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The Prime Acetabular Cup System is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

• 3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed.

Shells with BIOFOAM® coating are intended only for uncemented arthroplasty.

MicroPort is introducing the Prime BIOFOAM® Multi-Hole Shells as a line extension of its existing Prime Acetabular System (K170444, K171181, K180798, and K181598). The subject implants are single use only, are provided sterile, and are to be implanted only by orthopedic specialists in an operating room setting. Associated instrumentation is reusable, provided nonsterile, and are to be used only by orthopedic specialists in an operating room setting.

The Prime BIOFOAM® Multi-Hole Shell includes 10, 12, or 14 screw hole variations. The subject acetabular shells can be used with existing MicroPort devices listed in Section G, Table 3 to form a complete total hip system.

• Multi-Hole Acetabular Shells
  • Material: Ti alloy conforming to ASTM F620 O
  • Coating: Commercially Pure Ti Foam conforming to ASTM F67 O (BIOFOAM®)
  • Outer diameters: 42mm to 68mm with 2 mm increments O
  • Variants: 10, 12, or 14 screw holes O
  • Sterilized using Gamma Radiation O

This FDA 510(k) summary (K201157) is for the Prime BIOFOAM® Multi-Hole Shells, an acetabular shell used in total hip arthroplasty. The document asserts substantial equivalence to existing predicate devices based on design features, materials, and nonclinical bench testing.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format, nor does it provide numerical performance results against such criteria. Instead, it relies on demonstrating equivalence to predicate devices through design similarity and standard mechanical testing.

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

• Sample Size: Not specified. The document states "bench testing was performed" for mechanical tests, but doesn't quantify the number of units tested. For MR conditionality, predicate test results were leveraged, so no new test set was used for the subject device in this regard.
• Data Provenance: The document implies the mechanical bench testing was conducted by MicroPort Orthopedics Inc. The general provenance is regulatory submission data. The studies are non-clinical (bench) studies, not human subject studies, so concepts like "country of origin of the data" or "retrospective/prospective" do not directly apply in the same way they would for clinical trials. The data is generated ex vivo.

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

This section is not applicable as the studies described are non-clinical bench tests. "Ground truth" in this context typically refers to clinical diagnosis or outcomes for human subjects. For mechanical and material testing, the "ground truth" is defined by the physical properties measured against established standards (e.g., ISO, ASTM).

4. Adjudication Method for the Test Set

This section is not applicable as the studies described are non-clinical bench tests. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where expert consensus is needed to establish ground truth from patient data.

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 section is not applicable. The device described is a physical orthopedic implant (acetabular shell), not an AI/software device that assists human readers in interpreting medical images. Therefore, an MRMC study is outside the scope of this device's evaluation.

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

This section is not applicable. The device is an orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is established by:

• Standardized Test Methods: Adherence to recognized international and national standards such as ISO 7206 series and ASTM F series (F620, F67, F3090, F1820, F2068, F2052, F2119, F2503, F2182). These standards define how performance characteristics (like fatigue, frictional torque, material properties) are measured and evaluated.
• Material Specifications: Compliance with ASTM standards for material composition (e.g., ASTM F620 for Ti alloy, ASTM F67 for Commercially Pure Ti Foam).

8. The Sample Size for the Training Set

This section is not applicable. As a physical orthopedic implant (not an AI/ML device), there is no "training set" in the context of machine learning. The design and manufacturing process are subject to engineering design principles and quality control, not algorithmic training.

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

This section is not applicable for the same reason as point 8.

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

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

The R3 HA Coated Acetabular Shells are line additions to the existing R3 Acetabular System. The R3 HA Coated Acetabular Shells have the same design as the existing R3 Shells. The difference is the addition of HA coating. The R3 Ha Coated Acetabular Shells will be offered in No-Hole, 3-Hole and Multi-Hole design options. The R3 HA Coated Acetabular Shells will be used with existing R3 Acetabular Liners and accessories and existing Smith & Nephew femoral heads and femoral stems.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

Based on the provided FDA 510(k) summary for the "R3 HA Coated Acetabular Shells," there is no specific information on acceptance criteria for a device performance study or any human-in-the-loop or standalone AI performance studies.

This document is a 510(k) clearance for a hip implant, which typically focuses on demonstrating substantial equivalence to a predicate device rather than complex AI performance metrics. The clearance is for a medical device (hip implant), not a software or AI-driven diagnostic/treatment device.

Therefore, many of the requested categories for AI-related studies (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, and AI training set details) are not applicable to this document.

