetabular Cups, All-polyethylene, Cemented (K963313)

• Novation Crown Cup Acetabular Shells and Liners (K070479, K100269, K121392, K141960)

• Novation Crown Cup Acetabular Shells with InteGrip (K102975)

• Novation Crown Cup Constrained Liners and Rings (K071676)

• Exactech Integrip Acetabular Shells (K122798)

• Exactech Novation and AcuMatch E-HXL Acetabular Liners (K173583)

• Exactech Alteon Acetabular Cup System (K182502)

This document is a 510(k) premarket notification from the FDA for a medical device called "Alteon® HA Femoral Stems." It's important to understand that a 510(k) is a submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device, not a study proving device performance against specific acceptance criteria in the context of an AI/software device.

Therefore, the requested information pertaining to acceptance criteria and a study proving a device meets acceptance criteria in the context of an AI/software device is not applicable to this FDA submission. This submission is for a physical orthopedic implant (a femoral stem for hip replacement), not a "device" in the sense of an AI algorithm or diagnostic software.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, not on proving performance against specific acceptance criteria for a new, innovative diagnostic or AI-driven capability.

Here's a breakdown based on the context of the provided document, addressing why many of the requested fields cannot be filled:

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

   • Acceptance Criteria: Not explicitly stated in the context of performance metrics for an AI/software device. The "acceptance" here is the FDA's determination of substantial equivalence.
   • Reported Device Performance: The document describes non-clinical testing performed to show the new HA coating does not negatively impact the device's essential characteristics, maintaining equivalence to the predicate. Performance is demonstrated through engineering analyses (Range of Motion, Stem Neck Fatigue, Distal Stem Fatigue) and characterization of the new HA coating, ensuring it meets standards like ISO 21535:2007, ASTM F2068-2015, ISO 7206-6:2013, ISO 7206-4:2010, ISO 13779-2, and USP <161>, USP <85>, ANSI/AAMI ST72. No quantitative performance metrics in the sense of sensitivity, specificity, etc., for a diagnostic task are provided or relevant.

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

   • This is not applicable. The "test set" in the context of this 510(k) refers to the physical devices undergoing mechanical and chemical testing. There's no data set of patient images or information from which "data provenance" would be relevant.

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. There is no ground truth, expert consensus, or image review involved for this type of medical device submission. The "ground truth" for a mechanical implant is its physical and chemical properties and mechanical integrity, which are assessed through engineering tests, not expert medical review.

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

   • Not applicable. This refers to adjudication of medical image interpretations, which is not part of this submission. Mechanical testing results are objective measurements against 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 is for AI-powered diagnostic devices. The device in question is a physical orthopedic implant.

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

   • Not applicable. This is for AI algorithms.

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

   • Not applicable in the sense of a clinical ground truth for a diagnostic device. The "truth" for this device's performance is adherence to established engineering and material standards.

8. The sample size for the training set:

   • Not applicable. There is no AI model or "training set" for this physical implant.

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

   • Not applicable. There is no AI model or "training set" for this physical implant.

Summary of Relevant Information from the Document (Re-framed to align with the FDA 510(k) context):

The submission is for the Alteon® HA Femoral Stems, demonstrating substantial equivalence to the predicate device K162732 Exactech® Alteon® HA Femoral Stems. The key difference is the hydroxyapatite (HA) coating material/process.

The "study" conducted for this submission involves non-clinical testing and engineering analyses to demonstrate that the proposed device performs as intended and is substantially equivalent to the predicate.

Non-Clinical Tests and Analyses Done:

• Engineering analysis of Range of Motion (ROM): Per ISO 21535:2007.
• Engineering analysis of Stem Neck Fatigue Testing: Per ASTM F2068-2015 and ISO 7206-6:2013.
• Engineering analysis of Distal Stem Fatigue Testing: Per ASTM F2068-2015 and ISO 7206-4:2010.
• HA coating characterization: Per ISO 13779-2 and FDA Guidance document, "510(k) Information Needed for Hydroxyapatite Coated Orthopaedic Implants," dated February 1997.
• Bacterial endotoxins: Per USP <161>, USP <85>, and ANSI/AAMI ST72.

