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MectaPlug PE II is an intramedullary cement restrictor, designed to seal the intramedullary canal prior to cementation in total or partial hip arthroplasty, for primary or revision surgery.

Total hip arthroplasty is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia
• Avascular necrosis of the femoral head
• Acute traumatic fracture of the femoral head or neck
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty

Partial hip arthroplasty is indicated in the following cases:

• Acute traumatic fracture of the femoral head or neck
• Non-union of femoral neck fracture
• Avascular necrosis of the femoral head
• Primary pathology involving the femoral head, but with a non-deformed acetabulum

MectaPlug PE II is an intramedullary cement restrictor (plug), used to seal the intramedullary canal prior to cementation in total or partial hip arthroplasty. MectaPlug PE II prevents the cement from flowing down the diaphysis, thereby facilitating cement pressurization, MectaPlug PE II is composed of UHMWPE (ISO 5834-2) with a radiopaque stainless steel wire (ISO 5832-1).

MectaPlug PE II is positioned distal to the stem tip preventing cement from being displaced distally in the canal and increasing the intramedullary pressure at the bone-cement interface during insertion of the stem. A radio marker is included in the tip of the Medacta cement restrictor.

MectaPlug PE II has 6 discs divided in several leaves by oblique cuts and a central peg. The MectaPlug PE II device is available in the following sizes: S (Ø 8 to Ø 11), M (Ø 12 to Ø 15), L (Ø 16 to Ø 20), XL (Ø 21 to Ø 25), XXL (Ø 26 to Ø 30).

MectaPlug PE II is made in UHMWPE according to ISO 5834-2 Implants for surgery -- Ultrahigh-molecular-weight polyethylene Moulded forms and with a radiopaque wire in AISI 316LVM according to ISO 5832-1 Implants for surgery - Metallic materials - Part 1: Wrought stainless steel.

Mectaplug PE II implants are provided sterile and in single-use packages.

The provided document describes a medical device called "MectaPlug PE II," an intramedullary cement restrictor. It does not contain information about acceptance criteria for a study proving device performance, nor does it detail a study that would meet the typical requirements listed in your prompt (e.g., sample size for test/training sets, expert involvement, MRMC studies, ground truth establishment, etc.).

The document primarily focuses on:

• Regulatory Clearance (510(k) summary): Seeking FDA clearance for marketing by demonstrating substantial equivalence to predicate devices.
• Device Description: What the device is, its components, and sizes.
• Indications for Use: When and how the device is intended to be used.
• Comparison to Predicate Devices: Highlighting similarities and differences.
• Non-Clinical Studies: Listing various risk assessments and material characterization tests.
• Absence of Clinical Studies: Explicitly stating that no clinical studies were conducted.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document in the manner you requested, as the document states, “No clinical studies were conducted.” The "Performance Data" section solely lists non-clinical mechanical studies and material characterization, which are generally not presented with acceptance criteria in the format of clinical performance metrics like sensitivity, specificity, or reader improvement.

To directly answer your numbered points based only on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document lists non-clinical studies (e.g., "Risk that the cement restrictors are inadequate for femoral canal shape," "Risk of breakage of highly stressed parts") but does not provide specific quantitative acceptance criteria or reported performance outcomes from these studies. It focuses on the fact that these studies were conducted.
2. Sample sizes used for the test set and the data provenance: Not applicable, as no clinical studies with test sets are reported.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical studies with test sets are reported.
4. Adjudication method for the test set: Not applicable, as no clinical studies with test sets are reported.
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 medical implant (cement restrictor), not an AI/imaging diagnostic device. No MRMC study was conducted, and the document explicitly states, "No clinical studies were conducted."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used: Not applicable, as no clinical studies are reported. The non-clinical tests would rely on engineering specifications and material standards rather than "ground truth" as it pertains to clinical outcomes or expert consensus on clinical data.
8. The sample size for the training set: Not applicable, as no clinical studies or AI algorithm development are reported.
9. How the ground truth for the training set was established: Not applicable, as no clinical studies or AI algorithm development are reported.

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The KMI Cement Restrictor Implant is intended to be implanted inside the intramedullary canal for use as an absorbable bone cement flow restrictor plug. The safety and effectiveness of this device for use in the spine have not been established.