Here's a breakdown of what can be extracted from the document, tailored as much as possible to your request, but highlighting the absence of AI-specific performance criteria:

Acceptance Criteria and Study for R3 HA Coated Acetabular Shells

1. Table of Acceptance Criteria and Reported Device Performance

Summary of the Study Proving Acceptance Criteria were Met:

The study proving the device met the acceptance criteria was a non-clinical performance testing effort, specifically focusing on mechanical testing of the locking mechanism and coating evaluation for both StikTite and hydroxyapatite. This testing was conducted according to FDA guidance. The central argument for substantial equivalence relies on the fact that the R3 HA Coated Acetabular Shells share the same design (other than the HA coating), materials (with the addition of HA), and locking mechanism as already cleared predicate devices.

Regarding AI-Specific Information (Not Applicable to this Document):

The following points are not addressed in the provided 510(k) summary because this document pertains to a physical medical implant, not an AI software component or an AI-assisted diagnostic/treatment system.

2. Sample size used for the test set and the data provenance: Not applicable. (No AI test set described)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. (No AI ground truth described)
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. (No AI test set described)
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. (No AI component to evaluate)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. (No AI component to evaluate)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. (No AI ground truth described)
8. The sample size for the training set: Not applicable. (No AI training set described)
9. How the ground truth for the training set was established: Not applicable. (No AI ground truth described)

In conclusion, this document demonstrates that the R3 HA Coated Acetabular Shells met the acceptance criteria for a 510(k) clearance by proving substantial equivalence to predicate devices through non-clinical mechanical and coating performance testing, consistent with FDA guidance. It does not involve any AI components or related performance studies.

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

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

The R3 Acetabular System is for single use only and is intended for cementless use.

The subject of this Special 510(k) is the R3® Anteverted Liners. The subject R3 Anteverted Liners are a line extension to the R3 XLPE Liners that were cleared under premarket notifications K113848 and K093363. The R3 Anteverted Liners have same overall design, indication for use and material as the predicate R3 XLPE liners.

The subject R3 Anteverted Liners feature a 20° anteverted, or "face changing", entry angle to the articulating surface (Inner diameter). Also, a variable angle chamfer/bevel was added on the rim of the liner. The R3 Anteverted Liners have +4mm lateralized inside Diameter, 20° andle, and identical locking mechanism as the predicate R3 XLPE Liners, cleared under K113848 and K093363.

The R3 Anteverted Liners are available with Inner diameter (ID) sizes 28, 32, 36, 40 and 44mm and the Outer Diameter (OD) sizes ranging from 44 to 76-80mm.The R3 Anteverted Liner is manufactured from 10MRAD Cross-linked Polyethylene (XLPE) confirming to ASTM F648, as the predicate R3 XLPE Liners cleared under a premarket notification K113848 and K093363. The R3 Anteverted Liners are provided sterile and is intended for single use only.

The provided text describes a 510(k) submission for a medical device, the R3 Anteverted Liners, demonstrating substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria for a novel AI/software component.

Therefore, many of the requested details about acceptance criteria, study design for AI, and expert involvement are not applicable to this document. The document focuses on demonstrating that the new device, a modification of an existing hip implant component, is just as safe and effective as previously cleared predicate devices through mechanical testing and comparison of characteristics.

Here's an attempt to answer the questions based on the provided text, highlighting where information is not available or not applicable:

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

Since this is a submission for a physical medical device (hip implant liner) demonstrating substantial equivalence to predicate devices, the "acceptance criteria" are primarily related to safety and performance characteristics being equivalent or comparable, supported by mechanical bench testing. There isn't a table of discrete acceptance criteria with numerical targets and reported performance in the way one would see for an AI/software performance study.

The primary "acceptance criteria" is that the new R3 Anteverted Liners are substantially equivalent to the predicate R3 XLPE Liners and other referenced devices in terms of:

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

• Sample size: Not explicitly stated for each mechanical test. The tests were performed on the R3 Anteverted Liners.
• Data provenance: Not explicitly stated in terms of country of origin. The testing was "non-clinical bench (mechanical) testing" for a physical device manufactured by Smith & Nephew, Inc. It can be inferred to be prospective as it was performed to support the 510(k) submission for the new device.

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

This is not applicable to this document. Ground truth as typically defined for AI/software (e.g., expert annotations on images) is not relevant to the mechanical testing of a physical hip implant liner. The "ground truth" for mechanical testing is established by engineering standards and validated testing procedures.

