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The Alpha™ Metasul® Acetabular Insert is intended for use in total hip arthroplasty for treatment of the following:

• patient conditions of noninflammatory degenerative joint disease (NIDD), e.g., rheumatoid arthritis;
• Those patients with failed previous surgery where pain, deformity, or dysfunction persists;
• Revision of previously failed hip arthroplasty.

The Alpha Metasul Acetabular Insert (28mm and 32mm) is a hemispherically shaped design, composed of an outer component manufactured from ultra-high molecular weight polyethylene (UHMWPE) thermo-mechanically bonded to a wrought hot-forged CoCr alloy metallic inlay (in compliance with ISO 5832-12 and ASTM F1537). The Alpha Metasul Acetabular Insert is designed for use only with a Metasul femoral head. The Alpha Metasul Acetabular Insert is a metal-on-metal component, metal surfaces.

The Alpha Metasul 32mm Acetabular Insert, both standard and hooded, is available in sizes 52mm to 68mm (in 2mm increments). In turn, the proposed Alpha Metasul 32mm Acetabular Inserts are designed to mate with Allofit™ Acetabular Shells, sizes 48mm to 68mm (in 2mm increments). Both insert sizes mate the same basic design as the previously cleared Alpha Metasul 28mm Acetabular Insert and share many features with the Ringloc® Acetabular Liner and M2a -Taper Acetabular System.

The Alpha Metasul Insert has what is commonly referred to as a "poly-sandwich" design. The bearing surface of the insert, features a metallic Metasul inlay that is polished to a mirror-finish and themo-mechanically bonded into the proven polyethylene liner, which is then locked into the Allofit acetabular shell via a blocked in snap mechanism. On the hooded inserts, the face of this polyethylene liner incorporates an overhang of polyethylene extending beyond the midpoint of the metallic inlay to help prevent subluxation and instability.

This device is a Class III medical device, however, the provided documentation does not contain a study that proves the device meets specific acceptance criteria.

The document is a 510(k) Premarket Notification for the Alpha Metasul 28mm and 32mm Acetabular Inserts. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving efficacy or meeting specific performance acceptance criteria through a clinical study.

The "BASIS OF SUBSTANTIAL EQUIVALENCE" section states: "Performance tests, design comparisons, indications for use and labeling of the Alpha Metasul 28mm and 32mm Acetabular Inserts (Standard and hooded) demonstrations equivalent materials, designs, and indications for use to the predicate devices." This suggests that the submission relied on demonstrating similarity to already approved devices, rather than presenting novel performance data against pre-defined acceptance criteria.

Therefore, I cannot provide the requested information as it is not present in the provided text.

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The 32mm Epsilon Metasul Acetabular Insert and Metasul Femoral Head 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 (JJD), e.g., rheumatoid arthritis:
• those patients with failed previous surgery where pain, deformity, or dysfunction . persists:
• . revision of previously failed hip arthroplasty.

The Epsilon Metasul 32mm Acetabular Insert is a hemispherically shaped design, composed of an outer component manufactured from polyethylene (UHMWPE) (in compliance with ASTM F648) which is thermo-mechanically bonded to a wrought hotforged CoCr alloy metallic inlay (in compliance with ISO 5832-12). The Epsilon Metasul Acetabular Insert is designed for use only with a Metasul femoral head component, as a metal-on-metal system. The body's natural synovial fluid lubricates the metal surfaces. The Epsilon Metasul 32mm Acetabular Insert, both standard and hooded, is available in sizes designed to mate with Converge® Acetabular Shells, sizes 53mm to 81mm (in 2mm increments).

The Epsilon Metasul 32mm Insert has what is commonly referred to as a "polysandwich" design. The inner diameter, which forms the bearing surface of the insert, features a metallic Metasul inlay that is polished to a mirror-finish and thermomechanically bonded into the polyethylene liner, which is then locked into the Converge acetabular shell via the proven snap mechanism. On the hooded inserts, the face of the polyethylene outer diameter incorporates a 20° overhang of polyethylene extending superiorly from the midpoint of the insert face. This hood feature is designed to provide additional resistance to subluxation and instability.