Conclusion from Testing:
The non-clinical testing and analysis found that the difference in the applied HA coating does not change the intended use, safety, or performance requirements of the proposed devices, nor does it adversely affect their safety or effectiveness. This supports the claim of substantial equivalence to the predicate device. No clinical testing was submitted.

To reiterate, the framework provided in the request is designed for evaluating AI/software-as-medical-device (SaMD) products, which is not what the Alteon® HA Femoral Stems are.

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The Vantage® Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The Vantage® Total Ankle System is indicated for cemented use only.

The Vantage® Total Ankle System is a system of orthopedic implants intended for total ankle replacement. The system includes Tibial Plates, Tibial Inserts, Talar Components, and Locking Clips. This submission proposes three new components as line extensions of the Vantage Total Ankle System, which are modifications of their respective predicate components:

• 3D Tibial Plates
• 3D+ Tibial Plates ●
• 3D/3D+ Locking Clips ●

The proposed devices have the same indications for use and similar design characteristics as their predicate devices (cleared under K152217). The proposed tibial plates differ from the predicate in that they are additively manufactured, have minor geometrical modifications, and are offered in additional sizes. The proposed locking clips differ from the predicate in that they are offered in additional sizes.

The provided text describes the 510(k) summary for the Exactech® Vantage® Total Ankle System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study or a standalone algorithm performance study.

Therefore, many of the requested details, such as those pertaining to a multi-reader multi-case (MRMC) study, human reader improvement with AI assistance, standalone algorithm performance, or the sample size and ground truth establishment for training and test sets of an AI/ML device, are not applicable to this 510(k) submission.

This submission is for a traditional medical device (total ankle system implants and components), not an AI/ML-driven diagnostic or prognostic device that would typically involve the types of studies described in the prompt. The "acceptance criteria" here refer to the demonstration of substantial equivalence through non-clinical performance testing of mechanical properties and material characteristics, rather than diagnostic accuracy metrics.

Here's a breakdown of the available information based on your request, highlighting what is present and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a traditional medical device like this are primarily based on established ASTM standards and demonstrating mechanical equivalence to a predicate device. The performance is shown through passing these tests, rather than providing specific numerical thresholds for diagnostic accuracy.

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

• Not Applicable: This is not a study involving a "test set" of clinical data or images for an AI/ML algorithm. The "testing" refers to mechanical and material performance testing of the device components themselves.

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

• Not Applicable: "Ground truth" in this context refers to the defined mechanical and material properties as per ASTM standards, not expert medical opinion on clinical cases.

4. Adjudication method for the test set

• Not Applicable: No adjudication method for a test set of clinical data is described. The "adjudication" would be related to the interpretation and validation of engineering test results, which is part of standard test protocols.

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: This is a mechanical implant device, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not applicable.

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

• No: This is a mechanical implant device, not a standalone AI algorithm.

7. The type of ground truth used

• For mechanical and material testing, the "ground truth" is based on established engineering principles and recognized consensus standards (e.g., ASTM F2665, ASTM F1044, ASTM F1147, ASTM F1978, ASTM F1160, ASTM F1854). These standards define the parameters and methodologies for evaluating the device's performance characteristics.

8. The sample size for the training set

• Not Applicable: This is not an AI/ML device that requires a training set of data.

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

• Not Applicable: As above, this is not an AI/ML device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study described is a series of non-clinical engineering and material characterization tests designed to demonstrate the substantial equivalence of the Exactech® Vantage® Total Ankle System to a legally marketed predicate device (K152217).

