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Wright Medical total hip systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use

• non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• inflammatory degenerative joint disease such as rheumatoid arthritis;
• correction of functional deformity; and,
• revision procedures where other treatments or devices have failed.

Rough grit blast surfaces are intended for uncemented arthroplasty. The PROFEMUR® Z Revision Hip Stem is intended for cementless hip arthroplasty.

Design features of the subject stems are summarized below:

• Cementless modular stems
• Available in 9 sizes
• Manufactured from Titanium alloy with a heavy grit blasted surface.

The subject device is available in 9 sizes (from size 3 to 11). Although the proximal geometries are identical to the predicate from size 3-9, the distal stem length has increased, with two larger sizes (10 and 11) introduced.

This submission (K122778) is for a medical device (PROFEMUR® Z Revision Hip Stem) and as such does not contain information on software acceptance criteria or studies involving AI and human readers. The document details the substantial equivalence of the hip stem to previously cleared predicate devices, primarily through nonclinical (mechanical) testing, rather than clinical studies or algorithm performance evaluations.

Therefore, I cannot provide information on:

• Acceptance criteria and reported device performance related to an algorithm.
• Sample size used for the test set or data provenance for an algorithm.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method for an algorithm's test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth for an algorithm.
• Sample size for the training set or how ground truth was established for it.

The document explicitly states: "Clinical data was not provided for the class III hip stem." This further confirms that no clinical studies as you've outlined for AI/software evaluation were performed or submitted.

The "acceptance criteria" in this context are for the mechanical performance of the hip stem and its substantial equivalence to existing devices, evidenced by:

1. Nonclinical Testing: The PROFEMUR® Z Revision Hip Stems were tested in distal and proximal fatigue evaluation per the loading regimen prescribed by ISO 7206-4, -6 and -8. This demonstrates the device's mechanical integrity under specified stress conditions. The acceptance criteria for such tests would be successful completion of these fatigue evaluations without failure, meeting the standards set by ISO 7206.
2. Substantial Equivalence: The primary "study" is the demonstration of substantial equivalence to predicate devices (K021346, K112080, K121221) based on:
   • Identical Indications for Use: The new device shares the exact same intended uses as the predicate devices.
   • Similar Design Features and Materials: The subject device is a cementless modular stem, available in 9 sizes, manufactured from Titanium alloy with a heavy grit blasted surface, similar to the predicates. While distal stem length increased and new sizes were introduced, the fundamental scientific technology remained unchanged.

The conclusion is that the safety and effectiveness are supported by this substantial equivalence information, materials information, and analysis data, aligning with the FDA's 510(k) pathway for medical devices.

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Total hip replacement for patients with:

• Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, . osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
• . Femoral neck fractures.
• . Failed previous surgery where pain, deformity, or dysfunction persists.
• Revision of previously failed hip arthroplasty. .

Hemi-hip replacement for patients with:

• Femoral neck fractures. .
  This femoral stem is for cementless use only.

The CLS Brevius Stem with Kinectiv Technology is a modular, titanium alloy femoral stem designed to replace the proximal femur in total or hemi-hip arthroplasty. It is a wedge-shaped, collarless design with a proximal-to-distal taper and a trapezoidal cross-section. The proximal portion of the stem contains a tapered female junction to allow for attachment to Kinectiv Technology modular necks and features for attachment of insertion/extraction instrumentation.

The provided text is a 510(k) Summary for a medical device (CLS® Brevius™ Stem with Kinectiv® Technology) seeking clearance from the FDA. This type of document is used to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove a device meets specific acceptance criteria through a study as would be described for a diagnostic AI/ML device.

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. The document focuses on non-clinical (lab) performance testing and does not describe a clinical study of the type that would involve a test set, ground truth experts, or AI/ML performance metrics.

Here's a breakdown based on the information provided in the document and why certain sections are not applicable:

1. Table of acceptance criteria and the reported device performance

The document does not present acceptance criteria in a quantitative table format that measures diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it lists performance tests and concludes that the device is "safe and effective and substantially equivalent to the predicate devices."

