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The Anato™ Hip Stem is a sterile, single-use device intended for use in primary and revision total and hemi-hip arthroplasty to alleviate pain and restore function. The stem is designed for use with the currently available compatible Howmedica Osteonics' V40™ femoral heads and their compatible acetabular components. Head compatibility with the stems includes: V40130 Biolox Delta, Biolox Delta Universal Taper Heads and Sleeves, V40™ CoCr Heads, V40™ LFITM CoCr Heads, C-Taper Alumina Heads when used with the V40TM /C-taper Adapter, C-Taper Delta Heads when used with C-taper Adaptor, UHR® Universal Head, Unitrax® Heads when used with the Unitrax® V40™ Modular Adapter.

The indications for use for total hip arthroplasty include:

• noninflammatory degenerative joint disease, including osteoarthritis . and avascular necrosis;
• rheumatoid arthritis; .
• correction of functional deformity; .
• revision procedures where other treatments or devices have failed; and, ●
• nonunions, femoral neck fractures, and trochanteric fractures of the . proximal femur with head involvement that are unmanageable using other techniques.

Additional indication specific to use of Anato™ Hip Stem with compatible Howmedica Osteonics Constrained Liners:

• When the stem is to be used with compatible Howmedica Osteonics . Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
  The Anato™ Hip Stem is intended for cementless use only and is intended for total and hemi-arthroplasty procedures.

Howmedica Osteonics is introducing a monolithic, non-porous coated femoral hip prosthesis, which is intended for cementless, press-fit application. The basic design of the Anato™ Hip Stem is similar to two other commerically distributed total hip systems, which are Howmedica Osteonics' ABG® II Monolithic and Accolade® II Hip Stems.

The Anato™ and the Accolade® II stem are both made from the same material combinations. The subject device is similar in design to the ABG® II Monolithic stem as they are both anatomic stems with a 130 degree neck angle. There are normalization patterns (scales) on the anterior and posterior aspects of the proximal end of the stem to facilitate press-fit stability and load transmission. Based on 3-Dimensional simulations, these normalizations are designed to convert medial and lateral shear stresses to compressive forces, which may facilitate proximal loading.

The subject stem is manufactured from titanium (Ti-6Al-4V) alloy, commercially pure (CP) titanium coating, and PureFix® hydroxylapatite (HA) coating identical to the previously cleared Accolade® II Hip Stem.

The Anato™ Hip Stem has a shot peened neck and will be available in 8 sizes ranging from size 1 through 8 with two different neck versions (neutral and anteverted). As the stem is anatomic, there will be a right and left component for each size. The stem is designed only for use with compatible Howmedica Osteonics' femoral heads and acetabular components.

Here's the breakdown of the acceptance criteria and the study information based on the provided text, categorized as you requested.

The provided document describes a 510(k) premarket notification for a hip stem, which primarily relies on substantial equivalence to predicate devices rather than independent clinical efficacy studies. Therefore, many of the typical elements of AI/software device evaluation (like ground truth, expert consensus, MRMC studies, training set details) are not applicable in this context.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. The evaluation was based on non-clinical testing (mechanical fatigue) and comparison to predicate devices, not on a "test set" of clinical data.
• Data Provenance: Not applicable for clinical data. For non-clinical testing, it would refer to the testing facilities and methods as described by ISO standards.

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

• Not applicable. This device relies on mechanical testing standards and comparison to predicate devices, not on expert consensus or ground truth derived from expert review of individual cases. Decisions on substantial equivalence are made by regulatory bodies based on submitted documentation.

4. Adjudication Method for the Test Set

• Not applicable. There was no "test set" in the sense of clinical cases requiring adjudication. Mechanical test results are objective measurements against a standard.

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

• No, an MRMC comparative effectiveness study was not done. This is a medical device (hip stem), not an AI or imaging diagnostic tool that would typically involve human readers.
• Effect size of human readers with/without AI assistance: Not applicable.

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

• Not applicable. This device is a physical hip stem, not an algorithm or software. Its performance is evaluated through mechanical testing and material properties.

7. Type of Ground Truth Used

• Mechanical Testing Standards and Predicate Device Performance Data: Performance was established against recognized international standards (ISO 7206-4 and ISO 7206-6) for mechanical fatigue, and by demonstrating identical material compositions and similar design characteristics to legally marketed predicate devices. The "ground truth" for substantial equivalence is the proven safety and effectiveness of the predicates and compliance with relevant engineering standards.

8. Sample Size for the Training Set

• Not applicable. This is a physical device, not an AI model that requires a training set.

9. How Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set, there is no ground truth for it.

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The indications for use for total hip arthroplasty include:

• noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• rheumatoid arthritis;
• correction of functional deformity;
• revision procedures where other treatments or devices have failed; and,
• nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Additional indication specific to use of ABG™ II Monolithic Hip Stem with compatible Howmedica Osteonics Constrained Liners:

• When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability.
  The Stem is intended for cementless, press-fit use only and is intended for total and hemiarthroplasty procedures'.