• Objective: To show that the proposed new components (3D Tibial Plates, 3D+ Tibial Plates, and 3D/3D+ Locking Clips) have comparable safety and effectiveness to the predicate device, despite minor design and manufacturing differences (e.g., additive manufacturing, additional sizes).
• Methodology: A battery of tests was performed on the device components, adhering to recognized ASTM standards for total ankle replacement devices. These tests evaluated:
  • Fatigue strength of tibial plates and locking mechanisms.
  • Fixation stability of tibial plates.
  • Characteristics of porous surfaces (stereological evaluation, shear, tension, abrasion resistance, compression).
  • Residual particulate count.
  • Pyrogenicity.
• Conclusion: The tests concluded that the strength of the new components is "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." The pyrogenicity test demonstrated endotoxin levels below the specified limit (< 20 EU/device).

In essence, the "acceptance criteria" for this device are the successful completion of these non-clinical tests, demonstrating that the device components meet the necessary mechanical, material, and safety requirements to perform as intended and are comparable to existing, cleared devices on the market.

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The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi-arthroplasty is determined by the surgeon to be the preferred method of treatment.

• The cemented primary humeral stem, long/revision stem, fracture stems, and all Equinoxe glenoids are intended for cemented fixation.
• . The press-fit humeral stems are intended for press-fit applications but may be used with bone cement at the discretion the surgeon.
• . The reverse humeral components are intended to be used in cemented applications or in revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
• Humeral Heads are intended for use in cemented and press-fit applications. ●
  Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows:
  | P | L | F | Indications |
  |---|---|---|---|
  | √ | √ | | Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems |
  | √ | √ | | Congenital abnormalities in the skeletally mature |
  | √ | | | Primary and secondary necrosis of the humeral head. |
  | √ | | √ | Humeral head fracture with displacement of the tuberosities |
  | √ | √ | Pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable | |
  | √ | √ | Revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved) | |
  | | | √ | Displaced three-part and four-part upper humeral fractures |
  | | √ | | Spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases) |
  | √ | √ | | Revision of failed previous reconstructions when distal anchorage is required |
  | √ | √ | | To restore mobility from previous procedures (e.g. previous fusion) |
  The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
  The Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.

The Equinoxe Laser Cage Glenoids are intended to be used with Exactech Equinoxe Humeral Head components in Total Shoulder Arthroplasty. The Laser Cage Glenoids are composed of an Ultra High Molecular Weight Polyethylene (UHMWPE) body molded onto Ti-6Al-4V peripheral pegs and a central cage. The central cage and peripheral pegs of the implant are additively manufactured using direct metal printing (DMP) technology. The Laser Cage Glenoids are available in four sizes and four augment angle options.

The provided text describes a 510(k) premarket notification for the Exactech® Equinoxe® Laser Cage Glenoid, which is a medical device for shoulder arthroplasty. The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting a study to prove the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.

Therefore, many of the requested categories (acceptance criteria, device performance, sample size, ground truth, experts, adjudication, MRMC studies, standalone performance, training set) are not applicable in the context of this 510(k) submission, as it is not a clinical study assessing an AI/ML diagnostic device.

Here's an analysis based on the information available:

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

The document does not provide a table of acceptance criteria with reported device performance in a clinical or diagnostic sense. The "acceptance criteria" in a 510(k) submission for a device like this are related to demonstrating substantial equivalence, primarily through:

• Identical Indications for Use
• Identical Biocompatible Materials
• Same Design Features
• Dimensionally Comparable
• Provided sterile for single use only
• Conformity to the same recognized performance standards

The "reported device performance" in this context refers to the results of non-clinical (bench) testing to confirm the physical and mechanical properties, as well as sterility.

Acceptance Criteria and Reported Device Performance (Non-Clinical/Bench Testing)

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

Not applicable. This is a 510(k) submission for a medical implant, not a study of an AI/ML diagnostic device with a test set of data. The "test set" in this context refers to the physical devices undergoing bench testing. The sample size for these bench tests is not specified in the summary document, and data provenance in terms of country of origin or retrospective/prospective is not relevant.

