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The Symmetric(TM) Total Knee System consists of single use components intended for total knee arthroplasty with the following indications:

1. Rheumatoid arthritis,
2. Post-traumatic arthritis,
3. Osteoarthritis,
4. Degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
5. Failed osteotomies, unicompartmental replacement, or total knee replacement.
   All components are for cemented use only.

The Femoral components are cobalt chromium alloy (ASTM F75). Tibial articular inserts and patellar components are UHMWPE (ASTM F648). Tibial trays, metaphyseal and revision stems, femoral and tibial wedges and cones, and screws (K961157), are titanium (ASTM F1472). Coated cobalt chromium and titanium components feature a coating of plasma sprayed titanium (ASTM F1580).
The purpose of this 510(k) is to submit an additional sterilization method of a flexible bag system. Other descriptive details remain unchanged from the predicate.

This document is a 510(k) premarket notification for a medical device called the "Symmetric™ Total Knee System." It's important to note that this submission is for an additional sterilization method for an existing device, not for a new AI/software-driven device. As such, the information typically requested for AI device studies (like sample sizes, ground truth, expert adjudication, MRMC studies, standalone performance, training set details) does not apply to this specific submission.

Therefore, I cannot provide a table of acceptance criteria for AI performance or details of a study proving a device meets AI-specific criteria, as this document pertains to a physical orthopedic implant and its sterilization process, not an AI or software-based medical device.

Here's a breakdown of what the document does provide, and why the requested information isn't present:

Device: Symmetric™ Total Knee System (a knee joint prosthesis)
Purpose of 510(k): To submit an additional sterilization method (flexible bag system) for the device. The core device itself was previously cleared under K080199.

Missing Information (and why it's not applicable here):

1. Table of acceptance criteria and reported device performance: This document doesn't define acceptance criteria for AI performance. The "performance data" mentioned (Section VII) refers to "full sterilization qualification of the flexible bag sterilization vendor," not clinical or AI performance.
2. Sample size, data provenance for a test set: No test set for AI performance is discussed.
3. Number of experts and qualifications for ground truth: Not applicable, as there's no AI ground truth to establish.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study: Not applicable. Human readers are not using AI assistance with a knee implant.
6. Standalone performance study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

What the document does state regarding the study (sterilization-related):

• Study: "The full sterilization qualification of the flexible bag sterilization vendor is included in the submission." (Section VII. Performance Data)
• Conclusion: "The technological characteristics/features and performance characteristics for the Symmetric Total Knee System are substantially equivalent to the legally marketed predicate device. This 510(k) is submitted for the addition of the flexible bag chamber sterilization method." (Section VIII. Conclusions)

In summary, this document is about changes to the manufacturing process (sterilization) of a physical medical implant, not the evaluation of an AI or software algorithm.

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The Symmetric™ Total Knee Augments consist of single use components intended for attachment to the Symmetric Total Knee implants during total knee arthroplasty with the following indications.

1. Osteoarthritis
2. Rheumatoid Arthritis
3. Traumatic Arthritis or correction of posttraumatic joint deformity
4. Where the use of a more conservative procedure has failed or is unacceptable.
   All components are for cemented use.
   Additional indications for use:
   Whenever a cone is used, a revision stem is to be used as well.

