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Components of the Ascendant Acetabular System are intended for use in total hip arthroplasty for treatment of the following:

• Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
• Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
• Revision of previously failed hip arthroplasty.

The Ascendant Acetabular System consists of two modular shell options which mate with currently marketed insert components for replacement of the acetabulum during total hip arthroplasty. They are designed to provide congruency with the ability to effectively seal the acetabulum, and may be implanted with or without bone cement. Press-fit fixation (e.g. cementless) to the bone is achieved by an oversized shell with a grit blasted, Chemtex (chemically textured process) surface.

The provided text is a 510(k) summary for the Sulzer Orthopedics Ascendant Acetabular Shell System, a medical device for total hip arthroplasty. It details the product description, its intended use, and claims substantial equivalence to previously marketed devices.

Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics or statistical analysis.

The text focuses on:

• Product Description: Materials, surface, locking mechanism, dome hole, and variations of the shell (Cluster-Hole and Multi-Hole).
• Intended Use/Indications for Use: Specific patient conditions and scenarios for total hip arthroplasty.
• Substantial Equivalence: A claim that the device is similar to existing legally marketed devices based on materials, general design features, and intended uses. This is a regulatory pathway to market for Class II and Class III devices, implying that if the new device is substantially equivalent to a predicate device, it is considered as safe and effective as the predicate.

Therefore, I cannot provide the requested information as it is not present in the given input. The input describes the device and its regulatory clearance, but not the specific studies and acceptance criteria related to its performance attributes (e.g., strength, durability, biocompatibility) that would typically be part of a design verification and validation report submitted to the FDA, but not necessarily summarized in the public 510(k) summary provided.

If this were a submission for an AI/ML a medical device, the types of studies and acceptance criteria mentioned in the prompt (e.g., sample size, ground truth, expert adjudication, MRMC studies) would be highly relevant. However, for a mechanical implant like the acetabular shell, the "acceptance criteria" and "study" would refer to engineering tests (e.g., fatigue testing, wear testing, material strength, biocompatibility tests) rather than reader studies or AI model performance metrics.

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The Natural-Knee II CoCr Tibial Baseplate is a primary component intended for cemented use only in total knee arthroplasty in skeletally mature individuals for treatment of the following:

• Patient conditions of Noninflammatory Degenerative Joint Disease (NIDJD); . e.g., avascular necrosis, osteoarthritis and Inflammatory Joint Disease (IJD); e.g, rheumatoid arthritis.
• Correctable valgus-varus deformity and moderate flexion contracture. .

The CoCr tibial baseplate, manufactured from cast CoCr alloy (ASTM-F-75), is a nonporous, stemmed configuration and intended for cemented use only. The CoCr tibial baseplate is anatomic and asymmetric in design, available in sizes 00-5 and left and right configurations.

The provided document is a 510(k) summary for the Sulzer Orthopedics Inc. Natural Knee II System CoCr Tibial Baseplate, dated August 9, 2002. This document is a regulatory submission for a medical device and therefore does not contain information about acceptance criteria for device performance as it would be understood for a diagnostic AI/ML device, nor does it describe a study proving the device meets performance criteria in the context of AI/ML.

This document is for a mechanical medical device (a knee implant), not a diagnostic AI/ML device. Therefore, the questions posed, which are designed for assessing AI/ML device performance studies, do not directly apply to the content of this 510(k) submission.

Specifically:

• Acceptance criteria and reported device performance (Table): Not applicable for this type of device and document. Regulatory approval for such a device is based on "substantial equivalence" to a predicate device, which means demonstrating similar technology, materials, and intended use as a device already on the market. There are no performance metrics like sensitivity, specificity, or AUC as expected for an AI/ML diagnostic.
• Sample size and data provenance (test set): Not applicable. There is no "test set" in the context of an AI/ML algorithm evaluation.
• Number of experts and qualifications (ground truth): Not applicable. Ground truth, as defined for AI/ML, is not relevant here. Device safety and efficacy are typically supported by mechanical testing, biocompatibility studies, and comparison to predicate devices, not expert consensus on diagnostic interpretations.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating human performance with and without AI assistance in diagnostic tasks.
• Standalone algorithm performance: Not applicable.
• Type of ground truth: Not applicable.
• Sample size for training set: Not applicable. This device is not an AI algorithm that undergoes training.
• How ground truth for training set was established: Not applicable.