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 "ground truth" as typically defined for diagnostic performance studies was established. The assessments in this submission are based on engineering, material science, and regulatory compliance, not expert clinical interpretation of data.

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

Not applicable. No adjudication method for a test set of data was performed, as this is not a diagnostic performance study.

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 submission is for a physical medical implant (shoulder prosthesis), 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 is not an algorithm or AI-based device.

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

Not applicable in the conventional sense of diagnostic performance studies. The "ground truth" for this device's substantial equivalence claim relies on established engineering principles, material specifications, and validated manufacturing processes, all demonstrating that the new device is as safe and effective as the predicate devices. For non-clinical testing, the "ground truth" is defined by the recognized performance standards and internal engineering specifications, e.g., a peg must withstand a certain pull-off force.

8. The sample size for the training set

Not applicable. This is not an AI/ML device where a "training set" would be used.

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

Not applicable. No training set was used.

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The Equinoxe Stemless Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment.

Clinical indications for anatomic total shoulder arthroplasty are as follows:

• · Osteoarthritis, osteonecrosis or post-traumatic degenerative problems
• · Congenital abnormalities in the skeletally mature
• · Primary and secondary necrosis of the humeral head
• · Pathologies where arthrodesis or re sectional arthroplasty of the humeral head are not acceptable
• · Revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved)
• · To restore mobility from previous procedures (e.g. previous fusion)

In the USA, the Equinoxe Stemless Shoulder is only indicated for total shoulder arthroplasty.

The Equinoxe Stemless Shoulder humeral components are indicated for press-fit, uncemented use.

When used in total shoulder arthroplasty, the Equinoxe Stemless Shoulder System is intended to be used with the cemented Equinoxe glenoid components.

The Equinoxe Stemless Humeral Components are intended to be used with Exactech Equinoxe Stemless Humeral Heads and the Equinoxe glenoid components for use in Total Shoulder Arthroplasty. The Exactech glenoid components are indicated for cemented use. The proposed Equinoxe Stemless Humeral Components are additively manufactured from Ti-6Al-4V and have porous regions. The Equinoxe Stemless Humeral Components are available in in three sizes, with lengths between 17mm and 24mm.

This FDA 510(k) K192097 premarket notification is for a medical device called the Exactech® Equinoxe® Stemless Humeral Components. It is an orthopedic implant for shoulder arthroplasty.

It's important to note that this document describes a traditional 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device through engineering analyses and non-clinical testing. It does not involve studies with human subjects, AI algorithms, or deep learning models. Therefore, many of the requested fields (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone AI performance, training set sample size) are not applicable to this type of device submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail numerical sense for each test. Instead, it states that the devices "perform as intended and are substantially equivalent to the identified predicate devices" based on the non-clinical testing. The "reported device performance" is the conclusion that the device passes these tests, thereby demonstrating substantial equivalence.

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

• Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., number of units tested for fatigue). These would typically be determined by relevant ASTM or ISO standards for testing orthopedic implants, but are not detailed in this summary.
• Data Provenance: Not applicable in the context of this device. The "data" comes from engineering and laboratory testing of the physical device components, not from patient data or clinical images. It's not retrospective or prospective in the clinical sense.

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

Not applicable. "Ground truth" in this context is established by physical measurement against engineering specifications and industry standards for material properties, mechanical performance, and sterilization. It doesn't involve clinical experts establishing diagnoses or observations.

4. Adjudication Method for the Test Set

Not applicable. There's no "test set" in the sense of clinical cases requiring adjudication. The tests are physical and chemical evaluations.