Howmedica Osteonics is introducing a monolithic femoral hip prosthesis. The basic design of the ABG™ II Monolithic Hip Stem, referred as the ABG™ II, is similar to other total hip systems commercially distributed such as the Stryker ABG™ II Modular Hip System.

The subject hip stem is a TMZF (Ti-11.5 Mo-6Zr-2Fe) alloy femoral stem with a roughened hydroxylapatite coating in the proximal region. It is intended for cementless, press-fit application and designed for use with the currently available compatible Howmedica Osteonics' femoral heads, bipolar heads, and their compatible acetabular components.

The ABGTM II Monolithic Hip Stem is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. The stem is designed for use with the currently available compatible Howmedica Osteonics' femoral heads and their compatible acetabular components. Head compatibility with the stems includes: V40 Biolox Delta, Biolox Delta Universal Taper Heads and Sleeves, V40 CoCr Heads, V40 LFIT CoCr Heads, C-Taper Alumina Heads when used with the V40/C-taper Adaptor, C-Taper Delta Heads when used with C-taper Adaptor, UHR Universal Head, Unitrax Heads when used with the Unitrax V40 Modular Adapter.

The ABGTM II Monolithic Hip Stem will be available in 8 sizes ranging from size 1 through 8 with one neck angle of 130°. The ABG™ II Monolithic Hip Stem anatomic stem is made with 12° of anteversion built into the proximal portion of the stem.

This 510(k) summary (K110807) describes the ABG™ II Monolithic Hip Stem, a femoral hip prosthesis. The acceptance criteria and supporting study are detailed in the "Non-Clinical Testing" section.

Here's a breakdown of your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criteria / Performance Standard | Reported Device Performance | Based on the FDA Guidance Document "Non-clinical Information for Femoral Stem Prostheses (17 September 2007)", specifically related to fatigue testing. This implies the device must meet the performance requirements (e.g., endurance limits, strength) outlined in relevant standards cited or referenced within that guidance. | "The testing demonstrated that the ABG™ II Monolithic Hip Stem is substantially equivalent to devices currently cleared for marketing." This statement indicates the device successfully met the performance criteria established by the guidance document, specifically in relation 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)

This information is not provided in the document. The study was non-clinical (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)

This information is not applicable as the study was non-clinical laboratory testing. Ground truth in this context refers to engineering measurements and assessments, not expert clinical interpretation.

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

This information is not applicable as the study was non-clinical laboratory 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes the non-clinical testing of a hip implant device, not an AI or imaging diagnostic tool that would typically involve human readers.

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

This information is not applicable. This document describes the non-clinical testing of a hip implant device, not an algorithm.

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

The ground truth for this non-clinical testing would be the engineering specifications and performance requirements outlined in the "FDA Guidance Document entitled 'Non-clinical Information for Femoral Stem Prostheses (17 September 2007)'". This includes metrics derived from fatigue testing and Finite Element Analysis.

8. The sample size for the training set

This information is not applicable as the study was non-clinical laboratory testing of a physical device, not a machine learning model.

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

This information is not applicable as the study was non-clinical laboratory testing of a physical device. The "ground truth" for the non-clinical tests would have been established by established engineering principles and standards for fatigue testing of medical implants, as guided by the FDA document mentioned. Finite Element Analysis (FEA) was used to determine "worst-case sizes" for testing, which implies the FEA models themselves were built upon accepted engineering principles and material properties.

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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 using other techniques.
5. Revision of previously failed total hip arthroplasty.
   Cemented and Uncemented Applications (as based on mating shell)

Biomet Manufacturing Corp. is adding new +3 MaxRom™ and +3 Hi-Wall profiles to allow the surgeon an option for achieving more range of motion and joint stability in smaller patients.

The provided text is a 510(k) summary for a medical device (Biomet's 100 kGy E-Poly™ Acetabular Liners- Additional Profiles), not a study demonstrating device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth cannot be extracted directly from this document.

The document states:

• "Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."
• "Clinical Testing: None provided as a basis for substantial equivalence."

This indicates that the device's substantial equivalence was based solely on non-clinical testing, comparing it to predicate devices (K070399). Clinical performance criteria and studies as typically described for software or diagnostic devices are not applicable here.

Here's a breakdown of what can be inferred or stated based on the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Note: The specific, quantifiable acceptance criteria for "functional within its intended use" for the non-clinical testing are not detailed in this summary. These would typically involve mechanical, material, or biocompatibility testing data, but the summary only provides a general statement of compliance.

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

• Not applicable / Not provided. No clinical "test set" in the context of human studies for AI performance, for example, was used or described. The non-clinical testing samples (e.g., number of liners tested for mechanical properties) are not specified.

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

• Not applicable / Not provided. No human expert ground truth was established as this was a non-clinical submission.

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

• Not applicable / Not provided.

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 hardware medical device (hip implant component), not an AI or diagnostic imaging device. No MRMC study was conducted.

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

• Not applicable. This is a hardware medical device.