Summary based on the provided document:

The Natural-Knee II CoCr Tibial Baseplate is a mechanical orthopedic implant, specifically a component for total knee arthroplasty. Its approval relies on demonstrating substantial equivalence to an already legally marketed predicate device (the Natural Knee II System Non-porous Stemmed Tibial Baseplate) in terms of general design, intended use, and indications for use. The document specifies that the new device is manufactured from cast CoCr alloy (ASTM-F-75), is nonporous, stemmed, and intended for cemented use only. It is anatomic and asymmetric, available in sizes 00-5 and left/right configurations.

Indications for use include treatment of Noninflammatory Degenerative Joint Disease (e.g., avascular necrosis, osteoarthritis) and Inflammatory Joint Disease (e.g., rheumatoid arthritis), as well as correctable valgus-varus deformity and moderate flexion contracture in skeletally mature individuals.

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The MS-30 Lateral Femoral Stem is intended for cemented use in treatment of the following:

• Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
• Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
• Revision of previously failed hip arthroplasty.

The MS-30 Lateral Femoral Stem intended for cemented use, is a highly polished, collarless femoral component manufactured from forged stainless steel (Protasul S-30, ISO 5832-9). The lateral version offers the surgeon 12% more offset than with the standard version. The stem features a three dimensional conical wedge shape with rounded edges to aid in rotational stability, self-centering in the femoral canal and creation of a favorable cement mantle. The proximal portion of the stem has a male 12/14 taper for attachment of a Sulzer Orthopedics metallic or ceramic femoral head with a neck that accepts an optional Proximal Positioner, The distal portion is designed to accept the optional existing and new Distal Centralizer. It is available in six sizes.

The optional new distal centralizer manufactured from Sulene -PMMA (poly-methyl-methacrylate/poly-styrene, ISO 5833-1), is intended for use with the MS-30 Standard and Lateral Femoral Stems. The centralizer is conically shaped and designed with four wings for better centering of the stem within the diaphysis of the femur providing a favorable cement mantle. One of the wings is longer than the others indicating its position on the lateral side of the stem. It is offered in two sizes for each of the six stem sizes.

The MS-30 also features an optional proximal positioner which is manufactured from Sulene -PMMA. The proximal positioner, intended for cemented use, centers the femoral stem in the anterior/posterior plane. It inserts into the extraction hole and snaps onto the neck of the stem. Once the bone cement has polymerized, the upper portion of the positioner is removed leaving the cemented U-shaped portion creating a favorable cement mantle.

This submission describes a medical device, the Sulzer Orthopedics MS-30 Lateral Femoral Stem, which is a hip joint prosthesis. The document is a 510(k) summary for premarket notification to the FDA, indicating that the device demonstrates substantial equivalence to previously marketed devices. Therefore, this document does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria.

The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its performance against specific quantitative acceptance criteria through a clinical study with detailed statistical analysis and ground truth establishment.

However, based on the provided text, I can infer some aspects relevant to the concepts requested, even if direct answers are not present:

Key Takeaways from the Provided Document:

• Device Type: This is a cemented femoral stem component for hip replacement surgery.
• Approval Type: 510(k) premarket notification. This pathway relies on demonstrating substantial equivalence to a predicate device, rather than proving efficacy and safety through de novo clinical trials with rigorous performance metrics.
• No Performance Acceptance Criteria or Study: The document explicitly states "Analysis indicated that the device would survive physiologic loading." This is the closest mention to any 'performance' assessment, but it's not presented as a formal study with acceptance criteria and results in the format requested.
• Focus on Substantial Equivalence: The primary aim of this submission is to show that the MS-30 Lateral Femoral Stem is similar in intended use, materials, and general design to existing, legally marketed devices.

Given this context, I cannot populate the requested table or answer most of your detailed questions about acceptance criteria and study design because the provided text does not describe such a study or criteria for this specific device.

Here's a breakdown of why each numbered point cannot be fully addressed by the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The document confirms the device "would survive physiologic loading," which is a general statement about its mechanical integrity, not a specific performance metric against a defined acceptance criterion.
2. Sample sized used for the test set and the data provenance: Not applicable. No test set or clinical study is described. The "analysis" of physiologic loading likely refers to bench testing or simulation, not human 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. No test set or ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication process 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 mechanical 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. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth is established for device performance in the context of a clinical study.
8. The sample size for the training set: Not applicable. No training set is implied for this type of device submission.
9. How the ground truth for the training set was established: Not applicable.

Conclusion:

The provided document is a 510(k) summary for a medical device (femoral stem). It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with defined acceptance criteria and associated results. Therefore, the specific information requested about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not present in the given text.

