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The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and are indicated for the following:
• Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
• Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
• Patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity.
• Patients with acute femoral neck fractures.

The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and is indicated for the following:
• Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
• Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
• Patients suffering from disability due to previous fusion.
• Patients with previously failed endoprostheses and/or total hip components in the operative extremity.
• Patients with acute neck fractures.

The BIOLOX delta Ceramic Femoral Heads are fabricated from an alumina matrix composite and are available in diameters of 28, 32, 36, and 40mm with a range of offsets to accommodate various patient anatomies. They serve as an alternative to both metal and alumina ceramic femoral heads for use in total hip arthroplasty.

The BIOLOX OPTION Ceramic Femoral Head System consist of a ceramic head fabricated from an alumina matrix composite available in diameters of 28, 32, 36, and 40 mm and a titanium adapter for the femoral stem cone with a range of offsets to accommodate various patient anatomies. The system serves as an alternative to both metal and alumina ceramic femoral heads and is for use in both primary and revision total hip arthroplasty.

This appears to be a 510(k) summary for a medical device (BIOLOX Delta Ceramic Femoral Heads and BIOLOX Option Ceramic Femoral Head System), not a study describing acceptance criteria and performance of a device based on AI/ML or image analysis. The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, primarily through engineering analyses and material equivalence, rather than a clinical study with a test set, ground truth, or human reader involvement.

Therefore, many of the requested fields cannot be extracted directly from this document as they are not applicable to this type of regulatory submission. This document does not describe an AI/ML-based device that would typically have the requested performance metrics.

However, I can extract information related to the performance data presented within the context of a 510(k) submission for mechanical/material equivalence.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

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

• Not Applicable in the way implied by the request for an AI/ML study.
• The performance data relies on engineering analyses and material testing, not a "test set" of clinical cases or images. The "samples" would refer to test articles/components used in the mechanical and material tests. The document does not specify the number of individual components tested but refers to the completion of the tests.
• Data Provenance: The tests are likely conducted in a controlled laboratory environment by the manufacturer or a third-party testing facility, adhering to specified ISO/ASTM standards. The country of origin of these tests is not explicitly stated but would typically be where the manufacturer (Zimmer GmbH, Switzerland) conducts or commissions such testing.

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

• Not Applicable in the way implied by the request for an AI/ML study.
• This device is a mechanical implant. "Ground truth" in this context would refer to the validated standards and specifications (e.g., ISO standards) used for material and mechanical properties, not expert consensus on clinical cases. The interpretation of test results would be done by engineers and scientists (who are experts in their field) in accordance with these standards.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth, especially with image interpretation. For mechanical testing, adherence to standardized test protocols and data analysis governs the results.

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 mechanical implant device, not an AI/ML diagnostic aid that involves human readers interpreting cases.

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

• Not Applicable. This is a mechanical implant device, not an AI/ML algorithm.

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

• For this type of device, the "ground truth" (or reference standard) is primarily international standards and specifications (e.g., ISO, ASTM) for mechanical properties, material composition, and performance under specific simulated conditions (like wear and range of motion). There is no "pathology" or "outcomes data" ground truth directly described for the performance testing in this summary for substantial equivalence.

8. The sample size for the training set

• Not Applicable. This is a mechanical implant device, not an AI/ML algorithm, so there is no "training set."

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

• Not Applicable. No training set exists for this type of device.

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The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for the following:

Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion: patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.

The BIOLOX delta Ceramic Femoral Heads are fabricated from an alumina matrix composite and are available in diameters of 28, 32, 36, and 40 mm with a range of offsets to accommodate various patient anatomies. They serve as an alternative to both metal and alumina ceramic femoral heads for use in total hip arthroplasty.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BIOLOX delta Ceramic Femoral Heads:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device, its intended use, and a comparison to a predicate device. It does not explicitly state numerical acceptance criteria in terms of performance metrics (e.g., specific fatigue limits, wear rates, a certain number of cycles successfully passed). Instead, the performance is assessed against the substantial equivalence to a predicate device.

2. Sample Sizes and Data Provenance:

• Test Set Sample Size: Not specified. The document refers to "non-clinical testing" which implies mechanical and engineering tests, not patient data in the traditional sense of a "test set" for an AI or diagnostic device.
• Data Provenance: The "non-clinical testing" was likely conducted by Zimmer GmbH, which is located in Winterthur, Switzerland. However, the exact location of the testing facilities is not explicitly stated. The data is non-clinical/engineering (not patient data), so the concept of retrospective or prospective doesn't directly apply in the same way as clinical trials.