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

• Not Applicable. This document describes non-clinical (lab) performance testing of a physical medical device (femoral stem prosthesis), not a diagnostic AI/ML system. There is no "test set" of patient data in the context of diagnostic performance. The tests performed are engineering/mechanical tests on the device itself.

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

• Not Applicable. See point 2. Ground truth in the context of diagnostic AI/ML is not relevant here. The "ground truth" for non-clinical testing refers to established engineering standards and validated testing methodologies.

4. Adjudication method for the test set

• Not Applicable. See point 2.

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

• Not Applicable. This is a physical implant device, not an AI/ML diagnostic algorithm. Therefore, no MRMC study or AI assistance comparison was conducted.

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

• Not Applicable. See point 5.

7. The type of ground truth used

• For the non-clinical performance testing, the "ground truth" implicitly refers to the established engineering and biomechanical standards and validated test methods against which the device's performance (e.g., fatigue strength, stability) is evaluated. There is no "expert consensus," "pathology," or "outcomes data" ground truth in the AI/ML sense in this document.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device. There is no "training set" of data.

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

• Not Applicable. See point 8.

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1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
5. Revision procedures where other treatment or devices have failed.
   Porous coated components are intended for uncemented biological fixation.

The TaperIoc® Complete Microplasty Stems are an update to the existing TaperIoc® Microplasty Stems and are designed to replace the patient's natural hip, femoral neck, and head, due to disease or accident. The Taperloc® Complete Microplasty Stems will combine the design features of the Taperioc® Complete full-length stems to the shortened design of the existing Taperloc® Microplasty Stems. These design features include: a reduced neck angle, shorter/longer neck lengths, reduced Type 1 taper geometry with neck flats, polished neck, standard and high offset versions, two distal profiles, and an updated insertion hole. Stem sizes ranges are within the ranges of legally marketed predicates. The substrate material is Ti-6AI-AV, ASTM F-136. The proximal intramedullary region is sprayed with porous plasma spray.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Mechanical Testing: 6 worst-case stems were used for both distal and proximal stem fatigue testing. The sample size for the Range of Motion analysis is not explicitly stated but implies at least one simulation.
• Data Provenance: The data is from non-clinical testing performed by Biomet Manufacturing Corp. The country of origin is not explicitly stated, but the company is based in Warsaw, IN, USA. The data is prospective in the sense that it was generated for the purpose of this 510(k) submission, not gathered retrospectively from existing patient data.

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

This section is not applicable as the studies described are non-clinical mechanical engineering tests, not studies requiring human expert assessment of medical images or patient outcomes. The "ground truth" for these tests is defined by the international standards (e.g., ISO, ASTM) and the specified load/cycle requirements.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as above. There were no human expert assessments requiring adjudication. The tests were objective mechanical measurements against predefined pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This device is a hip implant, and the testing described is mechanical, not related to AI-assisted human reading.

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

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

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests was based on internationally recognized engineering standards and specifications. Specifically:

• Distal Stem Fatigue: ISO 7206-4:2002, ASTM F2068-03
• Proximal Stem Fatigue: ISO 7206-6:1992
• Range of Motion Analysis: ISO 21535:2009
• PPS Plasma Sprayed Coating: "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement" and 21 CFR 888.3358.

The "ground truth" is therefore adherence to these established mechanical performance and material characterization standards.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" as this is not an AI/machine learning device. The number of samples for mechanical testing (6 worst-case stems) served as the test set.

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

This section is not applicable for the same reason as above. There is no training set mentioned or implied.

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The PROFEMUR® Z Titanium Plasma Sprayed Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• inflammatory degenerative joint disease such as rheumatoid arthritis;
• correction of functional deformity; and.
• revision procedures where other treatments or devices have failed

The PROFEMUR® Z Titanium Plasma Sprayed Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.