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 orthopedic implant, not an AI-powered diagnostic or assistive device for human readers.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on:

• Established mechanical engineering principles.
• Relevant ASTM/ISO International Standards for orthopedic implants.
• FDA Guidance Documents (e.g., for sterility).
• Material specifications (e.g., for Ti-6Al-4V).
• Functional requirements for shoulder replacement devices.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is a physical implant, not a machine learning model.

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

Not applicable, as there is no training set.

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The Exactech Alteon Modular Dual Mobility (MDM) System is a component of the Alteon Acetabular System. The Alteon MDM System is indicated for skeletally mature individuals undergoing surgery for hip replacement due to osteoarthritis, theumatoid arthritis, osteonecrosis or post-traumatic degenerative problems of the hip. The Alteon Modular Dual Mobility System is also potentially indicated for ankylosing spondylitis, congenital hip dysplasia and to restore mobility resulting from previous fusion. The Alteon MDM System is also indicated for use in primary or revision patients at a high risk of hip dislocation.

The Alteon Acetabular System is intended for press-fit fixation.

The Alteon® MDM System provides modular implants for use in total hip arthroplasty (THA) to restore patient joint function. The Exactech® Alteon® Modular Dual Mobility (MDM) System is intended for use in total hip replacement as an interface between the acetabulum and femoral heads. The Alteon® MDM liners and inserts are manufactured from CoCr alloy and Ultra-High Molecular Weight Polyethylene containing vitamin E (alpha tocopherol), respectively. The Alteon® MDM liners and inserts are each available in seven configurations. The Alteon® MDM insert inner diameter (femoral head compatibility) includes 22mm or 28mm, while the Alteon® MDM liners are compatible with acetabular shells with outer diameters 46-68mm.

This document describes the Exactech® Alteon® Modular Dual Mobility (MDM) System, a medical device, and its 510(k) submission for FDA clearance. However, the provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) / Machine Learning (ML) enabled medical device.

The document details the device's indications for use, technological characteristics, and non-clinical testing performed to demonstrate substantial equivalence to predicate devices for regulatory clearance. The non-clinical tests are standard for orthopedic implants, such as biocompatibility, wear analysis, mechanical testing (fretting/corrosion, impingement, lever-out, axial push-out, torque out, offset pull-out), and range of motion analysis.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance (algorithm only) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This device is a physical orthopedic implant, not an AI/ML software device, and thus the type of studies and acceptance criteria you are asking about (related to AI/ML performance) are not applicable to this 510(k) submission.

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The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or posttraumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

All TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only, except the TRULIANT Porous Tibial Trays, which are indicated for cemented or cementless use.

Exactech Alteon Bone Screws are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Exactech Alteon Bone Screws are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

The Exactech Alteon Bone Screws are also indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The tibial tray implant and its porous structure is manufactured from Ti-6Al-4V titanium alloy using electron beam melting (EBM) technology. This product line represents a scope extension of the Truliant knee implant system. The previously cleared Alteon Bone Screws are now cleared for use with the TRULIANT Porous Tibial Trays.

This document does not describe a study involving an algorithm or AI. It is a 510(k) summary for a medical device (TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws), which means it focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance data from non-clinical (mechanical) testing.

Therefore, many of the requested categories, such as "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this type of submission.

Here's an analysis based on the information provided, focusing on the mechanical performance data:

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

Note: The document states that "The results of this non-clinical testing show that the strength of the TRULIANT Porous Tibial Tray is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." The specific numerical acceptance criteria (e.g., minimum load or cycles) and quantitative results for the mechanical tests are not provided in this 510(k) summary, but are implicitly met as per the FDA's clearance.

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

This information is not provided in the given text. For mechanical testing, sample sizes are typically determined by the relevant ASTM standards, but the exact numbers are not mentioned here. The data provenance is also not specified, as this is non-clinical lab testing rather than patient data.

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)

This is not applicable as the document describes mechanical and pyrogenicity testing, not studies requiring expert review for ground truth in the context of medical image analysis or clinical outcomes.

