Search Results

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.

Ask a specific question about this device

The DePuy LPS System is intended for use in replacement 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, ciant 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 cementless applications.

The ATTUNE® Revision Sleeve LPS™ Femoral Adaptors are designed as a component in the replacement of the natural articular surface of the knee joint or of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia. The ATTUNE Revision Sleeve LPS Femoral Adaptors are to be used to connect an ATTUNE Revision Femoral Sleeve to LPS System Components.

This document is a 510(k) summary for the ATTUNE® Revision Sleeve LPS™ Femoral Adaptors. It is a premarket notification for a medical device, which generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data for new acceptance criteria.

Based on the provided text, the device itself is a component of a knee replacement prosthesis, specifically an adaptor. The "performance data" section focuses on non-clinical tests to demonstrate substantial equivalence, not a study to prove acceptance criteria for a diagnostic AI device.

Therefore, many of the requested fields regarding acceptance criteria, study design for AI performance, sample sizes, ground truth establishment, and MRMC studies are not applicable to this document as it describes a mechanical orthopedic implant, not an AI/ML-driven diagnostic device.

Here's a breakdown of the information that can be extracted or inferred:

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

Since this is a mechanical device, the "acceptance criteria" are related to mechanical strengths, biocompatibility, and MRI safety, not a diagnostic performance metric like sensitivity or specificity.

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

This information is not provided as the tests are non-clinical (mechanical, material, safety) rather than clinical studies with patient data. The "test set" would refer to the number of physical devices or components tested.

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. Ground truth, in the context of expert consensus, is typically for diagnostic interpretation. For mechanical devices, material science and engineering standards define performance.

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

This is not applicable as it refers to expert adjudication for diagnostic ground truth.

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

A MRMC comparative effectiveness study is not applicable as this is not an AI/ML diagnostic or assistive device.

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

This is not applicable as this is not an AI/ML algorithm.

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

For mechanical aspects: Engineering standards and test methodologies serve as the "ground truth" for performance.
For biocompatibility: ISO standards for biological evaluation of medical devices.
For MRI safety: ASTM standards for testing medical devices in MRI environments.
For endotoxin testing: ANSI/AAMI ST 72:2019 standard.

8. The sample size for the training set

This is not applicable as there is no AI/ML model involved.

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

This is not applicable as there is no AI/ML model involved and therefore no "training set."

Ask a specific question about this device

The ATTUNE Revision LPS Insert is intended for use in prosthetic constructs for replacement of distal femur and resurfacing of the proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:

· malignant tumors (e.g., osteosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement;

· patient conditions of non-inflammatory degenerative joint disease (NIDJ), 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.

· post-infection bone loss, where the surgeon has elected to excise the bone and replacement is required.

The ATTUNE Revision LPS Inserts are designed to replace the tibio-femoral articular surface of the knee joint when used in conjunction with a femoral, tibial, patellar, and other associated prostheses as required. The ATTUNE Revision LPS Insert consists of an AOX™ Antioxidant Polyethylene bearing, AOX Antioxidant Polyethylene bushings, and a forged cobalt chrome molybdenum hinge post.

This document describes the FDA's clearance of the ATTUNE® Revision LPSTM Inserts, a medical device. It does not contain information about an AI/ML-driven device or study results related to AI performance. Therefore, I cannot extract the requested information to describe acceptance criteria and study that proves the device meets the acceptance criteria for an AI/ML-driven device.

The provided text pertains to a knee joint prosthesis and its 510(k) premarket notification to the FDA. The "acceptance criteria" and "study" discussed in this document relate to the mechanical performance, materials, and manufacturing processes of this physical medical device, demonstrating its substantial equivalence to previously cleared predicate devices.

Specifically:

• Acceptance Criteria and Device Performance: These are detailed under "Non-Clinical Testing" on page 4. The device performance is deemed acceptable if it meets the requirements of the listed functional verification tests (e.g., A/P Shear Fatigue, Insert Subluxation, Hinge Post Fatigue) and ANSI AAMI ST-72:2011 for bacterial endotoxin testing. The document states that the testing "verified that the implant performance is substantially equivalent to predicate devices for anticipated in-vivo loading."
• Sample size for test set and data provenance: Not applicable in the context of AI/ML. The "test set" here refers to the prototypes of the physical device or materials used for mechanical and material testing. The document doesn't specify the exact number of physical units tested but refers to standard engineering tests.
• Number of experts and qualifications, adjudication method, MRMC study, standalone performance: These concepts are relevant to the evaluation of AI/ML models, not physical medical devices like a knee implant. Therefore, this information is not present.
• Type of ground truth: For this physical device, the "ground truth" is defined by established engineering and biomechanical principles, industry standards (e.g., FDA Guidance, ANSI AAMI ST-72:2011), and comparison to the performance of predicate devices.
• Training set sample size and ground truth establishment for training set: Not applicable to a physical device. There's no "training set" in the AI/ML sense. The "training" for such a device would involve its design, manufacturing processes, and quality control, ensuring it meets established specifications.

Ask a specific question about this device

The DePuv LPS 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 ioint 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. .

It 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 and diaphyseal sleeves are intended for either cemented or cementless applications.

The technological characteristics of the DePuy LPS Universal Technological Hinge Insert Assembly are similar to the predicate devices Characteristics: including design, performance and material type.

This is a 510(k) summary for a medical device (DePuy LPS Universal Hinge Insert Assembly) and does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document discusses:

• The device's intended use and classification.
• Its substantial equivalence to predicate devices based on design, performance, and material type, as demonstrated by pre-clinical data (not clinical study data).
• The FDA's decision to clear the device for market.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment. The provided text is a regulatory filing, not a scientific study report.

Ask a specific question about this device

The MedX LPT 200 single diode tethered laser is a part of the infrared console system, as per 21 CFR 890.5500. The device is used when heat is indicated for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.

The MedX LPS 200 single diode Portable Laser is a rechargeable infrared device, as per 21 CFR 890.5500. The device is used when heat is indicated for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.

The MedX LPT 200 is a single diode. 200 mW tethered laser powered and controlled by the MedX 1100 Console. The MedX LPS 200 Portable Laser is a single diode, 200 mW laser that has embedded control and contains a rechargeable battery. The two devices have substantially equivalent output parameters. Both of these products use 808 nm near infrared laser diodes. Additionally these devices have been designed to produce therapeutic heating for the same indications of use as described in the ILY category. Therefore the requested indications of use for these two devices; when heat is indicated for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, and minor pain and stiffness associated with arthritis.

Both of the MedX Laser devices in this submission utilize a single semiconductor laser diode emitting approximately 200 mW (maximum + or - 10%) at the end of the fiber optic light guide. Both laser devices use 808 nm GaAlAs (galliumaluminum-arsenide) laser diodes.

The LPS 200 Portable Laser produces only continuous mode light at 808 nm. The tethered MedX laser is powered by the MedX 1100 console and is capable of continuous duty cycle or pulsing at 8, 146 and 1000 Hz at 80% duty cycle. The console and portable automatically turns itself off after the set treatment time has been delivered.

The MedX LPT 200 Tethered Laser and MedX LPS 200 Portable Laser are medical devices intended for therapeutic heating.

1. Table of Acceptance Criteria and Reported Device Performance

• Utilize single semiconductor laser diode emitting ~200 mW (maximum +/- 10%) at 808 nm.
• LPS 200 Portable Laser: Continuous mode light at 808 nm.
• LPT 200 Tethered Laser (with MedX 1100 Console): Continuous duty cycle or pulsing at 8, 146, and 1000 Hz at 80% duty cycle.
• Automatic shut-off after set treatment time. | * Devices have "substantially equivalent output parameters" to predicate devices (MedX 1100 Console, LCS 100 Portable Laser, LCT 100 Tethered Laser - K032231).
• Both devices use 808 nm GaAlAs laser diodes emitting "approximately 200 mW (maximum + or - 10%)".
• LPS 200 produces "only continuous mode light at 808 nm".
• LPT 200 (with console) is "capable of continuous duty cycle or pulsing at 8, 146 and 1000 Hz at 80% duty cycle".
• Both devices "automatically turn itself off after the set treatment time has been delivered". |
  | Safety | * Meet mechanical safety requirements.
• Meet electrical safety requirements.
• Meet thermal safety requirements.
• Meet environmental conditions requirements.
• Meet electromagnetic compatibility (EMC) requirements.
• Meet temperature control requirements.
• Safe for intended use. | * Testing was carried out across "mechanical, electrical, firmware, thermal safety, environmental conditions and electromagnetic compatibility, temperature control and irradiation distribution patterns".
• Devices "have been found to be safe in all areas for the intended use".
• "Meets the requirements of international and US medical electrical equipment standards for safety". |
  | Effectiveness | * Ability to warm surface temperature.
• Provide relief of minor aches and pains associated with minor muscle and tissue injury.
• Temporary increase in local blood circulation.
• Temporary relief of minor muscle and joint aches, pains, and stiffness.
• Relaxation of muscles.
• Relief for muscle spasms.
• Relief for minor pain and stiffness associated with arthritis. | * "Clinical practice in Canada has demonstrated the ability... to warm the surface temperature and provide relief of minor aches and pains associated with minor muscle and tissue injury."
• Specific heat testing data is available in Appendix I (not provided here).
• "Clinical practice and academic research demonstrate the successful use of the infrared lamp when heat is indicated for temporary increase in local blood circulation, temporary relief of minor aches and pains associated with minor muscle and minor joint pain associated with arthritis." |
  | Premarket Equivalence | * Substantial equivalence to predicate device K032231. | * "Technological characteristics are a combination of the predicate Device - K032231."
• "Indications for use are identical to these predicate products."
• FDA determined the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." |