The KMI Cement Restrictor Implant is a flexible, bio-resorbable restrictor designed to provide a quick and effective method of plugging the intramedullary canal with an easy-to-place absorbable bone plug. Based on the size of the canal and reamer used to form the channel, the appropriate size cement restrictor is selected and is guided into the canal to the desired depth. The KMI Cement Restrictors are malleable to take on the irregular shape of the canal, effectively sealing them at the desired friction-fit position. There are a variety of sizes and shapes offered, including cylindrical and cube versions. Each device can be custom shaped either by manual manipulation, by using a scalpel at the time of surgery, or by press-fitting into the canal.

This prompt describes a 510(k) premarket notification for a medical device and not a study that proves the device meets specific acceptance criteria via performance data. Therefore, many of the requested fields cannot be filled as they pertain to clinical trial design and results.

However, I can extract the information relevant to the device and its intended use, as well as the FDA's acceptance of its substantial equivalence.

Here's a breakdown of the provided information, noting what can (and cannot) be answered based on the input:

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

This document does not provide a table of acceptance criteria or reported device performance for the KMI Cement Restrictor. It is a 510(k) summary, which demonstrates substantial equivalence to a predicate device rather than providing performance data against predefined criteria. The FDA's letter states they have "reviewed your Section 510(k) premarket notification... and we have determined the device is substantially equivalent." This implies the device met the regulatory requirements for showing substantial equivalence, which is the "acceptance criteria" in this context, but no specific performance data is provided in the 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. This is a 510(k) submission, not a study report with a test set of data. Substantial equivalence is typically demonstrated through comparison of design, materials, and intended use to a predicate device, sometimes supported by non-clinical testing (e.g., biocompatibility, mechanical testing) but not necessarily a "test set" of clinical data for performance metrics.

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

Not applicable. No ground truth establishment for a test set is described in this 510(k) summary.

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

Not applicable. No test set or adjudication method is described.

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

Not applicable. This document pertains to a cement restrictor, not an AI or imaging device that would involve human readers or AI assistance.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. No ground truth is described in the context of device performance testing. The "ground truth" for a 510(k) itself is the existing legal market status and safety/effectiveness profile of the predicate device.

8. The sample size for the training set

Not applicable. This is not a study involving a training set.

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

Not applicable. No training set is described.

Summary of Device Information (from the provided text):

• Device Name: KMI Cement Restrictor
• Common Name: Bone Plug
• Classification Name: Cement Obturator
• Product Code: LZN (initially), later determined to be JDK (Surgical mesh) by FDA.
• Submitter: Kinetikos Medical, Inc.
• Predicate Device: Improve Absorabale Cement Flow Restrictor (K011943)
• Description: Flexible, bio-resorbable restrictor designed to plug the intramedullary canal as an absorbable bone plug. Malleable, can be custom shaped.
• Materials: L,D-L Lactic Acid Polymer
• Shelf Life: Two (2) years
• Intended Use: Implanted inside the intramedullary canal for use as an absorbable bone cement flow restrictor plug.
• Contraindications: Active local infection, allergic reaction to foreign bodies, poor/insufficient bone stock, clinical/functional abnormalities precluding good results, other patient risks, and spinal applications.

Key FDA Determination/Acceptance:

• Determination: The device is "substantially equivalent" to legally marketed predicate devices.
• Limitations/Warnings:
  • "THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS."
  • "WARNING: THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED."
  • These warnings must be prominently displayed in all labeling and promotional materials.

In conclusion, this document serves as a regulatory approval notice based on substantial equivalence to a predicate device, not a performance study detailing acceptance criteria and their fulfillment through specific test results.

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The Life Spine Cement Restrictor is intended for use in orthopedic surgeries involving the femoral canal, tibia, or the humerus.

This device is NOT intended for use in any spinal indications or acetabular cup surgeries. The safety and effectiveness of this device for implantation in the spine has not been established.

