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The Pinnacle® Constrained Polyethylene 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 of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

The Pinnacle™ Constrained Liner is indicated for use with the Pinnacle® Acetabular Cup in cementless application.

The subject Constrained Liner is intended to be used with the DePuy Pinnacle™ metal acetabular shells, and modular femoral heads to resurface the acetabular socket in cementless total hip arthroplasty.

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-6Al-4V). The liner component articulates with a metal femoral head of an appropriate diameter.

The Pinnacle® Constrained Liner mechanically constrains the femoral head within the ID 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 UHMWPE liner is held in the metal shell by means of a titanium locking ring.

The subject Pinnacle® Constrained Liners are UHMWPE acetabular cup liners that are available in a lateralized neutral or lateralized face-changing orientation. The liners have inner diameters (ID) intended for use with modular femoral heads within the 28mm-36mm size range. The outer mended for assemmer metrically the same as other Pinnacle Acetabular Liners, in a 48mm-60mm size range offering.

The provided text describes a medical device submission (K043058) for the DePuy Pinnacle® Constrained Acetabular Liners. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for AI/algorithmic performance evaluation.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices based on similarities in design, intended use, materials, and manufacturing methods. It states: "The design, while not identical to the predicates, does not raise any new issues of safety or effectiveness." This implies that extensive new performance studies (especially in the context of AI/algorithmic output) were likely not required, as the device is built upon established technology and similar to already cleared devices.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about the study, sample size, ground truth, experts, or adjudication methods because this information is not present in the provided text.

The document states:

• Device Name: DePuy Pinnacle® Constrained Acetabular Liners
• Indications 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 of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability. Also indicated for use with the Pinnacle® Acetabular Cup in cementless application.
• Basis of Substantial Equivalence: Similarities in design, intended use, material, and manufacturing methods to predicate devices (Biomet RingLoc II, Biomet Freedom, DePuy SROM™ Poly-Dial, DePuy Duraloc® Acetabular Cup System Constrained Liners).

Without information on a specific study related to AI/algorithmic performance, I cannot provide the requested details.

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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.

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The LPS Intercalary component is intended for use in primary and revision knee joint replacement and in oncology cases with the Limb Preservation System (LPS). The previously cleared indications for use for this system are the following:

The 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., osteosarcoma, chondrosarcoma, 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 distal femoral component, the tibial components, tibial stems, metaphyseal sleeves, and the non-porous coated straight and bowed stems are intended for cemented use only.

The intercalary component serves as a segmental component in the previously cleared Limb Preservation System (LPS, K003182). The dovetail intercalary component is a 3piece assembly 55 mm in length. The three pieces are comprised of a male segment, a female segment and a connecting pin. The male-female parts connect as a dovetail connection and locked with a pin screwed through both segments. The dovetail intercalary component is made of cobalt chrome.

The provided text is a 510(k) summary for a medical device called the "LPS Lower Extremity Dovetail Intercalary." This document is a regulatory submission to the FDA, primarily focused on establishing substantial equivalence to a previously cleared device. It does not describe a clinical study or performance testing with specific acceptance criteria that demonstrate the device meets those criteria.

Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, expert ground truth, adjudication, MRMC studies, or standalone performance studies cannot be extracted from this document, as they are not present.

The 510(k) summary explicitly states: "The substantial equivalence of the LPS Dovetail Intercalary is substantiated by its similarity in sterilization, packaging and indications for use to the LPS (K003182 cleared on June 27, 2001). The design and materials of the LPS Dovetail Intercalary have been modified from the existing LPS Intercalary component cleared in K003182, however DePuy believes this new component is substantially equivalent."

This indicates that the primary "study" or evidence for this device is a comparison to a predicate device (K003182) to demonstrate substantial equivalence, rather than a de novo clinical study with new performance criteria.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document does not describe specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity, mechanical strength thresholds) for the device itself, nor does it report device performance against such criteria. The focus is on substantial equivalence to a predicate device rather than de novo performance testing against new metrics.

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

• Cannot be provided. No test set or data provenance from a performance study is described.

