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The DePuy RECLAIM Monobloc Revision Femoral Stem is indicated for cementless use in the treatment of failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.

The subject devices in this line extension to the RECLAIM Monobloc Revision Femoral Stem (previously cleared through Primary Predicate 510(k) K221462 and with MRI Conditional status cleared through 510(k) K231873) include four new Standard length RECLAIM Monobloc Revision Femoral Stems and twenty-three new Short length RECLAIM Monobloc Revision Femoral Stems.

The line extension will extend the DePuy RECLAIM Monobloc Revision Femoral Stems portfolio by twenty-seven product codes.

The Subject Device RECLAIM Monobloc Revision Femoral Stems are revision implants that are intended to treat patients with prior failed hip replacement devices. They are made of Ti6Al4V alloy and present a grit-blasted tapered fluted intramedullary region with splines that are intended to be in interference of the previously reamed femoral cavity and in contact with the cortical bone in the canal in an uncemented use.

The provided text describes a 510(k) clearance letter for the RECLAIM Monobloc Revision Femoral Stem. This is a medical device, specifically a hip joint prosthesis, not an AI/Software as a Medical Device (SaMD). Therefore, the questions related to AI/SaMD performance criteria, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone algorithm-only performance," "number of experts for ground truth," and "training set size," are not applicable to this submission.

The clearance is for an expansion of the existing RECLAIM Monobloc Revision Femoral Stem (K221462 and K231873) to include additional sizes. The regulatory review focuses on mechanical performance and substantial equivalence to the predicate devices.

Here's the information extracted from the provided text regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for the mechanical tests (Neck Fatigue, MRI Safety, Range of Motion, Stem Fatigue). However, for medical device mechanical testing, typically a representative number of samples (e.g., 3-6 or more) for each configuration are tested according to relevant ISO or ASTM standards.

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. As these are physical device tests, they would be conducted in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This is a physical device, not an AI/SaMD for which expert-established ground truth would be required. The "truth" is determined by mechanical testing against established engineering standards.

4. Adjudication Method for the Test Set

Not applicable. This is a physical device, not an AI/SaMD where adjudications of expert interpretations are relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

Not applicable. This is a physical medical device (hip implant), not an AI/SaMD that assists human readers.

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

Not applicable. This is a physical medical device, not an AI/SaMD.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" is established by:

• Engineering Standards: Bench testing against industry-accepted standards (e.g., ISO, ASTM) for fatigue, range of motion, and other mechanical properties.
• Predicate Device Performance: Demonstrating that the subject device performs "as well as" or equivalently to the legally marketed predicate devices, which have already established safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/SaMD, therefore a "training set" in the context of machine learning is not relevant.

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

Not applicable. As above, there is no "training set" for this type of device.

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The EMPHASYS Acetabular System is indicated for use in total hip replacement procedures.
Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
   EMPHASYS Acetabular Cups are indicated for cementless use only.

The subject devices in this line extension to the EMPHASYS Acetabular System (previously cleared through Primary Predicate 510(k) K221636) include three additional porous-coated titanium alloy Acetabular Shells in a multi-hole configuration and ten corresponding AOX polyethylene Acetabular Liners in three configurations (Neutral, +4 Neutral and ELV)

This is a medical device submission, not a software or AI device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not applicable in the context of this document. This document pertains to the clearance of an acetabular system for total hip replacement, which involves physical device testing and comparison to predicate devices, not algorithmic performance.

Here's why each point is not applicable:

• A table of acceptance criteria and the reported device performance: This usually applies to diagnostic or AI algorithms where performance metrics like sensitivity, specificity, AUC are relevant. For a physical orthopedic implant, performance is assessed through mechanical and material testing against established standards, not necessarily a concise table of "acceptance criteria" as would be seen for software. The document states that testing was done for "Interconnection strength of shell and liner per ASTM F1820-22," implying adherence to a standard, but does not provide specific acceptance values or results in this summary.
• Sample sized used for the test set and the data provenance: Not applicable for a physical implant. "Test set" in an AI/software context refers to data. Here, it refers to physical units of the device tested in a lab.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is generally for classification/detection tasks. For an implant, "ground truth" would be the physical properties confirmed through engineering tests.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in expert reviews of data/images.
• 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 for AI-assisted diagnostic tools, not an orthopedic implant.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, ground truth relates to its material properties and mechanical performance confirmed by standardized testing, not expert consensus on medical images or pathology.
• The sample size for the training set: Not applicable. This is for AI/machine learning models.
• How the ground truth for the training set was established: Not applicable. This is for AI/machine learning models.