The Symmetric™ Total Knee Augments are intended to complement the Symmetric Total Knee System. The system consists of metallic wedges, stems, cones, sleeves, and offset trunnions that can be used with the Symmetric Total Knee System to provide increased bone contact and support during total knee arthroplasty when more conservative methods have failed.
The FEMORAL WEDGES are designed to fill voids remaining in the peripheral bone stock after the removal of diseased and damaged bone, and to provide indirect bone support for the femoral component. These wedges are made of Titanium 6Al-4V and have grit blasted surfaces where they are designed to be cemented to Symmetric Total Knee femoral implants and titanium plasma sprayed surfaces to provide good cemented fixation to bone. The components are available for the distal and posterior surfaces individually or combined. These wedges are symmetric so they will work on the medial or lateral side of either knee.
The TIBIAL WEDGES are designed to fill voids remaining in the peripheral bone stock after the removal of diseased and damaged bone, and to provide indirect bone support for the tibial component. These wedges are made of Titanium 6A1-4V and are designed for cemented fixation to Symmetric Total Knee tibial implants. The titanium plasma sprayed surfaces provide increased fixation for bone cement. The components are available in flat and wedged designs, and are able to be used on the medial or lateral side of the symmetric trays.
The TIBIAL and FEMORAL Cones are designed to fill voids remaining in the central bone stock after the removal of diseased and damaged bone, and to provide indirect bone support for the femoral or tibial component. These cones are symmetrically designed components designed for cemented fixation around the trunnion or revision stem of a Symmetric total knee implant. The cones are made of Titanium 6Al-4V and are internally grit blasted for cement fixation against the implant and externally plasma sprayed to provide increased cemented fixation to bone.
The OFFSET TRUNNIONS are designed to be attached to the trunnion of the femoral or tibial component utilizing a Morse Taper, and then has a Morse Taper of its own to receive a revision stem. The offset stems are made of Titanium 6A1-4V, and are designed to provide adjustments in stem position with respect to the primary implants trunnion, allowing the stem to line up with the patient's medullary canal more effectively.
The COATED AND PARTIALLY COATED REVISION STEMS are designed to be attached to the trunnion of the femoral or tibial component utilizing the Morse Taper. The stems are made of Titanium 6Al-4V and are titanium plasma sprayed to provide increased fixation.
The RECTANGULAR REVISION STEMS are designed to be attached to the trunnion of the femoral or tibial component utilizing the Morse Taper. The stems are made of Titanium 6AI-4V and are available in non-coated and titanium plasma spray coated styles. The rectangular shape is designed to provide cortical bone support while reducing cancellous bone loss.

Here's an analysis of the provided text regarding the Symmetric™ Total Knee Augments and its associated study, structured according to your requested points:

The provided text describes a 510(k) premarket notification for the Symmetric™ Total Knee Augments, a medical device. It focuses on demonstrating substantial equivalence to predicate devices, rather than directly proving the device meets an explicit set of acceptance criteria through a specific performance study in the way a diagnostic AI might. The "performance" here refers to the physical and material characteristics of the implants and their intended use.

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

The concept of "acceptance criteria" and "reported device performance" as typically applied to AI or diagnostic devices (e.g., sensitivity, specificity, accuracy thresholds) is not directly applicable here. This document is a 510(k) summary for a medical implant, which demonstrates substantial equivalence to existing devices rather than meeting a specific performance metric against a gold standard in a clinical study.

Instead, the "acceptance criteria" are implied by the similarities to predicate devices and the successful completion of non-clinical (mechanical) testing as outlined to the FDA for regulatory clearance. The "device performance" is therefore the demonstration of these similarities and the satisfactory results of the engineering tests.

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

• Test Set Sample Size: Not applicable in the context of a clinical test set as for diagnostic devices. The "testing" refers to mechanical and material characterization. The document does not specify sample sizes (e.g., how many wedges were fatigue-tested) but refers to "a writeup of the testing completed for this 510(k) is included in Section 18."
• Data Provenance: The testing is non-clinical, likely conducted in a laboratory setting, not geographically specific 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. This device is a mechanical implant. Ground truth is established through engineering design specifications, material standards (ASTM), and mechanical testing protocols, not expert consensus on medical images or patient outcomes.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical or diagnostic studies. This is a non-clinical, engineering-focused 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 a knee implant, not an AI or diagnostic tool that assists human readers.

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

Not applicable. This is a knee implant.