The modular PROFEMUR® Z Titanium Plasma Sprayed hip stem is an uncemented distal femoral implant designed to couple with Wright Medical Technology's PROFEMUR® CoCr modular necks. The stem design was developed from the previously marketed PROFEMUR® Z Hip Stem ('STEM' K021346) and features the identical modular neck taper socket and is made of the identical Titanium alloy (ASTM F620) as previous hip stem designs by Wright. The PROFEMUR® Z Titanium Plasma Sprayed Hip Stem features the identical substrate cross-sectional geometry as the PROFEMUR® Z Hip Stem (K0213146) with the addition of titanium plasma spray coating conforming to ASTM F1580 applied according to WMT specifications which covers the proximal 1/3 of the stem.

The provided text describes the PROFEMUR® Z Titanium Plasma Sprayed Hip Stem. As a Class III medical device, its clearance is primarily based on demonstrating substantial equivalence to predicate devices rather than meeting specific performance acceptance criteria through clinical or advanced non-clinical studies. The information available focuses on the device's design, materials, and manufacturing being identical or highly similar to previously cleared devices.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets those (or is substantially equivalent):

1. Table of Acceptance Criteria and Reported Device Performance

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

The "test set" for this device, as described, primarily refers to non-clinical (bench) testing performed on the device itself, comparing its physical and mechanical properties to established standards and predicate devices.

• Sample Size: Not explicitly stated for each test, but standard engineering tests would involve a sufficient number of samples to ensure statistical validity for the specific test (e.g., typically N=3 to N=5 or more for destructive tests like fatigue).
• Data Provenance: The tests are performed on the manufactured PROFEMUR® Z Titanium Plasma Sprayed Hip Stem. This is prospective testing of the device's physical samples. No human or animal data is described for these non-clinical tests.

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

This information is not applicable in the context of this 510(k) submission. The "ground truth" for the non-clinical tests is established by recognized international standards (ISO, ASTM) and the specifications of the predicate device, not by expert medical opinion on a test set.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication typically refers to the process of resolving discrepancies in expert human reviews for clinical or image-based studies. For non-clinical tests, compliance with standard test methods and evaluation against defined specifications are the "adjudication" mechanism.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done. This device is a mechanical implant, not an AI-powered diagnostic or assistive tool.

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

No standalone algorithm performance study was done. This device is a mechanical implant, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is based on:

• Engineering Standards: ISO 7206-4, 6, and 8 (for fatigue), ASTM F1875 (fretting corrosion), ASTM F2009 (axial disassembly), ASTM F1580 (titanium plasma spray coating).
• Predicate Device Specifications: The design, materials, and surface finish are compared directly to previously cleared predicate devices (e.g., K021346, K012091).
• WMT Specifications: Internal company specifications for manufacturing and coating application.

8. The Sample Size for the Training Set

There is no training set in the context of this 510(k) submission. This is not a machine learning or AI device. The process relies on demonstrating equivalence through engineering analysis and non-clinical testing.

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

Since there is no training set, this question is not applicable.

Summary of the Study Proving Acceptance Criteria (Substantial Equivalence):

The device's "acceptance" for market clearance (through 510(k)) is predicated on demonstrating substantial equivalence to legally marketed predicate devices. The "study" involves a comprehensive comparison and non-clinical testing program:

• Design & Material Comparison: A detailed analysis showing that the PROFEMUR® Z Titanium Plasma Sprayed Hip Stem is identical in material (ASTM F620), substrate cross-sectional geometry, modular neck taper socket, and non-coated surface finish to predicate devices (K021346).
• Coating Equivalence: The titanium plasma spray coating is shown to conform to ASTM F1580, applied to WMT specifications, and is "identical" to the coating used on another cleared predicate (K012091). This is supported by testing referenced in a vendor Master File (though specific results are not included in this summary).
• Mechanical Performance Testing: The coated stem underwent standard fatigue tests (ISO 7206-4, 6, and 8) and fretting corrosion and axial disassembly force tests (ASTM F1875 and F2009). While specific pass/fail criteria or results are not detailed in this summary, the completion of these tests in accordance with relevant standards implicitly demonstrates that the device performs acceptably and equivalently to current standards for hip stems.
• Intended Use & Indications Equivalence: The device's intended use and indications for use are stated to be "identical" to existing Wright PROFEMUR® hip stems, which have multiple prior 510(k) clearances.