4. Adjudication method for the test set

This is not applicable to this document. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert interpretations, typically in image analysis or clinical assessments, which is not what this submission describes. The validity of the mechanical tests is based on adherence to recognized standards and engineering principles.

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 is not applicable to this document. An MRMC study is for evaluating the performance of AI-assisted diagnostic tools. This document is for a physical orthopedic implant.

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

This is not applicable to this document. There is no AI algorithm involved in the R3 Anteverted Liners.

7. The type of ground truth used

The "ground truth" for the mechanical testing of the physical device is based on engineering standards and established testing methodologies to evaluate material properties and mechanical performance (e.g., strength, stability, wear characteristics) against predefined requirements derived from predicate device performance and regulatory standards.

8. The sample size for the training set

This is not applicable to this document. There is no AI algorithm with a training set.

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

This is not applicable to this document. There is no AI algorithm with a training set or ground truth establishment in this context.

Ask a specific question about this device

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

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

Total hip systems may be indicated for use (i) with bone cement , (ii) without bone cement , or (ii) for use with or without bone cement.

The subjects OXINIUM DH Femoral Heads are metal alloy devices processed via a proprietary oxidation process and are designed as a component to replace a hip joint. The subject OXINIUM DH Femoral Heads are designed for use with existing 510(k) cleared products consisting of Smith & Nephew hip stems, acetabular shells and liners and will articulate against existing acetabular shell and liner constructs. The subject Femoral Heads are comprised of Oxidized Zirconium manufactured from wrought Zirconium (Zr) -2.5 Niobium (Nb).

The purpose of this 510(k) submission is to add additional OXINIUM DH femoral heads to the Smith & Nephew Total Hip System.

This document is a 510(k) Summary for the OXINIUM DH Femoral Heads, and thus, does not contain information typically found in an AI/ML device submission, such as detailed acceptance criteria tables, sample sizes for test/training sets, expert qualifications or ground truth establishment methods for AI/ML models, or MRMC studies. The content focuses on demonstrating substantial equivalence to predicate devices through material properties and mechanical testing.

Therefore, many of the requested items cannot be extracted directly from the provided text.

However, I can provide information based on the mechanical performance tests described, which include "acceptance criteria" for the device's functional integrity.

Here's an attempt to answer based only on the provided text, while acknowledging that many AI/ML specific questions cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified in the document. For mechanical and biocompatibility testing, sample sizes are typically determined by the specific ASTM/ISO standards referenced, but these numbers are not disclosed.
• Data Provenance: The testing was conducted by Smith & Nephew, Inc. It is internal testing performed for FDA submission. The country of origin for the data is implicitly the USA, where the company is located. The nature of the data is prospective, in that the tests were performed to evaluate the new device.

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

• This question is not applicable to this type of device submission. This document pertains to physical medical devices (femoral heads) and their material/mechanical properties, not an AI/ML algorithm requiring expert establishment of ground truth.

4. Adjudication method for the test set:

• This question is not applicable. Adjudication methods are typically used in clinical studies or for interpreting diagnostic outputs, not for direct mechanical or biocompatibility testing of a physical device. Test results are compared against predefined criteria in the standards.

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

• This question is not applicable. This is not an AI/ML device.

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

• This question is not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• For Biocompatibility: The "ground truth" is defined by established international standards (ISO-10993) and FDA guidance for biological evaluation of medical devices, which dictate acceptable material behavior in a biological environment.
• For Mechanical Testing: The "ground truth" is defined by the technical specifications and performance requirements outlined in the referenced ASTM and ISO standards (e.g., ASTM F2009-00, ASTM F2068-15, ISO 7206-6). The device's performance is measured against these established engineering and safety criteria.

8. The sample size for the training set:

• This question is not applicable as this is not an AI/ML device that requires a training set. The device itself is manufactured from well-characterized materials and processes.

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

• This question is not applicable as this is not an AI/ML device.

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The DYNASTY® BIOFOAM® Shells are intended for use in cementless total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use

• non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• inflammatory degenerative joint disease such as rheumatoid arthritis;
• correction of functional deformity; and,
• revision procedures where other treatments or devices have failed.
  The DYNASTY® BIOFOAM® Shell is intended for cementless hip arthroplasty.

