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The Biolox® delta Ceramic Heads and Biolox® delta Option Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:

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

Specific indications for compatible components that can be used with the above modular heads include:
Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis. (K974558. K002757. K0213871)
Interlocking hip stems are indicated for non-cemented application, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard-type hip replacement prosthesis. (K990830, K042774)

The Biolox® delta component is a traditional, one-piece, ceramic head for primary hip arthroplasty. The material for the device is Zirconia-Platelet Toughened Alumina (ZPTA) 75% Alumina, 24% Zirconia, and 1% Platelet. The highly polished spherical surface articulates with a polyethylene liner acetabular component. The modular head attaches to a metallic femoral stem with a Type 1 taper. The ceramic heads are available in three sizes, with several offsets. There have been no changes in design or part numbers since their previous clearance in K192683.

The Biolox® delta Option component is a modular ceramic head with a Type I or 12/14 adapter sleeve, indicated for primary or revision hip arthroplasty. The material for the device is Zirconia-Platelet Toughened Alumina (ZPTA) 75% Alumina, 24% Zirconia, and 1% Platelet. The highly polished spherical surface articulates with a polyethylene liner acetabular component. The modular head attaches to any Biomet metallic femoral stem with either a 12/14 or Type 1 taper, using the associated adapter sleeve. There have been no changes in design or part numbers since their previous clearance in K192683.

The provided text is a 510(k) summary for a medical device (Biolox® delta Ceramic Heads), primarily focusing on the addition of MR Conditional labeling. It does not describe a study involving the performance of an AI/algorithm-based device that would have "acceptance criteria" related to diagnostic accuracy, sensitivity, specificity, or similar metrics.

Therefore, I cannot fill out the requested table or answer the questions regarding acceptance criteria and performance studies in the context of an AI device. The document describes physical tests for MR compatibility (RF-induced heating, image artifact, magnetic displacement) for a ceramic hip implant component, and asserts substantial equivalence to a predicate device based on identical intended use, indications, materials, design, and sterilization.

There is no mention of:

• Acceptance criteria for an AI/algorithm's performance.
• A test set with ground truth.
• Experts establishing ground truth.
• Adjudication methods.
• MRMC studies or human-in-the-loop performance.
• Standalone algorithm performance.
• Training sets or their ground truth establishment.

The document's purpose is to demonstrate the MR compatibility of a physical implant and its substantial equivalence to a previously cleared implant, not to evaluate an AI's diagnostic performance.

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OSS INDICATIONS

1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
4. Ligament deficiencies.
5. Tumor resections.
6. Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. *
7. Revision of previously failed total joint arthroplasty.
8. Trauma.
   These devices are to be used with bone cement unless composed of OsseoTi (titanium alloy, not licensed in Canada) or a proximal femur is indicated for use (USA).
   Biomet OSS Reduced size (RS) components offers a variety of component options for treatment in small adults and adolescents (12-21 years) that require proximal femoral, distal femoral, total femur, or proximal tibial replacement as well as, resurfacing components for the proximal tibia and distal femur (USA).

• Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.
  COMPRESS INDICATIONS
  The Compress Segmental Femoral Replacement System is indicated for:

1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
2. Tumor resections.
3. Revision of previously failed total joint arthroplasty.
4. Trauma.
   The Compress Segmental Femoral Replacement System components are intended for uncemented use.
   When components of the Orthopaedic Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, the user should refer to the package insert contained with the Compress components for full prescription information.
   EXPANDABLE INDICATIONS
   The Biomet Side Access Distal Femoral Expandable offers a treatment option for patients requiring distal femoral replacement who have not yet achieved full skeletal maturity (open epiphysis) or patients who require surgery who have significant residual leg length discrepancy. Indication for use of this device is most commonly tumor resection but could also involve osteoarthritis; rheumatoid arthritis; correction of deformity; and correction or revision of unsuccessful osteotomy, arthrodesis or previous joint replacement.
   The devices are single use implants intended for implantation with bone cement or with Biomet Compress.