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

The "ground truth" for this type of device is material specifications (ASTM standards), engineering design principles, and mechanical test results that demonstrate structural integrity and performance equivalent to or better than predicate devices. There is no "ground truth" in the clinical sense (e.g., pathology, outcomes data) for this 510(k) process as "No clinical data was utilized for the basis of substantial equivalence."

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI or machine learning model.

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

Not applicable. This device does not involve a training set.

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The Symmetric™ Total Knee System consist of single use components intended for total knee arthroplasty with the following indications.

1. Osteoarthritis (for cemented use only)
2. Rheumatoid Arthritis (for cemented use only)
3. Traumatic Arthritis (for cemented use only)
4. Where the use of a more conservative procedure has failed or is unacceptable.

The Symmetric™ Total Knee System is intended for the resurfacing of the knee joint. The system consists of metallic femoral and tibial components (including an available metaphyseal stem) and a polyethylene tibial insert and patellar component.

The FEMORAL COMPONENT is designed for left/right orientations. The femoral component is manufactured from cast cobalt chromium/molybdenum (CoCrMo). The femoral component will be available in eight sizes (1-8) and will have a central post (with a 5° valgus angle) and gussets to aid in rotational stability and to increase strength. It will be plasma sprayed with Commercially Pure Titanium (CPTi).

The TIBIAL TRAY is a symmetrically designed component, eliminating the need for left/right orientations. The tibial component is manufactured from wrought titanium alloy (Ti 6Al-4V). The tibial tray features a central post, a pair of gussets, and 2 to 4 pegs on the underside broviding rotational stabilization and increased tray strength. Four screw holes in the tibial tray allow for optional screw fixation. The tibial tray is designed with locking features permitting the UHMWPE tibial insert to be snapped into place. The tibial tray has 8 sizes (1-8) and is plasma sprayed with Commercially Pure Titanium (CPTi).

The TIBIAL INSERT is also a symmetrically designed component manufactured from Ultra-High Molecular Weight Polyethylene (ASTM F648). The inserts' articulating geometry is semiconstrained and is captured in the tibial tray by the mating capture features. The insert is available in nine thicknesses (10, 12, 14, 16, 18, 20, 25, 30, 35mm) and 8 sizes (1-8).

The METAPHYSEAL STEM is designed to be driven onto a tibial tray further increasing the fit and fill of the component allowing for a more stable system.

The REVISION STEM is designed to be driven onto a tibial tray or femoral component further increasing the stability of a revision component.

The PATELLAR COMPONENT is dome shaped and tracks nicely against the femoral component.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "No clinical data was utilized for the basis of substantial equivalence."
Therefore, there is no clinical test set, sample size, or data provenance related to clinical data. The evaluation was based solely on non-clinical testing.

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

Not applicable, as no clinical test set or ground truth derived from expert opinion on clinical cases was used. The substantial equivalence was determined through non-clinical testing and comparison to predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was performed on human readers as no clinical data was used. The evaluation was based on device performance in non-clinical tests.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not directly applicable in the context of this traditional medical device (knee implant). The "standalone" performance here refers to the device's physical and mechanical properties as tested in a laboratory setting, without human interaction in a 'use' scenario beyond the testing parameters. The non-clinical testing performed is essentially a standalone evaluation of the device's material and design integrity.

7. Type of Ground Truth Used

The ground truth for proving substantial equivalence was established through:

• Comparison to predicate device specifications: The physical dimensions, materials, and fixation methods were compared to those of the Beacon Cemented and Uncemented Total Knee System (K051510) and the Profix Total Knee System (K933958).
• Non-clinical testing methodologies: Performance was assessed against established engineering standards and guidance documents, specifically "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA (dated January 16, 2003)."

8. Sample Size for the Training Set

Not applicable, as this is a medical device submission based on substantial equivalence through non-clinical testing and comparison to predicate devices, not an AI/machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

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The wires are intended for use in the fixation of bone fractures, for bone reconstruction, or as a guide/aid for the insertion of other medical devices.