The "analysis" that indicated the device would "survive physiologic loading" is the extent of performance information provided, and it lacks the detailed structure of a study report with acceptance criteria.

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Components of the Allofit Acetabular System are intended for use in total hip arthroplasty for treatment of the following:

• patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular . necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
• those patients with failed previous surgery where pain, deformity, or dysfunction persists. .
• revision of a previously failed hip arthroplasty. .

This Special 510(k) submission seeks to obtain clearance for addition of the Allofit 32mm Alpha Durasul Inserts to the existing, previously cleared (K003578) Allofit 28mm Alpha Durasul Insert product line. The only difference from the existing product is the internal diameter of the insert (32mm vs. 28mm).

There are also no changes to the other previously cleared components of the system which are used in conjunction with the inserts (e.g, acetabular shells, dome hole covers, screw hole covers, instrumentation).

The Allofit 32mm Alpha Durasul inserts incorporate the same general design features as the existing, previously cleared Allofit 28mm Alpha Durasul insert components and Allofit 32mm Alpha inserts (standard Sulene polyethylene). The inserts are snapped into the respective Allofit titanium shell intraoperatively. A peripheral locking mechanism holds the insert within the shell. A peg shaped eminence at the apex of the insert slips into the dome hole of the shell and provides further stability of the insert within the shell. Upon impaction into the short spikes in the dome of the metallic shell minimally penetrate the polyethylene insert, providing additional resistance to rotation. Both a standard and hooded insert configuration will continue to be offered.

The Allofit 32mm Alpha Durasul inserts will also use the same materials as the previously cleared devices (ISO 5834-1/2). The Durasul material is identical to that which was previously characterized and cleared for use in the Allofit 28mm Alpha Durasul Inserts.

The provided text is a 510(k) summary for a medical device (Allofit Acetabular System 32mm Alpha Durasul Inserts) and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a diagnostic AI/ML device would.

This document describes a medical device rather than a software or AI/ML diagnostic tool. The "acceptance criteria" discussed in such a submission relate to showing substantial equivalence to a predicate device, primarily through design, materials, manufacturing processes, and intended use, rather than performance metrics like sensitivity, specificity, or AUC as one would expect for a diagnostic AI.

Therefore, many of the requested fields (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission.

Here's an analysis based on the information available in the document, and a clear indication where information is not present:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The submission demonstrates substantial equivalence to a predicate device rather than fulfilling specific performance acceptance criteria through clinical or diagnostic studies. The "acceptance criteria" here are implicitly tied to demonstrating that the new device (32mm Alpha Durasul Inserts) is as safe and effective as the previously cleared predicate device (28mm Alpha Durasul Inserts) and other existing components of the Allofit system.

1. A table of acceptance criteria and the 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. This submission is for a physical medical device (acetabular inserts), not a diagnostic algorithm. It does not involve a "test set" of patient data in the typical sense of AI/ML performance evaluation. The "test" here is the comparison against the predicate device based on design, materials, and established manufacturing controls.

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 is no "ground truth" to be established by experts for a test set in this context. The evaluation is based on engineering principles, material science, and regulatory comparison.

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

• Not applicable. No adjudication method for a test set is relevant for this device submission.

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

• Not applicable. This is not a diagnostic AI device, so MRMC studies and human reader improvement with AI assistance are not relevant.

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

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

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

• Not applicable. No "ground truth" in the clinical or diagnostic sense is used. The basis for safety and effectiveness is substantial equivalence to a predicate device, relying on established performance of similar materials and designs, backed by manufacturing quality systems and material standards (e.g., ISO 5834-1/2).

8. The sample size for the training set

• Not applicable. There is no "training set" for this physical device.

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

• Not applicable. There is no "training set" or "ground truth" in this context.

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The MOST System is intended to replace the proximal, distal or total femur and/or the proximal tibia, especially in cases that require extensive resection and restoration. Replacement of the distal femur would also include replacement of the proximal tibia and possible resurfacing of the patella, if necessary. Proximal femoral replacement components are available for press-fit or cemented applications. Components used for replacement of the distal femur and proximal tibia are cemented. Specific diagnostic indications for use of the MOST include:

1. metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) and trauma requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur and/or proximal tibia;
2. patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory (IJD), e.g. rheumatoid arthritis, requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur and/or proximal tibia; and
3. revision cases requiring resection(s) and replacement(s) of the proximal, distal or total femur and/or proximal tibia.