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)

• Cannot be provided. No test set requiring expert-established ground truth is described.

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

• Cannot be provided. No test set requiring adjudication 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

• Cannot be provided. This device is a total knee prosthesis component, not an AI or imaging device, so an MRMC study is not relevant and not discussed.

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

• Cannot be provided. This device is a physical implant, not an algorithm. Standalone performance for an algorithm is not applicable.

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

• Cannot be provided. As no specific performance study is detailed, no ground truth type is mentioned.

8. The sample size for the training set

• Cannot be provided. This device is a physical implant, not a machine learning model, so there is no concept of a "training set."

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

• Cannot be provided. Not applicable (see point 8).

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The 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 distal femoral component, the tibial components, and the non-porous coated straight and bowed stems are intended for cemented use only.

The LPS components are designed for the replacement of the mid-shaft portion of the femur. proximal, distal and/or total femur, and proximal tibia. Unlike primary hip and knee systems, this system is used when the amount of resection and restoration is extreme (e.g. in oncology cases, endstage revision). A total femoral replacement is possible in those cases where no part of the femur can be salvaged.

The provided text is a 510(k) Summary for a medical device called LPS (Total Knee Prosthesis/Femoral Stem Prosthesis). This document details the device's intended use, description, and its claim of substantial equivalence to previously cleared devices.

Crucially, this document is a 510(k) Summary for a device (a prosthetic implant), not an AI/ML-driven medical device or software product that would typically involve acceptance criteria and a study proving its performance in the manner requested.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, standalone performance, and training sets is not applicable to this type of medical device submission.

Here's an explanation based on the provided text, highlighting what is and isn't available:

1. Table of Acceptance Criteria and Reported Device Performance

• Not Applicable in the traditional sense for an AI/ML device. This document is for a physical orthopedic implant. Acceptance criteria for such devices typically revolve around mechanical testing, biocompatibility, sterilization validation, and conforming to relevant material standards. These are usually established through compliance with voluntary performance standards (as mentioned in section E) and internal company specifications, rather than clinical performance metrics like sensitivity, specificity, or AUC as seen in AI/ML products.
• Reported Device Performance: The document states that the substantial equivalence is based on:
  • Similarity in design, sterilization, and packaging to the LPS (K003182).
  • Similarity in materials (cobalt chrome) to the S-ROM Noiles Rotating Hinge Knee (K870730).
  • Similarity in indications for use to the Howmedica Global Modular Replacement System (GMRS) (K023087).

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

• Not Applicable. There is no "test set" in the context of an AI/ML algorithm being evaluated. The equivalence claim is based on comparison to existing, already-approved devices, along with what would typically be non-clinical performance data (e.g., mechanical tests) which are not detailed in this summary.

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

• Not Applicable. This is not a study requiring expert-established ground truth for an algorithm.

4. Adjudication Method for the Test Set

• Not Applicable.

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

• Not Applicable. This is for a prosthetic implant, not an AI-assisted diagnostic tool.

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

• Not Applicable.

7. The type of ground truth used

• Not Applicable in the context of AI/ML. For a physical implant, "ground truth" might refer to established engineering principles, material science data, and clinical outcomes data from similar predicate devices, which are implicitly part of the substantial equivalence determination.

8. The sample size for the training set

• Not Applicable. There is no "training set" for a physical medical device.

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

• Not Applicable.

Summary of what can be gleaned from the document regarding "acceptance" for this specific device:

The "acceptance" in this context refers to the FDA's determination of substantial equivalence to legally marketed predicate devices. The "study" that proves this involves demonstrating:

• Design Similarity: The LPS is similar in design to the previously cleared LPS (K003182).
• Material Equivalence: The specified material (cobalt chrome) is similar to materials used in the S-ROM Noiles Rotating Hinge Knee (K870730).
• Indications for Use Alignment: The indications for use are similar to the Howmedica Global Modular Replacement System (GMRS) (K023087).
• Conformance with Standards: The determination was also based on "conformance with voluntary performance standards," which would involve non-clinical testing (e.g., mechanical strength, fatigue, wear) to ensure the device performs as expected for its intended use and materials. Specific criteria for these tests are not provided in this summary but would be part of the full 510(k) submission.

