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The Univers Revers CA humeral head and adapters are indicated for:
• salvage of a failed reverse total shoulder, with an irreparable rotator cuff tear and a well-fixed
humeral stem, to an anatomic hemi-shoulder replacement; or
• conversion of a primary reverse total shoulder, for the relief of pain secondary to severe rotator
cuff arthropathy and an irreparable rotator cuff tear, to anatomic hemi-shoulder replacement
when insufficient glenoid bone stock is encountered intraoperatively after the humeral stem has
been implanted.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and
a functional deltoid muscle is necessary to use the device.

The subject device is a line extension to the Arthrex Univers Revers CA Heads and Adapters cleared in
K151527. The subject device components are smaller and are made of the same materials (cobalt
chromium, titanium, and UHMWPE) as the predicate. The subject devices are designed for use with the
Arthrex implantable devices cleared in K221232, K230366, K161782, K142863 and K170414. The
subject devices are labeled with MRI conditional claims in accordance with Arthrex labeling cleared
under K230513.

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study as the provided text does not contain information about an AI/ML device or software. The document is an FDA 510(k) clearance letter for a medical device called "Univers Revers CA Head and Adapter," which is a shoulder prosthesis. The performance data section refers to mechanical and biocompatibility testing, not AI/ML algorithm performance.

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The Univers Revers Shoulder Prosthesis System is in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The Univers Revers Shoulder Prosthesis System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

(Humeral) Stems are intended for cemented or cementless applications for use with Arthrex Humeral SutureCups. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.

The subject devices are comprised of size 33 humeral suture-cups, spacers and inserts. The subject devices are made of either titanium or UHMWPE. The subject devices are smaller versions than those cleared in K161782 and K142863. The subject devices are compatible with the Univers Revers Shoulder Prosthesis System and Univers Revers Modular Glenoid System devices.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML performance. Instead, it is a 510(k) premarket notification for a medical device called the "Univers Revers Humeral Cup Implant," which is a shoulder prosthesis.

The document discusses:

• Device Name: Univers Revers Humeral Cup Implant
• Manufacturer: Arthrex Inc.
• Regulatory Classification: Class II
• Product Codes: HSD, PHX
• Purpose of Submission: To obtain clearance for smaller size 33 humeral cup components for use with an already cleared shoulder prosthesis system.
• Technological Characteristics: The new components are made of the same materials (titanium or UHMWPE) as the predicates, have the same intended use/indications, packaging, shelf life, and sterilization. They simply expand the size range of cleared humeral implants.
• Performance Data: "Mechanical testing (i.e., PE liner/cup interface per ASTM F1820) was performed."
• Conclusion: The device is substantially equivalent to predicate devices, and mechanical testing demonstrates equivalent performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance as it relates to AI/ML, as this document is about a mechanical orthopedic implant, not an AI/ML powered device.

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The AGILON® XO Shoulder Replacement System is indicated for use for cementless inverse (reverse) total or hemi shoulder replacement in cases of:

• Non- inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, .
• . Post-traumatic osteoarthritis.
• Fractures,
• . Rheumatoid arthritis.

The main indications for the implantation of an AGILON® hemi shoulder prosthesis are:

• Multifragmental comminuted fractures of the humeral head,
• 3- and 4-Fragment-fractures of the proximal humerus,
• . Head-splitting fractures,
• . Dislocated head-splitting fractures,
• . Humeral head depression with more than 40% of joint surface depressed,
• . Interlocking chronic dislocation with deep HILL-SACHS lesion,
• . Fracture instability following internal fixation attempt in 3-fragment fractures (secondary dislocation, material loosening),
• Posttraumatic humeral head necrosis, ●
• . Omarthrosis.

AGLON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty, to treat a patient after an inverse shoulder has failed. It is not combined with a glenoid implant. It can be used in primary and revision cases.

The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are:

• . Rotator cuff tear arthropathy,
• . Chronic trauma shoulder,
• . Decentering of the humeral head after implantation of a humeral head prosthesis.