The new devices included in this submission are additional components to Biomet's Orthopaedic Salvage System (OSS) that offer surgeons additional prostheses options to be used in limb salvage reconstruction. The new devices include proximal femoral components and tibial components.

The provided text describes a 510(k) premarket notification for the Biomet Orthopaedic Salvage System (OSS™) and related components. This document focuses on demonstrating substantial equivalence to previously marketed predicate devices, primarily through non-clinical testing. As such, it does not contain the kind of detailed information about acceptance criteria for a device's performance, human reader studies, or training/test set specifics that would typically be found in an AI/ML device submission.

Therefore, many of the requested fields cannot be filled from this document. However, based on the information available, here's what can be provided and what cannot:

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

2. Sample sized 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 testing described is non-clinical (mechanical and material characterization), not involving human patient data or a "test set" in the context of AI/ML evaluation.

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/provided for this non-clinical submission. Ground truth determination by experts is not relevant to the mechanical and material testing described.

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

This information is not applicable/provided for this non-clinical submission. Adjudication methods are typically used for establishing ground truth in clinical evaluations, which were not performed 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

This information is not applicable/provided. This submission is for a physical orthopedic implant, 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

This information is not applicable/provided. This submission is for a physical orthopedic implant, not an AI/ML algorithm.

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

This information is not applicable/provided. The "ground truth" for the non-clinical tests would be established engineering standards, material properties specifications, and mechanical performance requirements, rather than clinical ground truth types listed.

8. The sample size for the training set

This information is not applicable/provided. There is no AI/ML training set involved in this submission.

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

This information is not applicable/provided. There is no AI/ML training set involved in this submission.

Summary of the Study:

The studies conducted for the Biomet Orthopaedic Salvage System (OSS™) - Proximal Femoral & Hybrid Tibial were non-clinical performance tests aimed at demonstrating the device's substantial equivalence to existing predicate devices.

The studies included:

• Device Fatigue Testing: Performed on proximal femoral and hybrid tibial components.
• Range-of-Motion (ROM) Analysis: Likely assessed the mechanical range of motion of the components.
• Material Characterization: Specifically for the OsseoTi™ material, confirming it is identical to previously cleared materials.

The conclusion of these non-clinical tests was that "the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices." No clinical testing was deemed necessary for this determination.

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Biolox® delta Option Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:

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

Specific indications for compatible components that can be used with the above modular heads include:

Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis. (K974558, K002757, K021380, K033871)

Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard-type hip replacement prosthesis. (K990830, K042774)

The Biolox® delta Option component is a modular ceramic head with a Type I or 12/14 adapter sleeve, indicated for primary or revision hip arthroplasty. The material for the device is Transition-Toughened-Platelet Alumina (TTPA) 75% Alumina, 24% Zirconia and 1% Platelet. The highly polished spherical surface articulates with a polyethylene liner acetabular component. The modular head attaches to any Biomet metallic femoral stem with a Type 1 taper or a 12/14 taper, using the associated adapter sleeve. There have been no changes in design or part numbers since the original submission in K082996 and K093549 (size 44mm).

The scope of this submission is to incorporate Biomet's entire Biolox® deta Option Ceramic Heads under unified part numbers, Indications and Contraindications, Instructions for Use, labeling and packaging.

The provided document is a 510(k) premarket notification for a medical device, specifically Biolox® delta Option Ceramic Heads. It primarily focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving the device meets specific acceptance criteria through a new clinical or non-clinical study for the current submission.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the way a de novo or PMA submission might.

Here's a breakdown of why this information is not present and what the document does state:

1. A table of acceptance criteria and the reported device performance: This is not available. The document states "No additional mechanical testing was conducted since there are no design changes to the device since clearance, K082996 and K093549." This means new acceptance criteria and performance data for this submission were not generated because the device itself hasn't changed. The substantial equivalence is based on prior clearances.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No new test set data was generated for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. No new test set data was generated for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No new test set data was generated for this submission.

