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Artisan Bone Plug: These bone plugs are intended to be placed in the femoral canal prior to the introduction of bone cement in a cemented hip procedure. The plug is placed distally to the femoral stem to help allow cement pressurization and to help prevent cement migration further down the femoral canal.
Universal Cement Restrictor: For cement spacers, mid-shaft restrictors and Cement Plugs: In cemented hip arthroplasty, when the cement spacer, restrictor and/or plug is thought to be advantageous.

The Artisan Bone Plug and Universal Cement Restrictor are commercially available devices that have been determined substantially equivalent in previous 510(k) premarket notifications. The purpose of this submission is to modify the labeling of these devices to add MR Conditional labeling and make other minor labeling updates.

Based on the provided text, the document is a 510(k) summary for a medical device (Artisan Bone Plug and Universal Cement Restrictor). It describes a labeling update for these devices, specifically adding "MR Conditional" labeling.

Crucially, the text explicitly states:

• "Clinical Testing: Clinical testing was not required as a basis for substantial equivalence."
• "There have been no changes to the technological characteristics of the subject devices as a result of the revision to the labeling. The subject devices have the same design and are manufactured from the same materials as the predicate devices."

Therefore, the document does not contain information about acceptance criteria or a study proving the device meets performance criteria in the context of clinical or AI-based performance. Instead, it relies on non-clinical testing for MR compatibility and the substantial equivalence to previously cleared predicate devices.

Here's why the requested information cannot be provided from the given text:

1. AI/Algorithm Performance: The device (Bone Plug/Cement Restrictor) is a physical implant, not an AI or software-based medical device. The concepts of "device performance" in terms of AI metrics (like sensitivity, specificity, accuracy), test sets, expert ground truth, adjudication, MRMC studies, or standalone algorithm performance are not applicable to the information provided.
2. Clinical Performance Study: The document explicitly states that clinical testing was not required for the substantial equivalence determination for this labeling update. The non-clinical testing mentioned is solely for MR compatibility (displacement, torque, image artifact, heating).
3. Acceptance Criteria Table: Since there are no clinical performance studies or AI-based performance metrics discussed, there are no acceptance criteria for such metrics. The "acceptance criteria" here would relate to regulatory compliance and the results of the non-clinical MR testing, which are described in a qualitative manner ("do not create a new worst case").

Summary of what can be extracted related to "study" and "criteria":

• Study type: Non-clinical testing for MR compatibility.
• Tests performed:
  • Magnetically Induced Displacement Force (ASTM F2052-15)
  • Magnetically Induced Torque (ASTM F2213-17)
  • Image Artifact (ASTM F2119-07, Reapproved 2013)
  • Heating by RF Fields (ASTM F2182-19)
  • Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2019 for pyrogenicity.
• "Proves device meets acceptance criteria": An engineering analysis was conducted which determined that the subject devices "do not create a new worst case" compared to devices previously tested for MR compatibility (K153345). For BET, the acceptance criterion was an "endotoxin limit of

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The Tornier Cement restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during joint arthroplasty. The Tornier Cement restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurisation when the implant is introduced.

The Tornier Cement Restrictor is a diaphyseal plug for orthopedic use. It is designed to occlude the medullary cavity before the introduction of acrylic cement. The Tornier Cement Restrictor is used to prevent the cement progression in the diaphysis and therefore facilitate the cement pressurization during the introduction of the implant. Its flexible mechanism makes it adaptable to different diameters of medullary canal to be occluded. The present device modification submission consists in the addition of a small diaphyseal plug and an extension of the indication for use.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification for the Tornier Cement Restrictor and primarily discusses its description, materials, indications for use, and its substantial equivalence to predicate devices. It does not include details on clinical studies, performance metrics, ground truth establishment, or expert reviews as requested in your prompt.

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The CEMSTOP Cement Restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during total hip arthroplasty. The CEMSTOP restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurization.

The CEMSTOP Cement Restrictor is inserted into the femoral canal prior to introduction of bone cement during total hip arthroplasty. It occludes the medullary canal and prevents the cement from flowing down the diaphysis and aids in cement pressurization. It is available in sizes. It is fabricated from gelatin and glycerol and is completely resorbed within a few days of implantation. The gelatin is porcine based.