Please note, that the patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary.

In case of revision surgery the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system can be performed in revision cases as follows:

• From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty ●
• . From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
• From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure ●
• . From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure

The AGILON® XO Shoulder Replacement System is a modular shoulder replacement system offering various components that can be combined to replace the shoulder joint with various options depending upon the size and of each patient. The components can be combined into an hemi or reverse shoulder:
Hemi Shoulder:

• Humeral Head Components (AGILON® XO Cap and AGILON® XO CTA Cap) ●
• o Humeral Stems (Cementless)
  Reverse Shoulder:
• Humeral Head Components (AGILON® Cap Inverse and AGILON® PE-Inlay) ●
• o Glenoid and Glenosphere Components (AGLION® XO Glenoid Baseplate and AGILON® Glenosphere)
• o Humeral Stems (Cementless)
  Metaphyseal components, stem extension pieces, and component connection fixation screws are intended to be used for hemi and reverse shoulder configurations.

This document describes the AGILON® XO Shoulder Replacement System, a modular shoulder replacement system. However, the provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics typically associated with AI/ML-driven medical devices.

Instead, this document is a 510(k) premarket notification summary for a traditional medical device (shoulder replacement system) and focuses on demonstrating substantial equivalence to legally marketed predicate devices. The "performance testing" section refers to mechanical and material property testing, which is standard for orthopedic implants, not performance studies for an AI/ML algorithm.

Therefore, I cannot populate the requested table and sections regarding acceptance criteria and performance study details for an AI system because that information is not present in the provided text. The document is about a physical implant, not a software device with performance criteria like sensitivity, specificity, or reader improvement.

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The Biocore9 Humeral Head Resurfacing Shoulder Component is intended for the reconstruction of painful and/or severely disabled shoulder joints resulting from osteoarthritis. For proper function of this device, the humeral head and neck must be of sufficient bone stock to support the loads on it. Also, the presence of an intact or reconstructable rotator cuff is important for proper functioning and dislocation resistance. Porous-coated components are intended for cemented use only. This device is indicated for hemi-arthroplasty only.

The Biocore9 Humeral Head Resurfacing Shoulder Component is intended for the reconstruction of painful and/or severely disabled shoulder ioints resulting from osteoarthritis and rheumatoid arthritis. For proper function of this device, the humeral head and neck must be of sufficient bone stock to support the loads on it. Also, the presence of an intact or reconstructable rotator cuff is important for proper functioning and dislocation resistance. Porous-coated components are intended for cemented use only. This device is indicated for hemi-arthroplasty only.

The Biocore9 Humeral Head Resurfacing component is a non-constrained orthopedic implant intended to replace the articular surface of the existing humeral head in the patient's shoulder joint. It is intended for the reconstruction of painful and or severely disabled shoulder joints resulting from osteoarthritis or rheumatoid arthritis for patients who would be candidates for total shoulder procedure, whose proximal humerus has not been excessively damaged by disease or trauma and where damage is primarily associated with the articular surface of the humeral head. It is primarily intended to articulate with intact, natural, glenoid. Components are available in five sizes with available outside diameters from 40 mm to 56 mm in 4 mm increments.

The Biocore9 Humeral Resurfacing Head Component is manufactured from Ti-6Al-4V alloy (ASTM F136-13) with a Titanium Nitride (TiN) thin film ceramic coating. The Humeral Resurfacing component is axisymmetric with a truncated shell and a tapered central stem. The component consists of a thin walled spherical shell. The Humeral resurfacing Component's rim is anatomical with a rounded relief. The exterior of the spherical surface is intended to articulate with the Glenoid.

The internal surface of the spherical shell is covered with a porous coating consisting of titanium beads. The stem is not porous coated.

