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

Acetabular shells and femoral stems with porous coatings are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented or uncemented use.

Indications for Biomet G7™ Freedom™ Constrained Liners:

The Biomet G7™ Freedom™ Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

The G7™ Acetabular System is a modular system, designed to provide numerous options for surgeons and patients in one compatible system. The titanium alloy (ASTM F136) shell is available in both a solid shell and limited hole design, with an apical hole and plug. The outer diameter of the shells is coated with Biomet's Porous Plasma Spray (ASTM F1580). The acetabular liners are manufactured from UHMWPE (ASTM F648) as ArComXL® or E1® (UHMWPE infused with vitamin E) and available in a Neutral, High Wall, or Ten Degree Face Changing design. Additionally, the system has provided for a constrained liner and head when such an option is required. The Biomet Freedom" product line has added a 32mm Freedom" head (cobalt chrome, ASTM F1537) to its offerings, as well as a new series of constrained liners (E1®, ASTM F648) designed for compatibility with the G7™ shells. A new line of cobalt chrome (ASTM F1537) femoral heads in varying sizes and neck lengths, with either a Type 1 or 12/14 taper, has been added to the system. The system is compatible with Biomet® ceramic heads and femoral stems.

The provided FDA 510(k) summary for the Biomet G7™ Acetabular System (K121874) describes a medical device, specifically a hip prosthesis system. This document is a premarket notification for a medical device and, as such, focuses on demonstrating "substantial equivalence" to previously cleared devices rather than presenting novel clinical study designs with acceptance criteria and device performance metrics in the way a diagnostic AI/ML device submission would.

Therefore, the information required to populate the requested table (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC, standalone studies, etc.) is not typically included or relevant in a 510(k) submission for a hip prosthesis system.

Here's why and what information is available in the document:

Why the requested information is not present:

• Device Type: The G7™ Acetabular System is a physical orthopedic implant (hip prosthesis), not an AI/ML diagnostic or predictive software device.
• Regulatory Pathway (510(k)): The 510(k) pathway demonstrates substantial equivalence to a legally marketed predicate device. This typically involves non-clinical (bench) testing to show that the new device performs similarly and does not raise new questions of safety or effectiveness compared to the predicate. It does not generally require extensive clinical trials with acceptance criteria, human reader studies, or detailed ground truth studies as would be expected for a diagnostic device.
• Focus of the Document: The document focuses on:
  • Descriptions of the device components and materials.
  • Identification of predicate devices for comparison.
  • Indications for Use.
  • A list of non-clinical (bench) tests performed.
  • A statement regarding the lack of clinical testing.

Information that is available or can be inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided because the testing for an orthopedic implant focuses on mechanical properties, material properties, and compatibility, rather than diagnostic accuracy or sensitivity/specificity metrics. The document states:

   • "Testing demonstrates that the modifications made to the G7™ Acetabular System do not introduce any new risks of safety or efficacy, and that the G7™ Acetabular System is substantially equivalent to the predicates." This is the overarching "acceptance" or conclusion. Specific numerical acceptance criteria for each bench test are not detailed in this summary.

2. Sample Size used for the test set and the data provenance: Not applicable in the context of clinical data for a diagnostic device. The "test set" here refers to the physical components of the implant undergoing bench testing. The sample sizes for these tests (e.g., number of implants tested for fatigue, push-out, etc.) are not specified in this summary. Data provenance would be from laboratory bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic AI (e.g., expert consensus on medical images) is not relevant for this type of device. Performance is assessed through engineering and material science standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the diagnostic sense. For mechanical testing, the "ground truth" would be established engineering standards, material specifications (e.g., ASTM standards listed for materials), and the performance characteristics of the predicate devices.

8. The sample size for the training set: Not applicable. This device does not involve a "training set" in the AI/ML sense.

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

Summary of Non-Clinical Testing (as listed in the document):

The document lists various non-clinical (bench) tests performed to support substantial equivalence. These tests evaluate mechanical aspects of the device components. While specific acceptance criteria for each of these tests are not provided in this summary, the overall conclusion is that the device passes these tests and is substantially equivalent.