The 32mm Metasul® Modular Femoral Head is manufactured from Protasul-21WF (wrought forged CoCrMo, in compliance with ISO 5832-12). The design incorporates a 12/14 Morse-type female taper and a beveled face that allows for easier reduction of the hip intraoperatively. This femoral head component is offered in both a standard and an eccentric version, and is designed specifically to articulate with Centerpulse Orthopedics acetabular inserts having a Metasul® Inlav.

The provided 510(k) Premarket Notification for the 32mm Epsilon Metasul Acetabular Insert and 32mm Metasul Femoral Head does not contain acceptance criteria or study results in the format requested.

This document is a regulatory submission for a medical device that demonstrates substantial equivalence to predicate devices. It focuses on device description, intended use, and comparison to existing products, rather than presenting a performance study with specific acceptance criteria and results.

Here's why the requested information is not available in the provided text:

• Type of Submission: This is a 510(k) premarket notification. For many Class II and Class III devices (like this one, which is Class III), substantial equivalence can be demonstrated through design comparisons, materials, and indications for use, without requiring extensive clinical performance studies to define acceptance criteria or measure performance against them in the same way an AI/software device would.
• Device Type: The device is a total hip replacement system component (metal-on-metal hip prosthesis). Its "performance" isn't measured by metrics like sensitivity, specificity, or object detection rates. Instead, performance is related to mechanical properties, biocompatibility, and clinical outcomes that are generally assessed through long-term follow-up and post-market surveillance.
• Content Focus: The document emphasizes:
  • Predicate Devices: Identifying similar devices already on the market.
  • Device Description: Detailed explanation of materials, design, and dimensions.
  • Intended Use: Specifying the patient conditions it's designed to treat.
  • Basis of Substantial Equivalence: Arguing that it's "substantially equivalent" to predicate devices based on design features, materials, and indications for use.

Therefore, I cannot populate the requested table and answer the following questions based on the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

In summary, the provided document is a regulatory submission for a physical medical device (hip implant components) focused on substantial equivalence, not a performance study for, for example, an AI algorithm that would typically have the requested performance metrics and study design details.

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The Durasul Bipolar is intended for non-cemented use in a hip hemi-arthroplasty in which it assumes the function of the natural femoral head in conjunction with a prosthetic femoral head component. Specific diagnostic indications for use of a bipolar include displaced femoral neck fractures, avascular necrosis of the femoral head, and non-union of femoral neck fractures.

The Durasul Bipolar consists of a polyethylene insert/liner and an outer CoCr shell. In vivo, the CoCr shell articulates directly with well-preserved articular cartilage while the Durasul insert articulates directly with a 22 or 26mm femoral head. The Durasul Bipolar components are available in a variety of sizes to allow the surgeon to replicate the natural anatomy of the hip joint as closely as possible when performing a hip hemi-arthroplasty.

This document describes the Durasul® Bipolar hemi-hip prosthesis and its regulatory clearance. It does not contain information about acceptance criteria and a study proving a device meets acceptance criteria in the way you've defined, which typically applies to AI/ML software or diagnostic devices with quantifiable performance metrics (e.g., sensitivity, specificity, AUC).

Instead, this document is a 510(k) summary for a traditional medical device (a prosthetic hip component). The "acceptance criteria" here are related to proving substantial equivalence to predicate devices, focusing on design, materials, and intended use, rather than specific performance metrics from a clinical study as you might expect for an AI/ML product.

Therefore, I cannot fill out your requested table and information points as they pertain to AI/ML or diagnostic device performance studies. The document states:

"Performance tests, design comparisons, and functional analyses conducted on the Durasul Bipolar demonstrate that this device is substantially equivalent to the predicate devices."