This document describes the Biocore9 Humeral Resurfacing System, a medical device. However, it does not contain information about studies proving the device meets acceptance criteria related to a machine learning or AI model's performance. The sections detailing "Non-Clinical Performance Testing" relate to the physical properties and performance of the implant itself (e.g., tensile strength, wear resistance), not the evaluation of an AI model's output.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device per your prompt. The provided text describes a traditional medical device (a prosthetic humeral head) and its materials, design, intended use, and non-clinical engineering performance testing for substantial equivalence to a predicate device.

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For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck and glenoid be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable.

The device is a single use implant intended to be used for hemiarthroplasty or in conjunction with the Arthrosurface glenoid component for total shoulder arthroplasty.

Both humeral and glenoid components of the OVOMotion™ Shoulder Arthroplasty System are intended for cemented use only.

The OVOMotion™ Humeral prosthesis incorporates an articular resurfacing component and a taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.

The Arthrosurface OVOMotion™ Shoulder Arthroplasty System is intended as hemiarthroplasty or in conjunction with Sponsor's previously cleared and commercially marketed glenoid prosthesis (K091196) to repair and replace a shoulder joint when both articular surfaces of the joint are affected.

Humeral articular components are manufactured from CoCrMo and mate with corresponding Ti fixation component. Glenoid components are made from Ultra High Molecular Weight Polyethylene (UHMWPE). Both humeral and glenoid components are available in multiple sizes and curvatures and are intended to be implanted using bone cement.

This document is a 510(k) premarket notification for a medical device called the OVOMotion™ Shoulder Arthroplasty System. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study to prove acceptance criteria for a new AI/software device.

Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, particularly for an AI/software-based medical device.

The information provided describes:

• The device: OVOMotion™ Shoulder Arthroplasty System, a shoulder arthroplasty (joint replacement) system.
• Its purpose: Reconstruction of painful and/or severely disabled shoulder joints due to post-traumatic degenerative disease or avascular necrosis.
• Materials: Humeral articular components from CoCrMo, Ti fixation components, and glenoid components from UHMWPE.
• Intended use: Hemiarthroplasty or total shoulder arthroplasty, intended for cemented use only.
• Regulatory classification: Class II medical device.
• Basis for clearance: Substantial equivalence to predicate devices (previously cleared shoulder arthroplasty systems).
• Non-clinical tests performed: Device comparative analysis, humeral head mechanical testing (Assembly & Disassembly, Resistance to Torque, Cyclic Fatigue, Fretting Corrosion, Static Compression to Failure, Shear Testing, Lever Out), and a Kinetic Chromogenic LAL Test for Bacterial Endotoxins.

None of these elements pertain to acceptance criteria for an AI/software device, clinical study data, ground truth establishment, or multi-reader, multi-case studies.

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The Univers Revers Shoulder Prosthesis System is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The Univers Revers Shoulder Prosthesis System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to rotator cuff deficiency.

(Humeral) Stems are intended for cemented or cementless applications for use with Arthrex Humeral Suture Cups. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.

The Arthrex Univers Revers Humeral Stems and Suture Cups is a line extension to the Arthrex Univers Revers Shoulder Prosthesis System. The proposed humeral stems, sizes 6 thru 15, are modified versions of the humeral stems cleared under K130129/K142863 and are designed to be shorter in medial to lateral width. The line extension also introduces a size 5 modular stem as well as modified versions of the Humeral Suture Cups.

The provided text is a 510(k) premarket notification for a medical device, specifically the "Arthrex Univers Revers Shoulder Prosthesis System." It details the device's indications for use, its substantial equivalence to a predicate device, and some testing performed. However, it does not describe an acceptance criterion in the context of device performance metrics or any study that proves the device meets such criteria in terms of clinical outcomes or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to a previously cleared device.

Therefore, I cannot provide the detailed information requested in the format of acceptance criteria and a study demonstrating device performance. This document pertains to regulatory clearance based on substantial equivalence to a predicate device, not a performance study against specific acceptance criteria for diagnostic accuracy or clinical efficacy in the way the request implies (e.g., sensitivity, specificity, or improvement with AI assistance).