• Poly Push Out
• Poly Lever Out
• Poly Torque Out
• Poly Rim Impingement
• Poly Deformed Cup Push Out
• Poly Deformed Cup Lever Out
• Poly Fatigue, Lever Out
• Poly Constrained Liner Rim Impingement and Lever Out Testing
• Range-of-Motion Study (Poly)
• Poly Deformed Cup Push In
• Freedom Head Pull Out of Constrained Liner
• Screw Pull Through
• Screw Torsional Properties
• Torque Curve for MIM Screw Hole Plugs
• Verification of Insertion Torque and Measurement of Torque Out
• Poly Wear Simulator
• Metal Head Justification
• MRI Justification
• Metal Head Axial Head Pull Off
• Metal Head Fretting/Corrosion

Conclusion:

The K121874 submission is for a traditional medical device (hip prosthesis) seeking 510(k) clearance by demonstrating substantial equivalence through non-clinical bench testing. It does not involve AI/ML components or clinical studies with the type of acceptance criteria, reader studies, and ground truth establishment typically requested for diagnostic software devices. Therefore, most of the specific categories in your request are not applicable to this document.

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The Lateralized Taperloo® Microplasty™ Femoral Components are indicated for use in patients requiring hip replacement due to the following:

• Non-inflammatory degenerative ioint 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 by other techniques.
• Revision of previously failed femoral head resurfacing component

The Lateralized Taperioc® Microplasty™ Femoral Components are intended for uncemented use only.

Specific indications for compatible components that can be used with the Lateralized Taperloc® Microplasty™ femoral Components include:

Constrained Liners (K030047)

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

The Lateralized Taperloc® Microplasty™ Femoral Components are straight, collarless, flat, tapered stems designed to match the geometry of the femur. The stems are proportionally sized and shaped in sizes 5.0mm to 25.0mm diameters. The stems are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F-136 or F-1472 and a proximal portion of each femoral stem is covered with Biomet's full plasma spray porous coating.

The provided text is a 510(k) summary for the Biomet Lateralized Taperloc® Microplasty™ Femoral Components. This document discusses the device's description, intended use, and substantial equivalence to a predicate device, primarily based on non-clinical testing. The document explicitly states that no clinical testing was performed or provided.

Therefore, it is not possible to complete the requested table and detailed study information as there is no clinical study described in the provided text that proves the device meets acceptance criteria. The device's clearance was based on demonstrating substantial equivalence through non-clinical mechanical testing to a legally marketed predicate device.

Here's a breakdown of why the requested information cannot be provided based on the input:

1. Acceptance Criteria and Reported Device Performance: This would typically involve clinical endpoints (e.g., success rates, complication rates) and their corresponding performance metrics from a clinical study. Since no clinical study was performed, there are no reported device performance figures of this nature. The "acceptance criteria" for a 510(k) without clinical data primarily relate to demonstrating substantial equivalence in design, materials, manufacturing, and non-clinical performance (e.g., mechanical strength, wear resistance) compared to a predicate device.

2. Sample Size, Data Provenance: No clinical study, therefore no sample size, test set, or data provenance.

3. Number of Experts, Qualifications, Adjudication Method: These points are relevant to establishing ground truth in clinical studies, particularly for imaging or diagnostic devices. Not applicable here.

4. MRMC Comparative Effectiveness Study: No clinical study, so no MRMC study.

5. Standalone Performance: This refers to the algorithm's performance in AI/diagnostic devices. Not applicable to a hip implant.

6. Type of Ground Truth: In clinical studies, this refers to the definitive diagnostic label (e.g., pathology, clinical outcome). Not applicable here as there is no clinical study data.

7. Sample Size for Training Set, Ground Truth for Training Set: These are relevant for AI/machine learning models. Not applicable to a physical hip implant device.

Conclusion based on the provided document:

• Acceptance Criteria: Not explicitly detailed in terms of clinical performance metrics because no clinical testing was performed. The implicit acceptance criteria were demonstrating substantial equivalence through non-clinical mechanical testing, materials, and design similarity to the predicate device (Taper 2 TM Porous femoral Stem - K050441).
• Study Proving Acceptance Criteria: A "Non-Clinical Testing" study was performed.
  • Description: "Mechanical testing has demonstrated equivalence between the Lateralized Taperloo® Microplasty™ Femoral Components and the predicates."
  • Details regarding study: The document does not provide details about the specific mechanical tests, their protocols, acceptance thresholds, or results beyond the general statement of equivalence.
  • Clinical Testing: "None provided."

The 510(k) clearance was based on the FDA's determination of substantial equivalence to a predicate device, supported by non-clinical (mechanical) testing, rather than a clinical study proving specific performance acceptance criteria for the new device.

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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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