The device is a straight or tapered hollow box with a fenestrated surface on many sides. The geometry is designed to contain bone cement. The exterior surface of the device has teeth to prevent the device from migrating from the desired location. The device is manufactured from PEEK-OPTIMA®. The device is made in a variety of sizes. The responsible surgeon will determine the correct size of the device in accordance with the anatomical size of the individual patient.

The provided document is a 510(k) summary for the Life Spine Cement Restrictor. It focuses on demonstrating substantial equivalence to previously cleared devices rather than reporting on specific performance criteria and a study proving those criteria are met, as would be expected for a novel device or a device with new indications requiring clinical data.

Based on the provided text, here's an analysis regarding your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "This is designated as a non-load bearing Class II device under CFR 21 878.3300 and no mechanical tests are required." This explicitly indicates that no specific performance acceptance criteria or corresponding test results are provided in this submission. The regulatory pathway chosen (Special 510(k) Summary) relies on substantial equivalence.

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.

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

No performance data, test sets, or data provenance (e.g., country of origin, retrospective/prospective) are mentioned because the device is classified as non-load bearing and no mechanical tests were required. The submission relies on substantial equivalence to predicate devices, not new performance data.

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

Not applicable. As no test set performance data is provided, there is no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set:

Not applicable. No test set or associated adjudication methods are described.

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

Not applicable. No MRMC study was done or reported in this document.

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

Not applicable. This is a medical device (cement restrictor), not an AI algorithm.

7. Type of Ground Truth Used:

Not applicable. No data requiring ground truth establishment is presented. The basis for clearance is substantial equivalence to predicate devices.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/algorithm-based device.

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

Not applicable. This is not an AI/algorithm-based device.

Summary from the Document:

The Life Spine Cement Restrictor was cleared based on its substantial equivalence to previously cleared predicate devices in terms of indications for use, design, function, and materials. Because it is a non-load bearing Class II device (CFR 21 878.3300), no mechanical tests or associated performance data were required for this submission. The critical aspect of its clearance was the comparison to existing devices on the market, not through a study demonstrating specific acceptance criteria for its own performance.

A key warning added during the 510(k) process is: "WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED." This indicates that while it met the criteria for substantial equivalence for its intended use (femoral canal, tibia, or humerus), there was specific concern about off-label use in the spine.

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The Life Spine Cement Restrictor is indicated for use as a cement restrictor in the femur, tibia, or humerus.

This device is not intended for spinal indications or acetabular cup surgeries. The safety and effectiveness of this device when implanted in the spine have not been established.

The device is a straight or tapered hollow box with a fenestrated surface on many sides. The geometry is designed to contain bone cement. The exterior surface of the device has teeth to prevent the device from migrating from the desired location. The device is manufactured from PEEK-OPTIMA®. The device is made in a variety of sizes. The responsible surgeon will determine the correct size of the device in accordance with the anatomical size of the individual patient.

This document is a 510(k) summary for a medical device (Life Spine Cement Restrictor), which primarily establishes substantial equivalence to a predicate device rather than presenting a study demonstrating performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance studies is not directly applicable or available in this type of submission.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. For a 510(k) submission, the primary "acceptance criterion" is typically demonstrating substantial equivalence to a legally marketed predicate device, not meeting specific performance metrics defined by the applicant. The document states:
"This is designated as a non-load bearing Class II device under CFR 21 878.3300 and no mechanical tests are required."
"The biocompatibility of this material for implantable contact over 30 days has been certified to ISO 10993 by the manufacturer of PEEK-OPTIMA®, Invibio."

So, the "performance" described is about material compliance and biocompatibility already established for the material itself, not the specific device's performance through new testing.

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

This information is not applicable/provided. No specific test set data is presented for direct evaluation of the device's performance against acceptance criteria in a study. The demonstration of safety and effectiveness relies on substantial equivalence and material certifications.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable/provided. There was no study requiring expert ground truth establishment for this 510(k) submission.

4. Adjudication Method

This information is not applicable/provided. No studies requiring adjudication were conducted for this submission.

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

This information is not applicable/provided. This device is a physical implant, not an AI or imaging-based diagnostic tool, so an MRMC study is irrelevant.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

This information is not applicable/provided. This device is a physical implant, not an algorithm.