In essence, the study demonstrating "acceptance" for this device is the body of evidence provided in the 510(k) submission that systematically compares the new device against its predicates and relevant engineering standards, asserting that any differences do not raise new questions of safety or effectiveness. No clinical testing was provided to support this Class III modular hip stem.

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The PROFEMUR® E Cementless Hip Stem is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications For Use:
The PROFEMUR® E Cementless Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. inflammatory degenerative joint disease such as rheumatoid arthritis;
3. correction of functional deformity; and,
4. revision procedures where other treatments or devices have failed

The PROFEMUR® E Cementless Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.

The modular PROFEMUR® E Cementless Hip Stems hip stem is an uncemented distal femoral implant designed to couple with Wright Medical Technology's PROFEMUR® CoCr modular necks. The stem design was developed from the previously marketed PROFEMUR® Z Hip Stem (STEM) K021346) and possesses the identical modular neck taper socket and is made of the identical Titanium alloy (ASTM F620) as previous hip stem designs by Wright.

The PROFEMUR® E Cementless Hip Stem is made of the same Titanium alloy and features a corundum blast surface finish similar to the PROFEMUR® Z Hip Stem (K021346). The PROFEMUR® E Cementless Hip Stem shares the rectangular cross-section of the predicate devices, and is designed to feature additional tapered lateral fins on each stem side.

Here's an analysis of the provided text regarding the PROFEMUR® E Cementless Hip Stem, focusing on the acceptance criteria and the study proving it.

Important Note: The provided text is a 510(k) Summary. A 510(k) submission generally aims to demonstrate substantial equivalence to a predicate device, rather than proving that a new device independently meets specific performance acceptance criteria through clinical studies. The focus is on showing the new device is as safe and effective as a legally marketed predicate device. Therefore, the "acceptance criteria" here are implicitly related to demonstrating this substantial equivalence, and the "study" is primarily non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the 510(k) summary, the device's acceptance criteria are framed in terms of its substantial equivalence to the predicate device, particularly in its mechanical performance.

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

• Sample Size for Test Set: Not explicitly stated as a number of devices or clinical subjects. The testing was non-clinical (i.e., laboratory testing on devices).
• Data Provenance: The document does not specify a country of origin for the data beyond stating "Wright Medical Technology, Inc. 5677 Airline Rd. Arlington, TN 38002" as the submitter. The testing itself involved mechanical evaluations of the device, not clinical data from patients. The study was non-clinical non-human.

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

Not applicable. This was a non-clinical, mechanical evaluation comparing a device to a predicate. It did not involve expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical, mechanical evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data was not provided for the class III modular hip stem."

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

Not applicable. This device is a physical, implantable medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established mechanical performance and material specifications of the predicate device (PROFEMUR® Z Hip Stem, K021346) and other previously cleared PROFEMUR® hip stems. The new device's performance was compared against these established standards.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for this type of non-clinical mechanical testing of a medical implant.

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

Not applicable. See point 8.

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The GLADIATOR® Plasma Classic Hip Stem is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. inflammatory degenerative joint disease such as rheumatoid arthritis;
3. correction of functional deformity; and,
4. revision procedures where other treatments or devices have failed

GLADIATOR® Plasma Classic Hip Stems are intended for use during uncemented hip arthroplasty.

The GLADIATOR® Plasma Classic Hip Stem is a straight uncemented stem, and features a rectangular cross-section, proximally a trapezoidal section manufactured from base material of Titanium alloy (Ti6Al4V - ASTM F620, equivalent to ISO 5832-3). The profile tapers vertically both in frontal and lateral view, to achieve fixation stability in three planes. The stem possesses a 0.5mm thick titanium plasma spray coating on the proximal third of the stem surface, conforming to ASTM F1580. The stem length ranges from 125 mm in length, is available in 10 sizes (1-10), and features 0.5mm thick titanium plasma spray on the proximal third of the stem surface. The stem is available in standard and extended neck offsets.