Here's a breakdown of why and what information can be extracted:

Why the request cannot be fully fulfilled from the provided text:

• Acceptance Criteria & Reported Device Performance (Table): The document doesn't define quantitative acceptance criteria for clinical performance (e.g., success rates, pain reduction scores, range of motion improvement) for the new device. It states the device's intended use and then relies on demonstrating equivalency to a predicate device through non-clinical testing (fatigue and abrasion).
• Sample Size & Data Provenance (for test set): There is no test set described in terms of patients or images for clinical performance. The "test set" for the mechanical tests (fatigue and abrasion) would be the physical implants themselves, not a clinical data set.
• Number of Experts & Qualifications / Adjudication Method: These points are relevant to studies involving human interpretation or clinical endpoints, which are not described here.
• Multi-Reader Multi-Case (MRMC) Study / Effect Size: This is specific to diagnostic or AI-assisted devices and is not applicable here as the device is a prostheses system.
• Standalone Performance: This would be for a diagnostic algorithm, not a physical implant.
• Type of Ground Truth: Ground truth (pathology, outcomes data) usually applies to diagnostic accuracy studies. While outcomes data would eventually be collected on this prosthesis in a clinical setting, this document is for premarket clearance based on equivalence, not a clinical trial demonstrating new outcomes.
• Sample Size for Training Set / How Ground Truth was Established (for training set): These relate to machine learning model development, which is not applicable to a shoulder prosthesis.

What can be extracted from the document related to "acceptance" in a regulatory sense and "study":

The "acceptance criteria" here are implicitly tied to demonstrating substantial equivalence and meeting the performance of the predicate device through bench testing.

• Implicit Acceptance Criteria (for mechanical properties):

  • Survivability of dynamic fatigue testing for 10 million cycles for both compression and torsion loading conditions.
  • Abrasion resistance using the new Humeral Suture Cups that "exceeded the predicate."

• Study Proving Device Meets Implicit Acceptance Criteria:

  • Study Name: Dynamic fatigue testing and abrasion testing.
  • Reported Device Performance:
    • Dynamic Fatigue Testing: All constructs survived 10 million cycles for both compression and torsion loading conditions.
    • Abrasion Testing: Abrasion resistance exceeded the predicate.
  • Sample Size for Test Set: Not specified, but generally refers to the number of physical device constructs tested in the lab.
  • Data Provenance (Test Set): Not applicable in the clinical sense. These would be lab-generated test results.
  • Ground Truth: Not applicable in the clinical sense. The "ground truth" for these tests are the physical properties and failure points observed in a controlled lab environment.
  • Other points (Experts, Adjudication, MRMC, Standalone, Training Set): Not applicable to this type of regulatory submission and testing.

In summary, the provided text is a 510(k) clearance letter and summary, which focuses on regulatory equivalence and non-clinical bench testing for a physical implant, not a clinical performance study with acceptance criteria for patient outcomes or diagnostic performance.

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Hemi or Total Arthroplasty Application of the Anatomical Shoulder Humeral Stems and Domelock System
The Anatomical Shoulder Humeral Stems and Domelock System are indicated for

• · Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
• · Avascular necrosis.
• · Conditions consequent to earlier operations.
• · Omarthrosis.
• · Rheumatoid arthritis.
• · Revision of shoulder prosthesis.

The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used in a total shoulder application, the Anatomical Shoulder Pegged and Keeled Glenoids Cemented and the Biomet all-polyethylene Keeled Glenoid are intended for cemented use only. The Biomet Modular Hybrid Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.

Reverse Application of the Anatomical Shoulder System
· The Anatomical Shoulder Inverse System is indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
· The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The Humeral Stems Cemented are intented use and the Humeral Stems Uncemented are intended for uncemented use. When used with the Anatomical Shoulder Glenoid Fixation, it is intended for uncemented use and requires two screws for fixation.