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 document pertains to a ceramic hip implant component, not an AI-assisted diagnostic or therapeutic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This document pertains to a ceramic hip implant component, not an AI or algorithmic device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No new clinical or performance data was generated for this submission.

8. The sample size for the training set: Not applicable. This document does not describe the development or testing of an algorithmic or AI device with a training set.

9. How the ground truth for the training set was established: Not applicable.

What the document does indicate regarding device performance and safety:

• Reliance on Predicate Devices: The core argument for substantial equivalence is that the Biolox® delta Option Ceramic Heads are technologically identical to previously cleared devices (K082996 and K093549).
• No Design Changes: The document explicitly states: "There have been no changes in design or part numbers since the original submission in K082996 and K093549 (size 44mm)." And later, "The technological characteristics of the Biolox® delta Option Ceramic Heads are the predicates. K082996 and K093549. There have been no changes to the devices since their original clearance..."
• No New Mechanical Testing: "No additional mechanical testing was conducted since there are no design changes to the device since clearance, K082996 and K093549."
• No Clinical Testing: "None provided as a basis for substantial equivalence."
• Minimal Changes: The only modifications mentioned for this specific submission are the addition of "traumatic arthritis" to the Indications for Use and a change in packaging to conform with K131684.
• Conclusion of Substantial Equivalence: Because there are no design changes and only minor labeling/packaging updates, the submission concludes: "thus no new risks of safety or efficacy have been introduced. The Biolox® delta Option Ceramic Heads remain substantially equivalent to the predicates and raise no new issues of safety or efficacy."

In summary, this 510(k) submission is a "me too" submission, where the manufacturer is seeking clearance for a device that is essentially the same as one already cleared. Therefore, the detailed performance data and acceptance criteria that would typically be associated with a novel device or significant modification are not part of this specific document. The "proof" of meeting acceptance criteria relies on the previous clearances of the predicate devices.

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Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:

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

Specific indications for compatible components that can be used with the above modular heads include:

Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis. (K974558, K002757, K021380, K033871)

Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard-type hip replacement prosthesis. (K990830, K042774)

The Biolox® delta component is a traditional, one-piece ceramic head indicated for hip arthroplasty. The material for the device is Transition-Toughened-Platelet Alumina (TTPA) 75% Alumina, 24% Zirconia and 1% Platelet. The highly polished spherical surface articulates with a polyethylene liner acetabular component. The modular head attaches to a metallic femoral stem with a Biomet Type I taper. The ceramic heads are available in three sizes, with several offsets.

The scope of this submission is:

• An inner taper change and distal face change requested by CeramTec for the purpose of increased burst strength and increased cost effectiveness.
• The one remaining size is previously cleared through K061312 and K073102. This submission seeks to incorporate all of Biomet's Biolox® delta Ceramic Heads (Monobloc) under unified Indications, Contraindications, Instructions for Use and labeling.

This document is a 510(k) Summary for the Biomet Biolox® delta Ceramic Heads, a medical device used in hip arthroplasty. The summary is intended to demonstrate substantial equivalence to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document focuses on non-clinical testing of a physical medical device (ceramic femoral head). Therefore, the concept of a "test set" for data (like in software or AI models) and "data provenance" (country of origin, retrospective/prospective) is not directly applicable in the same way. The "test set" here refers to the samples of ceramic heads and associated components used for the physical and mechanical tests.

• Sample Size for Test Set: The exact sample sizes for each specific test (burst, fatigue, pull-off, rotational stability) are not explicitly stated in this summary. The document mentions "worst case" testing, which implies specific configurations or conditions were selected for testing.
• Data Provenance: Not applicable in the context of physical device testing. The tests are conducted on manufactured devices.