Description of the Study Proving Device Meets Acceptance Criteria

The provided text describes a 510(k) submission for the MedX LPT 200 Tethered Laser and MedX LPS 200 Portable Laser. This is a premarket notification to demonstrate that the device is substantially equivalent to a legally marketed predicate device, rather than a de novo clinical trial to prove efficacy from scratch.

Here's a breakdown of the information requested:

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

• Sample Size: Not applicable. No new clinical trials were conducted. The submission relies on existing "clinical practice in Canada" and "over 30 years of research and clinical experience" with therapeutic heating, in addition to specific non-clinical heat testing.
• Data Provenance: Clinical data provenance is described as "clinical practice in Canada" and general "over 30 years of research and clinical experience." The "heat testing data" in Appendix I is non-clinical. The specific origin of test sets for mechanical, electrical, thermal, environmental, and EMC testing is not detailed beyond being "carried out" on the devices.

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

• Not explicitly stated. The submission refers to "clinical practice in Canada" and "academic research" which would implicitly involve healthcare professionals and researchers, but no specific number or detailed qualifications of experts are provided for a defined test set's ground truth.

4. Adjudication method for the test set:

• Not applicable. There is no mention of a specific adjudication method for a test set in the context of a new clinical study. The determination of substantial equivalence is made by the FDA based on the provided documentation.

5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study:

• No, a MRMC comparative effectiveness study was not done. The submission explicitly states: "No new clinical trials were performed on the submitted products for this 510(k) submission."

6. Standalone (algorithm only without human-in-the-loop performance) study:

• Not applicable. This device is a laser therapy product, not an AI algorithm. Its performance is assessed directly through its physical output and functional capabilities, as well as its clinical indications supported by prior art.

7. Type of ground truth used:

• The "ground truth" for effectiveness relies on:
  • Clinical Practice/Experience: "Clinical practice in Canada" and "over 30 years of research and clinical experience with therapeutic heating."
  • Academic Research: Cited as demonstrating successful use of infrared lamps for similar indications.
  • Non-Clinical Test Data: "Heat testing data" (Appendix I) demonstrating the ability of the device to warm the surface temperature.
  • Substantial Equivalence: The primary "ground truth" for regulatory approval in a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device.

8. Sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for the device's efficacy comes from historical clinical practice and research on therapeutic heating in general, and the predicate devices in particular.

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

• Not applicable, as there is no training set in the context of an AI algorithm. The basis for the claims of safety and effectiveness are established through:
  • Demonstration of identical indications for use to predicate products.
  • Documentation of technological characteristics being a combination of the predicate device.
  • Non-clinical testing (mechanical, electrical, firmware, thermal safety, environmental, EMC, temperature control, irradiation patterns) confirming functional and safety requirements.
  • Leveraging existing clinical experience and research on the predicate devices and the modality of therapeutic heating.

Ask a specific question about this device

The DePuy LPS 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 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 subject DePuy LPS Distal Femoral Component is a modular component that is designed to replace the distal portion of the femur. Unlike primary knee systems, the LPS System is used when the amount of bone resection and replacement is extreme (e.g. in oncology cases or endstage revision).