This broadly refers to engineering and material testing, and potentially comparison to the existing clinical history of the predicate devices. It does not describe a clinical study with a test set, ground truth established by experts, or statistical performance metrics.

To directly answer your request based on the provided text:

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

• Acceptance Criteria: Substantial equivalence to predicate devices (Centerpulse Orthopedics, Inc. Bipolar (K873815) and Exactech's AcuMatch L-Series Bipolar (K013211)). This means demonstrating similar design, materials, manufacturing processes, and intended use, and not raising new questions of safety or effectiveness.
• Reported Device Performance: The document states, "Performance tests, design comparisons, and functional analyses conducted on the Durasul Bipolar demonstrate that this device is substantially equivalent to the predicate devices." This indicates the device passed the necessary tests to be deemed substantially equivalent, but no specific quantitative performance metrics (like sensitivity, specificity, accuracy) are reported for clinical use in this document.

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 mentioned. This is a traditional device submission, not an AI/ML software submission that would typically involve a "test set" in this context. The "performance tests" would likely refer to bench testing (e.g., wear testing, fatigue testing) rather than a clinical dataset.

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 mentioned. Ground truth as understood for AI/ML models is not described here.

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

• Not applicable/Not mentioned.

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 mentioned. This is not an AI/ML diagnostic assistance device.

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

• Not applicable/Not mentioned. This is a physical prosthetic device, not an algorithm.

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

• Not applicable/Not mentioned. The "ground truth" here is the established safety and effectiveness of the predicate devices based on their history and testing.

8. The sample size for the training set:

• Not applicable/Not mentioned. This device does not use a "training set" in the AI/ML sense.

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

• Not applicable/Not mentioned.

In summary, this 510(k) pertains to a traditional orthopedic implant, and the regulatory process for such devices focuses on demonstrating substantial equivalence to already-approved predicate devices through engineering tests and regulatory comparisons, not on clinical performance metrics from a "study" with test sets and ground truth in the context of AI/ML or diagnostic accuracy.

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The Natural-Knee II Unicompartmental Knee is intended for use in:

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

The N-K II Unicompartmental All-Poly Tibia is intended to be used only with bone cement. The modular metal/polymer N-K II Unicompartmental Tibia and Femur are intended for use with or without bone cement.

The Natural-Knee II Unicompartmental Knee System is a conservative, cost-effective alternative to total knee replacement for patients with osteoarthritis primarily confined to one compartment. The N-K II Unicompartmental Knee System is intended for resurfacing of one side of the knee joint.

The N-K II Unicompartmental Modular Metal-backed Tibia is similar to the previously cleared N-K II Unicompartmental Tibia (K955778). The wrought titanium alloy tibial baseplate is a symmetrically designed component, eliminating the need for left/right orientations. The baseplate features three smooth pegs on the underside which aid in positioning and rotational stability. A smooth surface finish is provided on the inner surface of the tibial tray to minimize the potential for polyethylene wear. A screw hole is placed in the center of the baseplate for optional screw fixation. The baseplate is available in either a porous or non-porous version.

The all-poly tibia is designed with a single keel to position the component on the tibia and increase stability. Cement grooves on both the medial and lateral side of the keel increase the anchoring effect of the keel, while a dovetail cement channel around the perimeter of the distal surface, along with a T-pattern dovetail cement channel, act to resist movement in all directions. It is to be used only with bone cement for application directly onto the patient's resected proximal tibia.

The metal-backed and the all-poly tibias are both available in 6 sizes (1-6). The modular metal-backed tibia will be offered in 3 thicknesses (9, 11, and 13 mm). The insert thickness reflects the total amount of bone to be resected. The all-poly insert will be available in 4 thicknesses (7, 9, 11, and 13mm), in which the thickness is measured at the thinnest point from the distal to the proximal surface of the component.