Fracture Application of the Anatomical Shoulder Fracture System
The Anatomical Shoulder Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi and fracture shoulder arthroplasty in treatment of the following:

• · Complex 3- and 4-part fractures of the proximal humerus with subluxation of the head fragment
• · Complex 3- and 4-part fractures of the proximal humerus with loosening of the spongiosa in the bead fragment
• · Complex 3- and 4-part fractures of the proximal humerus with additional cross split of the head fragment
• · Fracture instability after osteosynthesis of 3- and 4-part fragments of the proximal humerus
• · Posttraumatic necrosis of the humeral head
• · Posttraumatic arthrosis after humeral head fracture

The Humeral Fracture Stems are intended for either cemented use. When used in a total shoulder application, the Anatomical Shoulder Pegged and Keeled Glenoids Cemented are intended for cemented use only.

The Anatomical Shoulder System is a modular shoulder prosthesis designed to be used in primary o revision, total or hemi shoulder arthroplasty.
Anatomical Shoulder Humeral Stems are available as either cemented or uncemented designs. Cemented stems are available in longer designs to support revision cases. All Humeral Stems possess a female oval taper geometry, which is the basis for all modularity with compatible mating components.
The Anatomical Shoulder Domelock System consists of a Humeral Head which is connected to the Anatomical Shoulder humeral stems using an adjustable Domelock Dome centric including an Expansion Ball and Expansion-pin. The Domelock Dome is used to set the orientation of the Domelock Humeral Heads. The male oval cone taper of the Domelock expansion ball component is compatible with all Humeral Stems of the Anatomical Shoulder System.
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component of the Anatomical Shoulder System or with the Biomet Modular Hybrid or all-polyethylene Keeled Glenoid for total arthroplasty.

I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for a medical device (Anatomical Shoulder Domelock Dome Centric) and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific performance acceptance criteria and detailing a study to prove they are met.

Here's why I cannot extract the requested information:

• No explicit acceptance criteria: The document does not list specific numerical or qualitative acceptance criteria for the device's performance. It describes modifications to an existing device to improve aspects like readability of a laser mark and ease of trialing, implying improvements but not setting quantified thresholds.
• No specific study proving criteria: The "Performance Data" section mentions "Functional relationship analysis" and "Finite Element Analysis for fatigue strength." These are analyses rather than comprehensive studies with defined test sets, ground truth, or statistical methods as you've requested.
• Emphasis on substantial equivalence: The core of a 510(k) submission is to show the new device is "substantially equivalent" to a legally marketed predicate device. This often relies on comparative technical characteristics and, in this case, a few minor design modifications, rather than a full-scale performance study against pre-defined acceptance criteria for a new type of device.
• No clinical data: The document explicitly states "Clinical data and conclusions were not needed to demonstrate substantial equivalence." This means there would be no human reader (MRMC) studies, standalone algorithm performance, or ground truth established from patient outcomes.

Therefore, your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. MRMC comparative effectiveness study details
6. Standalone performance details
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

cannot be answered from the provided text. The document describes a physical medical device (shoulder prosthesis components), not an AI/software device that would typically have the kind of performance studies and ground truth establishment you are inquiring about.

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The Arthrex Univers Revers CA Heads and Adapters are indicated for

• . salvage of a failed reverse total shoulder, with an irreparable rotator cuff tear and a well-fixed humeral stem, to an anatomic hemi-shoulder replacement; or
• . conversion of a primary reverse total shoulder, for the relief of pain secondary to severe rotator cuff arthropathy and an irreparable rotator cuff tear, to anatomic hemi-shoulder replacement when insufficient glenoid bone stock is encountered intraoperatively after the humeral stem has been implanted.
  The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device

The Arthrex Univers Revers CA Heads and Adapters consist of a line of CA Heads and Adapters which are designed to be used with the existing well-fixated Revers stem of the Univers Revers Shoulder Prosthesis System (K130129 and K142863). The Arthrex Univers Revers CA Heads and Adapters will convert existing reversed shoulder prosthesis to a hemi anatomic configuration. The cobalt chrome CA Head were designed with a larger area of articulation to allow for articulation with the acromion in patients with gross rotator cuff deficiency, similar to the Univers II The proposed Arthrex Univers Revers CA Heads have a CA Heads (K130675). similar spherical articulating surface as that of the previously cleared heads and are available in 14 nominal sizes. The Adapters are manufactured from Titanium and UHMWPE and are available in 3 nominal sizes.