7. Type of Ground Truth Used

This information is not applicable/provided for the device itself. The "ground truth" here is the established safety and effectiveness of the predicate device and the material from which both are made, as demonstrated by the predicate device's market history and the material manufacturer's certifications.

8. Sample Size for the Training Set

This information is not applicable/provided. There was no "training set" as this is not an AI/algorithmic device.

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

This information is not applicable/provided. No training set was used.

Summary of Device Acceptance and "Study" (as described in the document):

The acceptance of the Life Spine Cement Restrictor is based on demonstrating substantial equivalence to a previously cleared device, the SIGNUS Medical RABEA™ Cement Restrictor, regarding its intended use, design, function, and materials.

The "study" or evidence provided to meet this acceptance criterion is:

• Comparison to a Predicate Device: The Life Spine Cement Restrictor is compared in design, function, and materials to the legally marketed SIGNUS Medical RABEA™ Cement Restrictor (K993077).
• Material Certification: Both devices are manufactured from PEEK-OPTIMA®. The biocompatibility of this material for implantable contact over 30 days was certified to ISO 10993 by the material manufacturer, Invibio. This certification, held in a Device Master File by the FDA, serves as evidence for the material's safety.
• Regulatory Classification: The device is classified as a non-load bearing Class II device (CFR 21 878.3300), which means no mechanical tests were explicitly required for this submission.

Therefore, the "acceptance criteria" were met by showing:

1. The device is materially and functionally equivalent to a previously cleared device.
2. The material used is biocompatible according to established standards (ISO 10993), as certified by the material manufacturer.

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The Spinal USA Cement Restrictor System is intended as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.

This device is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.

The Spinal USA Cement Restrictor is a hollow rounded rectangular frame with various holes located throughout its geometry to hold bone cement. The exterior surface of the device has teeth on two opposing flat sides to prevent migration. The device comes in various sizes and is offered in straight and tapered styles. The device may be made from titanium alloy as specified in ASTM F136 or polyetheretherketone (PEEK) that conforms to ASTM F2026-02.

The provided 510(k) summary does not contain the detailed information necessary to fully answer all of the questions about acceptance criteria and study particulars. This document focuses on demonstrating substantial equivalence to predicate devices rather than reporting on specific performance studies with acceptance criteria in the format requested.

However, based on the information provided, here's what can be inferred or explicitly stated:

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

The 510(k) summary for the Spinal USA Cement Restrictor System (K060132) does not provide a table of acceptance criteria and reported device performance from a specific study in the way medical device performance studies typically present them (e.g., sensitivity, specificity, accuracy, etc., with associated targets).

Instead, the mechanism for demonstrating acceptable performance is through substantial equivalence to previously cleared predicate devices. The implicit "acceptance criteria" here are that the new device shares fundamental characteristics with predicate devices that have already been deemed safe and effective by the FDA.

The document states:

• "The Spinal USA Cement Restrictor System was demonstrated to be substantially equivalent to previous cleared devices such as the Scient'X Cement Restrictor (K052367), Quantum Cement Restrictor (K040276), and Fortitude Cement Restrictor (K021719)."
• The similarities that establish substantial equivalence are:
  • "the same indication for use"
  • "the same operating principle"
  • "the same basic design"
  • "the same materials"
  • "implanted using the same surgical techniques and equipment"

Therefore, the reported "performance" is that the device aligns with these characteristics of the predicate devices.

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

The 510(k) document does not report on a specific test set, sample size, or data provenance for performance evaluation. This type of information would be relevant if a clinical performance study was conducted, which is not described as the primary pathway for clearance in this summary.

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 applicable as the document does not describe a study involving expert-established ground truth for a test set.

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

This information is not applicable as the document does not describe a study involving expert adjudication for a 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

This information is not applicable. The device is a physical cement restrictor, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study or an assessment of human reader improvement with AI would be relevant.

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

This information is not applicable. The device is a physical cement restrictor, not an algorithm.

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

The concept of a "ground truth" as typically used in performance studies is not directly applicable here. The "truth" for substantial equivalence is based on the established safety and effectiveness of the predicate devices and the demonstration that the new device is sufficiently similar to them across key attributes.

