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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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Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

• Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• Inflammatory joint disease including rheumatoid arthritis
• Correction of functional deformity including congenital hip dysplasia
• Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics' Origin, NEO-T, Remedy and Pegasus femoral stems, and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve femoral stems are intended for cemented fixation only.

Signature Orthopaedics' BiPolar Head is intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The BiPolar Head is indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

• Acute femoral head or neck fracture
• Fracture dislocation of the hip
• Avascular necrosis of the femoral head
• Non-union of femoral neck fractures
• Certain high subcapital and femoral neck fractures in the elderly
• Degenerative arthritis involving only the femoral head

The Remedy™ and Pegasus™ hip stems are intended for cementless use in total hip arthroplasty. The Evolve™ hip stem is intended for cemented total hip arthroplasty. The Remedy™, Pegasus™ and Evolve™ hip stems connect to a femoral head (cobalt-chrome alloy or ceramic) via 12/14 taper connection.

The Remedy™ Hip Stem has a tapered wedge geometry. The stem is manufactured from titanium alloy per ASTM F136. The proximal stem is porous coated with titanium beads and particles per ASTM F67 and the distal stem is matte finished.

The Pegasus™ is a double tapered, straight stem with rectangular cross-section. The stem has a lateral wing for engaging the greater trochanter. The stem is manufactured from titanium alloy per ASTM F136. The stem is grit blasted below the resection line.

The Evolve™ Hip Stem is a highly polished, tapered wedge stem with a rounded crosssection. The Evolve™ Hip Stem is manufactured from high nitrogen stainless steel per ISO 5832-9. The Evolve™ Hip Stem is available in two variants, the Masters series and the Helios Series. Both variants share similar general geometry but are sized differently to provide a more complete range. The Evolve™ Hip Stem includes two accessories, the Evolve™ Distal Centralizer and Evolve™ Cement Plug. The Evolve™ Distal Centralizer is a PMMA cap that sits on the end of the Evolve™ Hip Stem and centralizes it within the femoral canal. The Evolve™ Cement Plug is manufactured from polyethylene per ASTM F648 and is pressed into the femoral canal prior to inserting the Evolve™ Hip Stem to allow cement pressurization.

The BiPolar Head consists of a stainless steel outer shell (per ISO5832-9) and a UHMWPE insert (per ASTM F648). The outer shell is highly polished to articulate against the patient's natural acetabulum. The insert articulates against a Signature Orthopaedics 28mm cobalt-chrome femoral head (K121297). The 28mm femoral head connects to a femoral stem from Signature Orthopaedics' range to complete the hip hemiarthroplasty.

The provided text describes a 510(k) premarket notification for various hip implants (Remedy™, Pegasus™ and Evolve™ Hip Stems and BiPolar Head) and details the non-clinical performance testing conducted to support their substantial equivalence claim to predicate devices. It does not present acceptance criteria in a quantitative format, nor does it detail a clinical study with a control group or human readers.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it lists general performance tests conducted and then concludes that "Non-clinical testing results support the substantial equivalence claim. The RemedyTM, Pegasus™ and Evolve™ Hip Stems and BiPolar Head are expected to perform adequately during clinical use."

The performance tests conducted include:

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

The document refers to "non-clinical testing and engineering evaluations." This implies in-vitro or bench testing, not patient data. Therefore, concepts like sample size, country of origin, or retrospective/prospective for a patient-based test set are not applicable here. The "test set" would consist of the orthopedic implants subjected to the various physical and mechanical tests. The sample sizes for each specific test are not reported. The company is Australia-based (Signature Orthopaedics Pty Ltd, Lane Cove, NSW 2066, Australia).

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 question is not applicable. The device is a physical hip implant. "Ground truth" in this context would refer to the physical and mechanical properties of the device as measured by engineering standards, not expert interpretations of medical images or clinical outcomes.

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

This question is not applicable as the evaluation involves non-clinical engineering tests, not human interpretation or adjudication of medical 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images, often with AI assistance. The document describes hip implants, which are surgical devices, and the testing performed is non-clinical engineering evaluation.

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

No, a standalone algorithm performance study was not done. This question is also relevant for AI/software as a medical device (SaMD) and does not apply to physical hip implants.

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

For this type of device, the "ground truth" for the non-clinical testing refers to established engineering standards, material properties, and biomechanical principles. For example, fatigue testing would compare the device's performance against known limits for medical implants, and material characterization would be compared against ASTM or ISO standards.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI/machine learning device. The "training" in this context would imply the manufacturing and design process of the device itself and the various components.

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

This question is not applicable for the same reason as point 8. The "ground truth" for the design and manufacturing of the implants would be established through engineering specifications, material selection criteria based on ISO/ASTM standards, and biomechanical research for hip implant design.

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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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