The MOST Options System (MOST) is used for the replacement of the proximal, distal or total femur and/or the proximal tibia. Replacement of the distal femur would also include replacement of the proximal tibia and possible resurfacing of the patella, if necessary. Unlike primary hip and knee systems, this system can be used where extensive femoral and/or tibial resection and restoration is required (e.g., oncology cases). Modularity of the system allows for the resection of varying amounts of the femur and the proximal tibia (and patella, if necessary) before implantation. A total replacement is possible in cases where no part of the femur can be salvaged. Moreover, the system provides additional options for revision or severe bone loss of the tibia. The components of the MOST System include:

• a distal femoral replacement (Condylar End or Hinged Femur) which mates with a tibial component via a hinge type mechanism (Hinge-Kit or 4mm Hinge Kit):
• a proximal femur replacement that is available in two designs to address the presence or absence of the greater trochanter;
• intramedullary (I/M) stems with Cancellous Structured Titanium (CSTi) and MOST segments which will be used in conjunction with the proximal and distal femoral replacements, the Proximal Tibia and the MOST Revision Stem Adapter;
• an all poly patella;
• a proximal tibia replacement (Proximal Tibia or Hinged Tibia) which mates with the Proximal Tibia Insert and Hinged Tibia Insert, respectively and features a distal female taper for attachment of a MOST Revision Stem Adapter, Sulzer Revision Stems or Hinged Tibia Stem Plug (Hinged Tibia only);
• femoral and tibial spacers for use in conjunction with the Hinged Femur and Hinged Tibia, respectively to augment uni-compartmental or bi-compartmental defects; and
• revision stem adapter with and without CSTi coating used to convert the MOST taper to the Sulzer taper.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample size, ground truth establishment, or study designs (MRMC, standalone). The document is a 510(k) summary for a medical device called the "MOST Options System," focusing on its description, intended use, and substantial equivalence to other marketed devices. It does not contain the results of any performance studies to demonstrate that the device meets specific acceptance criteria.

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Components of the Converge Acetabular System are intended for use in total hip arthroplasty for treatment of the following:

1. Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
2. Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
3. Revision of previously failed hip arthroplasty.

The Converge Acetabular System consists of four modular shell options which mate with currently marketed insert components for replacement of the acetabulum during total hip arthroplasty. They are designed to provide congruency with the ability to effectively seal the acetabulum, and may be implanted with or without bone cement.

Common Features:

• Substrate Material: All of the Converge shells are manufactured from titanium alloy (Ti-6AI-4V ELI, ASTM F136).
• Porous Coating: Cancellous Structured Titanium (CSTi) porous coating (commercially pure titanium, ASTM F1580) covers the entire outer surface of the Converge shells, with the exception of regions adjacent to the dome hole and screw holes, and a small band around the opening of the shell. The porous coating allows for biological fixation to occur.
• Shell/Insert Locking Mechanism: Because all four shells of the Converge System share the same internal locking mechanism, they can be used with the currently marketed Sulzer Orthopedics Inter-Op Acetabular inserts (standard polyethylene, Durasul and Metasul).
• Threaded Dome Hole Dome Hole Plug: A threaded dome hole is common to all four shells. During implantation, an impactor/alignment instrument is inserted into the dome hole. Once the shell is inserted and the tool removed, the dome hole provides visual access to the acetabulum. A threaded titanium dome hole plug (ASTM F67) can be screwed into place to prevent unwanted material migration.

Shell Options:
A. Converge Cluster-Hole Porous Shell with Sealed Screw Holes: Hemispherically shaped with screw holes sealed with plugs that can be removed for supplemental fixation. Features superior holes for increased fixation options. Sizes range from 39mm to 71mm in 2mm increments.
B. Converge Rim Flare Porous Shell with Spikes and Sealed Screw Holes: Designed to facilitate load transfer, limit tilting/rotation, and give flexibility in press-fitting. Features an offset radius in the rim region and three dome spikes. Includes two sintered screw hole covers that can be removed for supplemental fixation. Outer diameters range from 39-71mm in 2mm increments.
C. Converge Multi-Hole Porous Shell with Sealable Screw Holes: Hemispherical shell designed for scenarios with deficient acetabular bone stock (e.g., revision cases). Features five to nine screw holes (depending on size) for placement into the ilium, ischium, and pubis. Unused screw holes can be plugged with plugs manufactured from either Ti-6Al-4V (ASTM F136) or unalloyed titanium (ASTM F67). Available in outer diameters ranging from 43mm to 81mm, in 2mm increments.
D. Converge Protrusio Porous Shell with Sealable Screw Holes: Designed to accommodate a deeper acetabular socket caused by protrusio defects. Features a gradual buildup of material from the rim to the dome. Like the Multi-Hole shell, it features five to nine screw holes (depending on size) and uses the same screw hole plugs. Available in external shell diameters ranging from 53mm to 81mm, in 2mm increments.