The provided text describes a 510(k) premarket notification for the GLADIATOR® Plasma Classic Hip Stem. This submission aims to demonstrate substantial equivalence to existing predicate devices, not to prove the device meets specific acceptance criteria through a clinical study in the way a new drug or high-risk medical device might.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify a "test set" in the context of clinical data for the new device. The testing mentioned in the nonclinical section (fatigue and range of motion) would typically involve a small number of physical samples of the device components, rather than patient data. The document does not provide the number of samples used for these nonclinical tests.
• Data Provenance: The data provided is purely nonclinical (mechanical testing). Therefore, there is no country of origin for patient data and it is not retrospective or prospective clinical data.

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

• Not applicable. This is not a clinical study involving diagnosis or outcome assessment where expert consensus on "ground truth" would be established. The "ground truth" for the nonclinical tests would be the predetermined international standards (ISO 7206, ISO 21535) and the results of the physical tests against these standards.

4. Adjudication Method for the Test Set:

• Not applicable. There is no "test set" in the clinical sense requiring an adjudication method. The nonclinical tests follow established international standards.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not provided for the class III hip stem." This indicates that no human factors or reader performance studies were conducted.

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

• Not applicable. This device is a physical hip stem, not an algorithm or AI product.

7. The Type of Ground Truth Used:

• For the nonclinical tests, the "ground truth" is the compliance with established international standards (ISO 7206 series for fatigue and ISO 21535 for range of motion). These standards define acceptable performance parameters for hip joint prostheses.

8. The Sample Size for the Training Set:

• Not applicable. There is no training set in the context of a machine learning model or clinical trial for this device. The "training" for this type of device involves engineering design, material selection, and manufacturing processes guided by established engineering principles and prior knowledge from predicate devices.

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

• Not applicable. As there's no training set for a data-driven model, there's no ground truth to establish for it. The underlying "ground truth" for the device's design and manufacturing is the body of medical engineering knowledge, regulatory requirements, and the successful performance history of its predicate devices.

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The Taperloc Complete hip stems are intended for uncemented biological fixation. This is the same intended use as the predicate Taperloc® stems cleared in K101086.

Indications For Use:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
5. Revision procedures where other treatment or devices have failed.

Porous coated components are intended for uncemented biological fixation.

The Taperloc® Complete hip stems are a line extension of the legally marketed Taperloc® Complete stems cleared in K101086.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Taperloc® Complete, Sizes 5mm and 6mm:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample size (i.e., number of stems) used for the non-clinical fatigue tests. It only mentions "All components passed."

The data provenance is from non-clinical testing conducted in accordance with ASTM standards. This implies laboratory testing rather than human subject data. Therefore, questions of country of origin and retrospective/prospective do not apply in the typical sense for clinical studies.

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

This information is not applicable as the studies were non-clinical fatigue tests based on established ASTM standards, not clinical studies requiring expert interpretation or ground truth establishment in a medical context.

4. Adjudication Method for the Test Set

This information is not applicable as the studies were non-clinical fatigue tests. Adjudication methods are typically relevant for clinical trials where multiple evaluators assess outcomes and discrepancies need to be resolved.

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

This information is not applicable. The submission describes a medical device (hip stems) and its non-clinical performance, not an AI-assisted diagnostic or interpretative tool.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was adherence to the performance requirements specified in the respective ASTM standards:

• ASTM F-1612-95, Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components with Torsion: The standard itself defines the pass/fail criteria for the fatigue test.
• ASTM F-2068-03 Standard Specification for Femoral Prostheses - Metallic Implants: This standard specifies the requirements for femoral prostheses, including fatigue testing, and defines what constitutes a "pass."

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical implant, and the testing described is non-clinical performance evaluation, not machine learning model training.

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

This information is not applicable for the same reasons as above.

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Indications for the Arcos™ Interlocking Distal Stem include:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
   The Arcos™ Interlocking Distal Stems are single-use implants, intended for uncemented applications.