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

This information is not applicable as the document describes physical and mechanical testing of a medical device, not a diagnostic or AI-driven system that relies on expert interpretation for ground truth. The "ground truth" for these tests would be the established engineering standards and acceptable performance limits for orthopedic implants.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Physical test results are objectively measured against established criteria, not subject to 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:

This information is not applicable. This document describes the 510(k) submission for a physical medical device (ceramic femoral head), not an AI or diagnostic imaging device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

This information is not applicable as the document is about a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used:

The ground truth used for this device's testing is based on established engineering standards, material science principles, and functional requirements for orthopedic implants. The tests (burst strength, fatigue, pull-off, rotational stability) are designed to verify that the device meets these pre-defined physical and mechanical performance characteristics relevant to its intended use and safety. The comparison is against predicate devices which have already been deemed safe and effective based on similar physical tests.

8. The Sample Size for the Training Set:

This information is not applicable as there is no "training set" in the context of physical medical device testing for 510(k) clearance. This is not an AI or machine learning device. The manufacturing process and quality control would involve ongoing testing, but not in the sense of a machine learning training set.

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

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

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Intended for the replacement of diseased or deficient bone in the proximal femur. It is indicated for: Limb salvage procedures where radical resection and replacement of the bone is required Painful and disabled joint resulting from avascular necrosis osteoarthritis, rheumatoid arthritis or traumatic arthritis Correction of varus, valgus or post traumatic deformity Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Ligament deficiencies Tumor resections Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques Revision of previously failed total joint arthroplasty Trauma The METS® Modular Proximal Femur and its components are for single use only The METS® Modular Proximal Femur and its components are for cemented use only

The single use METS® Modular Proximal Femur is a standard modular system that is intended for the replacement of diseased or deficient bone in the proximal femur. The system is intended for cemented use only and comprises titanium (Ti) components including a trochanter section, shaft with or without an integral extension piece, stem and collar that is available hydroxyapatite (HA) coated or uncoated, stippled or smooth. The trochanter trunnion is made to interchange with Stanmore Implants Worldwide Limited's 28mm and 32mm Ø Cobalt Chrome femoral heads. The METS® Modular Proximal Femur is offered with an optional set of trochanters which are only to be used forhard tissue attachment using a plate and two screws, or Ti or cobalt chromium (CoCr) wire. The materials used in the manufacture of the systems include titanium (Ti), cobalt-chromium-molybdenum (CoCrMo)

I am sorry, but the provided text describes a medical device, the METS® MODULAR PROXIMAL FEMUR, which is a hip joint metal/polymer semi-constrained cemented prosthesis. The information focuses on its classification, intended use, indications for use, and a declaration of substantial equivalence to predicate devices based on non-clinical performance testing and clinical evaluation through published papers and post-market surveillance.

This document does not contain information about:

1. Acceptance criteria and reported device performance in a table format for AI/algorithm-based performance. The document refers to "non-clinical performance testing" for the device's physical attributes (disassembly force testing) and "clinical evaluation... based upon published papers and post market surveillance" to support its substantial equivalence. These are not performance metrics for an AI system.
2. Sample size used for the test set or data provenance related to AI validation.
3. Number or qualifications of experts used to establish ground truth for a test set.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study with human readers and AI assistance.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcome data, etc.) for AI models.
8. Sample size for the training set (for an AI model).
9. How the ground truth for the training set was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving an AI device's performance, as the provided text pertains to a traditional medical implant and its regulatory submission, not an AI or algorithm-based device.

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The METS® Modular Total Femur is intended for the replacement of the total femoral bone.
Limb salvage procedures where radical resection and replacement of the bone is required
Painful and disabled joint resulting from avascular necrosis osteoarthritis, rheumatoid arthritis or traumatic arthritis
Correction of varus, valgus or post traumatic deformity
Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
Ligament deficiencies
Tumor resections
Revision of previously failed total joint arthroplasty
Trauma
Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques
All of the METS® Modular Total Femur tibial and acetabular components are for cemented use only
All of the METS® Modular Total Femur and their components are for single use only

The single use METS® Modular Total Femur is a standard modular system that is intended for the replacement of diseased or deficient bone in the femur. The system is intended for cemented use only and comprises titanium (Ti) components including a trochanter section, shaft. The trochanter trunnion is made to interchange with Stanmore Implants Worldwide Limited's, 28mm and 32mm Ø Cobalt Chrome femoral heads. The METS® Modular Total Femur is offered with an optional set of trochanters which are only to be used for hard tissue attachment using a plate and two screws, or Ti or cobalt chromium (CoCr) wire. A range of shafts, femoral component (including axle, bushes and circlip), bumper and the SMILES knee (available in 3 types of arrangements and in a rotating or fixed configuration). The materials used in the manufacture of the systems include titanium (Ti), cobalt-chromium-molybdenum (CoCrMo) and ultra high molecular weight polyethylene (UHMWPE).