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

• Not applicable / Not provided in detail. For a non-clinical submission, "ground truth" would refer to established engineering standards, material specifications, or performance benchmarks related to mechanical properties, wear, biocompatibility, etc., when compared to the predicate device. The document only states "The components for cross-linked polyethylene in acetabular applications are adequately supported by biomechanical, materials data, and testing results provided within this Premarket Notification."

8. The sample size for the training set:

• Not applicable / Not provided. There is no "training set" in the context of an algorithm or AI.

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

• Not applicable / Not provided.

Summary of Device Performance Study (as per the document):

The device gained 510(k) clearance based on non-clinical laboratory testing that demonstrated substantial equivalence to existing predicate devices (specifically K070399). No clinical studies were conducted or provided as part of this submission for substantial equivalence. The non-clinical testing results "indicated that the device was functional within its intended use." The basis for substantial equivalence was also supported by the "intended use, indications and materials" being similar to the predicate, with the exception of added profiles (+3 MaxRom™ and +3 Hi-Wall).

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The Equator Plus™ Acetabular Cup System has the following indications for use:

• The patient should be skeletally mature.
• The patient's condition should be due to one or more of the following:
  1. Osteoarthritis.
  2. Rheumatoid arthritis.
  3. Tumor conditions involving the upper third of the femur or of the Acetabular.
  4. Ankylosing spondylitis.
  5. Psoriatic arthritis.
  6. Old osteomyelitis with a long infection-free period and a normal WBC, ESR and C-reactive protein.
  7. Non union of femoral neck fracture or avascular necrosis of the femoral head.
  8. Post-traumatic fracture/dislocation of the hip.
  9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling.
  10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.
  11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.

The Equator Plus™ Acetabular Cup System is comprised of two units the first is a coated outer shell manufactured from titanium alloy (Ti-6A1-4V). The second unit is a ultra high molecular weight polyethylene (UHMWPE) liner force fitted into an outer cobalt chrome metal dome casing. The UHMWPE liner is provided as a single pre-assembled component. The Equator Plus™ Acetabular Cup System is to be used as part of a modulary total hip replacement system in a cementless application.

Here's a breakdown of the acceptance criteria and study information for the Equator Plus™ Acetabular Cup System, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (an acetabular cup system), which primarily focuses on demonstrating substantial equivalence to predicate devices through testing and material qualification. It does not present a clinical study or performance data in the way one would for an AI/algorithm-based diagnostic or assistive device. Therefore, many of the requested fields related to clinical performance, ground truth, expert review, and AI specific metrics (like MRMC or standalone performance) will be answered as "Not Applicable" or "No information provided," as these types of studies are not relevant to the approval process described in this document for an orthopedic implant.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: In the context of this 510(k), acceptance criteria for orthopedic implants are typically centered around demonstrating substantial equivalence to already approved predicate devices. This is achieved through:

• Material compatibility and strength: Ensuring the chosen materials (titanium alloy, UHMWPE, cobalt chrome) meet industry standards and perform as expected under physiological conditions.
• Mechanical performance: Testing to ensure the components (shell, liner, interface) can withstand loads and stresses encountered in the body, resist wear, and maintain structural integrity. This is often done via analytical and mechanical testing, comparing results to those of predicate devices or established standards.
• Biocompatibility: Ensuring the materials are safe for implantation and do not elicit adverse biological responses.
• Design validation: Confirming that the device design facilitates proper surgical implantation and long-term function.

The document states that "Testing and materials qualification have demonstrated that the differences in the Equator Plus™ Acetabular Cup System do not raise any new issues of safety and effectiveness" and that the device has "proved and compliance to standards." This is the general statement of performance proving it met the (implied) acceptance criteria for substantial equivalence. Specific quantitative performance metrics (e.g., tensile strength values, wear rates) are not provided in this summary but would have been part of the detailed testing report submitted to the FDA.

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

• Sample Size: No information provided. This type of device approval relies on mechanical and analytical testing of the device itself and its components, not on a "test set" of patient data or images.
• Data Provenance: No information provided for clinical data, as it was not a clinical study. Mechanical and analytical testing data would originate from laboratory settings.

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

• Number of Experts: Not applicable. Ground truth, in the sense of clinical diagnoses or image interpretations by experts, is not relevant for this type of device submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Not applicable. (No clinical test set as described for an AI/algorithm device).

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

• No. This is an orthopedic implant, not an AI-assisted diagnostic or imaging device.

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

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

7. The Type of Ground Truth Used

• For the testing described, the "ground truth" would be established engineering and material science standards and specifications (e.g., ASTM standards for mechanical testing, ISO standards for biocompatibility, material properties of the chosen alloys and polymers). These define the expected performance thresholds and material characteristics. The device's performance against these standards constitutes its "truth" for this approval process.
• No "expert consensus," "pathology," or "outcomes data" in the typical clinical study sense were used as ground truth for initial device approval, as this is a pre-market notification demonstrating substantial equivalence through physical testing, not a clinical trial proving efficacy and safety in patients.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of an orthopedic implant approval. Device design and material selection are based on engineering principles and established medical knowledge, not machine learning training.

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

• Not applicable.

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