The provided text describes a 510(k) premarket notification for a medical device called "Arthrex Univers Revers CA Heads and Adapters." This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing de novo safety and effectiveness criteria. Therefore, the document does not contain information about acceptance criteria and a study to prove the device meets specific performance metrics in the way your request outlines for AI/software-based devices.

The information provided only discusses the substantial equivalence summary based on bench testing. Here's a breakdown of what is available and what is not in relation to your request:

1. Table of acceptance criteria and reported device performance:

• Acceptance Criteria: Not explicitly stated as pass/fail criteria for clinical performance in a typical sense for AI, but rather a demonstration of equivalence to predicates. The acceptance for this 510(k) submission is that the device's design, materials, and mechanical performance are comparable to cleared predicate devices and do not raise new questions of safety or effectiveness.
• Reported Device Performance: The document states that in-vitro testing (static loading, endurance, fretting corrosion, disengagement, torque out) was performed and demonstrated that the performance of the proposed devices is "substantially equivalent to that of the predicate devices." No specific numerical performance metrics from these tests are provided, nor are the acceptance criteria for these mechanical tests detailed.

Table (based on available information, highly summarized):

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

• Test Set (for in-vitro mechanical testing): Not specified in this document. Since it's mechanical testing, the "sample size" would refer to the number of devices tested for each mechanical property.
• Data Provenance: The nature of in-vitro testing suggests it's likely conducted in a lab setting, presumably by the manufacturer (Arthrex, Inc.). No country of origin is mentioned for the test data itself, but the manufacturer is based in Naples, Florida, USA. The testing is prospective in the sense that it's performed to support the 510(k) submission for this specific device.

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

• Not applicable. This document describes mechanical testing of a physical implant, not clinical performance based on expert review or ground truth labeling like in an AI study.

4. Adjudication method for the test set:

• Not applicable. This relates to clinical or interpretative studies, not mechanical bench testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This type of study applies to diagnostic imaging or interpretation devices, typically AI-powered. The device in question is a physical orthopedic implant. The document explicitly states: "Clinical data and conclusions are not needed for this device."

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

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

7. The type of ground truth used:

• Not applicable. For mechanical testing, the "ground truth" would be the measured physical properties against established engineering standards or predicate device performance.

8. The sample size for the training set:

• Not applicable. This device is a passive implant; there is no "training set" in the context of machine learning.

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

• Not applicable. Again, no training set for a physical implant.

In summary: The provided document is a 510(k) clearance letter for a physical orthopedic implant, focusing on its substantial equivalence to previously cleared predicates through in-vitro mechanical testing. It does not contain the detailed performance criteria, clinical study designs, or AI-specific information requested.

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For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable. The device is a single use implant intended to be used with bone cement.

The HemiCAP® Humeral Head XL (HHXL) Articular Resurfacing System incorporates an articular resurfacing component and a taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.

This document, K142942 for the HemiCAP® Humeral Head XL (HHXL) Articular Resurfacing System, is a 510(k) premarket notification. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed clinical study results in the same way a PMA (Pre-Market Approval) would.

Therefore, the document does not contain the kind of detailed information about acceptance criteria for device performance in a clinical setting, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance that you are requesting. It's a regulatory submission affirming the device's similarity to existing devices the FDA has already cleared.

Instead, this submission concentrates on non-clinical (bench) testing to demonstrate that the modified device performs similarly to its predicate.