This document is a 510(k) premarket notification for a medical device called the "CEMSTOP Cement Restrictor." It's a regulatory document from the FDA, not a study report. Therefore, it does not contain the acceptance criteria or a study proving the device meets those criteria in the format you requested.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to devices already approved by the FDA. This substantial equivalence is based on comparisons, not necessarily on a novel clinical trial or performance study against specific acceptance criteria.

Therefore, I cannot provide the information you requested about acceptance criteria and a study from this document.

Here's what the document does provide, which might be helpful in understanding why your request cannot be fulfilled by this particular text:

• Device Name: CEMSTOP Cement Restrictor
• Intended Use: A diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during total hip arthroplasty. It prevents cement from flowing down the diaphysis and facilitates cement pressurization.
• Material: Fabricated from gelatin and glycerol, completely resorbed within a few days of implantation. (Porcine-based gelatin).
• Predicate Devices: Exactly the same as cleared on K993841 by Encore Medical. Equivalent to BIOSTOP (Landos) cleared on K943727.
• Basis for Equivalence: Design, manufacturing method and facilities, packaging and sterilization are performed by the same company as the Encore Medical device.

To obtain the kind of performance data and acceptance criteria you're looking for, you would typically need to consult a clinical trial report, a risk assessment, or a specific performance testing document, not a 510(k) clearance letter.

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The BioBuck™ Cement Restrictor is a bullet-shaped plug with stabilizing and sealing rings intended for intramedullary occlusion during cemented hip and shoulder arthroplasty.

The BioBuck™ Cement Restrictor is a bioabsorbable version and modification of the Buck™ Cement Restrictor that was cleared for marketing by FDA on 27 June 1979 (K791125). The material for the BioBuck device is PolyActive®, a biocompatible copolyether. PolyActive is currently used to manufacture other cement restrictor devices (Shuttle Stop , K000587; SynPlug™ , K010840).

This document is a 510(k) summary for the BioBuck™ Cement Restrictor and primarily focuses on establishing substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria through performance data. Therefore, many of the requested elements for a study evaluating device performance cannot be extracted from this text.

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

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

The document does not explicitly state acceptance criteria or report specific performance data for the BioBuck™ Cement Restrictor. It focuses on the device's design, materials, and intended use being "identical" or "very similar" to predicate devices, implying that their established performance is sufficient for proving substantial equivalence.

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 provided because no specific performance study on a test set is described.

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

This information is not provided because no specific performance study on a test set is described.

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

This information is not provided because no specific performance study on a test set 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

This information is not provided. The device is a physical medical device (cement restrictor), not an AI or imaging diagnostic tool, so an MRMC comparative effectiveness study involving human readers and AI is not applicable.

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

This information is not provided. The device is a physical medical device (cement restrictor), not an algorithm.

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

This information is not provided because no specific performance study to establish ground truth is described. For this type of device, ground truth would likely relate to mechanical properties, biocompatibility, and clinical outcomes, but no such studies are detailed.

8. The sample size for the training set

This information is not provided because no training set is relevant for this type of physical device (cement restrictor).

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

This information is not provided because no training set is relevant for this type of physical device (cement restrictor).

Summary of what can be extracted related to "acceptance criteria" and "proof":

The "acceptance criteria" for the BioBuck™ Cement Restrictor, as presented in this 510(k) summary, are implicitly tied to demonstrating substantial equivalence to existing predicate devices.

The study that proves the device meets the acceptance criteria (i.e., substantial equivalence) is the comparison to predicate devices.

• Key points of this "proof" (comparison study):
  • Intended Use: "The intended use of the BioBuck Cement Restrictor is identical to the predicate devices."
  • Technological Characteristics/Principles of Operation: "The principles of operation for the BioBuck Cement Restrictor are identical to the Buck Cement Restrictor... The design and material of the BioBuck device has the same technological characteristics as one or more of the predicate devices."
  • Design and Material: "The BioBuck device shape and design are very similar to the Buck predicate device, and the BioBuck device is manufactured from the identical material as the Shuttle Stop and SynPlug predicate devices."
  • Predicate Devices Used: Buck™ Cement Restrictor (K791125), Shuttle Stop® Cement Restrictor (K000587), SynPlug™ Cement Restrictor (K010840).