Design features of the shells are summarized below:

• Shells manufactured from Titanium alloy substrate, coated with BIOFOAM® coating ● manufactured from commercially pure (CP) titanium
• Solid shell sizes: 46mm-68mm outer diameter
• Three different hole patterns:
• 10-hole shell sizes: 46mm-76mm outer diameter
• 3-hole shell sizes: 46mm-68mm outer diameter
• 5-hole shell sizes: 46mm-50mm outer diameter

The provided text is a 510(k) summary for the DYNASTY® BIOFOAM® Shell, an acetabular cup for hip arthroplasty. It focuses on demonstrating substantial equivalence to predicate devices rather than reporting the results of a primary clinical study with acceptance criteria and device performance. Therefore, the requested information about acceptance criteria and study details cannot be fully extracted from the provided text.

Specifically, the document states:

• "The subject DYNASTY® BIOFOAM® Shells were cleared in K121544 for use with metal/metal bearings. The shells are identical to shells in K082924, except that the subject device posses different screw hole patterns. Additionally, the DYNASTY® BIOFOAM® Shells were evaluated via post-impaction analysis of clearance, form and frictional torque. A review of these results concludes that the DYNASTY® BIOFOAM® Shells were cleared in K121544 and are equivalent to predicate devices."
• "The safety and effectiveness of the subject DYNASTY® BIOFOAM® Shells are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification."

This indicates that the device was evaluated through bench testing (post-impaction analysis of clearance, form, and frictional torque) and comparison to predicate devices, not through a clinical study that would establish clinical acceptance criteria and report device performance in human subjects.

Therefore, most of the requested fields related to a clinical study (sample size, data provenance, experts for ground truth, adjudication, MRMC study, standalone performance, type of ground truth, training set details) are not applicable or not provided in this type of regulatory submission.

However, based on the provided text, here's what can be inferred or stated:

Acceptance Criteria and Device Performance (Bench Test/Equivalence)

Study Details (for this 510(k) submission):

1. Sample size used for the test set and the data provenance: Not applicable for a clinical test set. The evaluation involved bench testing (post-impaction analysis) of the device components. The data provenance would be internal laboratory testing by the manufacturer.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for bench testing is typically based on engineering specifications and physical measurements, not expert clinical interpretation.
3. Adjudication method 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 medical device (hip implant) 510(k), not an AI 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: For the bench testing, the "ground truth" would be the engineering specifications and measurable physical properties of the device (clearance, form, frictional torque) compared against established design parameters or predicate device performance.
7. The sample size for the training set: Not applicable for this type of submission. There is no mention of an algorithm or training set.
8. How the ground truth for the training set was established: Not applicable.

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

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

The Reflection 3 Acetabular System is for single use only and is intended for cementless use.

Subject of this Traditional 510(k) premarket notification is a modification to the R3 22-36mm XLPE Acetabular Liners. The liners were originally cleared under K070756. Four vents have been added to the locking detail of the subject liners. The vents have been added to allow for improved fluid egress from behind the locking beads in an effort to minimize the potential for difficulty seating the liners during aggressive impaction.

K113848 is a 510(k) premarket notification for a modification to an existing device, the R3 XLPE Acetabular Liners, not a study involving AI or human readers. The provided text describes mechanical testing performed to demonstrate that the modified device is substantially equivalent to predicate devices, and thus does not include the typical elements of an AI-based regulatory submission.

Therefore, many of the requested categories are not applicable to this submission.

Here is the information that can be extracted or deduced from the provided document:

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

The document mentions that the submission was prepared in accordance with the "Guidance Document for Testing Acetabular Cup Prostheses," dated May 1995. This guidance document would contain the specific acceptance criteria for each test. The actual numerical acceptance criteria for each test are not explicitly stated in the provided text, nor are the specific numerical results.

The following types of mechanical tests were performed:

• Push-out Testing
• Torque-to-Failure Testing
• Lever-out Testing
• Fatigue Testing
• Post-Fatigue Push-out Testing

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in the provided text.
• Data Provenance: The document does not specify the country of origin for the test data. Given the "Submitted by Smith & Nephew, Inc. Advanced Surgical Devices Division, Cordova, Tennessee," it is highly likely the testing was conducted in the USA or by a facility contracted by a US entity for a US submission. The testing is a prospective assessment of the device's mechanical properties, not human-derived data.

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. This submission is for a medical device (acetabular liners) and involves mechanical testing, not a diagnostic algorithm that requires expert-established ground truth from images or clinical data. The "ground truth" here is the physical performance of the device against engineering standards.

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

• Not applicable. As this is mechanical testing of a physical device, there is no expert adjudication process in the sense of clinical interpretations or diagnoses. The "adjudication" is compliance with engineering standards and guidance.

