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In an anatomic shoulder configuration, the Humeris Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:

• A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
• Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).

In a reverse shoulder configuration, the Humeris Shoulder is indicated for primary or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.

The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The humeral stem of the Humeris Cementless Shoulder is intended for cementless use only. The humeral stem of the Humeris Cemented Shoulder is intended for cemented use only. The glenoid components of the Humeris Shoulder System are intended for cemented use only. The glenoid baseplate component is intended for cementless use with the addition of screws for fixation.

The Humeris Shoulder is a system of shoulder components that can be used in either an anatomic or a reverse configuration.

The Humeris Cementless Humeral Stem is manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and is available in diameters of 8-16mm and a length of 100mm. The distal end of the humeral stem is trapezoidal with a polished surface. The proximal portion of the humeral stem has a plasma sprayed commercially pure Titanium (CP Ti) and hydroxyapatite (HA) coating.

The Humeris Cemented Humeral Stem is also manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and is available in diameters of 6-14mm and a length of 100mm. The distal end of the humeral stem is trapezoidal with a polished surface.

Both humeral stems incorporate a female taper for attachment of compatible components. The Humeris humeral stems can be used with a straight or angled double taper connector or a centered spacer, a centered or offset humeral head and a 2 peg or 3 or 4 peg cemented glenoid for use in an anatomical shoulder configuration.

The straight and angled double taper connectors and the centered spacers have a male taper on each end and are used to connect the humeral stem to the humeral head. The straight double taper connector and three options of angled double taper connectors allow the angle of the head to be changed from 135° to 132° or 138° and the offset of the humeral head to be increased from +0 to +3 or +5 mm. The centered spacers also allow the offset of the humeral head to be increased from +0 to +3 or +5 mm. All of the double taper connectors and centered spacers are compatible with all sizes of humeral stems and humeral heads. The double taper connectors and the centered spacers are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3.

The humeral heads are available in diameters of 39 – 54 mm in centered and offset styles. The offset of the taper allows the head to be rotated relative to the cut surface of the humerus to provide optimal coverage of the bone. A female taper allows attachment to the double taper connector, which connects to the humeral stem. The humeral heads are manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12.

The 2 peg cemented glenoid component is available in sizes extra small, small, medium and large and features two pegs for cemented fixation to the glenoid bone. It is manufactured from ultra-high molecular weight polyethylene (UHMWPE) conforming to ISO 5834-2. Each peg contains a radiopaque marker manufactured from tantalum conforming to ASTM F560.

The 3 or 4 peg cemented glenoid component is also available in sizes extra small, small, medium and large. Sizes extra small and small have three fixation pegs. Sizes medium and large have four fixation pegs. The 3 or 4 peg cemented glenoid component is manufactured from ultra-high molecular weight polyethylene (UHMWPE) conforming to ISO 5834-2. The central peg contains a radiopaque marker manufactured from tantalum conforming to ASTM F560.

The Humeris humeral stems can also be used with a humeral cup and 135/145 adapter or a 135/145 humeral cup, a centered or eccentric glenosphere with or without a central screw, a glenoid baseplate, post extensions and standard (compression) or locking bone screws for use in a reverse shoulder configuration.

The humeral cup and the 135/145 humeral cup are available in two sizes, Ø36 and Ø40 mm. Each size is available in two versions, standard and mobility. Each version is available in three heights: +3mm, +6mm, +9mm; and is compatible with all sizes of humeral stems. A 24mm male taper allows attachment of the 135/145 cup to the humeral stem. If the humeral cup is used, it must be used with a 135/145 adaptor. Male tapers allow attachment of the humeral cup to the 135/145 adaptor and of the 135/145 adaptor to the humeral stem. The humeral cup and 135/145 humeral cup are preassembled, one-piece components manufactured from UHMWPE conforming to ISO 5834-2 and Ti-6Al-4V alloy conforming to ISO 5832-3.

The glenosphere is also available in Ø36 and Ø40 mm sizes and in centered and eccentric styles. The eccentric glenospheres are designed to be offset from the center of the glenoid baseplate. All glenospheres have a 10° tilt, meaning that the curvature of the glenosphere extends 10° beyond the equator of a hemisphere. This additional articular surface lateralizes the center of rotation to help reduce the potential for scapular notching by the humeral cup. All glenospheres mate with the glenoid baseplate via a taper lock. The glenospheres are also available with an optional central, cannulated screw. This screw can be threaded through the central post of the baseplate for additional security. The glenosphere components are manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12. The glenosphere screw is manufactured from Ti-6Al-4V allov conforming to ISO 5832-3.