The device consist of various diameter and length wires for use in the fixation of bone fractures, bone reconstruction, or as a quide or aide for insertion of other medical devices. The wires are made of 316LVM Stainless Steel.

This document is a 510(k) summary for a Bone Fixation Wire (Kirschner Wire) and does not contain information about acceptance criteria or a study proving device performance against such criteria. The document establishes substantial equivalence to a predicate device, and thus does not include a performance study with acceptance criteria in the context of AI/ML device evaluation.

Therefore, I cannot provide the requested information.

Here's why the input document doesn't contain the requested information:

• Device Type: The device described is a physical medical device (bone fixation wire), not a software or AI/ML device.
• Regulatory Pathway: The document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device already on the market, rather than proving novel performance against specific acceptance criteria through a clinical or algorithmic performance study.
• Date: The document is from 2008, predating the widespread use of sophisticated AI/ML in medical devices and the specific regulatory guidance around their evaluation.

To answer your questions about acceptance criteria and studies, the source document would need to be a regulatory submission (e.g., PMA, De Novo, or a 510(k) for an AI/ML device) that includes a performance study section.

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Indications For Use:

Triple arthrodesis
Isolated rearfoot arthrodesis
Midfoot arthrodesis
Comminuted trauma
Diabetic Charcot reconstruction
Most foot pathology not requiring fixation above the ankle

The E-Z Frame Surgical Boot is manufactured of light weight stable materials to allow the surgeon to stabilize the foot at or below the ankle for post surgical conditions. Presently liizarov or Sheppard Rings are used for this purpose and require multiple avenues of surgical intervention in the tibia to stabilize the distal support ring. With the E-Z Frame system a boot is stabilized on the distal leg (tibia) and further stabilized to the distal ring about the foot with carbon fiber rods that are attached to the boot and ring respectfully. Light weight materials are employed using 6061 Aluminum, ABS plastic, carbon fiber rods, FR10/11 laminate and small ASTM F 17-4 Stainless Steel Fixtures. The foot is stabilized to the distal ring using Kirshner Wires (K-Wire) purchased from PROMEX of Indianapolis, IN under 510 K: K960023. The boot utilized to stabilize the device on the tibia is purchased and modified from Darco International of Virginia.

This document is a 510(k) premarket notification for a medical device called the "E-Z Frame Surgical Boot," submitted to the FDA in 2005. It is a traditional submission for a physical medical device, not a software or AI-driven diagnostic device. Therefore, the questions related to AI/software performance, such as acceptance criteria, study design for performance, ground truth establishment, expert adjudication, MRMC studies, and standalone performance, are not applicable here.

The document primarily describes the device's components, its intended use, and its substantial equivalence to a predicate device. The FDA's letter confirms the clearance based on substantial equivalence to pre-amendment devices or previously cleared devices.

Here's an attempt to address the questions based on the provided text, indicating where information is not applicable:

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

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for this type of device. For a traditional medical device like a surgical boot, acceptance is typically based on mechanical integrity, biocompatibility of materials, and successful comparison to a predicate device's intended use and safety profile.
• Reported Device Performance:
  • Manufactured of light weight stable materials to allow the surgeon to stabilize the foot at or below the ankle for post-surgical conditions.
  • Stabilized on the distal leg (tibia) and further stabilized to the distal ring about the foot with carbon fiber rods that are attached to the boot and ring respectfully.
  • Employs lightweight materials: 6061 Aluminum, ABS plastic, carbon fiber rods, FR10/11 laminate, and small ASTM F 17-4 Stainless Steel Fixtures.
  • Foot stabilized to the distal ring using Kirshner Wires (K-Wire) (predicate K960023).
  • Boot utilized to stabilize the device on the tibia is purchased and modified from Darco International of Virginia.

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

• Not applicable. This is a physical device submission, not a study of algorithm performance on a test set of data. The "test" in this context refers to general mechanical and material quality and safety validations, not data-driven performance.