Summary of Relevant Information (from the document) for a Physical Device:

• Performance Testing: The EMPHASYS Acetabular System subject devices were compared to predicate devices. Testing and analyses included:

  • Interconnection strength of shell and liner per ASTM F1820-22.
  • No new worst-case was identified for: Range of motion, Deformation, Impingement, Unsupported Shell Fatigue, Analysis of shell and liner thickness, Articular clearance, Wear Friction, MRI Safety.

• Substantial Equivalence: The device is substantially equivalent to identified predicates with respect to intended use, indications, materials, geometry, range of sizes, and method of fixation. Performance testing and analyses demonstrate that it performs as well as the predicate devices.

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The INHANCE™ SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following:

• · Osteoarthritis
• · Post-traumatic arthrosis
• · Focal avascular necrosis of the humeral head
• · Previous surgeries of the shoulder that do not compromise the fixation

Fixation Methods:

The humeral stemless anchor is intended for cementless use. The anatomic glenoid and anatomic hybrid glenoid are intended for cemented use only.

The INHANCE INTACT™ instruments are intended to be used during orthopedic surgery with INHANCE™ Anatomic Stemless Shoulder System. Cases and trays are intended to hold joint reconstruction instruments during the sterilization process and for storage.

The current submission adds INHANCE INTACT™ Instruments to the INHANCE Stemless Anatomic Shoulder System. The implant components of the system are unchanged. The INHANCEINTACT™ Instruments are designed to facilitate a subscapularis sparing total shoulder arthroplasty for the INHANCE™ Anatomic Stemless Shoulder System.

The INHANCETM SHOULDER SYSTEM with a humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures.

The Anatomic Total Shoulder Prosthesis of individually packaged implants: a humeral stemless anchor (titanium alloy), an offset taper adapter (titanium alloy), a humeral head (cobalt- chromium) in combination with an anatomic glenoid (stainless steel x-ray marker pin embedded) or an anatomic hybrid glenoid featuring a metal central post (titanium alloy). All glenoid implants have a Cross-Linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-Linked, VE UHMWPE) bearing surface.

The provided submission does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found for an AI/ML medical device. This document describes a traditional medical device (shoulder joint prosthesis and associated instruments), not an AI/ML-driven diagnostic or therapeutic aid.

Therefore, the requested information elements (acceptance criteria table, sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and training set ground truth establishment) are not applicable or extractable from this 510(k) summary for an AI/ML device.

Here's a breakdown of what the document does state about testing and equivalence, in the context of a traditional medical device:

The submission focuses on demonstrating substantial equivalence of the "INHANCE INTACT™ Instruments" to predicate devices (K203108 and K212933) for use with the existing "INHANCE™ Anatomic Stemless Shoulder System."

Key points from the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section:

• No AI/ML Component: The device is a traditional orthopedic implant system and instruments. There is no mention of algorithms, AI, machine learning, or software functionality that would require performance metrics like sensitivity, specificity, or AUC against a ground truth.
• Implant Components Unchanged: The implant components of the INHANCE Shoulder System are identical to those of the predicate device.
• Focus on Instruments: The submission is primarily for the "INHANCE INTACT™ Instruments," which are new designs intended to facilitate a subscapularis sparing total shoulder arthroplasty.
• Non-Clinical Testing Only: "Clinical testing was not required to demonstrate substantial equivalence."
• Types of Non-Clinical Testing:
  • Biocompatibility Assessments: Conducted per ISO 10993-1 and FDA Guidance documents. The devices were found to be biocompatible.
  • Bench Testing: Covered "Design equivalence, equivalence of use of the device, material rationale and biocompatibility evaluation."

Therefore, I cannot populate the requested table and information points as they relate to AI/ML device performance criteria and studies. The provided text does not contain any of that specific kind of information.

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The ATTUNE Revision Hinge Knee is indicated in cases for cement use in patients who have reached skeletal maturity and for whom the surgeon has decided to resect both cruciate ligaments due to the following conditions:

1. Severe instability, gross deformity and/or bone loss
2. Failure of a previous knee reconstruction procedure.
3. Trauma or tumor resection
4. Absent or markedly insufficient collateral ligaments

The ATTUNE™ Revision Hinge Knee, comprised of a femoral, housing assembly, and tibial insert component, is compatible with devices of the ATTUNE Knee System and the ATTUNE Revision Knee System and is designed to replace the natural articulating surface of the knee joint in total knee arthroplasty. The femoral component is a metal/ultra-high molecular weight polyethylene (UHMWPE) implant intended for cemented use. The housing assembly component is composed of both metal and antioxidant (AOX) UHMWPE subcomponents. The tibial insert component is composed of AOX UHMWPE.

