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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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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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

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.

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. This submission covers 36mm diameter heads with neck lengths of -3, 0, +3 and +6.

The provided text describes a 510(k) submission for a medical device (36mm Biolox® delta Ceramic Heads), not a study evaluating an AI device or a device that meets acceptance criteria through a performance study. Therefore, most of the requested information cannot be extracted from this document.

However, I can extract information related to non-clinical testing and the absence of clinical testing.

Here's what can be extracted:

• Acceptance Criteria and Reported Device Performance: This document states that "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 the non-clinical acceptance criteria outlined in the relevant guidance document. However, the specific parameters and reported performance values are not detailed in this summary.

Table of Acceptance Criteria and Reported Device Performance (Based only on the provided text):

Information that CANNOT be extracted from the provided text:

1. Sample sizes used for the test set and the data provenance: Not applicable, as no clinical or AI-based performance study is mentioned.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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 hip implant, not an AI-assisted diagnostic device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a traditional medical device submission without AI or clinical outcome studies detailed.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Summary of what was found about the "study" (non-clinical testing):

• Clinical Testing: "None provided" - explicitly stated that no clinical testing was performed for this 510(k) submission.
• Non-Clinical Testing: "All parameters of the 'Guidance Document for the Preparation of PreMarket Notifications for Ceramic Ball Hip Systems' were meet for the devices contained in this 510(k)." This indicates regulatory compliance through in-vitro or bench testing as per guidance documents, not an AI or clinical performance study. The specific "study" is therefore the non-clinical testing performed to satisfy the guidance document, but details of this testing are not provided in the summary.

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The Porous Titanium Acetabular Shells are indicated for cemented or non-cemented use in total hip replacement in cases of:

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

Specific indications for compatible components (femorals, heads, liners, and screws) that can be used with the Regenerex™ Hip Products include:
Freedom® Constrained Liners (K030047): The Biomet Freedom® Constrained liner is indicated for use as a component of a total hip prosthesis in primary and/or revision patients at hip dislocation due to history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
Tri-Polar System (K991990): Indication #5 (Revision of previously failed total hip arthroplasty) is further specified to include recurrent dislocation.
OSS/Salvage Systems/Total Femur (K974558, K002757, K021380, K033871): Salvage/Oncology Hip and Total Femur components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrodesis.
Interlocking Stems (K990830, K042774): 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.
HA PMI Hip Femoral Stems (K030048): Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease.
Gross Hip Femoral (K001580) and Bohn Hip Femoral (K000262): These femoral components are also indicated for treatment in conjunction with tumor resection and trauma.
Taper 2 ™ Porous Femoral (K050441) and Balance Microplasty (K050251): Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. These stems are indicated for the revision of previously failed femoral head resurfacing component.
Color Buffed Femoral (K992903), CB DDH Femoral (K012019), Bi-Metric Hip (K992058), CB Answer Femoral (K991987), Reach Femoral (K982367): Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. The statement should read, "Revisions of hip replacement components".
150mm Bi-Metric Hip Stem (K983710): Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. They are not indicated for revision procedures.
Zirconia Ceramic Heads (K964431 and K991708): Indication #4 (Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques) is not applicable to these Zirconia Ceramic Heads.
Biolox® delta Ceramic Heads (K042091), Rx90™ Standard/Lateralized Femoral (K023085), Portrait Femoral (K010560), MalloryHead Smooth Femoral (K994007), Generation 4 Polished Femoral (K031734), Modular Reach Femoral (K994038), Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. The statement should read, "Revision procedures where other treatment or devices have failed".
Medallion Modular Hip System (K041850): Same list of five indications but cleared for uncemented use only.

Porous Titanium Acetabular Shells are Intended for use in reconstruction of the hip joint due to disease, deformly, or trauma. The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery. The device is a single use implant. This submission includes acetabular shells for use as reconstructive components. The acetabular shells range In size (OD) from 52mm to 80mm in 2mm Increments. The shell is constructed of a porous titanlum allov (Ti-6Al-4V) and has been designed for cemented or non-cemented use with the option of using screws for added fixation to the native bone. The wall of the shell is composed entirely of the porous material. The rim of the implant is solld titanlum for reinforcement and provides the mating geometry necessary to mate with the instrumentation. The acetabular shells are designed for use with commercially available all polyethylene acetabular liners. These polyethylene ilners are to be cemented into the acetabular shells.

