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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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The Consensus hip systems are designed for total or partial hip arthroplasty and are only intended to be used with compatible Consensus components per the appropriate system specific indications.

The general indications for use are:

• A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
• B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
• C. Proximal femoral fractures.
• D. Avascular necrosis of the femoral head.
• E. Non-union of proximal femoral neck fractures.
• F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.

Consensus hip system implants are intended for uncemented or cemented use per the system specific indications.

The Consensus hip systems are semi-constrained, hip prosthesis designed for either The Consensuring bio surgery. They include the Consensus® Hip System (CHS), the Unisyn™ Hip System, and the TaperSet™ Hip System (THS). All three hip systems utilize the exact same 12/14 Morse taper trunnion. These hip stems are compatible with previously cleared CoCr heads, zirconia heads, unipolar heads, bipolar heads, UHMWPE inserts and acetabular cups.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) summary for Consensus Orthopedics, Inc.'s hip systems, discussing their device description, indications for use, and substantial equivalence to predicate devices. It explicitly states:

"Clinical Performance Data: No clinical studies were performed."

The "Non-Clinical Performance Data" section mentions "All required testing per 'Guidance Document for the Preparation of Premarket Notifications of Ceramic Ball Hip Systems' were performed," and component testing according to ISO standards, but it does not provide specific acceptance criteria or report device performance against such criteria. It only lists the types of tests done.

Therefore, I cannot provide the requested table or information about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these details are not present in the provided text.

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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.

Ask a specific question about this device

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

• . noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
• rheumatoid arthritis; .
• correction of functional deformity;
• . femoral fracture
  This device may also be indicated in the salvage of previously failed surgical attempts.

The modification consists of a new material used in the manufacture of the Biolox® Ceramic Femoral Heads. The femoral heads, manufactured from Biolox® delta* material, are fabricated from an alumina matrix composite. The standard femoral head with a femoral stem through a taper fit. The Option femoral head includes a sleeve that is inserted into the head and attached to the femoral stem through a taper fit. The heads will be available in sizes 22, 28, 32, 36, 40 and 44mm.

The provided document is a 510(k) summary for a medical device, the Biolox® Ceramic Femoral Head. It describes the device, its intended use, and its comparability to predicate devices. However, this document does not contain information about:

• Acceptance criteria in terms of performance metrics
• A study proving the device meets acceptance criteria
• Sample sizes for test sets or training sets
• Data provenance
• Ground truth establishment or number/qualifications of experts
• Adjudication methods
• Multi-reader multi-case (MRMC) studies or standalone algorithm performance.

The document states: "Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions. Clinical Testing: None provided."

Therefore, I cannot provide the requested information from the given text. The information below is based solely on the explicit statements in the provided K082844 submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

No test set for performance evaluation (e.g., related to AI or diagnostic accuracy) is mentioned as no clinical testing was provided. The "Non-Clinical Testing" refers to mechanical testing.

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

Not applicable, as no test set requiring ground truth establishment by experts is described for AI or diagnostic performance.

4. Adjudication method for the test set

Not applicable, as no test set requiring adjudication is described.

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 reported. This submission does not involve an AI device.

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

Not applicable, as this submission does not involve an AI algorithm.

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

Not applicable, as no ground truth for AI or diagnostic performance was established.

8. The sample size for the training set

Not applicable, as this submission does not involve a machine learning model with a training set.

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

Not applicable, as this submission does not involve a machine learning model with a training set.

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The Excia Hip System is intended to replace a hip joint. The device is intended for: Patients suffering from severe hip 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, protrusion acetabuli, or slipped capital femoral epiphysis Patients suffering from disability due previous fusion Patients with acute femoral neck fractures. The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without u-CaP®. The Metha® Hip System (uncemented, press-fit fixation) is intended to replace a hip joint. The device is intended for: skeletally mature individuals undergoing primary surgery for total hip replacement 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, protrusion acetabuli, or slipped capital femoral epiphysis patients suffering from disability due to previous fusion patients with acute femoral neck fractures.

The Aesculap Implant Systems BIOLOX® delta Ceramic Femoral Heads are manufactured from an alumina matrix composite. The ceramic femoral head is offered in thee diameters of 28, 32, and 36 mm with a range of neck lengths. The BIOLOX® delta Ceramic head provides the surgeon another option to both the metal and alumina ceramic femoral heads for use in total hip arthroplasty.

The provided text describes a 510(k) submission for a ceramic femoral head (BIOLOX® delta Ceramic Femoral Head), which is a medical device used in hip replacement surgery. The documentation focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove the device meets specific acceptance criteria in the context of AI/algorithm performance.

Therefore, many of the requested categories in your prompt a.are not applicable or cannot be answered from the provided text, as the submission is for a physical orthopedic implant, not an AI or software-as-a-medical-device (SaMD) product.