This document is a 510(k) Premarket Notification from the FDA for the "ATTUNE™ Revision Hinge Knee" device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria in the context of an AI/software device.

Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies are not applicable to this particular document as it is for a mechanical implant and not an AI/software product. The information provided relates to the non-clinical testing of the physical implant's mechanical and material properties.

However, I can extract the relevant information regarding the tests performed for the determination of substantial equivalence (analogous to proving the device meets certain performance standards for a mechanical device).

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

The document does not explicitly state quantitative acceptance criteria with reported performance values in a direct side-by-side comparison. Instead, it states that "The following tests were performed in support of the to demonstrate substantial equivalence of safety and efficacy with the predicate devices." This implies that the device performed equivalently to the predicate devices in these tests, satisfying the FDA's requirement for substantial equivalence.

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

The document does not provide details on specific sample sizes for these tests (e.g., how many specimens were shear-tested or fatigue-tested). It also does not mention data provenance as these are mechanical/materials tests, not human data studies.

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 is a submission for a mechanical medical device, not an AI/Software device requiring expert-established ground truth from medical images or clinical data. The "ground truth" for these tests would be the established engineering and material science standards.

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

Not applicable for a mechanical device 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 is not an AI/software device.

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

Not applicable. This is not an AI/software device.

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

For the mechanical tests listed (Shear, Fatigue, Wear, Stability, Contact Pressure, Biocompatibility, MRI Safety Evaluation), the "ground truth" would be established engineering standards, material science specifications, and regulatory requirements relevant to orthopedic implants.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, so there is no training set mentioned.

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

Not applicable.

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Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
The EMPHASYS Acetabular Shell with RapiTite HA is intended for single use only.
INDICATIONS
Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
   EMPHASYS Acetabular Shells with RapiTite HA are indicated for cementless use only.

The EMPHASYS Acetabular Shell with RapiTite HA is a modular cementless porous-coated acetabular shell, with a hydroxyapatite (HA) coating applied conformally throughout the porous coating, offered in three configurations (No-Hole, 3-Hole, and Multi-Hole).

The provided text is a 510(k) summary for a medical device called "EMPHASYS Acetabular Shell with RapiTite HA". It details the device's purpose, indications, and comparison to predicate devices, and lists various tests conducted to demonstrate substantial equivalence.

However, the request asks for specific information regarding a study proving the device meets acceptance criteria and details about the data provenance, expert involvement, and ground truth establishment, often associated with a clinical or AI performance study.

The provided document does not contain information about a study that would require establishing ground truth with multiple experts, using a test set with specific data provenance, or performing MRMC comparative effectiveness studies. The "Animal & Performance Testing" section lists various mechanical, chemical, and biological tests that were performed (e.g., interfacial shear strength, fatigue testing, biocompatibility, bone ingrowth animal study), but these are primarily laboratory-based and do not involve human readers interpreting data or a "ground truth" derived from expert consensus in the way an AI/clinical performance study would.

Therefore, I cannot fulfill the request for information on the following points based on the provided text:

• A table of acceptance criteria and reported device performance related to a clinical/AI study. The document mentions acceptance criteria implicitly for the mechanical and biological tests (e.g., successfully passing ASTM standards), but not in the context of the requested AI/clinical performance study.
• Sample size for the test set and data provenance. The document mentions an "Animal Study" but no human test set.
• Number of experts and their qualifications for establishing ground truth. Not applicable to the studies described.
• Adjudication method for the test set. Not applicable.
• MRMC comparative effectiveness study and effect size. Not applicable.
• Standalone (algorithm only) performance. Not applicable as this is a physical medical device, not an AI algorithm.
• Type of ground truth used. Not applicable in the requested context.
• Sample size for the training set. Not applicable.
• How ground truth for the training set was established. Not applicable.

The document primarily focuses on demonstrating the substantial equivalence of a physical medical implant (an acetabular shell) through engineering, material, and biocompatibility testing, rather than a clinical performance study involving human interpretation or an AI algorithm.

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ATTUNE™ Revision Knee System: Candidates for total knee replacement include patients with A severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or rheumatod arthritis Moderate valgus, varus, or flexion deformities Avascular necrosis of the femoral condyle A previous unsuccessful knee replacement, osteotomy, or other knee procedure ATTUNE Revision Knee System implants are designed for use in total knee arthroplasty for patients with: Absence or loss of both cruciate ligaments Moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgment of the surgeon Bone loss that requires supplemental fixation in the clinical judgment of the surgeon The porous-coated metaphyseal sleeves are intended for either cementless applications. ANY NON POROUS-COATED COMPONENTS ARE INTENDED FOR CEMENTED USE ONLY.

DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves: The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are intended for use with the PFC, PFC Sigma, Sigma TC3 Revision Knee, or S-ROM knee prosthesis in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. These devices are for cemented use only. The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are also intended for use with the DePuy LPS prosthesis for replacement of the mid-shaft portion of the femur, proximal, distal femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include: Malignant tumors (e.g., osteosarcomas, gian cell tumors, bone tumors) requiring extensive resection and replacement; patient conditions of noninflammatory degenerative join disease (NIDD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis, requiring extensive resection and replacement; revision for failed previous prosthesis cases requiring extensive resection and replacement. The LPS prosthesis is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required. The Universal Stem and the Universal Metaphyseal Sleeve components are intended for cemented use only.

DePuy Sigma PS Femoral Components and DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components: Candidates for total knee replacement include patients with a severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. Total knee replacement may be considered for younger patients if, in the surgeon, an unequivocal indication for total knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to significant improvement in the quality of their lives. THE SIGMA C/R POROCOAT® FEMORAL COMPONENTS ARE INTENDED FOR CEMENTED OR CEMENTLESS USE AS THE FEMORAL COMPONENT OF A TOTAL KNEE REPLACEMENT SYSTEM. THE SIGMA PS FEMORAL COMPONENTS ARE INTENDED FOR CEMENTED USE AS THE FEMORAL COMPONENTS OF A TOTAL KNEE REPLACEMENT SYSTEM.

S-ROM™ NOILESTM Rotating Hinge Knee: The S-ROM NOILES Rotating Hinge Knee is indicated in cases for cement use in patients who have reached skeletal maturity and for whom the surgeon has decided to resect both cruciate ligaments due to the following conditions: 1. Severe instability, gross deformity and/or bone loss. 2. Failure of a previous knee reconstruction procedure. 3. Trauma or tumor resection. 4. Absent or markedly insufficient collateral ligaments.

DePuy P.F.C. TM SIGMA™ Total Knee Prosthesis and DePuy SIGMA™ Total Knee Prosthesis: The DePuy SIGMA™ and P.F.C. ™SIGMA™ Total Knee Prosthesis are intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. The DePuy SIGMA™ and P.F.C. ™SIGMA™ Total Knee Prosthesis are intended for cement use only.

ATTUNE™ Revision Knee System: A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component consists of a metal tibial base without porous coating, and a locking polyethylene insert. Some metal components have modular stems, porous and non porous-coated sleeves and/or modular augments. The patella component is an all polyethylene design Total knee arthroplasty may include supplemental fixation through stems, sleeves, and/or modular augments where bone loss requires said fixation in the opinion of the surgeon. Total knee arthroplasty may also include more constrained bearing surfaces where necessary to provide stability where musculoligamentous supporting structures are insufficient.

DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves: A Total Knee Prosthesis System is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant, with or without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial tray with or without porous coating, and a polyethylene insert and locking components. Some metal components have modular stems, sleeves and/or modular wedges. The patella component may be of an all polyethylene design or may be a metal backed polyethylene component. The wobble bit is an instrument used to aid implant assembly.

DePuy Sigma PS Femoral Components and DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components: A SIGMA™ Total Knee System is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant, with or without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial tray with or without porous coating, and a polyethylene insert and locking components. Some metal components have modular stems, sleeves and/or modular wedges or augments. The patella component is an all polyethylene design.

S-ROM™ NOILESTM Rotating Hinge Knee System: The S-ROM NOILES Rotating Hinge Knee System is a tricompartmental total knee replacement for both primary and revision cases. The S-ROM NOILES Rotating Hinge Knee System includes the femoral component with hinge pin, the tibial plateau assembly, and the distal femoral augmentation blocks. Replacement bumpers for the femoral component assembly and replacement hinge bearings for the tibial plateau assembly are also available.

DePuy P.F.C. TM SIGMA™ Total Knee Prosthesis and DePuy SIGMA™ Total Knee Prosthesis: The DePuy SIGMA™ and P.F.C.™ SIGMA® Total Knee Prosthesis is a total knee prosthesis composed of individually packaged femoral, tibial base, tibial insert and patellar components designed to replace the natural articular surface of the knee joint or after a failed previous implant. Some femoral and tibial components can be used with modular stems, porous and non-porous coated sleeves and/or modular augments when supplemental fixation is required in the judgement of the surgeon. The natural patella may or may not be resurfaced.