In essence, the "acceptance criteria" here are that the BioBuck™ Cement Restrictor is functionally and materially similar enough to established predicate devices that it presents no new questions of safety or effectiveness. The "study" is the detailed comparison of its characteristics against those of the legally marketed predicates. The FDA's letter acts as the "proof" by affirming that based on this comparison, the device is deemed "substantially equivalent."

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The ImproVise™ Absorbable Cement Flow Restrictor is intended for use as an absorbable bone cement flow restrictor for use in the intramedullary canal. This device is not intended for use in the spine.

The ImproVise™ Absorbable Cement Flow Restrictor is designed to provide a quick, simple, and effective method of plugging the intramedullary canal with an easy-to-place absorbable foam plug. Based on the size of the reamer used to form the channel, the appropriate size foam plug is selected and is then guided onto the tip of the tool. The ImproVise™ Insertion tool is then used to advance the plug down the canal to the desired depth, using the Cement Restrictor as a guide. The ImproVise™ foam plugs are deformable and bank against the irregular shape of the canal, effectively sealing the canal at the insertion point. The cement restrictors are available in sizes small, medium, large and extra-large (9.5-11 mm, 11-13 mm, 13-15 mm, 15-17.5 mm), both in straight cylindrical and tapered versions. The restrictor can be easily carved with a scalpel at the time of surgery, or press-fit into the bone. The ImproVise™ Absorbable Cement Flow Restrictor is manufactured from a proprietary polylactic acid foam, which is greater than 90% void space.

The provided text describes the regulatory clearance (510(k)) of the ImproVise™ Absorbable Cement Flow Restrictor and presents a comparison to a predicate device, the Resorbaplug™ Bone Plug. However, the document does not contain a study report or detailed acceptance criteria for the ImproVise™ device's performance, nor does it describe a study specifically designed to prove the device meets such criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed performance study against pre-defined acceptance criteria.

Despite the lack of explicit study details, some information relevant to the request can be extracted or inferred:

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

The only "performance" metric mentioned that resembles acceptance criteria, and for which data is provided for both devices, is:

Note: This is the only direct performance comparison provided in the document. It's listed in the "Performance" row of Table 1 under "Interference fit that provides 100N push-out force." The values (1.9-2.9 mm for ImproVise™ and 2.5 mm for Resorbaplug™) likely refer to the amount of interference fit (compression/diameter difference) required to achieve a 100N push-out force.

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

• Sample Size: Not mentioned in the provided text.
• Data Provenance: Not mentioned in the provided text (e.g., country of origin, retrospective/prospective). The data appears to be from laboratory testing rather than clinical study.

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

Not applicable. The performance metric (push-out force) is a physical test and does not involve expert interpretation or ground truth establishment in the traditional sense of clinical or diagnostic studies.

4. Adjudication method for the test set

Not applicable, as there is no expert interpretation or consensus involved for this physical performance test.

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 physical bone plug, not an AI or diagnostic imaging device, so MRMC studies involving human readers are irrelevant.

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

Not applicable. This device is a physical bone plug.

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

The "ground truth" for the reported performance (interference fit vs. push-out force) would be the objective measurement taken from mechanical testing apparatus. There is no expert consensus, pathology, or outcomes data mentioned in relation to this specific performance metric.

8. The sample size for the training set

Not applicable. This is a physical device, and the context provided does not involve machine learning or a "training set."

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

Not applicable.

Summary of Device Acceptance Criteria and Study (Based on Provided Text):

The provided 510(k) summary (K011943) for the ImproVise™ Absorbable Cement Flow Restrictor focuses on demonstrating substantial equivalence to a predicate device, the Resorbaplug™ Bone Plug (K920118). The core of this submission, concerning "acceptance criteria" and "proof," is the comparison of material, intended use, and a specific physical performance characteristic.

• Acceptance Criteria (Inferred from Substantial Equivalence): The implicit acceptance criteria are that the ImproVise™ device performs comparably to the predicate device, the Resorbaplug™, especially regarding its mechanical function as a cement flow restrictor. The key comparable performance metric identified is the "interference fit that provides 100N push-out force."
• Study That "Proves" Performance: The document itself is the "study" in the context of a 510(k) summary, as it presents data for the new device and compares it to the predicate. The "study" here is a comparative analysis, likely based on non-clinical (benchtop) testing as opposed to a full-scale clinical trial.
  • Evidence: The table (Table 1) directly compares the ImproVise™ to the Resorbaplug™ across various attributes including "Performance: Interference fit that provides 100N push-out force."
  • ImproVise™ Performance: 1.9-2.9 mm
  • Resorbaplug™ Performance: 2.5 mm
  • The close proximity of these values is presented as evidence of substantial equivalence and, by extension, that the ImproVise™ meets the expected performance for its intended use, as established by the predicate device.