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: Not applicable. For this type of device (femoral head prosthesis), "ground truth" is established through engineering principles, material science, and mechanical testing standards, rather than expert consensus on medical images or clinical diagnoses.
• Qualifications of Experts: Not specified, but implied to be engineers, material scientists, and regulatory specialists involved in medical device design, testing, and regulatory submissions.

4. Adjudication Method:

• Adjudication Method: Not applicable. This document describes a 510(k) submission for a medical device (a ceramic femoral head), not a study involving human readers or interpretation of results that would require an adjudication method like 2+1 or 3+1. The assessment is based on objective engineering test results and regulatory review.

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

• MRMC Study: No. This is a physical orthopedic implant, not a diagnostic or AI-assisted device that would involve human readers interpreting cases.

6. Standalone (Algorithm Only) Performance Study:

• Standalone Study: No. There is no algorithm involved in this device. The performance is assessed through non-clinical (mechanical) testing of the physical implant.

7. Type of Ground Truth Used:

• Ground Truth: The "ground truth" in this context is established through engineering principles, material standards, mechanical testing results, and comparison to established performance characteristics of predicate devices. This includes:
  • Results from pull-off testing.
  • Results from range of motion analyses.
  • Results from fatigue strength analysis.
  • Adherence to material specifications (alumina matrix composite).
  • Compliance with relevant ASTM or ISO standards for orthopedic implants (though not explicitly listed, this is inherent in regulatory submissions).

8. Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This is not an AI/machine learning device that uses a "training set." The development of the device relies on established engineering design principles, material science, and manufacturing processes, which are refined through iterative design and testing rather than a statistical training set.

9. How Ground Truth for Training Set was Established:

• Ground Truth for Training Set: Not applicable, as there is no training set in the context of an AI/ML model for this device. The "truth" for the device's design and manufacturing is derived from decades of knowledge in biomedical engineering, orthopedics, materials science, and testing standards for implantable medical devices.

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Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NiDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia, treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Subject of this Traditional Premarket Notification are Biolox Delta Ceramic Femoral Head line additions. The subject devices are ceramic femoral head components which are intended to be used in conjunction with existing Smith & Nephew 12/14 taper hip stems, and they are intended to articulate against appropriately sized, existing XLPE acetabular liners. The Biolox Delta Ceramic Femoral Heads are manufactured from Biolox delta ceramic material and will be offered in sizes 40 and 44mm with offsets of 0, +4, and +8mm.

Biolox Detta Ceramic Femoral Heads in smaller sizes (28, 32, and 36mm) have previously been cleared for market via premarket notification K083762. The only difference between the subject Biolox Delta Ceramic Femoral Heads and those cleared via K083762 is the size offering: the subject devices are offered with a larger diameter than the predicate devices. All other design features, including material choice, taper design, and articular surface finish, are identical. Additionally, Biolox Delta Ceramic Femoral Heads in the same size range have previously been cleared for market via K082844.

Here's an analysis of the provided text regarding the Biolox Delta Ceramic Femoral Heads, structured to address your specific questions.

It's important to note that this document is a 510(k) Premarket Notification summary for a medical device (femoral heads), not an AI/ML medical device. Therefore, many of the questions related to AI/ML specific concepts (like multi-reader multi-case studies, ground truth establishment for a training set, sample sizes for test/training sets in an AI context) are not applicable. The device's "performance" in this context refers to its mechanical and material properties, not diagnostic accuracy or predictive power.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states: "A review of the testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices." This implicitly means the device met the acceptance criteria derived from the referenced guidance documents. Specific numerical acceptance criteria or detailed test results are not provided in this summary, which is typical for a 510(k) summary. The acceptance criteria would be defined within the full test reports, per the cited FDA guidance documents.

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

• Sample Size: Not explicitly stated. The document refers to "Performance testing has been conducted" and evaluates various mechanical properties (burst, fatigue, wear, etc.). These tests typically involve a specific number of samples for each test type, based on engineering standards and statistical power requirements, but these numbers are not disclosed in this summary.
• Data Provenance: The data is from in-vitro mechanical and material performance testing conducted by Smith & Nephew, Inc. at their facilities, or by contract labs following established test methods. This is not patient data; it's device performance data.

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

• This question is not applicable to this type of device and study. "Ground truth" in the context of this device refers to the physical and mechanical properties being measured, compared against established engineering standards and predicate device performance. It doesn't involve expert consensus on diagnoses or interpretations of medical images. The "experts" would be the engineers and technicians performing and reviewing the materials and mechanical testing.

4. Adjudication method for the test set

• This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or expert review processes, typically for evaluating diagnostic accuracy or clinical outcomes. This document describes mechanical performance testing, not a clinical trial or expert review of clinical cases.