The provided text describes several knee prosthesis systems from DePuy, specifically outlining their intended use, indications for use, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to previously marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The devices in this application (ATTUNE™ Revision Knee System, DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves, DePuy Sigma PS Femoral Components, DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components, S-ROM™ NOILES™ Rotating Hinge Knee System, DePuy P.F.C.™ SIGMA™ Total Knee Prosthesis, DePuy SIGMA™ Total Knee Prosthesis) are being submitted with a modification to labeling to include updated MRI compatibility information and modernized/standardized language in the Instructions for Use (IFU) and labels. There are no changes in design, manufacturing, principle of operation, indication, or intended use of the devices themselves. Therefore, the "acceptance criteria" and "reported device performance" in this context relate to Magnetic Resonance (MR) Safety standards.

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

The document explicitly states: "No clinical tests were conducted to demonstrate substantial equivalence." The "tests" mentioned are non-clinical (bench testing) and refer to compliance with ASTM standards for MR safety and ANSI/AAMI for bacterial endotoxin. The document does not provide specific sample sizes for these non-clinical tests or their data provenance (e.g., country of origin, retrospective/prospective). It merely states that the tests were performed according to the specified standards.

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

This is not applicable as "No clinical tests were conducted." The ground truth for this submission is established through compliance with recognized industry standards for MR safety and bacterial endotoxin testing, not through expert-reviewed clinical data.

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

This is not applicable as "No clinical tests were conducted." The assessment is based on the results of non-clinical, standard laboratory tests.

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. The submission is for knee joint prostheses and concerns MR safety labeling, not an AI-assisted diagnostic or treatment system.

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

This is not applicable. The submission does not involve an algorithm or AI.

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

The "ground truth" for this submission is the compliance with established international and national standards for medical device safety, specifically:

• ASTM standards for Magnetic Resonance (MR) Environment safety (F2503-23, F2182-19E2, F2052-21, F2213-17, F2119-07).
• ANSI/AAMI ST 72:2019 for bacterial endotoxin testing.

8. The sample size for the training set:

This is not applicable as "No clinical tests were conducted." There is no "training set" in the context of this submission, which relies on non-clinical engineering and biological safety testing against established standards.

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

This is not applicable, as explained in point 8.

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The ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are intended for cementless use within the ATTUNE™ Total Knee Replacement System. Porous coated implants may be used with or without cement. Candidates for total knee replacement include patients with a severely painful and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).

The ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology are compatible with the ATTUNE Knee System composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant with or without porous coating. The tibial component may be comprised of a metal tibial base with or without porous coating, and a polyethylene insert and locking components, or be an all polyethylene device. The patella component may be of an all polyethylene design or a polyethylene patella with porous metal backing.

The FDA document provided is a 510(k) Premarket Notification clearance letter for a medical device: "ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology."

This document does not describe a study involving a medical device using Artificial Intelligence (AI). Instead, it concerns a physical orthopedic implant (a knee replacement component) and its substantial equivalence to previously cleared devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical, material, and chemical properties of the physical implant, and the tests performed to demonstrate their equivalence to a predicate device.

Therefore, I cannot provide information for the following points from your request as they are relevant only to AI/software-based medical devices, which this document does not cover:

• Sample sizes used for the test set and data provenance (e.g., country of origin, retrospective/prospective)
• Number of experts used to establish ground truth and their qualifications
• Adjudication method for the test set
• Multi-reader multi-case (MRMC) comparative effectiveness study and effect size
• Standalone (algorithm only) performance
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set
• How ground truth for the training set was established

However, I can extract information relevant to the physical device's acceptance criteria and the studies performed to demonstrate its substantial equivalence.

Here's what I can glean from the provided document regarding the physical device:

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

The document does not present a formal table of explicit numerical acceptance criteria for performance or a direct comparison to specific reported values for the new device. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests. The primary difference highlighted is the material grade.

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

Not applicable for this type of device. The tests mentioned (Oxygen Content Study, Recycling Study) are laboratory-based material and process characterization studies, not clinical trials with human patient data. Sample sizes would refer to the number of test coupons or components manufactured and tested, which is not specified in this summary.

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 is not an AI/clinical interpretation study. "Ground truth" in this context would refer to established material and mechanical standards, and the experts would be material scientists, engineers, and quality control personnel involved in the testing, not clinical "experts" establishing diagnostic ground truth.

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

Not applicable. This is not a study requiring adjudication of clinical interpretations.

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 a physical implant, not an algorithm.

