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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 SMS system is designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. Hip replacement 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, arthroplasty, hip resurfacing replacement or total hip arthroplasty

The SMS femoral stem is a cementless bone preserving short stem designed for proximal fixation in total or partial hip arthroplasty for primary or revision surgery.
The SMS implants are comprised of the following products:

• SMS Cementless Solid Standard Stem (available in 15 sizes from size 1 to 15); and ●
• SMS Cementless Solid Lateralized Stem (available in 15 sizes from size 1 to 15). .
  Both are available on the US market via the clearance - K181693 and K201673.
  SMS collared solid version, has been introduced as a product range extension to the stems currently marketed as the SMS product line (K181693 and K201673). Quadra P is the collared stem currently marked in US K192827.
  The SMS implants are line extensions to Medacta's Total Hip Prosthesis - AMIStem-H, Quadra-S and Quadra-H Femoral Stems (K093944), AMIStem and Quadra - Line Extension (K121011), AMIStem-P, AMIStem-P Collared and AMIStem-H Proximal Coating Femoral Stems (K173794), Quadra-H and Quadra-R Femoral Stems (K082792), AMIStem-H Proximal Coating (K161635), MiniMAX (K170845), and SMS (K181693 and K201673).
  The SMS implants are part of the Medacta Total Hip Prosthesis system. The Medacta Total Hip Prosthesis system consists of femoral stems, modular femoral heads and acetabular components. The acetabular components consist of metal cups and liners made of ultra-high molecular weight polyethylene (UHMWPE) or Highcross highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE). Acetabular components include the Mpact DM (K143453), VersafitCup (K083116 and K092265), VersafitCup CC Trio (K103352), Mpact (K103721 and K132879), Mpact 3D Metal (K171966) and Medacta Bipolar Head (K091967).
  The SMS stems can be combined with the CoCr ball heads (K072857, K080885 and K103721), Endo Head (K111145) or with the MectaCer BIOLOX® Forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the SMS Cementless Stem.

It's important to note that this document is a 510(k) summary for a medical device (hip implant), not an AI/ML powered device. Therefore, the questions related to AI/ML specific criteria (such as effect size of human readers with AI assistance, standalone algorithm performance, ground truth for training set, training set size) are not applicable to this submission.

Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list "acceptance criteria" in a quantitative manner as one might find for an AI/ML device (e.g., target specificity/sensitivity). Instead, the criteria are implicitly derived from the performance tests conducted to demonstrate substantial equivalence to predicate devices. The device's performance is demonstrated through satisfying these tests.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

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

• Sample Size for Test Set: Not explicitly stated in terms of number of devices. The "tests" here refer to mechanical and material property tests (e.g., fatigue testing, pull-off force, coating adherence). These tests are typically performed on a statistically relevant number of samples of the device and its components, but the exact count isn't in this summary.
• Data Provenance: The data is derived from non-clinical studies (laboratory testing) and in comparison to predicate devices. There is no mention of human subject data, so concepts like "country of origin" or "retrospective/prospective" don't directly apply in the clinical sense. These are engineering specifications leveraged from previously cleared devices.

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

• This question is not applicable. For this type of device (hip implant), ground truth isn't established by human experts reviewing medical images or patient data in the typical sense of AI/ML device evaluation. The "ground truth" or standard for performance is established by recognized international and national standards (e.g., ISO, ASTM) for the mechanical and material properties of orthopedic implants.

4. Adjudication method for the test set

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among human reviewers (experts) in establishing ground truth for diagnostic or prognostic studies, which is not the nature of the evaluation for this hip implant. The "adjudication" for mechanical tests would be adherence to the specified test methods and criteria outlined in the standards.

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 MRMC study was done. This study concerns a physical orthopedic implant, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no "effect size of human readers improving with AI assistance."

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

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

7. The type of ground truth used

• The "ground truth" for the performance evaluation of this device is based on established engineering and material standards (ISO 21535, ISO 7206, ASTM F2009, ASTM F1147, ISO 13779, European Pharmacopoeia, USP). The device is deemed safe and effective and "substantially equivalent" if it meets the performance requirements stipulated by these standards, generally by demonstrating that it performs as well as, or better than, the predicate devices for which these criteria were previously established.

8. The sample size for the training set

• Not applicable. This submission is for a physical medical device, not an AI/ML model that requires a training set. The "training" for this device would refer to the design and manufacturing process, which adheres to quality systems regulations.

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

• Not applicable. As above, there is no "training set" in the context of an AI/ML algorithm. The design and manufacturing of the device follow established engineering principles and standards.

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