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The hip prosthesis MasterLoc™ is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery.

Hip replacement is indicated in the following cases:

• · Severely painful and/or disabled joint as a result of arthritis, 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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

The MasterLoc™ Stem: Lateralized Plus implants are a line extension to Medacta's MasterLoc Stem product line (cleared under K151531 and K160289). The MasterLoc "" Stem: Lateralized Plus implants offer an additional caput-collum-diaphyseal (CCD) angle of 122° and neck offsets for various patient anatomies. The MasterLoc™ Stem: Lateralized Plus implants include cementless, flat, dual tapered design stems intended for total hip arthroplasty in primary or revision surgery.

The MasterLoc™ Stem: Lateralized Plus implants are made with a titanium alloy substrate (Ti6Al7Nb) according to ISO 5832-11 Second Edition 2014-09-15: Implants for Surgery -Metallic Materials - Part 11: Wrought Titanium 6-Aluminium 7-Niobium Alloy. The surface treatment consists of Ti coating with a thickness of 700 um in the proximal 2/3 of the shaft to improve proximal fixation. The distal portion of the stems are uncoated with a satin finish obtained from glass bead blasting.

The MasterLoc " Stem: Lateralized Plus implants are available in sizes 4 to 12, with a range of stem lengths from 126.5 mm to 147.5 mm. The stems have a Eurocone (12/14 taper with an angle of 5° 42' 30'') and the necks are polished.

This document is a 510(k) premarket notification for a medical device called the "MasterLoc™ Stem: Lateralized Plus," which is a hip prosthesis. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria in the same way a new drug or novel medical device might.

Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic accuracy for an AI/ML device is not directly applicable to this submission. This 510(k) is for a prosthetic implant, and its "acceptance criteria" are related to mechanical performance and biocompatibility to demonstrate it functions similarly to existing, cleared devices.

However, I can extract the information that is relevant to testing and performance data for this device, which serves a similar purpose of demonstrating safety and performance.

Here's a breakdown of the available information based on your requested categories, tailored to what's present in this 510(k) document:

Acceptance Criteria and Device Performance (Adapted for a Prosthetic Device):

This submission doesn't define "acceptance criteria" in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) or a specific "reported device performance" in that sense. Instead, the acceptance criteria are inherent in the standards to which the device was tested, and the "reported device performance" is the successful completion of these tests.

1. A table of acceptance criteria and the reported device performance:
As detailed above. The "acceptance criteria" are the successful completion of tests adhering to the specified ISO and EN standards. The "reported device performance" is that these tests were conducted and the device met the requirements of these standards, allowing for a substantial equivalence determination.

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

• Sample Size for Test Set: Not explicitly stated as a "test set" in the context of data for an algorithm. For mechanical testing, the sample size refers to the number of physical devices tested. This information is not provided in the document (number of stems tested for fatigue, ROM, pyrogenicity).
• Data Provenance: The tests conducted are non-clinical (mechanical and pyrogenicity) and were performed to international standards (ISO, EN, European Pharmacopoeia, USP). The location of these tests is not specified, but the submitter (Medacta International SA) is based in Switzerland. These are prospective tests performed on new devices manufactured for this submission, not retrospective data.

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. This is not a study requiring expert readers or ground truth establishment in the diagnostic sense. The "ground truth" for mechanical properties is determined by physical measurements against established engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no human interpretation or adjudication method described for the mechanical and pyrogenicity tests.

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 is not a diagnostic device or an AI/ML algorithm. No human reader studies were conducted as part of this submission.
The document explicitly states under "Clinical Studies": "no clinical studies were conducted."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is based on well-established engineering and material science standards (ISO, EN) and pharmacopoeia standards (USP, European Pharmacopoeia) for mechanical properties, material composition, and biocompatibility (pyrogenicity). These standards define acceptable limits and testing methodologies.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device that uses a training set.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.

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The hip prosthesis MasterLoc® is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery.

Hip replacement is indicated in the following cases:

· Severely painful and/or disabled joint as a result of arthritis, traumatoid 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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

A hip prosthesis consists of a femoral stem made of metal, a modular femoral head made of metal or ceramic, and acetabular components. The acetabular components consists of a metal cup, and a liner that is made of ultra-high molecular weight polyethylene (UHMWPE), or Highcross highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE). Acetabular components can be: Versafitcup, Versafitcup CC Trio, Mpact, Medacta Bipolar Head.