This document (K012739) is a 510(k) summary for a medical device and therefore does not contain acceptance criteria or detailed study results. 510(k) summaries are intended to demonstrate substantial equivalence to a legally marketed predicate device, not to prove clinical effectiveness or meet specific performance criteria through detailed studies.

Therefore, most of the information requested cannot be extracted from this document.

Here's what can be stated based on the provided text:

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

   • Not Available: This document does not specify acceptance criteria for performance or report device performance data from a study. The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device.

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 Available: This document does not describe a clinical performance study with a test set. This is a premarket notification for a new device based on substantial equivalence.

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 Available: No test set or ground truth establishment by experts is described in this document, as it's not a performance study.

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

   • Not Applicable/Not Available: No test set or 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 mechanical implant (acetabular system for hip replacement), not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant or described.

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

   • Not Applicable: This is a mechanical device, not an algorithm.

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

   • Not Applicable/Not Available: As no performance study with a test set is described, no ground truth is detailed.

8. The sample size for the training set

   • Not Applicable/Not Available: This isn't a machine learning algorithm or a study that would involve a "training set" in that context.

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

   • Not Applicable/Not Available: As above, the concept of a training set and its ground truth is not relevant to this type of device submission.

Summary of available information related to "proof" of meeting criteria:

The document states that the Sulzer Orthopedics Converge Acetabular System is found to be substantially equivalent to legally marketed predicate devices. This is the "proof" required for a 510(k) clearance, indicating that the device is as safe and effective as a device already on the market.

The basis for this substantial equivalence is described as similarities in:

• Materials: All shells manufactured from titanium alloy (Ti-6AI-4V ELI, ASTM F136) with Porous Coating Cancellous Structured Titanium (CSTi) via commercially pure titanium (ASTM F1580). Dome hole plug material is titanium (ASTM F67) or Ti-6Al-4V (ASTM F136).
• General design features: Modular shell options, internal locking mechanism, threaded dome hole, screw holes with optional plugs, and variations for different anatomical needs (Cluster-Hole, Rim Flare, Multi-Hole, Protrusio).
• Intended uses/Indications for Use: Total hip arthroplasty for noninflammatory degenerative joint disease (NIDJD), inflammatory joint disease (IJD), failed previous surgery where pain/deformity/dysfunction persists, and revision of previously failed arthroplasty.

Predicate Devices cited for substantial equivalence:

• Sulzer Orthopedics Inter-Op Acetabular System
• Zimmer Trilogy Acetabular System
• Stryker/Osteonics/Howmedica System 12 Acetabular System
• Smith & Nephew Orthopaedics Reflection Acetabular System
• DePuy Duraloc Acetabular System

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Components of the Converge Acetabular System are intended for use in total hip arthroplasty for treatment of the following:

• patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
• those patients with failed previous surgery where pain, deformity, or dysfunction persists.
• revision of a previously failed arthroplasty where there is sufficient bone stock to support the implant.

The Converge Acetabular System consists of the following shell components:

• I. Hemispherical: The Converge Hemispherical Shell is a porous coated, Ti-6A1-4V (ASTM F136) shell. The outer surface of the shell has CSTi porous coating (commercially pure titanium) to provide for biological fixation. The shell is available in various sizes ranging from 39mm to 65mm (in 2mm increments). The shell features 2 screwhole plugs that are sintered in place. The screwhole plugs can be removed intraoperatively before or after implantation if the surgeon opts to enhance fixation of the shell with bone screws. When left in place (no supplemental screws used), the screwhole plugs limit material ingress and egress (e.g., tissue, debris particles, cement, etc.).
• II. Rim-Flare: The Converge Rim Flare Shell is a Ti-6AI-4V metallic acetabular shell coated with CSTi porous coating. It is designed with an offset outer radius in the rim region which permits the loads to be transmitted to the periphery of the outer surface. An initial press-fit of the component is achieved by the offset radius in this region. Additionally, the outer design of the shell incorporates three pegs which are press-fit into the cancellous bone of the reamed acetabulum to minimize the potential for tilting or rotation of the device. The shell is available in various sizes ranging from 39mm to 71mm (in 2mm increments).
• III. Revision: The Converge Revision Shell is a Ti-6Al-4V metallic acetabular shell coated with CSTi porous coating. The Revision shell has up to nine screwholes which allow for screw placement into the illum, ischium and pubis. Those screwholes that are not utilized may be plugged after implantation to limit passage of tissue, debris particles, cement, etc. The shell is available in various sizes ranging from 43mm (in 2mm increments).
  All three Converge shells feature a central dome hole which allows for interface with the impactor/alignment instrument as well as for visualization of the acetabulum to ensure complete seating of the device. The dome hole may be plugged using a threaded cover to restrict unwanted material migration through the hole.
  All three of the Converge shell components will use existing Inter-Op instrumentation and will mate with currently marketed Inter-Op Acetabular Inserts (oxygenless packaged polyethylene, Durasul, or Metasul).