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 question is not applicable. This device is a ceramic femoral head (joint implant), not an AI/ML software device for diagnostic assistance. Therefore, an MRMC study related to human readers and AI assistance is irrelevant.

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

• This question is not applicable. This device is a physical implant, not an algorithm or software. "Standalone performance" in this context would refer to the device's mechanical integrity under simulated physiological conditions, which is what the performance testing ("femoral head burst, femoral head fatigue, wear performance," etc.) evaluated.

7. The type of ground truth used

• The "ground truth" for this device's performance is based on accepted engineering standards, material specifications, and the performance of legally marketed predicate devices.
  • Expert Consensus: Not in the sense of clinical experts, but rather consensus within the engineering community on test methods and material properties.
  • Pathology: Not applicable.
  • Outcomes Data: Not directly used as "ground truth" for the device performance tests described (which are primarily mechanical). Clinical outcomes would be observed post-market or in clinical trials, but this 510(k) relies on non-clinical performance data and substantial equivalence to predicates.

8. The sample size for the training set

• This question is not applicable. The device is a physical product, not an AI/ML model that requires a "training set" of data.

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

• This question is not applicable for the same reasons as point 8.

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Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomvelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques: femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Biolox Delta Ceramic femoral heads are for single use only.

The Biolox Delta Ceramic femoral heads feature a 12/14 taper and are intended to be used with existing Smith & Nephew femoral hip stems. The ceramic femoral head mechanically locks with the femoral hip stem via a taper junction and articulates against a Smith & Nephew polyethylene acetabular liner. The subject devices are similar in design and function to the Biolox Forte Alumina Ceramic femoral heads cleared via 510(k) premarket notifications K981847, K991162, and K022958 respectively.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Smith & Nephew Biolox Delta Ceramic Femoral Heads:

This document is a 510(k) Premarket Notification Summary for Substantial Equivalence, not a clinical study report with detailed acceptance criteria and performance metrics. Therefore, it primarily focuses on demonstrating that the new device (Biolox Delta Ceramic Femoral Heads) is substantially equivalent to legally marketed predicate devices, rather than establishing de novo performance against specific acceptance criteria through a dedicated study.

Because of this, many of the requested data points (sample sizes, ground truth details, expert qualifications, MRMC studies, standalone performance) are not applicable or not provided in this type of regulatory submission. The primary "study" is a review of mechanical data for equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. This submission relies on mechanical data analysis and comparison to predicate devices, not a clinical test set with human subjects or patient data.
• Data Provenance: The "mechanical data" originates from the manufacturer's testing or engineering analysis. The document does not specify country of origin for the data, nor does it refer to patient data (retrospective or prospective).

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 the sense of clinical interpretations or diagnoses by experts is not relevant here. The "ground truth" for mechanical testing is established by engineering standards and validated testing protocols. The "experts" involved would be engineering and materials specialists within Smith & Nephew, or independent testing labs, whose qualifications are not detailed in this summary.

4. Adjudication method for the test set

• Not applicable. There was no "test set" in the clinical sense requiring expert adjudication.

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

• Not applicable. This device is a ceramic femoral head (a physical implant), not a diagnostic AI/software device. MRMC studies are for evaluating reader performance in interpreting images or data.

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

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

7. The type of ground truth used

• For the mechanical testing: The "ground truth" would be established by engineering standards and validated mechanical testing protocols (e.g., fatigue testing, fracture testing, static and dynamic loading tests), and comparison against the performance of legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of an AI/machine learning model. For mechanical testing, the "sample size" would refer to the number of femoral heads subjected to various mechanical tests. This is not specified in the summary but would be sufficient to meet relevant ISO or ASTM standards for medical device testing.

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

• Not applicable. As above, no training set in the AI sense. For mechanical testing, the performance characteristics of the device itself and the predicate devices, under specified loading conditions defined by engineering standards, serve as the "ground truth" for comparison.

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The indications for use of the subject device, in keeping with those of other legally marketed Howmedica Osteonics' ceramic femoral bearing heads are as follows:

For Use as a Total Hip Replacement:

• Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid . arthritis, post-traumatic arthritis or late stage vascular necrosis.
• Revision of previous cup arthroplasty or other procedures .
• Clinical management problems where arthrodesis or alternative reconstructive techniques are . less likely to achieve satisfactory results.

For Use as a Bipolar Hip Replacement

• Femoral head/neck fractures or non-unions. .
• Asceptic necrosis of the femoral head. .
• Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular . involvement or distortion.