In essence, the "study" for this type of device is a comprehensive technical and comparative analysis against established benchmarks and predicate devices, rather than a clinical trial or algorithm performance evaluation.

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The Duraloc® Option Acetabular Cup System is for total hip replacement.

A 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. 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.
• Avascular necrosis of the femoral head. 2.
• Acute traumatic fracture of the femoral head or neck. 3.
• Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, 4. hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
• 5. Certain cases of ankylosis.

The acetabular cups are indicated for cementless application.

The Duraloc® Option Acctabular Cup System consists of a UHMWPE acetabular cup liner secured to a porous-coated Ti-6A1-4V acetabular shell. The acetabular system articulates with previously cleared 28mm fernoral heads, as well as with 22.225mm femoral heads internally documented by DePuy as line extensions to femoral heads cleared in K920317 and K980513.

The 28mm femoral heads were cleared in K920317 on March 19, 1992, K893872 on July 11, 1989, K883460 on October 11, 1998, K860701 on March 19, 1986, K891082 on June 9, 1989 and K011533 on January 28, 2002.

The acetabular cups are sized from 46mm to 66mm, in 2 mm increments. The liners are available in two styles: neutral and lipped. Liners with a 22,225mm inner diameter are offered in the outer diameter of 46mm. Liners with a 28mm inner diameter are offered in outer diameters of 48/50mm, 52mm, 54/56mm, 58/60mm, and 62/64/66mm.

The liner interlock allows the liner to be rotated to match the patient's anatomy. A locking ring, manufactured from Co-Cr-W-Ni alloy, is used to secure the liner.

The cups and liners are intended to be used in total hip arthroplasty to provide increased patient mobility and to reduce pain by replacing damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components.

The acetabular cups are indicated for cementless application.

The provided text describes a 510(k) summary for a medical device, the Duraloc® Option Acetabular Cup System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving device efficacy through clinical studies with acceptance criteria in the way a new drug or novel medical device might.

The 510(k) summary does not include:

• Acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy) for an AI/CADe device.
• Details of a study proving the device meets specific performance acceptance criteria.
• Information on sample sizes, ground truth establishment, expert qualifications, or adjudication methods for a diagnostic algorithm.
• Any mention of AI, CADe, or image analysis.
• Multireader multi-case (MRMC) studies or standalone performance studies.

Instead, the document focuses on:

• Substantial Equivalence: Comparing the Duraloc® Option Acetabular Cup System to previously cleared hip prosthesis devices (DePuy Pinnacle Acetabular System and DePuy Duraloc Cementless Acetabular Cup System).
• Device Description: Detailing the components and materials of the acetabular cup system.
• Intended Use and Indications: Specifying the conditions for which the device is intended, which are related to total hip arthroplasty to replace damaged hip joint articulation in various severe conditions like osteoarthritis, traumatic arthritis, avascular necrosis, etc.

Therefore, it is not possible to answer the detailed questions about acceptance criteria, study design, expert involvement, or AI performance based on the provided text. The document pertains to a hardware medical device (hip prosthesis) seeking 510(k) clearance, not a software/AI medical device that would have performance metrics like those requested in the prompt.

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A Delta Total shoulder prosthesis is indicated for use in: Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional Deltoid muscle is necessary to use the device.

The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. All other components are intended for cemented use only.

The Delta Shoulder prosthesis is a modular total shoulder prosthesis that was designed specifically for use in patients with non-functional rotator cuffs. The articulation of this design is "inverted" compared to traditional total shoulder prosthesis. Unlike traditional total shoulder prosthesis, the Delta Shoulder is designed such that the "ball" of the articulation is incorporated into the glenoid prosthesis, and the "cup" of the articulation is incorporated in the humeral prosthesis. The distal surface of the metaglene components are coated with a hydroxyapatite coating (HA) and are intended to be used with 4 metaglene screws for fixation.

This 510(k) submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically associated with AI/ML-based medical devices.