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. Ground truth for a dataset is not relevant to this type of device submission. The "ground truth" for the device itself would be its ability to physically stabilize the foot as intended and its safety through material and design evaluation, usually performed by engineers and regulatory bodies.

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

• Not applicable. No adjudication method for a test set of data.

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

• Not applicable. This is not an AI/software device.

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

• Not applicable. This is not an AI/software algorithm.

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

• Not applicable for an AI data-driven context. For this device, the "ground truth" for its performance is its physical stability, material compatibility, and engineering design meeting specified standards for orthopaedic devices, which is evaluated through engineering tests and comparison to predicate devices, not data-based ground truth.

8. The sample size for the training set

• Not applicable. There is no training set for an AI/software model.

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

• Not applicable. There is no training set for an AI/software model.

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OSTEOARTHRITIS
RHEUMATOID ARTHRITIS
TRAUMATIC ARTHRITIS
WHERE THE USE OF A MORE CONSERVATIVE PROCEDURE HAS FAILED OR IS UNACCEPTABLE
INTENDED FOR NON-CEMENTED USE SINGLE USE ONLY

The Signal Medical Corporation HHS Acetabular Component is manufactured of ASTM I-136 or F-75. The design is made available in twelve (12) sizes ranging from 48mm to 70mm, in two mm increments. The cup is coated with an F-67 sintered beaded surface for F-136 or F-75 beads for an F-75 cup to enhance bone ingrowth. The device is designed in three models, one with three circumferentially spaced pins or spikes at 120 degree intervals to provide for a primary skeletal fixation and reduce the chance of rotation, one with screw holes and one with both screw holes and spikes. The ultra high molecular weight polyethylene inserts, ASTM F648, are secured to the acetabular shell using a crown-taper fit. They are designed to accept 28mm femoral heads on their inside diameter from 48mm to 70mm and 32mm femoral heads from 54mm to 70mm. This device is intended for single use only.

This document is a 510(k) summary for a medical device (HHS Acetabular Component), not a study report for an AI/ML powered device. As such, it does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details that are typically found in such studies.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other requested information as it is not present in the provided text.

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Osteoarthritis. Where the use of a more conservative procedure has failed or is unacceptable. The device is intended for non-cemented use.

The Signal Medical Corporation Great Toe Implants are manufactured from ASTM F75 Cobalt Chrome. The porus coating is ASTM F75 sintered beads, -45+60 mesh. The device is intended for non-cemented use. The stem of the device is intended to be inserted into the proximal end or base of the first phalangel bone. The convex surface of the implant is intended to articulate with the distal end or head of the first metatarsal bone. The design is made available in multiple sizes equivalent to the toe implants in the Townley Great Toe Joint 510K (K911378) and the Zimmer Great Toe 510K (K823405).

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

The document is a 510(k) summary and an FDA clearance letter for the Signal Medical Corporation Great Toe Implants. It focuses on:

• Device Description: What the device is made of and its general function.
• Intended Use/Indications for Use: What the device is for (osteoarthritis, when conservative procedures fail).
• Substantial Equivalence: The FDA's determination that this device is substantially equivalent to previously marketed predicate devices (Townley Great Toe Joint 510K (K911378) and Zimmer Great Toe 510K (K823405)). This is the core of a 510(k) submission, confirming that a new device is as safe and effective as a legally marketed one without requiring new clinical trials or extensive performance testing if the predicate device itself didn't necessitate them.
• Regulatory Information: FDA regulations, general controls, and contact information.

This type of submission typically relies on comparison to predicate devices, material testing, and sometimes bench testing, rather than extensive clinical studies with specified acceptance criteria as would be found in a Premarket Approval (PMA) application or a more complex medical device.

Therefore, I cannot provide the requested table or answer the questions related to acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment because this information is not present in the given text.

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• Osteoarthritis
• Rheumatoid Arthritis
• Traumatic Arthritis
• Where the use of a more conservative procedure has failed or is unacceptable.