The provided text is a 510(k) Summary for a medical device (Porous Titanium Acetabular Shells) seeking substantial equivalence to predicate devices. It does not present any acceptance criteria or a study proving that the device meets those criteria from an AI/algorithm performance perspective.

Instead, it focuses on demonstrating substantially equivalent technological characteristics and intended use compared to existing devices already on the market.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance in the context of AI/algorithm performance. The document only states the following regarding testing:

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

This indicates that the FDA clearance for this device was based on engineering and material testing (non-clinical) to show it performed similarly to existing devices, not on a study evaluating an AI's diagnostic or predictive performance.

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The Taper 2™ Porous Femoral Stem is indicated for use in patients requiring total hip replacement due to the following:
• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
• Revision of previously failed femoral head resurfacing component.
Taper 2™ Porous Femoral Stems are intended for uncemented use only.

The Taper 2™ Porous Femoral Stem is a short, tapered stem, designed to provide Device Description: The Tapel 2 - Porous Femoral Seem of Children Station of Services of Services of Services

This 510(k) pertains to a medical device, specifically a femoral stem for hip replacement, and thus the acceptance criteria are not related to diagnostic performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" here refer to demonstrating substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

This submission does not involve a "test set" in the context of clinical performance data using patient data. For medical devices like prosthetic implants, validation primarily relies on non-clinical testing (e.g., mechanical, material, and sometimes in-vitro studies) to demonstrate safety and effectiveness and substantial equivalence to existing devices.

• Sample Size: The document does not specify exact sample sizes for non-clinical tests. It refers to "testing" and "performance data," which would typically involve multiple samples of the device and predicate devices for mechanical and material characterization.
• Data Provenance: Not applicable in the context of patient data. The "provenance" here is in-house testing by the manufacturer and reference to existing scientific literature ("Reference literature" mentioned).

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

Not applicable. This is not a study that establishes ground truth through expert review of patient data. The ground truth for device performance is established through engineering and scientific testing standards.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" requiring adjudication by experts in this context.

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

No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This submission is for a prosthetic implant and does not involve human-in-the-loop diagnostic tasks. Therefore, no effect size of human readers' improvement with AI assistance is reported.

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

No. This device is not an algorithm or AI system. It is a physical medical implant.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Engineering Standards and Specifications: The device is designed and tested to meet specific mechanical strength, fatigue life, and material composition standards relevant to orthopedic implants.
• Biocompatibility Standards: Materials are tested to ensure they are biocompatible and do not elicit adverse reactions in the body.
• Comparison to Predicate Devices: Performance is measured against established predicate devices, which have a known history of safe and effective use. The "performance data" and "reference literature" mentioned likely refer to these types of evaluations.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for this type of medical device submission. The device is designed, manufactured, and tested, not "trained" like a machine learning algorithm.

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

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

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Balance® Hip System Standard Femoral stems:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Correction of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
   The Balance® Hip System Standard Femoral stems are intended for uncemented use only.

Balance® Hip System Microplasty® stems:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed femoral head resurfacing components.
   The Balance® Hip System Microplasty® Stems are intended for uncemented use only.

The Balance® Hip System Femoral stems are collarless, porous coated stems available in 10mm increments of length. The proximal geometry of the Balance® Hip System Standard and Microplasty® stems provide immediate three point (anterior-proximal, inferior-medial, and distal-lateral) fixation. The top of the stems have a threaded hole to accommodate the inserter / extractor tool.

This is a 510(k) premarket notification for the Balance® Hip System and as such describes demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance as one might see for a novel device. The document repeatedly states that the new device, the Balance® Hip System, is "substantially equivalent" to predicate devices. There is no independent study with acceptance criteria and a reported device performance. The only performance data mentioned is for "non-clinical testing," which "demonstrates that the Balance® Hip System is technically equivalent to the predicate femoral hip stems."

Therefore, for this particular document, I cannot fulfill all sections of your request as it pertains to a new device performance study with acceptance criteria.

However, I can extract the following information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no formal table of "acceptance criteria" or "reported device performance" against such criteria in the context of a new efficacy study. The submission asserts substantial equivalence to predicate devices. The "performance" is implicitly that the device performs equivalently to the listed predicates in a non-clinical setting.