The LPS Distal Femoral Component is manufactured from cobalt-chromemolybdenum alloy and is available in two sizes, X-small low profile and XX-small, both in left and right configurations. The surface has a highly polished mirror finish for smooth articulation with the polyethylene component of the tibial plateau/hinge assembly and the resurfaced patella.

This document is a 510(k) summary for a medical device called the "DePuy LPS Distal Femoral Component." It describes the device's intended use, indications for use, and establishes its substantial equivalence to previously cleared predicate devices. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through testing.

Therefore, I cannot provide a detailed response to your request, as the information you are asking for (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, etc.) is not present in the provided text.

This 510(k) submission focuses on demonstrating the new device's substantial equivalence to existing devices based on design, materials, packaging, and sterilization, rather than presenting original clinical or performance study data with specific acceptance criteria.

Ask a specific question about this device

General Indications for the NexGen Complete Knee Solution Femoral Components:

• This device is indicated for patients with severe knee pain and disability due to:
• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration. particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

Porous coated femoral components may be used cemented or uncemented (biological fixation).

Specific Indications for the LPS-Flex Porous Femoral Components:

• · LPS- Flex porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation).
• · Specific uses with the LPS-Flex femorals:

Intended Use:

• Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
• The LPS-Flex femoral, when used with the LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.

Specific Indications for the NexGen Knee GSF Knee Porous Femoral Components:

• · CR-Flex GSF and LPS-Flex GSF porous coated femoral components may be used cemented or uncemented (biological fixation).
• · Specific uses with CR-Flex GSF or LPS-Flex GSF femorals:
• Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
• The CR-Flex GSF femoral, when used with 90prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong" Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee® Flex Congruent articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.
• The LPS-Flex GSF femoral, when used with LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees.

The LPS-Flex Fixed-bearing Knee is a semi-constrained, condylar system for use without the cruciate ligaments when additional stability is required to prevent anterior subluxation of the femur relative to the tibia in flexion. The LPS-Flex Porous femoral component is designed to have a maximum active, load bearing range of motion of 155 degrees. It contains a fiber metal pad to allow for cementless use.

The GSF Porous femoral components include both LPS-Flex GSF and CR-Flex GSF versions and are part of the Zimmer Flex-series of semi-constrained, non-linked, condylar knee prostheses that are designed to have a maximum active, load bearing range of motion of 155 degrees. The GSF designation indicates that the femoral component is designed to better match distal femoral anatomic features more typical of female patients. They contain fiber metal pads to allow for cementless use.

The provided document is a 510(k) summary for a medical device (NexGen® Complete Knee Solution LPS-Flex Porous Femoral Component, NexGen Knee Gender Solutions™ Female (GSF) Porous Femoral Components). It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information related to software or AI-driven diagnostic devices, nor does it present specific acceptance criteria or a study proving that such criteria are met.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies for an AI device from this document. The document explicitly states:

"Clinical data and conclusions were not needed for these devices."

And the performance data section states:

"Mechanical testing of the proposed devices indicate that they are substantially equivalent to the predicate devices."

This indicates that the clearance for these orthopedic implants was based on substantial equivalence to existing predicate devices, primarily through non-clinical mechanical testing, rather than through clinical studies with acceptance criteria as would be typical for a diagnostic or AI-driven device.

Ask a specific question about this device

The DePuy LPS Diaphyseal and Metaphyseal Sleeves are intended for use in primary and revision knee joint replacement in the treatment of patients presenting bone loss and deformity associated with bone tumors resection, trauma, infection, and difficult revision arthroplasty.

The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with distal femoral, proximal femoral, and proximal tibial replacements. The metaphyseal sleeve is intended to enhance the fit and fill of the metaphyseal region of the distal femur with femoral replacements.

The DePuy LPS 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 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 diaphyseal and metaphyseal sleeves are intended for either cemented or cementless applications.

The DePuy LPS Diaphyseal Sleeve is a modular, porous-coated, cone-shaped component designed to enhance the fit and fill of the diaphyseal femoral canal with distal femoral, proximal femoral and proximal tibial replacements. The existing LPS Metaphyseal Sleeve (K040281) is a modular, porous-coated, flared component designed for enhanced fit and fill of the metaphyseal region of the distal femur with femoral replacements. Both are manufactured from titanium alloy.

This 510(k) Pre-Market Notification provides information about a medical device rather than a study evaluating device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes is not available in the provided document.