Other Considerations:

• Pathological considerations or age considerations which indicate a more conservative . acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
• Salvage of failed total hip arthroplasty .

The subject V40" Biolox® delta Ceramic Femoral Heads mate with Howmedica Osteonics' V40™ taper femoral stems fabricated from Titanium, CoCr or stainless steel alloys. The V400 Biolox® delta Ceramic Femoral Heads are available in 28, 32 and 36 mm diameters and a variety of neck offsets.

The provided text describes a line extension to a medical device, specifically Alumina V40 Ceramic Femoral Heads, changing the material to Zirconia Toughened Alumina (ZTA) and adding additional sizes. This is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with performance metrics in the way a novel AI or diagnostic device would.

Therefore, many of the typical acceptance criteria and study details requested (like specific performance metrics, sample sizes for test/training sets, expert qualifications, HRMC studies, etc.) are not applicable to this type of submission.

Here's an analysis based on the provided text, addressing the points where information is available or indicating when it's not applicable:

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

   Acceptance Criteria	Reported Device Performance and Basis of Equivalence
   Intended Use: Similar to predicate devices (original Alumina V40 Ceramic Femoral Heads and other legally marketed Howmedica Osteonics' ceramic femoral bearing heads).	The indications for use of the subject device are stated to be in keeping with those of other legally marketed Howmedica Osteonics' ceramic femoral bearing heads, covering Total Hip Replacement and Bipolar Hip Replacement. This confirms similarity in intended use.
   Design: Similar to predicate devices.	Stated as: "The features of the new components are substantially equivalent to the predicate devices based on similarities in intended use and design."
   Material: Zirconia Toughened Alumina (ZTA) for the femoral heads, compatible with specific femoral stems (Titanium, CoCr, or stainless steel alloys).	The device modifies the material from alumina to Zirconia Toughened Alumina (ZTA). Compatibility is implied by mating with existing V40™ taper femoral stems fabricated from Titanium, CoCr, or stainless steel alloys.
   Mechanical Strength: Equivalent to predicate devices.	"Mechanical testing demonstrates substantial equivalence of the new components to the predicate devices in regards to mechanical strength." (Specific metrics for mechanical strength are not detailed in this summary, but the claim of equivalence through testing is made.)
   Manufacturing Methods, Packaging, Sterilization: Identical to predicate devices.	"In addition, the intended use, manufacturing methods, packaging, and sterilization of the predicate and new components are identical."
   Availability: In 28, 32, and 36 mm diameters, and various neck offsets (with added offsets for 28 and 36mm diameter heads).	The device is available in 28, 32, and 36 mm diameters and a variety of neck offsets. The submission adds "additional offsets of 28 and 36mm diameter heads." This is a descriptive feature, not a performance criterion in the same sense as mechanical strength.

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

   • Not Applicable in the traditional sense of a clinical test set. This submission is for a material and size line extension based on similarities to a predicate device and engineering testing, not a clinical trial with patient data or a diagnostic study with a test set of images.
   • The "Substantial Equivalence" section mentions "Mechanical testing." The specific sample sizes for these mechanical tests are not provided in this summary. Data provenance would refer to the lab where the mechanical testing was performed.

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 the context of expert consensus is relevant for diagnostic or AI-driven devices. For a medical implant line extension, "ground truth" would relate to the validated mechanical properties of the materials and designs, primarily evaluated through engineering standards and testing, not expert interpretation of patient data.

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

   • Not Applicable. Adjudication methods are used in studies involving expert readers or clinical endpoints. This is a mechanical/material 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:

   • Not Applicable. This type of study is for evaluating diagnostic performance, particularly of AI-assisted systems. The V40™ Biolox® delta Ceramic Femoral Heads are an orthopedic implant, not a diagnostic tool requiring human reader interpretation of images.

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

   • Not Applicable. This is for algorithm performance, not a medical implant.

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

   • Ground Truth Concept: For this device, the "ground truth" for demonstrating substantial equivalence primarily relies on established engineering standards and specifications for mechanical properties and material composition, as demonstrated through the "mechanical testing" mentioned. The performance of the predicate device, which has been legally marketed, serves as the benchmark.

8. The sample size for the training set:

   • Not Applicable. This is not a machine learning device, so there is no "training set."

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

   • Not Applicable. Refer to point 8.

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The subject devices are single use devices. They are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures. They can be used with all Howmedica Osteonics C-Taper* hip stems made from Titanium or CoCr alloys. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylenc bearing surfaces.

Indications for Use as a Bipolar

• Femoral head/neck fractures or non-unions, .
• Aseptic necrosis of the femoral head, .
• . Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
• Pathological conditions or age considerations that indicate a more conscrvative acetabular . procedure and an avoidance of the use of bone cement in the acetabulum,
• . Salvage of failed total hip arthroplasty.