The design of the femoral component of the proposed N-K II Unicompartmental Knee System will not change. This premarket notification only seeks to obtain clearance for the addition of cementless use of the previously cleared porous-coated femur (K955778).

The provided text is a 510(k) summary for a medical device (Natural-Knee® II Unicompartmental Knee System). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The 510(k) summary focuses on demonstrating "substantial equivalence" to already cleared predicate devices based on design features, indications for use, materials, and labeling. It does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for a test set or data provenance for performance evaluation.
• Information about experts for ground truth establishment.
• Adjudication methods.
• A multi-reader multi-case (MRMC) comparative effectiveness study.
• A standalone algorithm performance study.
• Details about the type of ground truth used for performance evaluation.
• Sample size for a training set or how ground truth was established for training.

Therefore, I cannot fulfill your request for this specific information based on the provided text. The document's purpose is to establish substantial equivalence for regulatory clearance, not to report on specific performance criteria derived from clinical or technical studies that would typically be associated with AI/software-as-a-medical-device performance claims.

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The Alloclassic SL Offset Femoral Stem is intended for prosthetic replacement without bone cement 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 a previously failed hip arthroplasty. .
• patients who require a total hip replacement. .

The Alloclassic Zweymüller SL Offset Femoral Stem is very similar to the previously cleared Alloclassic Zweymüller SL Femoral Stem in that it is:

• a conically shaped straight stem with a rectangular cross section (for rotational stability). 1.
• the same design, distal to the line of resection. 2.
• manufactured from wrought Ti-Al-Nb titanium alloy (Protasul-100™, ISO 5832-11/ASTM 3. F1295).
• grit blasted, below the neck, to enhance the bone-prosthesis interface. 4.
  In contrast, this stem provides an additional 6.25mm of offset (per size) and has a CCD/neck angle of 121° (vs. 131° for SL stem). Overall, this new design provides a higher offset sometimes needed for:
• 1. correcting insufficient soft tissue balancing,
• 2. restoration of leg length, and
• sufficient joint stability following total hip arthroplasty. 3.

The provided text is a 510(k) summary for a medical device called the "Alloclassic™ Zweymüller™ SL Offset Femoral Stem." This type of document is a submission to the FDA to demonstrate substantial equivalence to an existing legally marketed device. It typically focuses on design, materials, and intended use comparison rather than clinical study data proving performance against specific acceptance criteria in the way a diagnostic AI device would.

Therefore, many of the requested points, especially those related to clinical studies, diagnostic performance, ground truth, and expert evaluation, are not applicable to this type of regulatory submission for a prosthetic hip stem. The document does not describe a study to prove the device meets acceptance criteria in a quantitative sense of diagnostic accuracy or clinical outcomes assessed by a clinical trial. Instead, it argues for substantial equivalence based on design and material similarities to a predicate device.

Here's a breakdown based on the available information:

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

• Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy) that a diagnostic device would have. The "acceptance criteria" for a 510(k) submission for a hip stem are typically related to demonstrating substantial equivalence in terms of:
  • Same indications for use.
  • Similar design principles (shape, material, mechanism of action).
  • Similar materials of construction.
  • Similar manufacturing processes.
  • No new questions of safety or effectiveness.
• Reported Device Performance: The document does not report performance data from a clinical study for the new device itself. Instead, it highlights design differences and their intended benefits:
  • Provides an additional 6.25mm of offset (per size).
  • Has a CCD/neck angle of 121° (vs. 131° for the SL stem).
  • These design changes are intended for:
    • Correcting insufficient soft tissue balancing.
    • Restoration of leg length.
    • Sufficient joint stability following total hip arthroplasty.
  • The document implies that the performance (safety and effectiveness) is substantially equivalent to the predicate device due to shared fundamental 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 document describes a 510(k) submission based on design and material comparison, not a clinical study with a test set of patient 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 determination by experts is described in this document.