Instead, this document pertains to a traditional medical device (a shoulder prosthesis) and focuses on demonstrating substantial equivalence to legally marketed predicate devices, as required for 510(k) clearance by the FDA. This regulatory pathway does not typically involve the kind of performance metrics, clinical studies, or AI/ML-specific validation often seen in submissions for software-as-a-medical-device (SaMD) or AI-enabled devices.

Here's why the requested information cannot be fully provided based on the given text:

• Device Type: The "Delta Shoulder" is a physical medical implant (a shoulder prosthesis), not an AI/ML diagnostic or prognostic tool. Therefore, the concept of "device performance" in terms of accuracy, sensitivity, or specificity against ground truth, as would be relevant for AI, does not apply in the same way.
• Regulatory Pathway: The 510(k) pathway for traditional devices primarily involves demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing indications for use, design, materials, sterilization, packaging, and often includes bench testing (e.g., mechanical strength, wear) and sometimes animal studies, but generally not human clinical trials with performance metrics against a defined ground truth as would be done for an AI algorithm.
• Content of the Document: The provided text is a 510(k) summary and the FDA clearance letter. It describes the device, its indications for use, identifies predicate devices, and states that substantial equivalence was determined based on "detailed device description, design rationale, product testing, literature and conformance with voluntary performance standards." However, it does not detail the specific "product testing" or "voluntary performance standards" in a way that allows for the extraction of acceptance criteria and reported performance metrics in the format requested for AI/ML devices.

Therefore, many of the requested fields are not applicable or cannot be extracted from this document.

However, I can extract the relevant information regarding the basis for clearance and what's available:

1. Table of acceptance criteria and the reported device performance:

• Similarity in Indications for Use: The device is intended for "Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint," requiring an anatomically and structurally suited joint and a functional Deltoid muscle.
• Similarity in Design: Modular total shoulder prosthesis, "inverted" articulation (ball on glenoid, cup on humeral), HA-coated metaglene component for cementless application with screws, other components for cemented use.
• Similarity in Sterilization and Packaging.
• Product Testing: Not detailed, but typically involves mechanical and biocompatibility testing for implants.
• Literature and conformance with voluntary performance standards: Specific standards are not listed but are implied to have been met. |
  | Biocompatibility: | Implied to have been demonstrated through material selection and potentially testing, consistent with predicate devices and voluntary standards. |
  | Mechanical Performance: | Implied to have been demonstrated through "product testing" and "conformance with voluntary performance standards," ensuring the device can withstand physiological loads and wear over its intended lifespan, comparable to predicate devices. This typically includes fatigue, static strength, and wear testing, but specific results or acceptance criteria are not provided in this summary. |

The following points cannot be addressed from the provided text as they are not relevant to a 510(k) submission for a physical implant device in this context:

2. Sample sizes used for the test set and data provenance: No "test set" in the context of AI/ML performance evaluation is discussed. The validation is primarily against predicate devices and design verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI is not established here.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-enabled device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI/ML sense. The "ground truth" for a physical implant is typically its ability to function safely and effectively within the human body, assessed through engineering principles, preclinical testing, and post-market surveillance.
8. The sample size for the training set: Not applicable. No AI model is being trained.
9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) submission for a traditional, physical shoulder prosthesis. The "acceptance criteria" and "study" are framed around demonstrating substantial equivalence to existing devices through design comparison, product testing (not detailed here), and adherence to standards, rather than through performance metrics of an AI/ML algorithm against a ground truth.

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The DePuy ACE® Universal and Troch Entry Femoral Nail System is intended to treat proximal, middle and distal third fractures, severely comminuted shaft fractures extending beyond the isthmus, spiral, long oblique and segmental fractures, non-unions and malunions, lengthening of the bone, fractures with bone loss, bi-lateral fractures, pseudoarthrosis of the femoral shaft, supracondylar fractures, subtrochanteric fractures, with or without involvement of lesser trochanter, subtrochanteric/intertrochanteric combination fractures, ipsilateral femoral shaft and neck fractures, stable and unstable proximal fractures of the femur, including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, proximal or distal non-unions and malunions, leg length discrepancies secondary to femoral inequality, femur reconstruction following tumor resection, stable femoral fractures without necessity for interlocking, long subtrochanteric fractures, and revision procedures involving the replacement of implanted hardware.