8. The sample size for the training set

This information is not applicable. The document does not describe a training set as this is not an AI/ML device or a device requiring a training phase for its function.

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

This information is not applicable for the reasons stated above.

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This device is intended for use in conjunction with Standard PMMA cement. The Interbody Innovations Cement Restrictors are designed to occlude the medullar canal before the introduction of PMMA, in total hip or knee replacement.

This device is not intended for use in spine applications. The safety and effectiveness have not been established when implanted into the spine.

The Interbody Innovations Cement Restrictors is a hollow curved rectangular frame that is machined from extruded Polyetheretherketone (PEEK). It contains tantalum inserts that serve as location and orientation markers for radiographs. The device is intended to be used in conjunction with standard PMMA

Let's break down the information provided in the 510(k) summary (K051371) to extract details regarding acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary for a Surgical Mesh, specifically a Cement Restrictor. These devices are typically cleared based on substantial equivalence to existing predicate devices, rather than extensive clinical efficacy studies with predefined acceptance criteria for performance metrics like accuracy, sensitivity, or specificity, as one might find for diagnostic AI algorithms. The "performance data" section for these types of devices usually focuses on material properties, biocompatibility, and mechanical characteristics.

Therefore, the interpretation of "acceptance criteria" and "study" will be tailored to what is relevant for this specific type of medical device submission.

Acceptance Criteria and Device Performance

For this device, the acceptance criteria are primarily related to material compliance and biocompatibility, as the function and design are substantially equivalent to existing cleared devices.

Study and Data Details

Given the nature of this device (a cement restrictor cleared via substantial equivalence), the "study" referred to in the document is primarily the demonstration of material equivalence and biocompatibility, rather than a clinical effectiveness study.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the context of clinical performance data for this type of 510(k). The "test" here refers to material and biocompatibility testing, which typically uses standardized samples of the material itself. The document does not specify the number of material samples tested.
   • Data Provenance: The biocompatibility certification (ISO 10993-1) is from the manufacturer of the PEEK-Optima material. ASTM F2026 compliance is a material standard. This data is likely retrospective, based on prior testing of the raw material. The country of origin for the material manufacturer is not specified.

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

   • Not applicable. "Ground truth" in the sense of expert consensus on diagnostic imaging is not relevant for this material and mechanical device submission. Material properties and biocompatibility are established through laboratory testing and standardized protocols, not expert clinical consensus review.

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

   • Not applicable. Adjudication methods are relevant for subjective interpretations, typically in diagnostic imaging or clinical trials. Material testing results are objective.

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/diagnostic imaging device.

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

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

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

   • The "ground truth" for this submission are material specifications (ASTM F2026) and biocompatibility standards (ISO 10993-1).

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

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

   • Not applicable. No training set is used.

Summary of the "Study" for K051371:

The "study" or performance data for the Interbody Innovations Cement Restrictor primarily consists of:

• Material Equivalence: Demonstration that the device is constructed of the same material (PEEK-Optima) as the predicate device(s) and that this material complies with ASTM F2026.
• Biocompatibility: Reliance on the manufacturer of the PEEK-Optima material having an FDA Device Master File and certifying biocompatibility to ISO 10993-1 requirements for implantable contact greater than 30 days.

This approach is typical for Class II devices that achieve market clearance through a 510(k) pathway by demonstrating substantial equivalence, often relying on material properties and existing predicate devices rather than new clinical effectiveness trials.

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The Skelite™ Resorbable Cement Restrictor is intended to be used in orthopaedic surgeries, such as those involving the femoral and tibia canals in hip stem and total knee replacement. This device is not appropriate for acetabular cup surgeries, nor is it intended for any spinal indications.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the Skelite™ Resorbable Cement Restrictor. It does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria.

This letter is a regulatory document stating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It includes:

• Trade/Device Name: Skelite™ Resorbable Cement Restrictor
• Regulation Number and Name: 21 CFR 878.3300, Surgical mesh
• Regulatory Class: II
• Product Code: JDK
• Date of Clearance: November 21, 2005
• Intended Use: Orthopaedic surgeries involving femoral and tibia canals in hip stem and total knee replacement.
• Limitations: Specifically states "THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. WARNING: THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED."