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 is a hardware orthopedic implant, not an AI-assisted diagnostic device.

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

• Not Applicable. This is a hardware orthopedic implant, not an algorithm.

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

• Not Applicable. No ground truth is described as there is no diagnostic study. The "ground truth" for the substantial equivalence argument is the established safety and effectiveness of the predicate device (K030373), which is assumed to be safe and effective based on its own prior regulatory clearance.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of an AI/diagnostic device. For a hip stem, this would refer to design validation and verification activities (e.g., mechanical testing, fatigue testing) often done on prototypes, but these are not clinical "training sets."

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

• Not Applicable. As above, no training set or ground truth in the AI/diagnostic sense is applicable here. The "ground truth" for design validation is typically engineering specifications and performance standards established through biomechanical testing, material science, and established surgical principles.

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The Converge RETi-Lock Multi-Hole Reinforcement Cup is 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 Converge RETi-Lock Multi-Hole Reinforcement Cup is a hemispherical acetabular reinforcement shell made of titanium alloy. It is designed to expand the surgeon's options for treatment in cases when acetabular bone stock is deficient. This device also has a fixation plate designed to match the contour of the ilium of the acetabulum and a hook designed to attach to the obturator foramen. Numerous screw holes in the cup and along the plate help to ensure fixation in good bone stock.

The provided text describes a 510(k) summary for the "Converge RETi-Lock Multi-Hole Reinforcement Cup," a medical device for total hip arthroplasty. However, the document does not contain any information regarding acceptance criteria, device performance metrics, or study details (like sample size, ground truth, expert qualifications, or comparative effectiveness studies).

Instead, the document focuses on:

• Sponsor and Contact Information: Centerpulse Orthopedics, Inc.
• Trade and Common Name: Converge RETi-Lock Multi-Hole Reinforcement Cup, Non-porous, press-fit, acetabular shell system.
• Classification: Class II device (Product Codes LZO, KWA, JDI, LWJ).
• Predicate Devices: Ascendant Acetabular System (K022985) and Restoration GAP II Cup (K980774).
• Device Description: A hemispherical acetabular reinforcement shell made of titanium alloy, designed to expand treatment options for deficient acetabular bone stock, with a fixation plate and hook, and screw holes for fixation.
• Intended Use/Indications For Use: Treatment of noninflammatory degenerative joint disease (NIDJD), inflammatory joint disease (IJD), failed previous surgery where pain/deformity/dysfunction persists, and revision of previously failed hip arthroplasty.
• Basis of Substantial Equivalence: Stated as "Performance testing, design comparisons, and functional analyses conducted on the Converge RETi-Lock Multi-Hole Reinforcement Cup demonstrate that this device is substantially equivalent to the predicate devices."

Therefore, I cannot provide the requested table and study details because the necessary information is not present in the provided text. The document only states that performance testing was done to demonstrate substantial equivalence, but it does not elaborate on the specific criteria, results, or methodology of that testing.

To answer your request, I would need a different type of document that includes the actual study results, acceptance criteria, and methodological details of the performance testing.

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The Epsilon™ Durasul® Constrained Acetabular Liner is intended for use in treatment of primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle, or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered. The fixation method of the acetabular components with which this device is intended to be used is porous cementless with supplemental screws, and the fixation method of the femoral components with which this device is intended to be used is cemented, porous cementless, or non-porous cementless fixation, as indicated for use by each respective femoral component.

This device consists of two components: a liner and a ring, which will be assembled and attached to one of the corresponding Centerpulse Orthopedics Inc. acetabular shells. The liner mates with previously-cleared Centerpulse Orthopedics Inc. acetabular shell components via a snap lock mechanism. The metallic reinforcing ring provides added femoral head constraint once assembled. The fixation method of the acetabular components is porous cementless with supplemental screws, and the fixation method of the femoral components is cemented, porous cementless, or non-porous cementless fixation, as indicated for use by each respective femoral component. At the time of surgery, the constrained liner and ring will be assembled to the corresponding acetabular shell and femoral head.