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

This is not applicable for the type of testing described. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, not for standardized mechanical tests.

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

This is not applicable. This document describes the clearance of a physical medical device (tibial tray and bone screws) through non-clinical testing, not an AI-powered diagnostic or assistive tool.

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

This is not applicable. This document does not pertain to an algorithm.

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

For the mechanical tests, the "ground truth" would be the physical properties and performance of the device under controlled laboratory conditions as measured against established ASTM standards. For pyrogenicity, it's the measured endotoxin level. This is not "expert consensus", "pathology," or "outcomes data" in the clinical sense.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable. There is no "training set" and thus no ground truth to establish for it in this context.

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All Exactech® Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech® Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where stock is present, and to restore mobility resulting from previous fusion.

Exactech® Highly Polished Femoral Stems are intended for cemented fixation.

The Exactech® Alteon® Highly Polished Femoral Stem implants are manufactured from forged Cobalt Chromium Alloy (Co-28Cr-6Mo) with a polished neck finish and polished surface finish. The Alteon® Highly Polished Femoral Stems are available in different combinations of stem length, neck offset, and diameter to accommodate an array of patient anatomies. The femoral stem has a 12/14 taper and has a trapezoidal cross-sectional stem geometry with a distal taper.

Alteon® Highly Polished Femoral Stem implants are collarless femoral stems and are intended for cemented use only.

The document provided is a 510(k) premarket notification for a medical device, the Exactech® Alteon® Highly Polished Femoral Stem. It is not an AI/ML device, and therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics (such as MRMC studies, standalone performance, training set details, or expert ground truth adjudication) is not applicable.

The document discusses the device's substantial equivalence to a predicate device (Avenir Cemented Hip Stem, K131884) based on its indications for use, technological characteristics, and non-clinical testing.

Here's a breakdown of the relevant information provided:

1. Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in the way one might for an AI device's performance metrics (e.g., specific sensitivity/specificity thresholds). Instead, it describes performance requirements through non-clinical testing designed to demonstrate that the device performs as intended and is substantially equivalent to predicate devices.

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

This information is not applicable as the studies described are non-clinical (mechanical and material testing), not clinical studies involving patient data or a "test set" in the context of AI. The tests involve physical samples of the device.

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

This information is not applicable. Ground truth, in the context of device performance, is established through standardized engineering tests and material science principles, not expert consensus on diagnostic or prognostic classifications.

4. Adjudication Method:

Not applicable for non-clinical, engineering-based testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not an AI device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This is not an AI algorithm. The performance described is for a physical medical prosthetic.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance is established by engineering standards, material properties, and biomechanical principles. For instance, the pyrogen testing relies on established biological assay standards (USP, ANSI/AAMI ST72) to determine the absence of pyrogens. Mechanical tests like fatigue testing rely on established engineering methodologies to assess durability under simulated physiological loads.

8. Sample Size for the Training Set:

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

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The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

The Exactech Equinoxe Small Reverse Shoulder is a subsystem of the Exactech Equinoxe Reverse Shoulder System which provides small reverse glenoid plates, small reverse glenospheres, screw components, humeral liners, and surgical instrumentation for use in reverse total shoulder arthroplasty. The modifications proposed by this submission describe minor geometry changes to the predicate Exactech Equinoxe Small Reverse Shoulder Glenospheres and Humeral Liners. As well as minor geometry modifications, this submission proposes Equinoxe Locking Cap compatibility with the Small Reverse Glenoid Plates and Small Reverse Glenospheres.

This document describes the Exactech Equinoxe Small Reverse Shoulder Glenospheres and Humeral Liners. The submission is a "Special 510(k)", which implies that minor changes have been made to a previously cleared device. Therefore, the "study" described focuses on demonstrating that these minor changes do not alter the substantial equivalence to the predicate device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the traditional sense of a clinical or in-vitro study with a distinct test set of data. The "test set" here refers to the specific design modifications and components that underwent engineering analysis and pyrogen testing.
• Data Provenance: The data provenance is internal to Exactech, Inc., as the tests and analyses were conducted by the manufacturer for their device modifications. The information is retrospective in terms of being generated to support the specific 510(k) submission for changes to an existing product. No external or prospective data is mentioned.