The provided text describes a medical device, the METS® MODULAR TOTAL FEMUR, and its regulatory clearance process (510(k) summary). However, it does not contain information related to software performance, AI algorithms, or detailed acceptance criteria for a study proving such performance.

The "Performance Data" section specifically states:

• Non Clinical Testing: "The results of the non-clinical performance testing demonstrate that the device is safe and effective and substantially equivalent to the predicate devices. The Performance testing included: knee fatigue and wear test, disassembly force testing for the taper connections, ASTM F1800-07." This refers to mechanical and material performance of the physical implant, not a software or AI component.
• Clinical Performance Conclusions: "Clinical evaluation was carried out based upon published papers and post market surveillance." This indicates a review of existing literature and real-world data, not a specific clinical study with defined acceptance criteria for a device's performance that would involve expert review or ground truth establishment in the way your request describes.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and reported device performance: This document does not define numerical acceptance criteria for "device performance" in the context of an algorithm or AI.
2. Sample size used for the test set and data provenance: No such test set is described for performance evaluation in the context of an algorithm.
3. Number of experts used to establish ground truth and their qualifications: Not applicable to the type of performance data presented.
4. Adjudication method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted or reported for this device's performance as described.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical implant.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable as there is no mention of a training set for an algorithm.
9. How ground truth for the training set was established: Not applicable.

The document focuses on the mechanical safety and effectiveness of a femoral implant and its substantial equivalence to previously cleared predicate devices, based on physical testing and literature review. It is not an AI/software device and thus does not include the type of performance study details you are asking for.

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The 44mm E1™ Acetabular Liner with 44mm Biolox® delta Option Ceramic Head or 44mm M2a Magnum™ Modular Head is for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:

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

Specific indications for compatible components that can be used with the 44mm Biolox® delta Option Ceramic Head include:
Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis. (K974558, K002757, K021380, K033871)
Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard-type hip replacement prosthesis. (K990830. K042774)

Biomet Manufacturing Corp. is addinq a size 44mm liner to their line of E1™ Acetabular Liners to allow the surgeon more options. Additionally, the 44mm Biolox® delta Option Ceramic Head is added to the ceramic option line. The 44mm M²a Magnum™ may be used when a Co-Cr-Mo option is needed. This submission is a line extension of the previously cleared systems.

This document is a 510(k) Summary for a medical device (44mm E1™ Acetabular Liner with ceramic or modular heads) and does NOT contain information about acceptance criteria or a study proving the device meets said criteria.

The purpose of a 510(k) submission is to demonstrate that the device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its performance against specific acceptance criteria in a study format often seen with AI/software devices. For traditional medical devices like hip implants, substantial equivalence is typically shown through demonstrating similar technological characteristics, materials, and intended use as a predicate device, often supported by non-clinical (e.g., mechanical) testing rather than clinical performance studies.

Therefore, I cannot extract the requested information from the provided text because it is not present. The document explicitly states:

• "Non-Clinical Testing: All parameters of the 'Guidance Document for the Preparation of PreMarket Notifications for Ceramic Ball Hip Systems' were met for the devices contained in this 510(k)." This indicates that the device met certain standards, but it doesn't provide the specific acceptance criteria or a "study" in the sense of a performance evaluation with reported metrics.
• "Clinical Testing: None provided." This confirms that there was no clinical study performed, which would be the typical place to find performance data, ground truth establishment, and details about sample sizes, experts, etc.

In summary, this document is a regulatory submission focused on demonstrating substantial equivalence, not a performance study report as you've outlined in your request.