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. No MRMC study was conducted. This device is a physical implant, not an AI-assisted diagnostic tool. No human readers or AI were involved in the testing for this submission.

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

• Not applicable. This is a physical medical device. There is no algorithm to evaluate.

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

• The "ground truth" for this submission is established through physical mechanical testing according to recognized engineering standards and FDA guidance documents (specifically, the "Guidance Document for Testing Acetabular Cup Prostheses," dated May 1995). The acceptance criteria outlined in such guidance documents serve as the standard for performance.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of mechanical testing for a physical medical device. This term applies to machine learning models.

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

• Not applicable. As above, there is no training set for a physical device's mechanical testing.

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

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

The Reflection 3 Acetabular System is for single use only and is intended for cementless use.

Subject of this Abbreviated Premarket Notification are R3 XLPE Acetabular Liner line additions in an anteverted liner option. Anteverted liners modify the face opening of the acetabular liner component. The subject devices are intended to be used in conjunction with existing R3 Acetabular Shells, and they are intended to articulate against appropriately sized, existing Smith & Nephew femoral heads. They are manufactured from XLPE material and will initially be offered in inner diameters of 32 and 36mm and outer diameters of 48-72/74mm.

R3 XLPE Acetabular Liners have previously been cleared for market under premarket notifications K070756 and K092386 in liner options of 0°,0° lateralized +4mm, 20°, and 20° lateralized +4mm. The subject R3 XLPE Anteverted Liners are very similar to the R3 XLPE 20° lateralized +4mm Acetabular Liners cleared under K070756. The differences are described below.

• The face of the acetabular liner has been changed by 20° to re-orient the opening face of . the liner relative to a given shell orientation when necessary
• Four vents have been added to the locking detail of the subject R3 XLPE Anteverted . Liners.

This document describes the R3 XLPE Anteverted Liners, a medical device. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study that Proves the Device Meets Acceptance Criteria:

The device's performance was evaluated through a series of tests conducted in accordance with the guidance titled "Guidance Document for Testing Acetabular Cup Prostheses," dated May 1995. A review of these tests demonstrated that there were no new issues related to the safety or effectiveness of the R3 XLPE Anteverted Liners. This evaluation compared the new device's performance against established criteria and the performance of previously cleared predicate devices.

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

The document does not specify the exact sample sizes used for the performance tests (e.g., number of liners tested for fatigue, wear, etc.). The data provenance is laboratory testing in accordance with an FDA guidance document, rather than clinical data from human subjects. Therefore, details like country of origin or retrospective/prospective are not applicable in the context of this device's testing.

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

Not applicable. The ground truth for this device's performance was established through engineering and materials testing standards outlined in the "Guidance Document for Testing Acetabular Cup Prostheses," not through expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. As the evaluation was based on standardized physical and mechanical tests, there was no need for an adjudication method among human reviewers. The results would be objectively measured against predefined criteria in the guidance document.

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

Not applicable. This device is an orthopedic implant, not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC study involving human readers and AI is irrelevant to its evaluation.

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

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

7. The Type of Ground Truth Used

The ground truth used for assessing the device's performance was engineering and materials testing standards and criteria as detailed in the "Guidance Document for Testing Acetabular Cup Prostheses." This includes objective measurements of properties like range of motion, attachment loads, fatigue life, wear rates, degradation, and corrosion resistance.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no concept of a "training set" in the context of its development and evaluation as described here.

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

Not applicable, as there is no training set for this type of device evaluation.

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

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

The Reflection 3 Acetabular System is for single use only and is intended for cementless use.

Subject of this Traditional Premarket Notification are CoCr and Oxinium Femoral Head line additions in sizes 40 and 44mm and R3 XLPE Acetabular Liner line additions with inner diameters of 40 and 44mm.

The provided text is a 510(k) summary for medical devices (CoCr and Oxinium Femoral Heads and R3 XLPE Liners) seeking clearance based on substantial equivalence. It does not describe an AI/ML device or a study proving that the device meets acceptance criteria. Instead, it details the device description, intended use, and argues for substantial equivalence to previously cleared predicate devices.

Therefore, I cannot extract the information required in your request about acceptance criteria, study details, sample sizes, expert involvement, or ground truth, as these elements are specific to the evaluation of AI/ML performance studies, which is not present in this document.

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

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

The Reflection 3 Acetabular System is for single use only and is intended for cementless use.

Subject of this Abbreviated Premarket Notification are line additions to the R3 Acetabular System. The line additions consist of R3 Multi-Hote Shells and 36mm XLPE Acetabular Liners.