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

Not applicable. This submission relies on engineering analyses and standardized pyrogen testing, not expert consensus on diagnostic images or clinical outcomes. The "ground truth" for the engineering analyses is based on established mechanical principles, material science, and design specifications. For pyrogen testing, the ground truth is defined by the standards (USP <161>, USP <85>, ANSI/AAMI ST72).

4. Adjudication Method for the Test Set

Not applicable. No clinical or expert review adjudication was performed for these engineering and sterility tests. The evaluation is based on meeting pre-defined engineering tolerances and standard test limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This is a submission for a modification to a medical device (implants), not an AI or diagnostic imaging device that would typically involve human readers.

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

Not applicable. This device is a physical implant for shoulder arthroplasty, not an algorithm or software. "Standalone" performance is not a relevant concept here.

7. The Type of Ground Truth Used

The ground truth used in this submission is based on:

• Engineering specifications and tolerances: for the mechanical and dimensional properties.
• Established industry standards: for pyrogen testing (USP <161>, USP <85>, ANSI/AAMI ST72).

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for this type of device modification submission. Device design and engineering are not typically "trained" in the machine learning sense.

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

Not applicable, as there is no training set.

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The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The TRULIANT Cemented Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only. The TRULIANT Porous Femoral Components are indicated for cemented or cementless use.

Truliant femoral components are for use in resurfacing femoral bone as part of tricompartmental total knee arthroplasty employing modular components from the Optetrak / Optetrak Logic and Truliant device families.

Proposed Truliant porous femoral components represent modifications to Optetrak Logic porous femoral components cleared per 510(k) K140302. The proposed Truliant porous femoral components are identical to other Truliant femoral components but employ a porous structure identical to that used for the cited predicate femoral components and can be implanted as part of an uncemented surgical approach.

Proposed and predicate devices operate using the same fundamental scientific technology, have the same intended use and design features, employ the same materials of construction, are offered in similar product size scopes, are implanted using similar surgical techniques and the same or similar instrumentation, have equivalent Indications for Use statements, and, size for size, are compatible with the same Optetrak, Optetrak Logic, and Truliant patellar and tibial components.

The provided document is a 510(k) summary for the Exactech Truliant Porous Femoral Components. This type of submission is for medical devices seeking clearance from the FDA by demonstrating substantial equivalence to a legally marketed predicate device. The document does not describe a study assessing the performance of a diagnostic or AI-driven device against acceptance criteria in the way requested in the prompt.

Instead, the "acceptance criteria" here refer to the criteria for demonstrating substantial equivalence to an existing predicate device, primarily through engineering analysis and simulated use activities for a physical orthopedic implant.

Therefore, many of the requested fields about AI-specific performance, reader studies, and ground truth establishment are not applicable to this document. I will answer the relevant parts based on the information provided.

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

Since this is an orthopedic implant and not an AI/diagnostic device, the acceptance criteria are related to mechanical performance, biocompatibility, and maintaining similar characteristics to the predicate device. The document does not provide a quantitative table of acceptance criteria with specific thresholds and device performance values. Instead, it broadly states that "engineering studies referenced in this 510(k) submission demonstrate proposed Truliant porous femoral components are substantially equivalent to cited cleared predicate Optetrak Logic porous femoral components."

The "performance" described is about meeting the requirements for substantial equivalence to the predicate device.

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

The document refers to "simulated use activities" and "engineering analysis of device press-fit" and "surgeon expert evaluation." It does not provide specific sample sizes for these tests, nor does it specify data provenance (e.g., retrospective/prospective clinical data or country of origin) as this is likely primarily bench testing and expert design review for a 510(k) of an orthopedic implant.