All the auxiliary components of the prosthesis are supplied in single-use individual packages.

The MasterLoo® stems can be combined with the CoCr ball heads, Endo Head or with the MectaCer BIOLOX® forte or MectaCer BIOLOX® delta femoral heads. Refer to the MectaCer BIOLOX® forte or MectaCer BIOLOX® delta femoral heads package insert and to CoCr heads package insert for more information about ball heads.

The provided text is a 510(k) summary for the Medacta MasterLoc Stem, a hip prosthesis. It describes the device, its indications for use, and a comparison to a predicate device to demonstrate substantial equivalence. However, it does not describe acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device, which is what your request implies by questions about sample sizes for test/training sets, ground truth, experts, and MRMCs.

This document describes the regulatory clearance process for a physical medical device (hip implant) based on its similarity to existing, legally marketed predicate devices. The "performance testing" section refers to mechanical and material testing, not the performance of an AI algorithm.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance (for an AI/ML device): The document refers to mechanical engineering standards (e.g., ISO 7206-4, ISO 7206-6, ASTM F2009-00) for testing the physical implant's strength, durability, and stability. It states that "The new test successfully met acceptance criteria" without detailing the specific criteria or exact performance values, as these are related to the mechanical properties of the implant, not diagnostic accuracy of an AI.
2. Sample size used for the test set and data provenance: Not applicable, as this is not an AI/ML study.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: Not applicable.
6. If a standalone performance study was done: The document describes "Performance Testing" for the physical implant, which is a standalone evaluation of its mechanical properties against standards, not an AI algorithm's performance.
7. The type of ground truth used: For a physical implant, "ground truth" would be established by engineering standards and validated physical testing against those standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a physical hip implant, not an AI/ML medical device. Therefore, the specific questions you asked regarding AI/ML device validation and ground truth establishment are not addressed by this text.

Ask a specific question about this device

The hip prosthesis MasterLoc® is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery.

Hip replacement is indicated in the following cases:

· Severely painful and/or disabled joint as a result of arthritis, traumatoid 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, surface replacement

arthroplasty, or total hip replacement.

A hip prosthesis consists of a femoral stem made of metal, a modular femoral head made of metal or ceramic, and acetabular components. The acetabular components consists of a metal cup, and a liner that is made of ultra-high molecular weight polyethylene (UHMWPE), or Highcross highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE). Acetabular components can be: Versafitcup, Versafitcup CC Trio, Mpact, Medacta Bipolar Head.

All the auxiliary components of the prosthesis are supplied in single-use individual packages.

The MasterLoc® stems can be combined with the CoCr ball heads, Endo Head or with the MectaCer BIOLOX® forte or MectaCer BIOLOX® delta femoral heads. Refer to the MectaCer BIOLOX® forte or MectaCer BIOLOX® delta femoral heads package insert and to CoCr heads package insert for more information about ball heads.

The provided text describes a 510(k) premarket notification for a hip prosthesis called the "MasterLoc Stem." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance against specific acceptance criteria for a novel AI/software medical device.

Therefore, the information required to answer your prompt, which is tailored for an AI/software medical device (e.g., acceptance criteria for model performance, training/test set details, expert ground truth establishment, MRMC studies), is not present in the provided document.

The document details:

• Device Name: MasterLoc Stem
• Regulation Number/Name: 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
• Regulatory Class: Class II
• Product Codes: LZO, LPH, MEH, KWY, LZY
• Indications for Use: Cementless use in total or partial hip arthroplasty in primary or revision surgery for conditions like arthritis, avascular necrosis, femoral head/neck fracture, or failure of previous hip surgery.
• Predicate Devices: K052792 ANTHOLOGY Hip Stem (Smith & Nephew, Inc.) and K072857 Medacta Total Hip Prosthesis (Medacta International).
• Performance Testing: Mechanical testing (e.g., ISO 7206-4, ISO 7206-6, EN ISO 21535, ASTM F2009-00) for risks like breakage, limited range of motion, coating adhesion, and modular connection instability. These are physical product performance tests against engineering standards, not AI/software performance criteria.

In summary, this document does not contain the information needed to fill out your requested table and details for an AI/software medical device.

If you have a document describing the validation of an AI/software medical device, please provide that, and I would be happy to help.

Ask a specific question about this device