In addition to the above indications, the Universal Nail, when used in the retrograde mode, is also indicated for treatment of femoral shaft fractures in obese or multiple trauma patients and supracondylar fractures, including those with severe, extra-articular comminution and/or intra-articular involvement, osteoporosis, non-unions, malunions, pathologic fractures, and those proximal to total knee prosthesis.

The DePuy ACE® Universal Nail is a revision of the ACE® AIM Femoral Nail (K871539). The Universal Nail is a slightly bowed intramedullary nail with proximal holes and distal lateral / medial holes and anterior/ posterior holes. The nail is "universal" in design, as it requires no right or left device configurations. It is designed to be inserted in either an antegrade or retrograde approach. The nail sizes include 8mm through 15mm diameters and lengths of 280mm through 500mm.

The Troch Entry Nail (TEN) is similar in design to the ACE® Trochanteric Nail System (K010780) and the ACE® Long Trochanteric Nail System (K013563). The Troch Entry Nail is a slightly bowed femoral intramedullary nail with proximal and distal holes. It is intended for antegrade insertion only. This nail includes a small proximal bend for insertion just lateral to the tip of the greater trochanter. Due to this bend, the nail designs require a right and left anatomic version. This nail system includes 9mm, 11mm and 13mm diameters in lengths of 280mm through 500mm in right and left versions.

The Nail System includes intramedullary nails, screws, and end caps. All components are manufactured from ASTM F-136 Ti 6A1-4V alloy with titanium type II anodise (TiMaxTM).

The medical device being described is the DePuy ACE® Universal and Troch Entry Femoral Nail System, an intramedullary rod used for bone fixation. Based on the provided text, the submission is a 510(k) premarket notification, which establishes substantial equivalence to legally marketed predicate devices, rather than proving a device meets specific performance acceptance criteria through clinical studies.

Therefore, the document does not contain information related to specific acceptance criteria or a study designed to prove the device meets such criteria.

Here’s why and what information is available:

• Substantial Equivalence (510(k) pathway): The FDA’s letter clearly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This means the device's safety and effectiveness are established by demonstrating it is as safe and effective as a legally marketed predicate device, not by meeting new, specific performance acceptance criteria through a dedicated study for that purpose.
• Lack of Performance Study Details: The document does not describe any clinical or non-clinical study that would generate "reported device performance" against predefined "acceptance criteria." There are no sections detailing sample sizes, data provenance, expert panels, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

Therefore, the full table and subsequent detailed questions about a performance study cannot be answered from the provided text.

Here is the information that can be extracted or inferred from the provided text, related to the nature of the submission:

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

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

• Sample size: Not applicable/Not provided. No test set for a performance study is described.
• Data provenance: Not applicable/Not provided.

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

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

4. Adjudication method for the test set

• Not applicable/Not provided.

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/Not provided. This device is an intramedullary rod, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable/Not provided. This device is an intramedullary rod, not an algorithm.

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

• Not applicable/Not provided.

8. The sample size for the training set

• Not applicable/Not provided. This device is an intramedullary rod, not an AI/algorithm product requiring a training set.

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

• Not applicable/Not provided.

In summary: The provided document is a 510(k) premarket notification for an intramedullary rod system, where FDA approval is granted based on substantial equivalence to existing predicate devices. It does not contain the details of a performance study with acceptance criteria, sample sizes, expert ground truth, or other elements typically found in submissions for novel diagnostic algorithms or devices requiring de novo performance evaluation.

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The Sigma Co-Cr Tibial Trays 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 Sigma Co-Cr Tibial Trays are intended for cemented use only.

The DePuy Sigma Co-Cr Tibial Trays are Co-Cr-Mo alloy tibial trays similar in design to the Darwin tibial trays cleared in K943462. The Sigma Co-Cr Tibial Trays are intended for use with the Darwin (now PFC Sigma) femoral and patella components, previously cleared in K943462.