Missing Information:

Crucially, the document lacks detailed information on the methodology of the mechanical testing, exact sample sizes for these tests, the precise definition of the "1.9-2.9 mm" range (e.g., mean, range, standard deviation, confidence interval), or the specific test standards followed. This level of detail would typically be found in a full test report, not a 510(k) summary.

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SynPlug™ is a cylindrical plug intended for intramedullary occlusion during cemented hip and shoulder arthroplasty.

The proposed SynPlug™ cement restrictor is identical in intended use and fundamental scientific technology to the parent Shuttle Stop® cement restrictor that was cleared for marketing by FDA on May 4, 2000 (K000587). Design changes were made to prevent cement leakage and migration, increase pressure resistance, and improve the ease of handling of the cement restrictor. These design modifications are limited to the following:

• Adoption of a cylindrical shape for the proposed SynPlug
• Elimination of sidewall slots and addition of five flanges
• Increase in the rigidity of the proposed device
• Expansion of the number of available sizes for the proposed device to 13, designed to fit intramedullary canal diameters of 9 to 21 mm
  This submission also contains a description of instrumentation sets that have been developed to facilitate the selection of cement restrictor size by assessment of the intramedullary canal diameter and provide correct insertion of the cement restrictor. The SynPlug Instrumentation Set consists of 14 measuring probes for the measurement of canal diameters from 9 to 21 mm, two insertion rods, and a sterilization tray for holding the instruments during sterilization. The Shuttle Stop Instrumentation Set is identical to the SynPlug Instrumentation Set with the exception that only five measuring probes are provided to correspond with the four sizes of Shuttle Stop and a probe measuring the maximum intramedullary canal diameter for which the largest size Shuttle Stop can be used, 8 to 20 mm.

I am sorry, but the provided text does not contain the information required to populate the requested table and answer the questions. The document is a 510(k) summary for a medical device called SynPlug™, which is a cement restrictor. It describes the device, its intended use, and states that it is substantially equivalent to a predicate device.

However, it explicitly states:

• "The differences between the proposed and parent devices are minor and do not raise new issues of safety or effectiveness."
• "These design modifications were validated according to IsoTis' Design Control Procedures, in compliance with the design control procedure requirements of the Quality Systems Regulations as specified in 21 CFR 820.30."

This indicates that the submission relies on design control validation and substantial equivalence claims rather than reporting on a specific study that tested the device against explicit acceptance criteria with performance metrics, ground truth, or expert involvement as described in your prompt.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics for the SynPlug™ are listed.
2. Sample size used for the test set and the data provenance: No test set data is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is mentioned.
4. Adjudication method: Not applicable as no test set or ground truth is described.
5. MRMC comparative effectiveness study results: No such study is mentioned.
6. Standalone performance results: No standalone performance metrics are provided.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: No training set is mentioned for an AI/algorithm.
9. How the ground truth for the training set was established: Not applicable.

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The CEMSTOP cement restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during total hip arthroplasty. The CEMSTOP restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurisation.

The CEMSTOP restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurisation. Biocompatible, this device is completely resorbed within several days at 37 ℃ and resists the temporary temperature rise generated by polymerisation of acrylic cement. The CEMSTOP Cement Restrictor is available in diameters of 6mm, 8mm, 10mm, 12mm, 14mm, 16mm and 20mm.

This submission is a 510(k) for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through clinical or performance trials. Therefore, much of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth cannot be directly extracted from the provided text.

The core of the document is a 510(k) Summary of Safety and Effectiveness, which declares the device's characteristics and its equivalence to a legally marketed predicate device.

Here's a breakdown of what can be inferred or directly stated, and what cannot:

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

This information is not provided in the document. 510(k) submissions typically do not include detailed performance acceptance criteria in the same way a clinical trial might for a novel device. The "performance" being demonstrated here is primarily the technological 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):

This information is not provided. This is not a study that involved a "test set" in the sense of patient data or clinical samples. The basis for substantial equivalence is "material, design and indications."