To answer your request about acceptance criteria and the supporting study, you would need to refer to the original 510(k) submission (K051836) itself, which is not provided here. The 510(k) submission would contain the detailed information on testing, performance data, and how the manufacturer demonstrated substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information from the given document as it is outside the scope of this regulatory clearance letter.

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The NovaSpine Cement Restrictor device is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.

The NovaSpine Cement Restrictoris NOT intended for any spinal indications.

The NovaSpine Cement Restrictor "NSCR" is an implanted device for use as non-load bearing cement containment in orthopedic surgery. It will be used to contain standard bone cement such as Polymethylmethacrylate (PMMA) in the diaphysical canal of the femur or tibia.

The device is a straight or tapered rectangular hollow box construction with serrations on two opposite sides and flat surfaces on the remaining two sides. The device is fenestrated on all sides. The device is made in a variety of sizes the use of which will be determined by the responsible surgeon in accordance with the physical characteristics of each patient.

The NovaSpine Cement Restrictor is a Class II device intended for use as a non-load bearing cement containment in orthopedic surgeries, specifically within the diaphysical canal of the femur or tibia, to contain standard bone cement like Polymethylmethacrylate (PMMA).

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the following information is not available or not applicable:

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

• The document describes a 510(k) submission, which primarily relies on substantial equivalence to predicate devices rather than a direct clinical study of the device itself. Therefore, a "test set" in the context of clinical performance data for this device is not detailed. The design controls and material specifications are the primary "test" here, which are checked against industry standards and predicate devices.

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

• Not applicable, as there's no mention of a clinical test set requiring expert ground truth assessment. The FDA's review process involves expert staff, but not in the context of establishing ground truth for a device's performance data as one would for an AI/diagnostic device.

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

• Not applicable.

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 cement restrictor, not an AI-powered diagnostic tool.

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

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

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

• The "ground truth" for this device's acceptance is its compliance with material standards (ASTM F136/ISO 5832-3), classification as a non-load bearing Class II device, and its substantial equivalence to previously cleared predicate devices. There's no clinical "ground truth" established through a specific study described here.

8. The sample size for the training set:

• Not applicable, as this is not an AI/machine learning device.

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

• Not applicable.

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The Scient'x Cement Restrictor is intended as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.

This device is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.

The Scient'x Cement Restrictor is a hollow trapezoidal block with 1mm toothed serrations on opposite sides to prevent migration and has a threaded hole on the superior surface to attach an insertion tool. The parts are machined from PEEK that conforms to ASTM F2026-02. As peek is radiolucent gold wire radiographic markers inserted into small holes and serve as location and orientation markers for radiographs.

This document is a 510(k) summary for the Scient'x Cement Restrictor and does not contain information about acceptance criteria or a study proving the device meets those criteria. The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against pre-defined acceptance criteria in the same way a clinical trial or a more rigorous performance study might for a novel device.

The information provided focuses on:

• Device Description: The physical characteristics of the cement restrictor.
• Intended Use: What the device is designed for.
• Predicate Devices: Other legally marketed devices to which the Scient'x Cement Restrictor is compared for substantial equivalence.
• Regulatory Classification: Its class and product code.
• Labeling Limitations: A warning regarding its use in spinal indications because safety and effectiveness in that context have not been established.

Therefore, I cannot extract the requested information (acceptance criteria, study summary, sample sizes, ground truth details, MRMC study, standalone performance) from the provided text as it is not present. This document is a regulatory submission, not a performance study report.

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PolyGraft™ BGS Cement Restrictor is indicated for use as a bone cement flow restrictor plug in the femur, tibia, and/or humerus.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the PolyGraft™ BGS Cement Restrictor. It states that the device is substantially equivalent to legally marketed predicate devices for the indications for use stated in the enclosure. However, the document does not contain or reference any information about:

• Acceptance criteria for device performance.
• A study proving the device meets acceptance criteria.
• Specific performance metrics for the device.
• Clinical study details like sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document primarily focuses on regulatory approval, specifically indicating a warning that the device is not intended for spinal indications and that its safety and effectiveness in the spine have not been established. It also outlines general FDA regulations and requirements.

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

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