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

For this physical device, the "ground truth" for material and manufacturing quality would be established by:

• International standards: Such as ASTM F-2924 and ASTM F-3001 for Titanium alloy chemistry, and other standards for mechanical properties (e.g., fatigue strength, tensile strength).
• Internal specifications and validation methodologies: Defined by the manufacturer based on engineering principles and regulatory requirements.
• Analytical chemistry and material characterization techniques: To determine oxygen content, microstructure, etc.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model.

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

Not applicable. This is a physical device, not an AI model.

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The VELYS Robotic-Assisted Solution is intended for stereotaxic surgery to aid the surgeon in identifying the relative position and orientation of anatomical structures, planning the position of the femoral and tibial implant components intraoperatively, and preparing the bones during unicompartmental knee arthroplasty.

When indicated for unicompartmental knee arthroplasty, the VELYS Robotic-Assisted Solution is indicated for use with the SIGMA HP Partial Knee Implants and INTUITION Instruments for SIGMA HP Partial Knee and their cleared indications for use.

The VELYS™ Robotic-Assisted Solution is an image-free robotic-assisted surgery system. It is intended for stereotaxic surgery to aid the surgeon in identifying the relative position and orientation of anatomical structures and landmarks, planning the position of the femoral and tibial implant components intraoperatively, and preparing the bones during total knee arthroplasty (TKA) and unicompartmental knee arthroplasty (UKA).

The image-free system uses a dedicated optical tracking device to acquire anatomical landmarks intra-operatively. These landmarks are then used to plan the femoral and tibial implant locations based on the surgeon's preferred surgical technique and placement preferences. Following the planning step, the VELYS™ Robotic-Assisted Solution helps the surgeon to execute the bone preparation according to the plan.

The system includes a Robotic-Assisted Device that constrion and orientation of the saw handpiece and blade inside each resection plane on the patient's femur and tibia. The surgeon actuates and manipulates the saw handpiece, within the planned resection plane, to execute the bone resection. This is analogous to using manual instruments in TKA or UKA. If the patient's leg moves during the resection, the Robotic-Assisted Device compensates for such movement in real-time.

The Robotic-Assisted Device is assembled with a Robotic-Assisted Device arm, mounted on the Operating Room (OR) bed rail, for a minimal footprint

The VELYS® Robotic-Assisted Solution incorporates several software subsystems, including applications responsible for general operation of the system and clinical applications dedicated to the surgery workflow.

The users interact with the clinical applications via a touchscreen and footswitch to navigate through the surgery steps. Case Reports including key surgical procedure information are stored on the system and can be retrieved by the surgeon for future use. Cases Reports including PHI are only available to the surgeon who performed the procedure.

The provided text describes a 510(k) submission for the VELYS Robotic-Assisted Solution, primarily focusing on its expanded indication for unicompartmental knee arthroplasty (UKA). The document outlines the device's intended use, technological characteristics, and the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Based on the provided document, here's a breakdown of the requested information:

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

The document mentions "Performance testing activity included," followed by a list. However, it does not explicitly state specific quantifiable acceptance criteria or the numerical results for these tests. It only lists the types of tests performed.

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

The document states:

• "Bench testing was performed on the subject device, VELYS™ Robotic-Assisted Solution for Unicompartmental Knee Arthroplasty (UKA)..."
• "Cadaveric Resection Accuracy and Soft Tissue Study" was performed.

The sample sizes for the test sets (e.g., number of cadavers, number of test runs) are not specified in the provided text.
The data provenance is generally "Bench testing" and "Cadaveric Study," implying a controlled laboratory environment. The country of origin of the data and whether it was retrospective or prospective is not specified.

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)

The document does not provide information on the number of experts used or their qualifications to establish ground truth for any of the performance tests. The focus is on technical performance rather than clinical interpretability requiring expert adjudication.

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

Given that the performance tests are largely technical (e.g., robotic alignment, resection accuracy), rather than diagnostic interpretations, adjudication methods like 2+1 or 3+1 are not applicable and are not mentioned in the 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

The document explicitly states: "No clinical data was necessary to support the determination of substantial equivalence."
Therefore, an MRMC comparative effectiveness study was not performed for this submission. The device is a robotic-assisted surgical tool, not an AI-powered diagnostic imaging tool that would typically involve human reader studies.

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

The device is described as a "Robotic-Assisted Device" where "The surgeon actuates and manipulates the saw handpiece, within the planned resection plane, to execute the bone resection." While the system has "Robotic-Assisted Device" that "compensates for such movement in real-time," it is fundamentally a human-in-the-loop system. The tests mentioned (e.g., resection accuracy, dynamic compensation) assess the integrated human-robot system's performance, rather than a standalone AI algorithm without human interaction.

