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Indications for use of the ConsensusTM Hip System or UNISYN™ Hip System

• A) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
• B) Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
• C) Proximal femoral fractures.
• D) Avascular necrosis of the femoral head.
• E) Non-union of proximal femoral neck fractures.
• F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa vara, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities

Acetabular components are indicated for cemented and cementless use. Consensus femoral stems are indicated for cemented and cementless use. UniSyn femoral stems are indicated for cementless use only. HA coated implants are indicated for cementless use only.

The Consensus Hip 36mm CoCrMo (ASTM F799 or ASTM F1537) femoral head is offered with four different offsets, -5mm, neutral, +5mm and +10mm. Other than size, it incorporates no new design features. Female head taper is identical to the head taper design for the cleared devices.

The 36mm acetabular insert is offered in sizes 54 - 68 (2 mm increments), in neutral, 10 and 20 degree hooded configurations. Material for all 36mm insert sizes is crosslink UHMWPE (ASTM F648). Hooded configurations incorporate a titanium alloy x-ray marker (Ti 6Al-4V ELJ ASTM F136). Insert locking detail of the subject device is identical to the locking detail of the cleared devices.

The provided text is a 510(k) summary for a medical device: a 36mm CoCrMo Femoral Head and Acetabular Insert for the Consensus Hip System. This document focuses on demonstrating substantial equivalence to previously cleared devices, rather than presenting a study with acceptance criteria and a detailed performance evaluation of a new AI/software device.

Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is not applicable to this type of regulatory submission.

This 510(k) relies on the following for demonstrating safety and effectiveness:

• Comparison to Cleared Device: The primary argument is that the new 36mm femoral head and acetabular insert are substantially equivalent to existing, legally marketed devices. The only change is the addition of a new size (36mm).
• Intended Use, Material, Design Features, and Type of Interface: These aspects of the new components are stated to be identical or highly similar to predicate devices.
• Materials Data: The submission mentions "materials data" was provided to support safety and effectiveness, implying biocompatibility and mechanical properties testing relevant to the materials used (CoCrMo and UHMWPE) rather than clinical performance data.

In summary, this document does not contain the kind of study design and performance data typically associated with evaluating a novel AI/software medical device against specific acceptance criteria.

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Indications for use of the UNISYN™ HIP SYSTEM

A) Significantly impaired joints resulting from rheumatoid, osteo, and posttraumatic arthritis.

B) Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.

C) Proximal femoral fractures.

D) Avascular necrosis of the femoral head.

E) Non-union of proximal femoral neck fractures.

F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities

The Body, HA Plasma, Modular Hip is part of the Unisyn modular hip system. The system consists of three parts; the neck, the body, and the stem. There are thirty-three different proximal bodies with six different cone diameters with multiple medial projections for each size. There are also cone-only bodies with and without collars. The surface of the body is plasma sprayed with a secondary coating of hydroxylapatite.

This document is a 510(k) summary for a medical device (Hayes Medical, Inc. UniSyn Modular Hip System) seeking clearance from the FDA. It does not describe a traditional clinical study with acceptance criteria and device performance as one would find for a software or diagnostic device.

Instead, this 510(k) pertains to a physical orthopedic implant and is a "Special 510(k)" because the only change made to a previously cleared device (UniSyn Hip System, K003649) is the addition of a hydroxylapatite coating to the existing TPS coating on the surface of the bodies.

Therefore, the typical metrics, sample sizes, expert ground truth, and study types requested in your prompt (e.g., MRMC, standalone algorithm performance) are not applicable to this type of regulatory submission for a physical implant. The "acceptance criteria" here are met by demonstrating "substantial equivalence" to predicate devices, primarily through material and design information, rather than a performance study as you've outlined.

However, I can extract information related to the substantial equivalence argument, which is the closest analogy to "acceptance criteria" in this context.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation for the "Reported Device Performance": In a 510(k) for an implant device, particularly a Special 510(k) that involves a minor modification to a previously cleared device, the "performance" is demonstrated by showing that the modified device remains as safe and effective as the predicate device(s). This is achieved by comparing various attributes (intended use, materials, design, technological characteristics) to predicates and arguing that any differences do not raise new questions of safety or effectiveness. The text explicitly states: "The safety and effectiveness of the Body, HA Plasma, Modular Hip are adequately supported by the substantial equivalence information and materials data provided within this Special 510(k) submission."