Here's what information can be extracted or inferred from the provided text, and what cannot:

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

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

• Sample Size: Not specified. The document references non-clinical (bench) testing, not clinical studies. The "test set" in this context refers to the number of physical device samples subjected to mechanical testing.
• Data Provenance: Not applicable. This is not clinical data. The testing would have been performed in a laboratory setting, presumably by the manufacturer.

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. "Ground truth" usually refers to clinical diagnoses or outcomes established by medical professionals. The testing described is mechanical (bench) testing. The "truth" is whether the device meets engineering specifications and replicates the performance of the predicate device, typically evaluated by engineers and quality control personnel.

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

• Not applicable. Adjudication methods are used in clinical studies when multiple human observers interpret data. For mechanical testing, the results are typically quantitative measurements against predefined specifications.

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. This is a mechanical orthopedic implant, not an AI or imaging device. MRMC studies are not relevant here.

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

• No. This is a mechanical orthopedic implant. "Standalone algorithm performance" is not relevant.

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

• Not applicable in the clinical sense. For the non-clinical testing, the "ground truth" would be the engineering specifications and performance characteristics of the predicate device, against which the new device's mechanical test results were compared to establish "substantial equivalence."

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. There is no training set or clinical "ground truth" establishment in this document.

In summary, this 510(k) submission primarily relies on comparing the modified device's non-clinical performance (mechanical testing) and design characteristics to a legally marketed predicate device to demonstrate substantial equivalence, rather than providing new clinical study data with acceptance criteria for a new clinical performance claim.

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The Equinoxe Resurfacing Humeral Head System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total arthroplasty is determined by the surgeon to be the preferred method of treatment. The Equinoxe Resurfacing Humeral Head System is intended for use in patients with the following conditions where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable.

• Osteoarthritis .
• Avascular Necrosis .
• Rheumatoid Arthritis
• Post-traumatic Arthritis .
• Correction of functional deformity 0
• Fractures of the humeral head 0
  The Equinoxe Resurfacing Humeral Head System is intended for uncemented use only.

The Equinoxe Resurfacing Humeral Head System is intended as a cementless humeral resurfacing system that can be used in hemi- shoulder arthroplasty (where it does not articulate with a glenoid component) or total shoulder arthroplasty (where it articulates with a glenoid component). Implantation of this device involves minimal bone removal. The overall design goal of the Equinoxe Resurfacing Humeral Head System is to provide a bone-preserving option for treating degenerative conditions of the shoulder joint.
The Equinoxe Resurfacing Humeral Head System is a modular system, consisting of an articular humeral head component and a humeral cage component mated together via Morse taper connection to provide stabilization of the implant assembly. The dome shaped resurfacing humeral head component is manufactured from cobalt-28Chromium-6Molybdenum alloy per ASTM F1537 with titanium plasma coating per ASTM F1580 and Hydroxylapatite coating per ASTM F1185 on the non-articulating or bone-contacting surface. Manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) with titanium plasma coating per ASTM F1580, the cylindrical cage component features multiple fins for anti-rotation. The variable sizing options and the modular composition of the Equinoxe Resurfacing Humeral Head System facilitates selection and anatomic reconstruction of the native humeral head.
If utilized in total shoulder arthroplasty procedures, the System is compatible with the following Equinoxe Shoulder Glenoid components: Keeled Glenoids, Pegged Glenoids, Caged Glenoids, and Augmented Glenoids cleared with the following 510(k)s: K042021, K093430, K113309, K103419, K111379, and K121220.
The Equinoxe Resurfacing Humeral Head System is accompanied by a complete instrumentation and trial system to assist the surgeon in the implantation of each component.

The provided document is a 510(k) summary for the Exactech® Equinoxe® Resurfacing Humeral Head System, which is a medical device. It does not describe an AI/ML device or a study involving acceptance criteria and device performance in the context of AI. The document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and comparison of characteristics like indications for use, materials, and design features.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from this document as it pertains to AI/ML device studies.

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