The glenoid baseplate has a round base with a central, cannulated post and four peripheral, threaded screw holes. The outer edges of the baseplate are tapered to lock with the glenosphere component.

The glenoid baseplate is used with 4.5mm standard or locking bone screws for added stability. The bone screws are available in lengths from 20 - 50mm in 5mm increments. Each screw allows an angulation of +/- 12° around the axial axis of the screw hole.

Optional post extensions are available to extend the central post of the baseplate and provide additional anchoring in cases with poor bone quality. The post extensions are available in 6mm and 10mm lengths. When used, the post extensions screw into the baseplate post.

The glenoid baseplate, standard and locking screws, and post extensions are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3. The backside of the baseplate and the post extensions are coated with a plasma sprayed CP Titanium and Hydroxyapatite coating.

I am sorry, but the provided text does not contain information about acceptance criteria and study proving device meets acceptance criteria for an AI/ML powered device. The document is a 510(k) premarket notification for a shoulder joint prosthesis (Humeris Shoulder) and details its indications for use, device description, materials, and non-clinical testing. It explicitly states under "Clinical Testing" that "Clinical testing was not necessary to determine substantial equivalence of the Humeris Shoulder to the predicate devices." Therefore, I cannot generate the requested table and study information.

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The Humelock Reversed Shoulder is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.

The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

During primary or revision surgery, if the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or the glenoid bone fractures during the procedure, a taper adapter can be used to convert the Humelock Reversed Shoulder to an anatomic hemi-shoulder prosthesis.

The humeral stem of the Humelock Reversed Cemented Shoulder Prosthesis is intended for cemented use only. The humeral stem of the Humelock Reversed Cementless Shoulder Prosthesis is lockable with two cortical bone screws and is intended for cementless use only. An optional anti-rotation spoiler can be used with either the cementless or the cemented stems.

The glenoid baseplate and post extension are intended for cementless use with the addition of screws for fixation.

The Humelock Reversed Shoulder is a total shoulder prosthesis designed for use in patients with a non-functional rotator cuff. The articulation of this design is inverted compared to a traditional total shoulder prosthesis. The reverse shoulder is designed so that the ball of the articulation is on the glenoid side and the mating cup fits into the humeral stem. The components of the system include a glenoid baseplate, standard and locking bone screws, optional baseplate post extensions, centered and eccentric glenospheres with and without central screws, humeral cups, cementless and cemented humeral stems, optional cortical bone screws, an optional humeral spacer, an optional anti-rotation spoiler and an optional taper adapter for use in hemi-shoulder replacement.

The Humelock glenoid baseplate has a round base with a central, cannulated post and four peripheral, threaded screw holes. The outer edges of the baseplate are tapered to lock with the glenosphere component.

The glenoid baseplate is used with 4.5mm standard or locking bone screws for added stability. The bone screws are available in lengths from 20 - 50mm in 5mm increments.

Optional post extensions are available to extend the central post of the baseplate and provide additional anchoring in cases with poor bone quality. The post extensions are available in 6mm and 10mm lengths. When used, the post extensions screw into the baseplate post.

The glenoid baseplate, standard and locking screws, and post extensions are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3. The backside of the baseplate and the post extensions are coated with a plasma sprayed CP Titanium and Hydroxyapatite coating.

The Humelock Reversed Glenosphere is available in 36 and 40 mm diameter sizes in centered and eccentric styles. The eccentric glenospheres are designed to be offset from the center of the glenoid baseplate. All glenospheres have a 10° tilt. Although not physically tilted, the curvature of the glenosphere extends 10° beyond the equator of a hemisphere. This additional articular surface lateralizes the center of rotation to help reduce the potential for scapular notching by the humeral cup. All glenospheres mate with the glenoid baseplate via a taper lock; the glenosphere incorporates a female taper while the edges of the baseplate form a male taper. The glenospheres are also available with an optional central, cannulated screw. This screw can be threaded through the central post of the baseplate for additional security.

The glenospheres are manufactured from Co-Cr-Mo conforming to ISO 5832-12. The glenosphere screw is manufactured from Ti-6Al-4V conforming to ISO 5832-3.