The remaining points of your request are not applicable to this 510(k) submission type, as it relates to a physical orthopedic implant device, not an AI/software device or a diagnostic requiring performance metrics like sensitivity/specificity derived from expert reviews.

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 pertains to a physical implant, not a software or diagnostic device. Substantial equivalence for this type of device is typically demonstrated through engineering assessments, material characterization, and comparison to predicate devices, not through a "test set" of patient data in the context of performance metrics.

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

• Not applicable. This submission does not involve a "ground truth" derived from expert consensus on patient data.

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

• Not applicable. There is no "test set" in the context of expert adjudication for this physical implant.

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 a physical implant, not an AI-assisted diagnostic or imaging system.

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

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

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

• Not applicable. "Ground truth" in the context of expert review or pathology is not relevant for this implant's regulatory clearance. The "truth" here is established via engineering principles, material science, and the regulatory history of predicate devices.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

• Not applicable. As above, there is no "training set" or need for "ground truth" establishment in this context.

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Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. .
• Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. .
• . Proximal femoral fractures
• . Avascular necrosis of the femoral head
• . Non-union of proximal femoral neck fractures
• Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa ● vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomaliacia, osteoporosis, pseudarthrosis conversion and structural abnormalities.

The Consensus Acetabular Shell System consists of four modular shell options which mate with currently marketed polyethelyne insert components for replacement of the acetabular surface during total hip arthroplasty. The shells are designed to be implanted without bone cement. Cementless (press-fit) fixation is achieved by coating the external surface of the cup with commercially pure (CP) titanium sintered beads.

All of the shell options have the following common features:

• The substrate material of the Consensus Shells is titanium alloy (ASTM F136, Ti-6AI-4V) ●
• · The shell is porous coated with commercially pure (CP) titanium sintered beads (ASTM F67, irregular bead geometry).
• · The shells have the same internal locking mechanism as the previously cleared Consensus Acetabular Shells (K922561).
• · The apical dome hole of the shells is threaded to accept an impaction tool for implanting the component. After implantation and the impaction tool is removed, a threaded titanium (ASTM F67 or F136) hole plug can be inserted into the threaded hole to prevent migration of unwanted particles through the dome hole.

The following shell options are available:

• · Total Hemispherical in no screw holes or three (3) quadrant screw holes options.
• · Hemispherical with rim flare in no screw holes or three (3) quadrant screw holes options.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves the device meets specific criteria. The document is a 510(k) summary for a medical device (Consensus Acetabular Shell System), which primarily focuses on device description, intended use, and demonstrating substantial equivalence to previously cleared predicate devices.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on this text.

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The 32 mm ceramic femoral head is design for use with the Consensus® or UniSyn ® Hip Systems, and is not intended for substitution with components of other systems. The indications for use are:

With Consensus® System:

1. Primary intervention of rheumatoid arthritis, osteoarthritis, post traumatic arthritis or degenerative arthritis, and avascular necrosis with a non-acute fracture of the femoral neck.
2. Osteoarthrosis involving femoral and acetabular articular surfaces.
3. Avascular osteonecrosis and/or non-union of acute femoral neck fractures.
4. Fracture or dislocation of the hip.
5. Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.

With UniSyn® System:

1. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
2. Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.
3. Proximal femoral fractures.
4. Avascular necrosis of the femoral head.
5. Non-union of proximal femoral neck fractures.
6. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.
7. Indications for the use of the UniSyn Hip System must be carefully considered with respect to the patient's entire evaluation and alternative procedures. Patient selection is dependent on age, general health, available bone stock and quality, and any prior surgery or anticipated future surgery. Prosthetic replacement is generally indicated only for patients who have reached skeletal maturity. Total joint replacement in younger patients should be considered only when explicit indications outweigh the associated risks of the surgery and modified demands regarding activity and joint loading are assured. This includes all patients who may or may not have multiple joint involvement, for whom restoration of joint mobility leads to an expectation of greater mobility and an improvement in the quality of life.

Not Found

The provided text describes a 510(k) premarket notification for a 32 mm Zirconia Ceramic Femoral Head. It is a regulatory document and does not contain information about acceptance criteria or a study proving the device meets such criteria.

The document primarily focuses on:

• The FDA's review and determination of substantial equivalence to legally marketed predicate devices.
• The product name and regulation details.
• The indications for use for the device when used with specific hip systems (Consensus® or UniSyn®).

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details (sample size, provenance, expert qualifications, adjudication, MRMC study, standalone performance), or ground truth establishment based on the provided text.