This 510(k) summary (K030923) is for a medical device (Epsilon™ Durasul® Constrained Acetabular Liner), not an AI/ML device. Therefore, the concepts of acceptance criteria related to device performance in terms of AI/ML metrics (like accuracy, sensitivity, specificity, AUC) and the study designs typically used to prove them (like standalone studies, MRMC studies, or training/test sets with ground truth established by experts) are not applicable.

This submission is for a physical orthopedic implant. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering performance tests and design comparisons demonstrating substantial equivalence to predicate devices, rather than the performance of an AI algorithm.

However, based on the provided text, I can extract information relevant to the device's regulatory acceptance, which is based on demonstrating substantial equivalence to legally marketed predicate devices.

Here's a breakdown of the information that is applicable from your request, interpreted for a physical medical device:

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

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail table format as one might expect for an AI/ML device. Instead, the "acceptance criteria" for this physical implant are implicitly met by demonstrating "substantial equivalence" to predicate devices. This equivalence is established through various performance tests, design comparisons, and functional analyses.

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

This information is not applicable and not provided. For a physical device, "test set" would refer to the number of devices or components subjected to mechanical and material testing. The summary does not specify the number of units tested, the country of origin of the materials, or if the testing was retrospective or prospective.

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

This is not applicable as there is no "ground truth" in the AI/ML sense for this type of device submission. The device's safety and effectiveness are established through engineering testing and comparison to existing, cleared devices, not through expert consensus on diagnostic interpretations.

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

Not applicable. This concept relates to expert review and consensus for AI/ML ground truth establishment.

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. MRMC studies are specific to evaluating human reader performance with and without AI assistance for diagnostic tasks. This is a physical orthopedic implant.

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

Not applicable. "Standalone performance" refers to an AI algorithm's performance without human interaction. This is a physical medical device.

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

Not applicable. The "ground truth" for this device's acceptance is its ability to meet engineering specifications and demonstrate comparable performance/safety to its predicates, often through established material and mechanical testing standards and clinical literature supporting the predicate technology.

8. The sample size for the training set

Not applicable. There is no "training set" for a physical device in the AI/ML sense.

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

Not applicable.

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The Wagner Cone Prosthesis is intended for prosthetic replacement of the proximal portion of the femur in total hip arthroplasty. This device is intended for cementless application where primary fixation occurs predominantly in the distal region. Specific diagnostic indications for use of the Wagner Cone Prosthesis are:

• 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.

This stem is a titanium-aluminum-niobium alloy conical configuration with a taper. The design features a circular cross-section with eight equally spaced conical longitudinal flutes down the long axis of the stem for rotational stability. The stem's core diameter tapers gradually from the proximal end to the distal end.

The provided document is a 510(k) premarket notification for the Wagner Cone Prosthesis, a hip joint implant. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information regarding acceptance criteria, device performance metrics, or study results in the context of AI/ML device evaluation.

The 510(k) approval process for orthopedic implants typically relies on demonstrating substantial equivalence to a legally marketed predicate device through:

• Design comparisons: Showing the new device has similar materials, design features, and operating principles to approved predicate devices.
• Functional analyses: Testing the physical and mechanical properties of the device (e.g., strength, fatigue life, wear resistance) to show it performs comparably to or better than predicate devices. These tests are usually conducted in a laboratory setting according to recognized standards (e.g., ISO, ASTM).
• Performance tests: These refer to mechanical and material tests, not clinical performance in the sense of a diagnostic or predictive AI/ML model.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details related to AI/ML device performance from this document. The questions you've asked (sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are highly relevant to AI/ML device submissions but are not addressed in this type of traditional medical device 510(k) summary.

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The tibial spacer 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.
• . Those patients with failed previous surgery where pain, deformity, or dysfunction persists.