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Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:

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

Specific indications for compatible components that can be used with the above modular heads include:

Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis. (K974558, K002757, K021380, K033871)

Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis. (K990830, K042774)

Biolox® delta Option Ceramic Heads are designed to be the bearing surface of a total hip joint replacement. A highly polished spherical head in a variety of diameters articulates with a polyethylene liner acetabular component. The modular head attaches to a metallic femoral stem via a taper adapter. Adapters are available for either Biomet's Type I taper or Biomet's 12/14 taper in a variety of neck lengths.

This 510(k) premarket notification describes a medical device, the Biolox® delta Option Ceramic Heads, which is a component of a total hip joint replacement. The document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting de novo clinical study data to meet specific acceptance criteria for a novel device.

Therefore, many of the requested categories (2-9) regarding specific study details, sample sizes, expert involvement, and ground truthing are not applicable or provided in this 510(k) submission. The core of this submission is non-clinical testing and comparison to predicates.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of the "Acceptance Criteria" for this type of submission: In a 510(k) submission for substantial equivalence, the "acceptance criteria" are typically defined by regulatory guidance documents and the demonstration that the new device is as safe and effective as a legally marketed predicate device. For the Biolox® delta Option Ceramic Heads, fulfilling all parameters outlined in the "Guidance Document for the Preparation of Pre-Market Notifications for Ceramic Ball Hip Systems" serves as the primary acceptance criterion related to device performance and safety.

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

• Sample Size: Not applicable. No clinical test set data from human subjects is presented or required for this type of 510(k). The evaluation relies on non-clinical testing and comparison to predicates.
• Data Provenance: Not applicable. The "testing" mentioned is non-clinical, likely mechanical and material testing, rather than data from human subjects.

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

• Not applicable. No expert ground truth establishment for a test set of human data is described as clinical testing was not provided.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set requiring adjudication is described.

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

• No. This type of study was not conducted or presented. The submission explicitly states "Clinical Testing: None provided."

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

• Not applicable. This medical device is a physical implant (ceramic hip head), not an algorithm or AI system.

7. Type of Ground Truth Used

• Not applicable. For this 510(k), the "ground truth" for the device's acceptability is established through conformity to regulatory guidance documents for ceramic hip systems (non-clinical testing) and demonstration of substantial equivalence to predicate devices with established safety and effectiveness records. There isn't a "ground truth" in the clinical sense (e.g., pathology, outcomes data) derived directly from a study for this submission.

8. Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

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Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:

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

Specific indications for compatible components that can be used with the above modular heads include:
Salvage/Oncology Hip and Total Femur System components also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis.
Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard-type hip replacement prosthesis.

The 100 kGy E-Poly™ Acetabular Liners are intended for cemented and uncemented applications with the following indications for use:

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

Biolox® delta Ceramic Heads are designed to be the bearing surface of a total hip joint replacement. The highly polished spherical surface articulates with a polyethylene liner acetabular component. The modular head attaches to a metallic femoral stem with a Biomet Type I taper.

The 100 kGy E-Poly™ acetabular liners for the Biolox® delta Ceramic Heads are a larger size of the previously cleared 100 kGy E-Poly™ liners, K070364 and K070399.

This document is a 510(k) summary for a medical device (Biolox® delta Ceramic Heads with 100kGy E-Poly™ Acetabular Liners) and does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical studies of AI/software devices.

Instead, this document describes:

• Device Description and Indications for Use: The purpose and intended applications of the hip replacement components.
• Substantial Equivalence Claim: The device's technological similarity to previously cleared predicate devices (K042091, K051411, K061312 for ceramic heads; K070364, K070399 for acetabular liners).
• Non-Clinical Testing Confirmation: It states that all parameters of the "Guidance Document for the Preparation of PreMarket Notifications for Ceramic Ball Hip Systems" were met. This is a crucial point regarding "acceptance criteria" in this context; however, the specific acceptance criteria (e.g., mechanical strength thresholds, wear rates, biocompatibility standards) and the detailed results of the non-clinical tests are not provided in this summary.