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 information is not provided. There was no "ground truth" to establish for a test set in this 510(k) submission.

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

This information is not provided. There was no "test set" or adjudication process 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:

This is not applicable. The device is a "CEMSTOP Cement Restrictor," a physical diaphyseal plug, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI performance is irrelevant.

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

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

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

This information is not applicable. The submission relies on demonstrating substantial equivalence to a predicate device based on its design, material, and indications, rather than establishing a new "ground truth" through clinical or laboratory data.

8. The sample size for the training set:

This information is not applicable. There is no "training set" for this type of device submission.

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

This information is not applicable. There is no "training set" or "ground truth" establishment in the context of this 510(k) submission.

Summary derived from the document:

The provided document describes a 510(k) submission for the CEMSTOP Cement Restrictor. The submission aims to demonstrate substantial equivalence to a previously marketed predicate device, the BIOSTOP G Cement Restrictor (Landos, Inc.).

The basis for claiming substantial equivalence is that the CEMSTOP Cement Restrictor shares the same technological characteristics (design and material) and indications for use as the predicate device.

Its intended use is as a diaphyseal plug to occlude the medullary cavity before the introduction of acrylic cement during total hip arthroplasty, preventing cement flow and facilitating pressurization. The device is biocompatible and resorbable.

The FDA reviewed the submission and determined that the device is substantially equivalent, allowing it to be marketed. This determination is based on the comparison to the predicate device, not on specific performance criteria met through a detailed study on a "test set."

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The indications for the use of the Osteonics® Universal Distal Hole Plug, in keeping with those of other legally marketed Osteonics accessory products for cemented arthroplasty, are as follows:

For cement spacers, mid-shaft restrictors, distal plugs, and cement plugs:

• In cemented hip arthroplasty, when the cement spacer, restrictor and/or plug is thought to be advantageous.

The Osteonics® Universal Distal Hole Plug is a single use component which is intended for optional use in cemented arthroplasties of the hip as determined by the physician. The Universal Distal Hole Plugs are manufactured from polymethylmethacrylate (PMMA) or PMMA mixed with Barium Sulfate (BaSO2) and are available in one universal size. The Universal Distal Hole Plug is cylindrical in shape, has a rounded distal tip, and flares very slightly from the proximal to The Universal Distal Hole Plug also employs a friction-fit design which secures it in distal end. the distal hole of any commercially available Osteonics® cemented hip stem. The Universal Distal Hole Plug is assembled to the hip stem intraoperatively and inserted into the femoral canal.

The provided text does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) Premarket Notification Summary for a medical device (Osteonics® Universal Distal Hole Plug), which focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria and study details. The document primarily describes:

• Device Identification: Osteonics® Universal Distal Hole Plug (K992462)
• Sponsor Information: Howmedica Osteonics Corp.
• Classification: Surgical Mesh 21 CFR §878.3300
• Predicate Devices: Osteonics® Omnifit® Universal Distal Cement Spacer (K914406) and Osteonics® Universal Distal Spacer (K894708)
• Device Description: Single-use, made from PMMA or PMMA mixed with Barium Sulfate, cylindrical, rounded tip, friction-fit design to secure in the distal hole of a cemented hip stem.
• Intended Use: For cement spacers, mid-shaft restrictors, and cement plugs in cemented hip arthroplasty, when the device is considered advantageous.
• Technological Comparison: Substantially equivalent in material and basic mechanical function to predicate devices, but lacks fins and is available in one universal size.

The FDA's letter (pages 2-3 of the input) confirms the substantial equivalence determination but does not detail performance studies or acceptance criteria.

In summary, the provided text does not contain the information requested in your prompt regarding acceptance criteria and performance studies.

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The Link femoral cement restrictor plug system is used to constrict the flow of bone cement (PMMA) into the distal section of the femoral canal during a cemented total hip arthoplasty.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "Link, Cement Plug" and its related "Femoral Cement Restrictor Plug System." It does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.

The letter is a regulatory document affirming that the device is substantially equivalent to a legally marketed predicate device, thereby allowing it to be marketed. It does not delve into the specific technical or clinical performance studies.

Therefore, I cannot provide the requested information based on the provided text.

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