A 510(k) submission primarily demonstrates "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical trials or detailed performance studies.

Here's a breakdown of what can be extracted and what cannot:

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

Not applicable. The document does not describe acceptance criteria and performance data in the way a clinical study or validation report would. The basis of substantial equivalence relies on similarity to predicate devices in intended use, indications for use, materials, and design, not on meeting specific quantitative performance metrics defined by acceptance criteria in a study.

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. No test set or associated data provenance is mentioned.

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

Not applicable. No ground truth establishment is described for a test set.

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

Not applicable. No adjudication method is 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. This device is a physical orthopedic implant (sleeves for knee replacement), not an AI-assisted diagnostic tool.

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

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

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

Not applicable. No ground truth is described.

8. The sample size for the training set

Not applicable. This device is a physical orthopedic implant, and as such, there is no "training set" in the context of an AI or software algorithm.

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

Not applicable. There is no training set mentioned.

Ask a specific question about this device

The DePuy LPS 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., theumatoid 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 is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.

The distal femoral component, the S-ROM Tibial Tray and the non-porous coated straight and bowed stems are intended for cemented use only.

The DePuy LPS Proximal Tibial Component is a modular component that is designed to replace the proximal portion of the tibia. Unlike primary knee systems, the LPS System is used when the amount of bone resection and replacement is extreme (e.g. in oncology cases or endstage revision).

The distal end of the LPS Proximal Tibial Component has a female Morse-type taper that is designed to accept either a DePuy LPS Segment Component or a tibial stem. The proximal/superior surface is designed with a central stem hole to allow it to accept the stem of the LPS tibial plateau/hinge assembly. The top surface has a highly polished mirror pr nish for smooth articulation with the polyethylene component of the tibial plateau/hinge assembly. The anterior surface has a Porocoat beaded Co-Cr-Mo porous coating.

This document is a 510(k) summary for a medical device called the "DePuy LPS Proximal Tibial Component." It describes the device, its intended use, and its substantial equivalence to previously cleared devices. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it involve an AI/algorithm-based device.

Therefore, I cannot provide the requested information in the format specified because the input text does not contain any of the details required for such a response, particularly regarding acceptance criteria, performance metrics, ground truth, expert involvement, or AI/algorithm performance studies.

Based on the provided text, none of the requested information (acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment) is available as this is a traditional medical device submission, not an AI-powered one.

Ask a specific question about this device

The LPS Upper Extremity is intended for use in replacement of the proximal, mid-shaft or intercalary portion, distal and/or total humerus. This system is especially designed for cases that require extensive resection and restoration. Specific diagnostic indications for use include:

• Primary bone neoplasnms (e.g., osteosarcomas, chondrosarcomas, Ewing's sarcomas) requiring extensive resection(s) and replacement(s) of the proximal and/or distal humerus;
• Metastatic bone disease and pathologic fractures with extensive bone loss or where other forms of treatment such as internal fixation are inadequate;
• Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (JD), e.g., rheumatoid arthritis, requiring extensive resection and replacement of the proximal and/or distal humerus;
• Patients suffering from congential or acquired deformity, such as post-traumatic deformity and/or arthritis;
• Communited fractures of the proximal, distal and/or humeral shaft where forms of fixation are indadequate;
• Persistent humeral fracture non-union;
• Patients suffering from severe cuff tear arthropathy that does not respond to any conservative therapy or better alternative surgical treatment;
• Revision shoulder or elbow arthroplasty cases requiring extensive resection(s) and replacements of the proximal, distal or total humerus.
• Severe trauma requiring extensive resection and replacement.
  The LPS Upper Extremity components are for CEMENTED USE ONLY.

The LPS Upper Extremity components are designed for the replacement of the mid-shaft or intercalary portion of the humerus, proximal, distal and/or total humerus. Unlike primary shoulder and elbow systems, this system is used when the amount of resection and restoration is extreme (e.g. in oncology cases, end-stage revision). A total humeral replacement is possible in those cases where no part of the humerus can be salvaged.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance results, or any study conducted to prove the device meets specific criteria. The document is a 510(k) summary for the 'LPS Upper Extremity' device, which outlines its indications for use, device description, and substantial equivalence to previously cleared devices. It does not include details on clinical trials, performance testing, sample sizes, expert ground truth establishment, or any comparative effectiveness studies. Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving the device meets them based on the given information.

Ask a specific question about this device