Therefore, I cannot provide a response filling in the requested table and study details (sample size, experts, adjudication, MRMC, standalone performance, ground truth, training set) because the provided text does not contain this information.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and established non-clinical testing guidelines, rather than presenting a clinical study with new performance metrics against specific acceptance criteria for a novel AI/software device.

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Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. Correction of varus, valgus, or posttraumatic deformity. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. Cemented and uncemented applications. The Regenerex™ femoral augments are indicated for use with the Vanguard™ Total Knee System. The Regenerex™ tibial augments are indicated for use with standard and offset Biomet® Tibial Trays.

Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. Correction of varus, valgus, or posttraumatic deformity. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Ligament deficiencies. Tumor Resection. Revision of previously failed total joint arthroplasty. Trauma. These are single use implants. These devices are for cemented use only.

The Regenerex™ Ultra Porous Construct- Titanium Knee Augments are designed for attachment to selected commercially available Biomet® tibial base plates and femoral components using bolts, cement or a combination of both (depending on the augment). The augments are manufactured to interface with selected femoral and tibial Biomet® components. The femoral augments come in nine (9) different sizes that correspond with the sizes of the femoral components. The thickness options for the femoral augments vary from 5mm to 15mm. The tibial augments are available in 10° wedge and block form. The block augments are available in three (3) thicknesses for nine (9) tibial sizes. The OSS femoral augments are available in a 3,5mm thick anterior flange augment. The OSS tibial augments are available in monoblock and block form. The monoblocks are only available in 10mm thicknesses for three tibial sizes, while the block augments are available in 10mm and 20 mm sizes for three tibial sizes.

The provided document is a 510(k) premarket notification for the Regenerex™ Ultra Porous Construct- Titanium Knee Augments. The content primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than providing a detailed study proving the device meets specific performance acceptance criteria.

Therefore, many of the requested details about acceptance criteria, specific study design, and performance metrics are not present in 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." (Page 1)
"Clinical Testing: None provided as a basis for substantial equivalence." (Page 1)

This means the submission relies on non-clinical testing and comparison to predicates, not specific clinical performance studies with detailed acceptance criteria as one might find for a novel device requiring more extensive validation.

Given the information provided, here's what can be inferred and what cannot:

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

Missing: Specific quantifiable acceptance criteria (e.g., tensile strength, fatigue life, wear rate thresholds) and the exact numerical performance results for these criteria. The document only provides a general statement of functionality.

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

Not provided. The document mentions "non-clinical laboratory testing" but does not specify the sample size, type of test specimens, or the provenance of any data used for these tests. It is implied these were laboratory tests on the device itself, not patient data.

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

Not applicable/Not provided. Since the testing was non-clinical and no clinical data was presented, there was no "ground truth" derived from expert review of patient data in the context of this 510(k) submission.

4. Adjudication method for the test set

Not applicable/Not provided. No clinical test set requiring adjudication by experts was presented.

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 device is a medical implant (knee augments), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this submission.

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

No. As mentioned above, this is a physical implant, not an algorithm.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" would be established by standard engineering and material science specifications, predicate device performance data, and regulatory standards for mechanical and material properties of implants. However, the document does not detail these specific standards or how the device's performance compared against them. It only states it was "functional within its intended use."

8. The sample size for the training set

Not applicable/Not provided. There is no "training set" in the context of this 510(k) submission as it is not a machine learning/AI device.

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

Not applicable/Not provided. As above, no training set was involved.

In summary: The provided 510(k) notification for the Regenerex™ Ultra Porous Construct- Titanium Knee Augments relies heavily on a comparison to predicate devices and general non-clinical laboratory testing to assert substantial equivalence. It does not contain the detailed performance data, acceptance criteria, sample sizes for patient data, or expert review methodologies that would be typical for clinical studies validating a new diagnostic or AI-driven device. The statement "Clinical Testing: None provided as a basis for substantial equivalence" is key in understanding the limited scope of detailed performance data in this particular document.

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