Indications for Use as a Total Hip:

• Painful disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis,
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other . procedure,
• Clinical management problems where arthrodesis or alternative reconstructive techniques . are less likely to achieve satisfactory results,
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques . as indicated by deficiencies in the acetabulum.

The subject Biolox® Delta Ceramic Femoral Heads mate with Howmedica Osteonics` C-Taper femoral stems fabricated from Titanium or CoCr alloys. The Biolox® Delta Ceramic Femoral Heads are available in 28, 32 and 36 mm diameters and a variety of neck offsets.

The provided text describes a 510(k) premarket notification for a line extension to the Biolox® Delta Ceramic Femoral Heads. This is a medical device, and the submission focuses on demonstrating substantial equivalence to a predicate device, primarily through mechanical testing. The information provided does not detail acceptance criteria or a study design in the way one would typically describe for AI/ML-based device performance. Instead, the study outlined is a mechanical testing study to demonstrate safety and effectiveness for a physical medical device.

Therefore, many of the requested fields are not applicable to the provided document.

Here's an analysis of the information, addressing your points where possible:

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

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for the performance of an AI/ML device. Instead, it refers to "mechanical testing" to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion is that the new components perform equivalently or better than the predicate devices under mechanical stress.

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: Not explicitly stated for the mechanical testing. For physical device testing, this typically refers to the number of units tested.
• Data Provenance: Not applicable in the context of clinical data or patient data. The "data" here refers to mechanical test results, likely generated in a lab setting.

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. For mechanical testing of a physical device, "ground truth" is established by engineering standards and measurement equipment, not clinical expert consensus.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical expert review of data (e.g., medical images), not for mechanical testing of physical components.

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 medical device (femoral heads), not an AI/ML diagnostic or assistive device that would involve human readers.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for the mechanical testing would be based on established engineering standards and specifications for material properties and mechanical performance (e.g., fatigue strength, fracture toughness) relevant to implantable medical devices.

8. The sample size for the training set

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

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

Not applicable. No training set is involved.

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The subject devices are single use devices. They are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures. They can be used with all Howmedica Osteonics C-Taper* hip stems made from Titanium or CoCr alloys. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylene bearing surfaces.

Indications for Use as a Bipolar

• Femoral head/neck fractures or non-unions,
• Aseptic necrosis of the femoral head,
• Osteo-, theumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
• Pathological conditions or age considerations that indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum,
• Salvage of failed total hip arthroplasty

Indications for Use as a Total Hip:

• Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis,
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results,
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.

The subject Zirconia-Toughened-Alumina (ZTA) Ceramic Femoral Heads feature:

• Biolox® Delta material: this material is a composite of approximately 75% Alumina ceramic, with the balance consisting of zirconium oxide, chromium oxide, and other oxides,
• A C-Taper bore to mate with C-Taper* stems made from Titanium or CoCr alloys,
• Sizes:
  • 28mm diameter with neck lengths of -2.5mm, +0mm, +2.5mm, +5mm,
  • 32mm diameter with neck lengths of -2.5mm, +0mm, +2.5mm, +5mm,
  • 36mm diameter with neck lengths of –2.5mm. +0mm. +2.5mm. +5mm.

The provided text is for a 510(k) Summary of Safety and Effectiveness for a medical device (Zirconia-Toughened-Alumina Ceramic Femoral Heads), not an AI/ML device. Therefore, the concepts of acceptance criteria, test set, ground truth, expert adjudication, MRMC studies, or training sets as they relate to AI/ML performance metrics are not applicable to this document.

The document discusses the substantial equivalence of a new device to predicate devices based on:

• Intended Use: The new device shares identical indications for use but has a slightly broader compatibility with hip stems (CoCr or Titanium alloys).
• Design: Same basic design, C-Taper bore, and outer diameters as predicate devices, with neck length options falling within the range of cleared predicate devices.
• Material: Made from ZTA ceramic, similar to one of the cited predicate devices.
• Performance Data: Mechanical testing demonstrated that the new device's mechanical properties were "substantially equivalent" to the predicate devices.

The "acceptance criteria" in this context are implicitly that the new device performs mechanically at least as well as the predicate devices, and that its design, material, and intended use are sufficiently similar to warrant substantial equivalence without requiring new clinical studies. The study proving this involves mechanical testing, not the kind of studies you would conduct for an AI/ML diagnostic device.

Therefore, I cannot fill out the requested table or answer the questions related to AI/ML device performance for this document.

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