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)

The document mentions "Surgeon expert evaluation." However, it does not specify the number of surgeons, their qualifications, or how their input was used to establish a "ground truth" in the context of typical AI/diagnostic device evaluation. For a physical implant, expert evaluation would likely involve assessing design, surgical technique, and perceived performance against the predicate.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies with human readers interpreting results (e.g., radiology reads). This information is not applicable to the documentation provided, as it pertains to a physical orthopedic implant and its engineering/simulated use evaluation.

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, as this document is not about an AI-assisted device or diagnostic tool.

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

This question is not applicable. The device is a physical knee implant, not an algorithm.

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

For an orthopedic implant seeking 510(k) clearance, the "ground truth" for substantial equivalence is primarily based on:

• Demonstrating equivalent materials, design, indications for use, and technological characteristics to the predicate device.
• Satisfactory results from engineering analyses (e.g., stress, fatigue, press-fit) and simulated use activities to ensure mechanical performance is equivalent or better than the predicate.
• Compliance with relevant standards (e.g., for pyrogenicity).
• Surgeon expert evaluation likely provides qualitative validation of the design and surgical approach.

8. The sample size for the training set

This question is not applicable, as this is an orthopedic implant, not an AI model requiring a training set.

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

This question is not applicable, as this is an orthopedic implant, not an AI model.

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All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

• · Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
• · Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
• · Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

The Alteon Monobloc Revision Femoral Stem is a distally tapered, press-fit prosthesis featuring a 12/14 trunnion that is used on the femur side of a total or hemi hip arthroplasty. The Alteon Monobloc Revision Stem system is intended to treat typical Total Hip Arthroplasty primary and revision cases. Compared to predicate Alteon Monobloc Revision Stems implants, proposed Alteon Monobloc Revision Stem line extension implants offer a longer stem length option, a reduced neck offset option, and options for intermediately sized stem diameters to accommodate an array of patient anatomies.

This document describes the Exactech® Alteon® Monobloc Revision Stem and its line extensions. It is a 510(k) premarket notification, indicating that the device is being submitted for clearance based on its substantial equivalence to a predicate device, not through a study proving it meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this context. This submission focuses on comparing the new device to a previously cleared device (K150066) to demonstrate substantial equivalence based on design, materials, and non-clinical testing, rather than a clinical study evaluating diagnostic performance.

Here's a breakdown based on the provided document:

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

This document does not specify general "acceptance criteria" in the way one would for a diagnostic or AI device's performance (e.g., sensitivity, specificity, accuracy thresholds). Instead, the "acceptance criteria" revolve around demonstrating substantial equivalence to the predicate device through non-clinical testing.

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

• Sample Size for Test Set: This document does not refer to a "test set" in the context of clinical data or AI performance evaluation. The "testing" refers to non-clinical, bench-top engineering tests (fatigue, range of motion, pyrogenicity). The sample sizes for these engineering tests are not specified in this summary.
• Data Provenance: Not applicable as no clinical data or patient-specific data is involved in this summary for demonstrating substantial equivalence. The data comes from internal laboratory testing.

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. "Ground truth" usually refers to a definitive diagnosis or outcome for clinical data. This submission is based on non-clinical engineering testing, not expert interpretation of clinical data.

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

• Not applicable. This concept applies to clinical data review by experts, not to non-clinical engineering tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is an orthopedic implant, not a diagnostic imaging device or an AI-powered tool. Therefore, an MRMC study is irrelevant.

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

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

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

• The "ground truth" for this submission are the accepted engineering standards for performance and material properties (e.g., USP <161>, USP <85>, ANSI/AAMI ST72 for pyrogen testing, and general industry standards for fatigue strength and range of motion for hip implants). This is not clinical ground truth.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI device.

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

• Not applicable. There is no "training set ground truth."

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