The provided text is a 510(k) summary for the Sulzer Orthopedics Converge Acetabular System. It details the product, its intended use, and claims substantial equivalence to a previously cleared device. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested table or answer the specific questions about the study that proves the device meets the acceptance criteria. The document focuses on regulatory compliance through substantial equivalence, not on a performance study with defined acceptance criteria.

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The Allegretto Unicompartmental Knee system is intended to replace the medial or lateral compartment of the femorotibial knee joint, damaged as a result of non-inflammatory joint disease or trauma.

The system is an intermediate solution between osteotomy and a total prosthesis, and is indicated in cases of predominantly unicompartmental degeneration in which there is a fairly intact capsular ligament (CL) system.

The Allegretto Unicompartmental Knee system is indicated for use in treatment of:

• 1. Unicompartmental noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis and arthritis secondary to a variety of diseases and anomalies.
• 2. Passively correctable valgus-varus deformity and moderate flexion contracture.
• 3. Those patients with failed previous surgery where pain, deformity or dysfunction persists.

The Allegretto Unicompartmental Knee system consists of a metallic distal femoral resurfacing component and a polyethylene proximal tibial resurfacing component. The device is intended for partial replacement of the articulating surfaces of the knee when only one side of the joint (medial or lateral) is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single-use implant intended for implantation with bone cement.

The femoral resurfacing component employs a symmetrical device design that can be used in left or right orientations. The component also features a radius of curvature to reproduce knee morphology for optimal bone coverage and a better kinematic, and two cruciate pegs to aid in its rotational stability. The femoral component is manufactured from Protasul™-2, a CoCrMo alloy that conforms to ISO standard 5832-4 and ASTM F 75.

The femoral component is also available in a distally reinforced version that is identical to the component described above with the exception of an additional 2mm buildup of material on the distal portion of the component. This additional material provides a better fit for patients with pronounced wear of the femoral condyle due to aseptic necrosis, revision, or dysplasia (valgus gonarthrosis).

The tibial component is manufactured from Sulene™-PE, an Ultra-High Molecular Weight Polyethylene (UHMWPe) that conforms to ISO 5834-1,2 and ASTM F 648. The allpolyethylene tibial component features universal geometry that allows it to be used in left and right knee applications. The superior articulating surface is basically flat, with a slight articulating surface curve to increase the bearing surface of the femoral component. A recessed groove pattern on the inferior surface of the device assists in fixation with bone cement. In addition, radiolucent wire is molded into the poly to assist in radiographic location.

This looks like a 510(k) premarket notification for a medical device submitted to the FDA in 2001. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data with acceptance criteria and performance metrics in the way a modern AI/ML device submission would.

Therefore, the provided document does not contain the information requested regarding acceptance criteria, a study proving device performance against those criteria, sample sizes, ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies because these are generally not components of a 510(k) submission for mechanical implants like the Allegretto Unicompartmental Knee System.

Instead, the submission focuses on:

• Product Description: Detailing the components, materials, and design of the Allegretto Unicompartmental Knee System.
• Intended Use/Indications for Use: Clearly stating the conditions for which the device is designed (e.g., unicompartmental noninflammatory degenerative joint disease, trauma).
• Substantial Equivalence: Listing predicate devices (Stryker Howmedica Osteonics SCR Unicompartmental Knee, Sulzer Orthopedics Natural Knee Uni Knee, etc.) and asserting that the Allegretto device is similar in intended use, materials, design, and operational principles. The FDA's letter (K011954) confirms this substantial equivalence.

In summary, the device's "acceptance" here is based on its similarity to already legally marketed predicate devices, implying that their established performance and safety profiles are sufficient for the new device. No new clinical study proving performance against defined acceptance criteria is referenced or required for this type of submission.

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