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

For the "Cadaveric Resection Accuracy and Soft Tissue Study," the ground truth for resection accuracy would likely be precise measurements of the actual bone cuts compared to the planned cuts post-resection using highly accurate metrology (e.g., CMM, 3D scanning). For other tests like "Sagittal Border Guard Evaluation" and "Dynamic Compensation Performance Test," the ground truth would be engineering specifications and measurements of the robot's or system's physical behavior against those specifications. The document doesn't specify the exact methods for ground truth establishment, but it is implied to be based on physical measurements against design specifications.

8. The sample size for the training set

This device is not an AI/ML device in the sense that it performs a diagnostic or predictive function learned from a large dataset. It is a robotic-assisted surgical system with software that aids in planning and execution. Therefore, the concept of a "training set" in the context of machine learning model development is not applicable to the information provided. The system's "training" would be its engineering design, calibration, and validation rather than statistical learning from a dataset.

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

As the concept of a "training set" in the AI/ML context is not applicable here, the method for establishing its ground truth is also not relevant/described. The "ground truth" for the device's functionality would be its design specifications and physical principles.

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

The PINNACLETM Constrained Acetabular Liner is indicated for use with the PINNACLETM Acetabular Cup in cementless application.

The PINNACLE™ Constrained Acetabular Liner is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The liner is manufactured from ultra-high molecular weight polyethylene (UHMWPE), which locks into a porous coated, hemispherical outer shell component manufactured from titanium alloy (Ti-Al6-V4). The liner component articulates with a metal femoral head of an appropriate diameter.

The PINNACLE™ Constrained Acetabular Liner mechanically constrains the femoral head within the inner diameters of the liner by providing greater than 180 degrees femoral head capture combined with a titanium constraining ring which fits over the opening diameter of the liner. The UHMWPE liner is held in the metal shell by means of a titanium locking ring.
The PINNACLE™ Constrained Acetabular Liners are UHMWPE acetabular cup liners that are available in a lateralized neutral or lateralized face-changing orientation. The liners have inner diameters compatible with standard metal femoral heads sized 28, 32, and 36mm, as well as larger diameter unipolar, Self-Centering (bipolar) and Modular M femoral heads sized 40 and 44mm. The outer diameters (OD) are geometrically the same as other Pinnacle Acetabular Liners, in a 48mm-76mm size range offering.

This document is a 510(k) premarket notification for the PINNACLETM Constrained Acetabular Liners. The submission is not for a new device but for an expansion of the labeling to include updated MRI compatibility information, standardization of language and symbols, and inclusion of new internationally recognized symbols and implant cards for international markets. Crucially, the document states: "There is no change to the indications, intended use, safety, fit, form or technological characteristics of the devices."

Therefore, the acceptance criteria and study information typically associated with a new or significantly modified device, especially regarding clinical performance or algorithm evaluation, are not provided in this regulatory document. The focus of this submission is on demonstrating the device's acceptable performance in an MRI environment.

Here's an analysis based on the provided text, but it will be limited due to the nature of the submission:

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

The document focuses on MRI safety evaluation. The acceptance criteria are implicit in the adherence to established ASTM standards for MRI compatibility. The reported performance indicates that the device met these standards.

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

The document refers to "Non-clinical testing" and "full test data present and reviewed in the FDA cleared submission 'K231873 - DePuy Hip Portfolio MRI Bundled Traditional 510(k)'". This indicates that the testing was non-clinical (ex-vivo/in-vitro), not involving human subjects. The sample size would refer to the number of devices or components tested, but this specific detail (the exact number of liners tested) is not provided in this document. The provenance is not explicitly stated beyond "DePuy Ireland UC" as the submitter, implying the testing was conducted or overseen by them.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the study involved non-clinical MRI safety testing of a physical device, not an AI or diagnostic device requiring human expert ground truth establishment.

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

This is not applicable for non-clinical testing of device properties like MRI compatibility.

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

An MRMC study was not done. This submission 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. This submission is for a physical orthopedic implant, not an algorithm.

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

The "ground truth" here is the objective measurement of physical properties of the device under MRI conditions, compared against the limits established by the referenced ASTM standards.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable for the same reason as above.

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ATTUNE™ Total Knee System Indications for Use
Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

ATTUNE™ Cementless Knee System Indications for Use
The ATTUNE™ Cementless CR and PS Femoral Components are intended for cementless use within the ATTUNE™ Total Knee Replacement System.
Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).