This document describes a medical device, the DePuy Sigma Co-Cr Tibial Trays, and its regulatory submission. It is a 510(k) premarket notification, which means the manufacturer is claiming that their new device is "substantially equivalent" to an existing, legally marketed device (the predicate device). This type of submission generally does not involve a clinical study to prove new acceptance criteria based on performance because the device is not claiming novel performance, but rather equivalence in safety and effectiveness to a predicate.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth for a device performance study is not applicable to this 510(k) submission.

Instead, the "acceptance criteria" and "study" in this context refer to the criteria for demonstrating substantial equivalence to the predicate device, which is a regulatory assessment rather than a performance study.

Here's how to address the questions given the nature of a 510(k) for substantial equivalence:

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

Since this is a substantial equivalence submission, the "acceptance criteria" are the demonstration of equivalence to the predicate, and the "performance" is a comparison to the predicate's known characteristics.

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

Not applicable. This is a claim of substantial equivalence based on design, materials, manufacturing, and intended use comparison, not a clinical performance study with test sets or data provenance.

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

Not applicable. There was no "ground truth" to establish for a test set in the context of a clinical performance study. The "ground truth" here is the regulatory determination of substantial equivalence by the FDA, based on the submitted information and comparison to the predicate device.

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

Not applicable. There was no "test set" for clinical performance that would require an adjudication method.

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

Not applicable. This device is a total knee joint replacement prosthesis (a physical implant), not a diagnostic device or AI system that would involve human readers or AI assistance.

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

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

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

Not applicable to a clinical performance study. The "ground truth" in this regulatory context is the established safety and effectiveness profile of the predicate device, to which the new device is compared for equivalence.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an algorithm that requires a training set.

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

Not applicable. As above, this is a physical medical device, not an algorithm.

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Total ankle arthroplasty is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. Total ankle arthroplasty is indicated for patients with ankle joints damaged by severe rheumatoid, post traumatic or degenerative arthritis.

The Agility Ankle Revision Prosthesis is additionally indicated for patients with a failed previous ankle surgery.

CAUTION: The Agility Ankle Prosthesis is intended for cemented use only.

The Agility Ankle Revision Prosthesis is a modular ankle prosthesis that is comprised of a tibial tray, a polyethylene tibial insert and a revision talar component. The Agility Ankle revision talar component is designed to replace the Agility Ankle primary talar component in revision ankle arthroplasty. It is designed for use with the existing Agility Ankle tibial tray and either the existing polyethylene tibial insert or revision (+2) tibial insert.

The distal surface of the Agility Ankle revision talar component is a rectangular shape and is designed with a fin in the anterior-posterior plane to be cemented into the bone. This distal surface and fin are porous coated with Porocoat. The superior surface is a convex shaped and highly polished to articulate with the polyethylene tibial insert.

The Agility Ankle revision (+2) tibial insert component is manufactured from Ultra High Molecular Weight Polyethylene. It is designed to slide into the existing Agility Ankle tibial tray and is designed to articulate with either the primary or revision Agility Ankle talar components. As with the current tibial insert, the revision insert is designed with lateral and medial ears that slide into the grooves of the tibial tray. The only difference is that the revision insert is 2mm thicker to allow the insert to be used in revision cases and in primary cases where the soft tissues surrounding the ankle are lax.

The provided text is a 510(k) summary for the Agility Ankle Revision Prosthesis. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that a new device meets specific acceptance criteria through a study. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study to prove device performance.

Specifically:

• No table of acceptance criteria and reported device performance is present. The document focuses on demonstrating equivalence to a previously cleared device (K920802, the Agility Ankle).
• No study data related to sample size, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or training set information is included.
• The document explicitly states that "The determination of substantial equivalence for this device was based on a detailed device description, and conformance with voluntary performance standards," rather than a new clinical or performance study demonstrating novel acceptance criteria.