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The cobalt-chrome unipolar femoral head is design for use with the Consensus® or UniSyn ® Hip Systems, and is not intended for substitution with components of other systems. The indications for use are:

With Consensus® System:

• A) Primary intervention of rheumatoid arthritis, osteoarthritis, post traumatic arthritis or degenerative arthritis, and avascular necrosis with a non-acute fracture of the femoral neck.
• B) Osteoarthrosis involving femoral and acetabular articular surfaces.
• C) Avascular osteonecrosis and/or non-union of acute femoral neck fractures.
• D) Fracture or dislocation of the hip.
• E) Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.

With UniSyn® System:

• A) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
• B) Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.
• C) Proximal femoral fractures.
• D) Avascular necrosis of the femoral head.
• E) Non-union of proximal femoral neck fractures.
• F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.
• G) Indications for the use of the UniSyn Hip System must be carefully considered with respect to the patient's entire evaluation and alternative procedures. Patient selection is dependent on age, general health, available bone stock and quality, and any prior surgery or anticipated future surgery. Prosthetic replacement is generally indicated only for patients who have reached skeletal maturity. Total joint replacement in younger patients should be considered only when explicit indications outweigh the associated risks of the surgery and modified demands regarding activity and joint loading are assured. This includes all patients who may or may not have multiple joint involvement, for whom restoration of joint mobility leads to an expectation of greater mobility and an improvement in the quality of life

The cobalt-chrome unipolar femoral head is design for use with the Consensus® or UniSyn ® Hip Systems, and is not intended for substitution with components of other systems.

This is a 510(k) premarket notification for a medical device (Consensus Unipolar Head, CoCr), which focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance criteria or a study proving the device meets those criteria.

Therefore, the provided document does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML-driven medical device.

The information in the document pertains to:

• The FDA's determination of substantial equivalence for a hip joint femoral prosthesis.
• The regulation number and name for the device.
• The product code and regulatory class.
• The indications for use for the device when used with the Consensus® Hip System and the UniSyn® Hip System.

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The cross-linked polyethylene acetabular insert is design for use with the Consensus or UniSvn ® Hip Systems, and is not intended for substitution with components of other systems. The indications for use are:

With Consensus® System:

• A) Primary intervention of rheumatoid arthritis, osteoarthritis, post traumatic arthritis or degenerative arthritis, and avascular necrosis with a non-acute fracture of the femoral neck.
• B) Osteoarthrosis involving femoral and acetabular articular surfaces.
• C) Avascular osteonecrosis and/or non-union of acute femoral neck fractures.
• D) Fracture or dislocation of the hip.
• E) Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.

With UniSyn® System:

• A) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
• B) Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.
• C) Proximal femoral fractures.
• D) Avascular necrosis of the femoral head.
• E) Non-union of proximal femoral neck fractures.
• F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.
• G) Indications for the use of the UniSyn Hip System must be carefully considered with respect to the patient's entire evaluation and alternative procedures. Patient selection is dependent on age, general health, available bone stock and quality, and any prior surgery or anticipated future surgery. Prosthetic replacement is generally indicated only for patients who have reached skeletal maturity. Total joint replacement in younger patients should be considered only when explicit indications outweigh the associated risks of the surgery and modified demands regarding activity and joint loading are assured. This includes all patients who may or may not have multiple joint involvement, for whom restoration of joint mobility leads to an expectation of greater mobility and an improvement in the quality of life.

Cross Linked Polyethylene Acetabular Insert

I am sorry, but there is no information about acceptance criteria or a study proving that the device meets acceptance criteria in the provided text. The document is a 510(k) clearance letter from the FDA, which states that the device is substantially equivalent to previously marketed devices and lists its indications for use. It does not contain performance data or details of a study with acceptance criteria.

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The Ti coated porous acetabular shell is design for use with the Consensus® or UniSyn ® Hip Systems, and is not intended for substitution with components of other systems. The device is intended primarily for uncemented, press-fit applications. The indications for use are:

With Consensus® System:

1. Primary intervention of rheumatoid arthritis, osteoarthritis, post traumatic arthritis or degenerative arthritis, and avascular necrosis with a non-acute fracture of the femoral neck.
2. Osteoarthrosis involving femoral and acetabular articular surfaces.
3. Avascular osteonecrosis and/or non-union of acute femoral neck fractures.
4. Fracture or dislocation of the hip.
5. Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.