The Arcos™ Interlocking Distal Stem was designed to be a part of the Arcos™ Modular Femoral Revision System, a modular system using interchangeable stems and proximal bodies commonly seen in femoral revision surgery. The proximal bodies consist of broached, calcar-replacing, and cone-style implants, made from Ti-6Al-4V (ASTM F-136) and featuring a roller hardened taper, is fully porous coated (Ti-6AL-4V, ASTM F-1580) with a fine buffed finish on the bullet-tip. The distal stems will be offered in a range of diameters from 15-26mm and lengths of 200mm, 250mm, and 300mm. The stems are offered in porous cylindrical with proximal taper and splined tapered designs. The stem provides holes for interlocking screws to provide temporary rotational stability. The system also includes auxiliary implants to aid in fixation. The system is intended for uncemented applications

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets them:

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

Important Note: The acceptance criteria for the "Kaessmann Transverse Screws Torsional Fatigue Test" are less quantitatively defined in the provided document. It states "determine the ability... as stated in the package insert" and that "the device was functional within its intended use." This suggests the criteria might be qualitative or specified in detail within the package insert, which is not included here.

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

• Distal Pot Fatigue Test: Six stems were used for this test.
• Kaessmann Transverse Screws Torsional Fatigue Test: The sample size for this test is not explicitly stated in the provided document. It mentions the screws were "tested... two separate times," but not the number of screws per test.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that this is a pre-market submission for a physical medical device, these would be laboratory-based mechanical tests, not clinical studies involving human patients.

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

This information is not applicable to the type of testing performed. The studies described are mechanical engineering tests (fatigue and torsional strength) of physical components, not clinical diagnostic studies requiring expert human interpretation of data for ground truth establishment.

4. Adjudication method for the test set

This information is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are used in clinical studies to establish a consensus ground truth among human readers/experts, which isn't relevant to mechanical bench 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

An MRMC comparative effectiveness study was not done. This type of study relates to the performance of AI algorithms, often in diagnostic imaging, and is not relevant to the mechanical testing of orthopedic implants.

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

This is not applicable. The device described is a physical orthopedic implant system, not a software or AI algorithm.

7. The type of ground truth used

For both tests, the "ground truth" is established by engineering standards and direct physical measurement/testing against a predefined threshold (e.g., surviving 5 million cycles, demonstrating rotational stability). It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of mechanical bench testing for a physical implant. Training sets are used in machine learning for AI algorithms.

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

This is not applicable for the reasons stated above.

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The Compress® Segmental Femoral Replacement System is indicated for:

1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
2. Tumor resections.
3. Revision of previously failed total joint arthroplasty.
4. Trauma.
   The Compress® Segmental Femoral Replacement System components are intended for uncemented use.

The Compress® Seqmental Anti-Rotation Spindles are not joint replacements but rather a method of fixing a segmental joint replacement to the patient's host bone. It utilizes the same spring-enhanced, stress-sharing design as the predicate Compress® Segmental Femoral Replacement System to generate stress on the host bone which helps prevent bone atrophy and promotes bone growth. It is intended to be used in conjunction with a knee or hip implant.
The complete device consists of an anchor plug, a spindle and either a proximal or distal femoral component. This 510(k) addresses modifications to the spindles. Holes are being added to the collar of the spindles to allow placement of pins to prevent rotation of the initial weeks following implantation. Additional sizes of spindles are also being added to the line.

The provided text describes modifications to an existing medical device, the Compress® Segmental Anti-Rotation Spindles, and its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria against specific performance metrics involving human readers or a standalone algorithm. The device, which is a method of fixing a segmental joint replacement, underwent non-clinical testing.

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
The document states "Non-Clinical Testing: Mechanical testing (resistance to rotational torque) and engineering analyses (greater wall thickness, smaller pin holes) of the Compress® Segmental Anti-Rotation Spindles demonstrated that the device will functional within its intended use compared to the predicate device."