These Tibial Spacers are optional components designed to mate with the previously-cleared Natural-Knee II Cemented Modular Tibial Baseplate. Like the Tibial Baseplate, the Tibial Spacers are manufactured from cobalt chrome alloy. The tibial spacers are available in seven sizes (00 through 5) and in two thickness levels. They are available in both medial and lateral and both left and right configurations to match the radial contour of the baseplates.

The provided text is a 510(k) summary for a medical device called "Tibial Spacer for the Natural-Knee® II Cemented Modular Tibial Baseplate." It describes the device, its intended use, and states that it is substantially equivalent to a predicate device.

However, the document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through clinical data, statistical analysis, or expert review related to AI/ML or diagnostic performance. The basis of substantial equivalence is stated as "Performance testing, design comparisons, and functional analyses conducted on Tibial Spacers for the Natural-Knee® II Cemented Modular Tibial Baseplate demonstrate that the Tibial Spacer is substantially equivalent to the predicate device."

Therefore, based only on the provided text, I cannot fill out the requested table or answer the specific questions related to acceptance criteria, diagnostic performance studies, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, as these concepts are not mentioned in the context of this 510(k) submission.

This document is for a traditional medical device (a knee implant component) and not an AI/ML-driven diagnostic or image analysis tool, which is typically where the "acceptance criteria" and "study proving criteria met" for performance metrics like sensitivity, specificity, or AUC would be detailed. The "performance testing" mentioned likely refers to mechanical and biocompatibility testing common for implantable devices, not diagnostic accuracy.

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The Alloclassic™ Zweymueller™ SL/SLL Femoral Stem is intended for prosthetic replacement without bone cement 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 a previously failed hip arthroplasty. ●
• patients who requires a total hip replacement. .

The Alloclassic™ Zweymueller™ SL/SLL Femoral Stem is designed as a conical straight stem with a rectangular cross section to ensure rotational stability. Distally the SLL stem is up to 20% longer than the same size SL stem, while maintaining the same conical features. This provides the surgeon with greater freedom of choice even in primary operations. A SLL stem of the same size as the pre-selected SL stem can be implanted to achieve primary stability in cases of unexpected poor bone quality. Distally the stem is anchored primarily by its edges; proximally the surfaces anchor against the bone cortex.

The general design of the Alloclassic™ Zweymueller™ SL/SLL Femoral Stem with the slim neck and short taper remains unchanged as compared to the design of the previously cleared Zweymueller™ SL Femoral Stem.

The modified design increases the patient's range of motion by up to 12° following a total hip replacement. The risk of impingement and ultimately the risk of dislocation are reduced following a total hip replacement.

The Alloclassic™ Zweymueller™ SL/SLL Femoral Stem is manufactured from wrought Ti-Al-Nb titanium alloy (Protasul-100™, ISO 5832-11 / ASTM F1295-92). The entire stem below the neck of the hip stem is grit blasted to provide enhanced bone/prosthesis interface.

This 510(k) summary describes a medical device, specifically a femoral hip stem for total hip replacement. However, it does not contain information about a study proving the device meets acceptance criteria in the way a typical AI/software device submission would. This document is for a physical orthopedic implant.

Therefore, many of the requested categories for AI/software-based acceptance criteria and studies are not applicable to this submission. This is a common characteristic of medical device submissions for physical implants, where "acceptance criteria" are generally met through manufacturing standards, material testing, mechanical testing (e.g., fatigue strength, static strength), and comparison to a predicate device based on its established safety and effectiveness.

Here's a breakdown of the requested information, indicating why much of it is not found in this document for this type of device:

Acceptance Criteria and Device Performance (Not Applicable in the traditional software sense)

Explanation: This document is for a physical femoral hip stem. Its "performance" is assessed through its material properties, mechanical integrity, and biological compatibility, usually demonstrated via non-clinical bench testing and adherence to recognized standards, rather than diagnostic accuracy metrics. The key "acceptance criteria" for this specific submission revolve around demonstrating substantial equivalence to a previously cleared predicate device (K962101).