With UniSyn ® System:

1. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
2. Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.
3. Proximal femoral fractures.
4. Avascular necrosis of the femoral head.
5. Non-union of proximal femoral neck fractures.
6. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.
7. Indications for the use of the UniSyn Hip System must be carefully considered with respect to the patient's entire evaluation and alternative procedures. Patient selection is dependent on age, general health, available bone stock and quality, and any prior surgery or anticipated future surgery. Prosthetic replacement is generally indicated only for patients who have reached skeletal maturity. Total joint replacement in younger patients should be considered only when explicit indications outweigh the associated risks of the surgery and modified demands regarding activity and joint loading are assured. This includes all patients who may or may not have multiple ioint involvement, for whom restoration of ioint mobility leads to an expectation of greater mobility and an improvement in the quality of life.

Acetabular Shell, Porous Ti TI Coating

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving the device meets acceptance criteria.

The document is a letter from the FDA regarding a 510(k) premarket notification for an "Acetabular Shell, Porous Ti TI Coating." It states that the device is substantially equivalent to legally marketed predicate devices and lists its intended uses. However, it does not include any performance data, clinical study results, or specific acceptance criteria.

Therefore, I cannot provide the requested information in the table or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies.

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The Consensus® Knee System and the CoCr/Ti porous or CoCr nonporous tibial baseblate is design for use as a system, and is not intended for substitution with components of other systems. This device is intended for cemented use only. The indications for use are:

• Primary intervention of rheumatoid arthritis, osteoarthritis, post traumatic arthritis or degenerative arthritis.
• Failed osteotomy or unicompartmental replacements.
• Replacement of unsatisfactory cemented or press fit knee components, if sufficient bone stock exists.

Tibial Baseplate, Cast, CorCr/Ti Porous and CoCr Non-Porous

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is an FDA 510(k) clearance letter for a tibial baseplate, indicating that the device is substantially equivalent to previously marketed devices. It outlines the indications and contraindications for use, but does not include any performance metrics, study designs, or data related to acceptance criteria.

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The Consensus® CoCr/Ti Femoral Component is intended for use with the Consensus® Knee System and is not intended for substitution of components from other systems. This device is intended for cemented use only. The indications for use are as follows:

• Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis;
• Intervention of failed osteotomies and unicompartmental replacements;
• Replacement of unsatisfactory cemented or press fit knee components if sufficient bone stock exist.

The porous femoral knee component will be available in a left and right configuration and is designed to replicate the natural anatomy of the femur. The design of the femoral component incorporates a swept-back radius on the outer condyle surfaces to allow for smooth articulation throughout the range of motion. The outer articular surface of the femoral component will also have a deepened trochlear groove to allow for more anatomic tracking of the patellar component and improved range of motion. The material will be cast CoCrMo alloy (ASTM F75-92). The inner box geometry of the femoral component is designed to allow a minimum bone resection of 10mm distal, 9mm posterior, and 6.5mm anterior. The anterior flange of the femoral component is angled 4°outward, posterior to anterior, to reduce the potential for notching the anterior femur. The anterior flange will also incorporate a stepped chamfer which allows for positioning the trochlear groove in a more anatomic position. A smooth tapered peg will be located on each distal condyle to provide medial-lateral stability and enhanced fixation. The surfaces of the inner box geometry of the porous femoral component will incorporate a sintered porous coating of CoCr beads (ASTM F75-92), which will subsequently be coated with Titanium alloy (ASTM F67-95). The porous coating is designed to enhance cement fixation.

The provided document, a 510(k) Premarket Notification for the HAYES MEDICAL, INC Consensus® Knee System CoCr/Ti Femoral Component, focuses on establishing substantial equivalence to predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the manner requested, i.e., a clinical study with detailed performance metrics and ground truth establishment for an AI/device.

Instead, the document describes the device's technical specifications and intended use, and argues that these are similar to existing devices already on the market. The FDA's letter (K983004) confirms this substantial equivalence, allowing the device to be marketed, with specific limitations regarding cemented use only.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document is a regulatory submission for a medical device (a knee implant), not a study report for an AI or diagnostic device that would typically involve acceptance criteria, performance metrics, and human expert evaluation in the way described in your request.

If the request refers to the structural integrity and material properties of the knee implant, then the "acceptance criteria" and "study" would likely refer to engineering and biocompatibility tests (e.g., ASTM standards for materials, fatigue testing, etc.) which are not detailed in this public summary. The "Substantial Equivalence" section mentions that "The technological differences... have been thoroughly documented and tested in order to verify that no new issues of safety and effectiveness are raised by the design," implying such testing was done, but specifics are not provided.

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