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

• Sample Size for Test Set: Not applicable. The document refers to "non-clinical testing" rather than a clinical trial with a defined test set of patients. The testing details (e.g., number of components tested) are not provided.
• Data Provenance: The testing is "non-clinical" and likely conducted in a laboratory setting. No country of origin for such data is specified, but the applicant is based in Warsaw, Indiana, USA. The testing is not described as retrospective or prospective clinical data.

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

Not applicable. This is not a study involving expert assessment of clinical outcomes or images where ground truth would be established by experts. The "ground truth" for substantial equivalence would be based on engineering principles and comparisons to existing devices.

4. Adjudication method for the test set:

Not applicable, as there is no clinical test set requiring adjudication in the context of 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 submission is for an orthopedic implant (hip stem), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not applicable, as this submission is for an orthopedic implant, not an algorithm or software device.

7. The type of ground truth used:

The "ground truth" for this 510(k) submission is the established performance and safety of the predicate devices (Mallory-Head® Total Hip System, Mayo Conservative Hip Prosthesis, Bi-Metric® Total Hip System). The new device is deemed "substantially equivalent" based on comparison to these known devices, using material properties, design specifications, and non-clinical performance data (e.g., mechanical testing).

8. The sample size for the training set:

Not applicable. There is no concept of a "training set" in this 510(k) submission for an orthopedic implant.

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

Not applicable.

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Rx90™ Low Profile Acetabular Shells are intended for cemented or non-cemented total hip replacement 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 using other techniques.
5. Revision of previously failed total hip arthroplasty.

Specific indications for compatible components that can be used with the above acetabular shells include:

Salvage/Oncology Hip and Total Femur System (K002757, K021380, K033871)
9. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis
10. Correction of varus, valgus or post traumatic deformity
11. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
12. Ligament deficiencies
13. Tumor resections
14. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques
15. Revision of previously failed total joint replacement
16. Trauma

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 Freedom™ Constrained Liners are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high dislocation due to a history of prior dislocation, joint or bone loss, soft laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. (030047)

The Rx90™ Low Profile Acetabular System is a metal backed shell with a polyethylene inner liner intended for cemented or cementless replacement of the acetabular portion of a total hip replacement. The metallic shell is available in diameters of 40mm to 70mm and two different hole configurations. Liners are available with internal diameters of 22mm, 28mm, 32mm and 36mm. Liner styles include Hi-Wall, 10 Degree, MROM, +5mm Hi-Wall, +10 Degree, +5mm Flat Face and Constrained.

The provided 510(k) summary for the Biomet Rx90™ Low Profile Acetabular System indicates that no clinical testing was performed to demonstrate the device meets acceptance criteria. The submission relies solely on non-clinical mechanical testing and substantial equivalence to predicate devices.

Therefore, many of the requested details regarding clinical studies, sample sizes, ground truth establishment, and expert involvement are not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable. No clinical test set was used. Non-clinical mechanical testing implicitly uses test specimens for evaluation, but the sample size and provenance of these materials are not detailed in this summary.

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

• Not applicable. No clinical test set was used requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and 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 medical implant (acetabular system), not an AI-assisted diagnostic or treatment device. No MRMC study was performed.

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

• Not applicable. This is a hardware medical device; it does not involve algorithms or AI that would have standalone performance.

7. The Type of Ground Truth Used

• For the non-clinical mechanical testing, the "ground truth" would be established engineering standards or internal specifications for mechanical properties (e.g., strength, durability, wear resistance). The specific standards or methods used are not detailed in this summary, but the general statement is "Mechanical testing has demonstrated the ability of the device to perform as expected."

8. The Sample Size for the Training Set

• Not applicable. No clinical training set was used.

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

• Not applicable. No clinical training set was used.

Summary of Device Acceptance:

The Biomet Rx90™ Low Profile Acetabular System gained 510(k) clearance based on substantial equivalence to previously marketed predicate devices (K920639, K926107, K030055, K023357) and non-clinical mechanical testing. The summary explicitly states "Clinical Testing: None provided," indicating that the device's acceptance was not based on human clinical trials demonstrating performance against specific disease outcomes or patient data. Instead, the focus was on demonstrating that its technological characteristics (materials, design, function) are similar or identical to predicate devices and that it performs as expected under mechanical stress.

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