Study Details (Not a clinical efficacy or AI performance study in this context)

Since this K030373 submission is for a physical orthopedic implant and is based on substantial equivalence, it does not describe a clinical study in the sense of comparing the device's diagnostic performance or clinical outcomes in a trial. The "study" here refers to the comparison made by the manufacturer to demonstrate equivalence to a predicate device.

1. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" of patient data in the context of an AI algorithm or diagnostic study. The comparison is made against the design, materials, and indications of a predicate device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a diagnostic test is not relevant here. The "ground truth" equivalent would be established clinical history and performance of the predicate device.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device (Zweymueller™ SL Femoral Stem, ref. K962101). The manufacturer asserts that the new device is substantially equivalent because it has the "same indications for use, basic design, sizes, material, sterilization method of manufacture."

7. The sample size for the training set: Not applicable. There is no training set for an AI algorithm.

8. How the ground truth for the training set was established: Not applicable.

Summary of the Device's "Acceptance Criteria" Met by this Submission:

The "acceptance criteria" for this 510(k) submission are met by demonstrating Substantial Equivalence (SE) to a legally marketed predicate device. The key points for demonstrating SE are:

• Same Indications for Use: The Alloclassic™ Zweymueller™ SL/SLL Femoral Stem has the same intended use for total hip replacement in cases of noninflammatory degenerative joint disease (NIDJD), inflammatory joint disease (IJD), failed previous surgery, or revision of failed hip arthroplasty, and for non-cemented use with specific acetabular components and femoral heads.
• Similar Basic Design: The general design (conical straight stem, rectangular cross-section for rotational stability, slim neck, short taper) remains unchanged compared to the predicate, with the primary modification being the SLL stem's distal length.
• Same Material: Manufactured from wrought Ti-Al-Nb titanium alloy (Protasul-100™, ISO 5832-11 / ASTM F1295-92).
• Same Mechanism of Action/Fundamental Scientific Technology: Both devices function as a femoral component in total hip replacement, anchoring to bone.
• Similar Performance Characteristics: The submission implies that the minor design modification (SLL stem length affecting range of motion) does not raise new questions of safety or effectiveness, particularly because the SLL stem is presented as an option within the existing design philosophy. The increase in range of motion (up to 12 degrees) and reduced risk of impingement/dislocation are presented as improvements without compromising safety.

Study/Evidence that Proves Acceptance Criteria:

The "study" in this context is the comparison and technical assessment presented by Centerpulse Orthopedics Ltd. to the FDA, asserting that the Alloclassic™ Zweymueller™ SL/SLL Femoral Stem is substantially equivalent to the predicate device K962101 (Zweymueller™ SL Femoral Stem). This comparison highlights:

• Explicit statement of equivalence: "Centerpulse Orthopedics believes the Alloclassic™ Zweymueller™ SL/SLL Femoral Stem is substantially equivalent to the previously cleared, Zweymueller™ SL Femoral Stem (ref. K962101 as Exhibit 9) as it has the same indications for use, basic design, sizes, material, sterilization method of manufacture."
• Description of modifications and why they don't impact safety/effectiveness: The SLL stem is longer distally, maintaining conical features, to give broader surgical choice and achieve primary stability in poor bone quality. The slim neck and short taper are unchanged. The modified design increases range of motion and reduces impingement/dislocation risk, suggesting a benefit, not a deficit, in performance.
• Material conformity: The device is made from a specified medical-grade titanium alloy (Protasul-100™, ISO 5832-11 / ASTM F1295-92), which is common for such implants.
• Indications for Use parity: The indications are listed and stated to be the same as the previously cleared device.

The FDA's decision to clear the device (MAR 0 6 2003) signifies their agreement with the manufacturer's assessment of substantial equivalence.

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