This document K092386 is a 510(k) summary for R3 Multi-Hole Shells and 36mm XLPE Acetabular Liners. It is a premarket notification for a medical device seeking clearance based on substantial equivalence to predicate devices, rather than establishing acceptance criteria through a study demonstrating device performance against specific metrics.

Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The document describes:

• Device Description: Line additions to the R3 Acetabular System.
• Intended Use and Indications For Use: Broad medical conditions for which the hip components are indicated.
• Substantial Equivalence: Lists predicate devices to which the current device is considered equivalent.

The 510(k) process primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily on proving that it meets specific numeric performance acceptance criteria through a new clinical or laboratory study with a predefined sample size, expert ground truth, or adjudication methods for that specific study. While testing (e.g., mechanical testing for orthopedic implants) is typically performed to ensure safety and effectiveness and may be summarized, the detailed structure of acceptance criteria and the study as requested (including sample size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) is not part of this 510(k) summary.

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The REFLECTION 3 Acetabular System is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, osteonecrosis, avascular necrosis, post traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseased and anomalies, and congenital dysplasia; old remote osteomyelitis with and an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

The R3 Acetabular System is for single use only. The R3 Acetabular System is intended for cementless use.

The REFLECTION 3 Acetabular System consists of Acetabular shells and liners. The R3 shells are manufactured from titanium alloy. The design of the shells and liners are similar to the REFLECTION 3 Acetabular Shell, the 10MRad REFLECTION 3 Acetabular Liner cleared under K061253 and the DePuy Pinnacle Acetabular Shell cleared under K033273. The REFLECTION 3 liners are manufactured from cross-linked polyethylene. The proposed modifications will include:

• · The addition of Asymmetric Porous Coating to the outside of the R3 Acetabular Shell
• · The addition of the R3 MAX shell with Asymmetric Porous Coating to the outside of the shell
• · The addition of the R3 MAX shell with Titanium Bead Porous Coating to the outside of the shell

The Acetabular shells feature two locking grooves that correspond to locking beads on the XLPE liners, as cleared in K061253. There are also 12 indentions in the face of the shell that mate with twelve tabs of the XLPE liner to prevent rotation. The R3 Acetabular Shells and the R3 MAX shells will be offered in sizes 40mm-68mm.

This document is a 510(k) summary for the Smith & Nephew REFLECTION 3 Acetabular System. It states that the device is substantially equivalent to previously cleared devices.

Here's an analysis based on the provided text:

Key Takeaway: This 510(k) submission primarily relies on substantial equivalence to previously cleared predicate devices, rather than presenting a de novo study with specific performance acceptance criteria and a detailed study proving those criteria were met. Therefore, many of the requested sections will state "Not applicable" or reflect that a comparative effectiveness study was not the basis of this particular submission.

Here's a breakdown of the requested information:

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

   Acceptance Criteria	Reported Device Performance
   Design Features: Similar to predicate devices	Similar to Smith & Nephew REFLECTION Acetabular System (K920430, K932755, K990666), REFLECTION Interfit Shell (K9640094, K990666), 10MRad REFLECTION Acetabular Liner (K002747), REFLECTION 3 Acetabular System (K061253), and DePuy Orthopaedics Inc. Pinnacle Acetabular System (K033273).
   Overall Indications: Similar to predicate devices	Similar to predicate devices (as listed in Section A. Intended Use and Indications for Use).
   Materials: Similar to predicate devices	R3 shells: titanium alloy. Liners: cross-linked polyethylene. Similar to predicate devices.
   Safety and Effectiveness: Demonstrated through design control activities and substantial equivalence.	"Design Control Activities have been completed and the results indicated that the subject device is safe and effective." The FDA's substantial equivalence determination implies acceptance of this claim based on comparison to predicates.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: Not applicable. This submission relies on substantial equivalence and design control activities, not a clinical test set with a specific sample size.
   • Data Provenance: Not applicable for a dedicated test set. The data presented here is descriptive of the device modifications and comparisons to existing devices.

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. There was no specific test set requiring expert ground truth establishment for performance evaluation in this 510(k) summary.

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

   • Not applicable. No test set was described that required an adjudication method.

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-based device, and no MRMC comparative effectiveness study was performed or described in this document.

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

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

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

   • Not applicable in the context of a performance study for this submission. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices. The modifications were assessed through "Design Control Activities."

8. The sample size for the training set

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable. As above, no training set was used.

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