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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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