LPS TM Limb Preservation System Indications for Use
The DePuy LPS System is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:

• · malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement;
• · patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement;
• · revision cases for a failed previous prosthesis requiring extensive resection and replacement;
• · severe trauma requiring extensive resection and replacement.
  The LPS System is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.
  The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only.
  The porous-coated metaphyseal sleeves are intended for either cemented or cementless applications.

Sigma™ High Performance (HP) Partial Knee System Indications for Use
The SIGMA™ High Performance Partial Knee System is indicated for single compartmental knee replacement in skeletally mature individuals with osteoarthritis, post-traumatic arthritis of the tibiofemoral surfaces or a history of gout or pseudogout. All components are intended for CEMENTED USE ONLY.

ATTUNE™ Total Knee System: A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.

ATTUNE™ Cementless Knee System: A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant with or without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.

LPS - Limb Preservation System: The DePuy LPSTM Limb Preservation System is designed for the replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia. The DePuy LPS system offers a variety of component options (including, but not limited to, proximal femoral bodies, segmental components, distal femoral components, femoral stems, tibial stems, proximal tibial components, hinged tibial insert bearings, metaphyseal sleeves, and adapters). The components, which can be used in conjunction with certain components from other systems, are for treatment of patients presenting bone loss and deformity associated with bone tumors resection, trauma, infection, and difficult revision arthroplasty. A total femoral replacement is possible in those cases where no part of the femur can be salvaged.

Sigma High Performance (HP) Partial Knee System: The DePuy SIGMATM High Performance Partial Knee System is a single compartmental knee prosthesis, composed of individually packaged femoral, and tibial components designed to be used in various combinations to replace the natural articular surfaces of the knee joint. The unicompartmental femoral components are Co-Cr-Mo metal implants. The metal backed tibial components are Co-Cr-Mo with polyethylene inserts. The all-polyethylene unicompartmental tibial component are manufactured from polyethylene. The unicompartmental femoral components are designed for individuals who require a higher than normal degree of flexion (up to 155°).

This document (K233980) is a 510(k) premarket notification for several DePuy knee systems. It primarily focuses on adding updated MRI compatibility information and standardizing language in the Instructions for Use (IFU) and labels. The core claim for substantial equivalence relies on non-clinical performance data related to MRI safety and bacterial endotoxin testing, rather than a clinical study of device performance in a human-in-the-loop or standalone AI context.

Therefore, the requested information regarding acceptance criteria, study design for device performance, sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided from this document as it pertains to a different type of device (knee implants) and regulatory submission (510(k) for labeling changes related to MRI safety, not an AI/software as a medical device performance study).

However, I can extract the acceptance criteria for the non-clinical performance tests that were conducted, and the reported performance as implied by the conclusion of substantial equivalence.

Here's what can be extracted and what cannot:

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

For MRI safety, the acceptance criteria are implicit in meeting the standards listed. The reported "performance" is that the devices meet these standards, thus proving MRI safety.

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

• Sample Size: Not applicable in the context of clinical or AI performance. The "test set" here would refer to the physical devices tested for MRI compatibility and bacterial endotoxin. The document does not specify the number of individual devices subjected to these non-clinical tests.
• Data Provenance: Not applicable for a typical AI/software study. The "data" here are the results from physical and chemical testing of the devices.

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

• This is not applicable as there is no "ground truth" established by experts in the context of an AI or diagnostic device study. The ground truth for these tests is defined by the physical properties measured according to established ASTM and ANSI standards.

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

• This is not applicable as this is not an image-based or diagnostic AI study requiring human 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

• No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical tests were conducted to demonstrate substantial equivalence." (pages 6, 9, 12, 15)

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

• This is not applicable as the device is a knee implant, not an algorithm or software. The "performance" assessment is of the physical and material properties of the implant itself in relation to MRI safety.

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

• The "ground truth" for the non-clinical tests is established by the physical and chemical properties measured according to the specified ASTM and ANSI international standards for MRI compatibility and bacterial endotoxin levels.

8. The sample size for the training set

• Not applicable. There is no AI model or training set involved in this regulatory submission.

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

• Not applicable. There is no AI model or training set involved in this regulatory submission.

In summary: This FDA 510(k) submission for DePuy knee systems is related to changes in labeling for MRI compatibility, not an AI/software/diagnostic device. The "study" described focuses on non-clinical bench testing to demonstrate MRI safety and bacterial endotoxin compliance, adhering to recognized industry standards, rather than clinical performance or AI algorithm validation.

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