Here's an analysis based on the provided text, highlighting what is applicable and what is not:

1. Table of acceptance criteria and the reported device performance

This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence through material and technological characteristics comparisons, and references general performance testing guidance for orthopedic implants, rather than specific acceptance criteria for a new performance claim or a new algorithm.

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

Not applicable. This is a physical device, and the "test set" concept as used for AI/algorithm validation (e.g., images for classification) does not apply. The document mentions "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable," along with other specific guidance documents for orthopedic implants (e.g., testing orthopedic implants with modified metallic surfaces, testing metallic plasma sprayed coatings, testing non-articulating modular implant components, acetabular cup prostheses, femoral stem prostheses, ceramic ball hip systems, UHMWPE). These guidances typically entail mechanical, fatigue, wear, and biocompatibility testing of the physical implant components, not data-driven performance.

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 for AI/algorithm training or validation, is not relevant for this physical device submission.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements in expert labeling for AI/algorithm ground truth, which is not relevant here.

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 not an AI/SaMD product.

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

Not applicable. This is not an AI/SaMD product.

7. The type of ground truth used

Not applicable. Ground truth for AI/algorithm validation is not relevant. The "ground truth" for this device's performance would be established through physical testing and material characterization against established standards and predicate device performance.

8. The sample size for the training set

Not applicable. This is not an AI/SaMD product.

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

Not applicable. This is not an AI/SaMD product.

Summary of Device and Performance Information Provided:

• Device Name: BIOLOX® delta Ceramic Femoral Head
• Manufacturer: Aesculap Implant Systems, Inc.
• Device Description: An alumina matrix composite ceramic femoral head, offered in 28, 32, and 36 mm diameters with a range of neck lengths for use in total hip arthroplasty.
• Intended Use: To replace a hip joint for patients suffering from severe hip issues due to various conditions (rheumatoid arthritis, traumatic arthritis, avascular necrosis, fractures, congenital hip dysplasia, etc.)
• Substantial Equivalence Claim: The device is claimed to be a line extension to previously cleared Aesculap Implant Systems Excia and Metha Hip Systems and substantially equivalent to the Zimmer BIOLOX® delta Ceramic Femoral Head (K071535).
• Performance Data (General): The document states that all required testing per various guidance documents for orthopedic devices was completed where applicable. These guidances typically cover mechanical, material, and biocompatibility aspects relevant to physical implants. There are no specific performance metrics or acceptance criteria explicitly listed in this summary, as the focus is on compliance with general testing standards for similar orthopedic devices to demonstrate substantial equivalence.

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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.

The provided text is a 510(k) summary for a medical device called the "BIOLOX® delta* Ceramic Femoral Head." This document outlines the device's summary of safety and effectiveness to gain market clearance via substantial equivalence to predicate devices, rather than a study typically associated with AI/ML-based diagnostic devices. Therefore, many of the requested categories related to AI/ML study design (e.g., test set, training set, ground truth, expert adjudication, MRMC studies) are not applicable.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of the "Study" (510(k) Equivalence):

For this type of device (a Class II orthopedic implant), the "study" is a demonstration of substantial equivalence to legally marketed predicate devices. This is a regulatory pathway where the new device does not need to prove efficacy and safety from scratch in a de novo clinical trial if it can show it is as safe and effective as a device already on the market.

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

• Not Applicable (N/A): This is not an AI/ML diagnostic device with a "test set" in the traditional sense. The equivalence was primarily demonstrated through non-clinical mechanical testing and comparison of design, materials, and intended use to predicate devices.
• The "data" for equivalence is derived from:
  • Non-clinical mechanical testing: Performed on the BIOLOX delta Ceramic Femoral Head. Details on the number of samples tested are not provided, but it would typically involve a sufficient number to meet testing standards for orthopedic implants (e.g., ISO standards).
  • Comparison to predicate devices: This involves reviewing the design, materials, manufacturing processes, and indications for use of previously cleared devices (Biomet K061312, DePuy K062748, Howmedica Osteonics K052718).

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

• Not Applicable (N/A): No "ground truth" was established by experts in the context of interpreting medical images or clinical outcomes for this device. The assessment for substantial equivalence is performed by FDA reviewers based on the submitted technical documentation and regulatory guidelines.

4. Adjudication Method for the Test Set

• Not Applicable (N/A): There was no "test set" requiring adjudication in the context of an AI/ML study.

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

• Not Applicable (N/A): No MRMC study was conducted. This device is a passive implant, not an AI-assisted diagnostic tool.

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

• Not Applicable (N/A): This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used

• Engineering/Material Standards and Predicate Device Performance: The "ground truth" for this submission is based on established engineering and material science standards for orthopedic implants, and the regulatory acceptance of existing predicate devices. The device's performance (primarily mechanical in this case) is compared against these benchmarks and the performance of devices already deemed safe and effective by the FDA.

8. The Sample Size for the Training Set

• Not Applicable (N/A): There is no "training set" as this is not an AI/ML device.

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

• Not Applicable (N/A): There is no "training set" or corresponding ground truth establishment process in this context.

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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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