The Signal Medical Corporation 28mm Ceramic Femoral Heads are manufactured from zirconium oxide. The design is made available in three (3) sizes identical to the cobalt chrome femoral heads in the Signal Medical Corporation 510K (K971681) (-3.5, 0, +3.5). These ceramic femoral heads should only be used on the Signal Medical Corporation (SMC) femoral component of the hip, and should never be resterilized.

The provided text is a 510(k) summary for a medical device: "Signal Medical Corporation 28mm Ceramic Femoral Heads". This document is a regulatory approval, not a scientific study report. As such, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The 510(k) process is about demonstrating substantial equivalence to a legally marketed predicate device, not necessarily proving performance against specific quantitative acceptance criteria in a clinical study.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert adjudication, or MRMC studies for this device based on the given text.

The document primarily states:

• Device Description: 28mm Ceramic Femoral Heads made from zirconium oxide, available in three sizes, to be used only with Signal Medical Corporation's femoral component.
• Indications for Use: Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, and where conservative procedures have failed or are unacceptable.
• Regulatory Classification: Class II, Product Code LZO.
• Substantial Equivalence: The FDA determined the device is substantially equivalent to devices marketed prior to May 28, 1976.
• Limitation: "package insert must reflect that Signal Medical Corporation's 28 mm Zirconia Ceramic Femoral Head is only to be used with Signal Medical Corporation's cobalt-chrome hip stems with the 5.708 degree trunnions."

There is no mention of specific performance metrics, acceptance criteria, or any clinical or technical study results in this 510(k) summary document that would allow me to answer your detailed questions.

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This femoral component of the hip is indicated for use in patients with: 1 - Osteoarthritis - 2 Rheumatoid Arthritis - 3 Traumatic Arthritis and when the use of a more conservative procedure has failed or is unacceptable.

The Signal Medical Corporation Femoral Component of the Hip is manufactured with cobalt chromium alloy (ASTM F-75). The design is made available in four (4) sizes ranging from 10.5mm to 15mm. The stem portion of the femoral component is essentially identical to the DePuv AML Femoral Component (K852198) and the BioPro Horizon Femoral Component (K962769). The collar will be available in two different angular settings of 20 degrees to the horizontal and 35 degrees to the horizontal. The device will be offered with and without a sintered beaded surface, as depicted on the engineering drawings. The taper on the trunnion is a standard 5.708 degree angle as found on the Whiteside Biomechanics (K961625) and the StelKast Proform Cemented Femoral Component (K951083). The device has a circumfrential collar to load the bone on the cortical arc and distribute the compressive load of the implant as proximally as possible. The stems distal to the collar are essentially identical in geometry and size as the DePuy AML (K852198) and the BioPro Horizon (K962769). The non-sintered beaded surface device will have a 5mm hole in the distal tip of the implant to accommodate a cement centralizer from the StelKast Corporation (K951083). This device is designed for cemented use only in the non-porous coated version. With the porous sintered beaded surface, the device is designed for both cemented and non-cemented press-fit use.

The provided text is a 510(k) summary for a medical device (SMC Femoral Component) and does not describe any acceptance criteria or a study proving the device meets them in the context of an AI/ML medical device. This document is a regulatory submission for a traditional medical implant, a hip femoral component, seeking substantial equivalence to predicate devices. It focuses on the physical design, materials, and intended uses of the implant.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because these concepts are not applicable to the content of this 510(k) submission.

The document implicitly states the acceptance criteria were met by the FDA's determination of substantial equivalence to predicate devices (DePuy AML Femoral Component K852198, BioPro Horizon Femoral Component K962769, Whiteside Biomechanics K961625, and StelKast Proform Cemented Femoral Component K951083). This determination is based on the device's design, materials, and indications for use being similar to those legally marketed devices. However, this is a regulatory acceptance, not a performance study as would be conducted for an AI/ML device.

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