• Test Set Sample Size: Not specified. The testing was mechanical and engineering analysis, not involving a population sample in the typical sense.
• Data Provenance: Not specified, but given it's mechanical and engineering testing, it would be laboratory-generated data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The testing was non-clinical, mechanical, and engineering analysis. Ground truth for such tests is typically established by engineering specifications and physical measurements, not expert consensus in the medical image interpretation context.

4. Adjudication Method for the Test Set
Not applicable. There was no human interpretation or ground truth establishment based on expert consensus for this non-clinical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
"Clinical Testing: None provided as a basis for substantial equivalence."
Therefore, no MRMC comparative effectiveness study was done.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical implant, not a software algorithm.

7. Type of Ground Truth Used
For the non-clinical testing, the "ground truth" was based on engineering specifications and physical testing results (e.g., measurements of rotational torque, wall thickness, pin hole size) compared to the predicate device's performance and design.

8. Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device.

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Indications for the Biomet® Modular Revision Femoral System Include:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
   The Biomet® Modular Revision Femoral System hip components are single-use implants, intended for uncemented applications.

The Blomet® Modular Revision Femoral System is a comprehensive, press-fit revision stem design that provides the surgeon with multiple styles of modular proximal and distal bodies for reconstruction of various defects commonly seen in femoral revision surgery. The proximal bodies will consist of broached, calcarreplacing, and cone-style implants. The system also includes auxiliary implants to aid in fixation. A single set of instrumentation is provided for all styles. The system is intended for uncemented applications

The provided document K090757 is a 510(k) summary for the Biomet® Modular Femoral Revision System. It describes a medical device, specifically a hip implant system, and its substantial equivalence to previously marketed devices.

Based on the content of K090757, I cannot provide details on "acceptance criteria" for software performance or "study that proves the device meets the acceptance criteria" in the context of AI/ML-driven medical devices. This document pertains to a traditional orthopedic implant, and the regulatory submission relies on non-clinical testing and substantial equivalence to predicate devices, rather than clinical efficacy studies or performance metrics for an AI algorithm.

Here's why and what information can be extracted:

Why the requested information cannot be fully provided:

• No AI/ML Component: The device is a physical femoral revision system (hip implant). There is no indication of any AI or machine learning component.
• Focus on Substantial Equivalence: The 510(k) process for this type of device focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily done through technological characteristics comparison and non-clinical (e.g., mechanical, material) testing, not clinical studies with performance metrics like sensitivity, specificity, or reader improvement.
• No Clinical Testing: The document explicitly states under "Clinical Testing": "None provided as a basis for substantial equivalence." This means no human clinical trials were conducted to assess the device's performance against specific clinical acceptance criteria.

Information that can be extracted from the document related to the study (in a general sense of "evaluation"):

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

   • Acceptance Criteria: Implicitly, the acceptance criterion for a 510(k) submission not requiring clinical data is that the device demonstrates substantial equivalence to predicate devices through technological characteristics and non-clinical testing, ensuring it is as safe and effective. The document states, "The results indicated that the device was functional within its intended use."
   • Reported Device Performance: The document doesn't provide specific performance metrics in a table format. It generally states that "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."

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

   • Not applicable. No "test set" in the context of an AI/ML algorithm was used. Non-clinical laboratory testing would involve mechanical or material samples, but specific numbers and provenance are not detailed in this summary.

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

   • Not applicable. No "ground truth" for a test set was established by human experts in the context of an AI/ML device.

4. Adjudication method for the test set:

   • Not applicable. No "adjudication method" for interpreting results from a test set of data was performed for an AI/ML device.

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

   • Not applicable. No clinical studies, especially MRMC studies comparing human performance with and without AI assistance, were performed or described.

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

   • Not applicable. No algorithm is involved.

7. The type of ground truth used:

   • Not applicable in the AI/ML sense. For this orthopedic device, the "ground truth" for safety and effectiveness is largely established by adherence to engineering standards, material properties, and comparison to the known performance of predicate devices through non-clinical testing.

8. The sample size for the training set:

   • Not applicable. There is no AI/ML algorithm that would require a "training set."

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

   • Not applicable.

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