The 510(k) process primarily relies on comparing a new device to an existing, legally marketed predicate device to establish that the new device is as safe and effective as the predicate. It generally does not require new clinical trials or studies to establish performance against novel acceptance criteria unless the device has significant differences in technological characteristics or indications for use from the predicate.

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The Orthogenesis LPS is intended for use in replacement of the mid-shaft or intercalary portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and restoration. Specific diagnostic indications for use include:

• metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur;
• 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 of the proximal and/or distal femur;
• patients suffering from severe arthropathy of the hip and/or knee that does not respond to any conservative therapy or better alternative surgical treatment;
• revision cases requiring extensive resection(s) and replacements of the proximal, distal or total femur or proximal tibia.

The distal femoral and tibial components, tibial stems and non-porous coated femoral stems are intended for cemented use only.

The Orthogenesis LPS Proximal Tibial Replacement system is designed to be implanted for the The Orthogenesis Er of Proximal Troul'se primary knee systems, this system is used when the amount of resection and restoration is extreme (e.g. in oncology cases, endstage revision). It consists of a titanium tibial replacement, a polyethylene tibial bearing component, Orthogenesis LPS stems and Segments.

The provided text is a 510(k) summary for a medical device called the Orthogenesis LPS Proximal Tibial Replacement. This document is a premarket notification to the FDA, demonstrating that the device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) summary does not typically include detailed studies proving the device meets specific acceptance criteria in the way a clinical trial or performance study would for a novel device or a PMA submission. The focus of a 510(k) is to establish substantial equivalence to a predicate device, often relying on design comparisons, material testing, and conformance to voluntary performance standards, rather than direct human clinical outcome studies for acceptance criteria performance.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, and expert involvement are not present in this 510(k) summary.

Here's a breakdown of what can be extracted and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable / Not Provided. This 510(k) summary does not describe a clinical test set in the sense of a patient cohort or data set used to evaluate the device's performance against clinical acceptance criteria. The "product testing" mentioned likely refers to bench testing of materials and mechanical properties, not human clinical data.

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

• Not Applicable / Not Provided. Ground truth for a clinical test set is not specified because a clinical test set is not described.

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

• Not Applicable / Not Provided. No adjudication method is described as a clinical test set is not detailed.

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. This device is a prosthetic implant, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is not relevant.

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

• No. This device is a prosthetic implant, not an algorithm.

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

• Not Applicable / Not Provided. As no clinical test set is described, no specific type of ground truth is mentioned. The "ground truth" for a 510(k) in this context is primarily the established safety and effectiveness of the predicate device, which the new device aims to be substantially equivalent to, based on non-clinical data.

8. The sample size for the training set

• Not Applicable / Not Provided. This device does not involve a "training set" in the context of machine learning or AI.

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

• Not Applicable / Not Provided. As no training set is relevant, no ground truth establishment for it is described.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per 510(k) framework):

The "study" in this context is the Substantial Equivalence Determination process outlined in the 510(k) submission.

• Basis of Equivalence: The manufacturer, DePuy, Inc., asserts that the Orthogenesis LPS Proximal Tibial Replacement is substantially equivalent to the S-ROM Noiles Rotating Hinge Knee (K896048 and K905810) and the Orthogenesis LPS system.
• Evidence for Equivalence: This determination was based on:
  • A detailed device description: Comparing the new device's features to the predicate.
  • Product testing: Likely referring to bench testing for mechanical properties, material compatibility, and other engineering specifications, demonstrating that the device meets relevant performance standards (though specific results or criteria are not detailed in this summary).
  • Conformance with voluntary performance standards: Implies that the device has been tested against recognized industry standards applicable to knee prostheses.
  • Comparison of Indications for Use, design, materials, sterilization, and packaging to the predicate devices.

Conclusion: The FDA's issuance of a letter stating substantial equivalence (K011810) on SEP - 7 2001, effectively serves as the "proof" within the 510(k) regulatory pathway that the device meets the necessary criteria (which are primarily about being as safe and effective as a legally marketed predicate device). This approval does not typically involve the presentation of new clinical data from human studies unless there's a significant difference from the predicate device that raises new safety or effectiveness questions.

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