The humeral cups are one-piece constructs consisting of a pre-assembled Ti-6Al-4V alloy shell and a UHMWPE insert. A 24mm diameter tapered post on the inferior surface of the shell locks into the female taper on the superior surface of the humeral stem. The humeral cups are available in 36mm and 40mm diameters and in standard and mobility styles. The standard cups offer a slightly deeper articular surface to provide additional constraint while the mobility cups are not as deep to provide slightly less constraint. The humeral cups are available in heights of +3mm, +6mm.

If additional height of the humeral articulation is needed, a +9mm humeral spacer can be used between the humeral stem and the humeral cup. The +9mm humeral spacer adds 9mm of height resulting in construct heights of +12mm, +15mm. The spacer has a 24mm male taper that mates with the humeral stem and a 24mm female taper that mates with the humeral cup.

The humeral cups are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and UHMWPE conforming to ISO 5834-1 and ISO 5834-2. The +9mm humeral spacers are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3.

The Humelock Reversed Shoulder includes both cemented humeral stems. The cementless humeral stems are available in diameters 8 to 16 mm. The distal end is cylindrical with a grit blasted surface and two unthreaded screw holes oriented in the medial/lateral direction. Bone screws can be used to provide additional early fixation and stability of the stem. Cortical bone screws are available in lengths from 18 - 40mm in 2mm increments. The proximal portion of the cementless humeral stem has a plasma sprayed CP Titanium and Hydroxyapatite coating.

Cemented stems are available in diameters 6 to 14 mm. The distal end of the cemented humeral stem is trapezoidal with a polished surface. The cemented humeral stems incorporate a 24mm diameter female taper for attachment of compatible components.

Both the cementless and cemented stems are compatible with an optional spoiler, which can be attached to the lateral side of the stem to provided additional resistance to rotation. The spoiler is fixed to either stem using an M6 hex screw.

The spoiler and hex screw are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3.

During primary or revision surgery, if the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or the glenoid bone fractures during the procedure, the Humelock Reversed cementless and cemented stems can be used with an eccentric taper adapter and 50, 52 or 54mm eccentric humeral heads for conversion to an anatomic shoulder hemi-arthroplasty. The taper adapter has a 24mm male taper to mate with the humeral stem and a 10mm male taper to mate with the humeral head. The taper adapter is manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3. The eccentric humeral heads are manufactured from wrought Co-Cr-Mo conforming to ISO 5832-12.

This document does not contain an acceptance criteria table or a study description as typically found in submissions for AI/ML-based medical devices. The document is a 510(k) premarket notification for a Class II medical device, the Humelock Reversed Shoulder, a type of shoulder prosthesis.

Here's why the requested information isn't available in this document:

• Device Type: This document pertains to a physical medical device (a shoulder joint prosthesis), not a software or AI/ML-based diagnostic/therapeutic tool.
• Regulatory Pathway: The 510(k) pathway for traditional medical devices primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, often through non-clinical performance testing (mechanical, biocompatibility, etc.) rather than extensive clinical studies with specific performance metrics like accuracy, sensitivity, or specificity commonly seen in AI/ML device submissions.
• Focus of Testing: The non-clinical testing described (range of motion, fatigue, torsional fatigue, pyrogenicity) evaluates the physical and mechanical integrity and safety of the implant, not its diagnostic or predictive performance.

Therefore, I cannot provide the requested information. The document explicitly states under "Clinical Testing": "Clinical testing was not necessary to determine substantial equivalence of the Humelock Reversed Shoulder to the predicate devices." This confirms that no clinical study, of the type you're asking about, was conducted or required for this particular 510(k) submission.

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The Humelock II Reversible Shoulder System is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.

The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The humeral stems are intended for cemented or cementless use. The metaglene baseplate is intended for cementless use with the addition of screws for fixation.

The Humelock II Reversible Shoulder is a total shoulder prosthesis designed for use in patients with a non-functional rotator cuff. The components of the system include a glenoid baseplate, standard and locking bone screws, optional baseplate post extensions, centered and eccentric glenospheres with and without a stabilization screw, 135/145° humeral cups, standard humeral cups and a 135/145° adaptor. These components are intended for use with the previously cleared Humelock II Cemented Humeral Stems and the Humelock II Cementless Humeral Stems. The design of the Humelock II Reversible Shoulder allows conversion from an anatomic shoulder configuration to a reverse shoulder configuration either intraoperatively or during revision of an anatomic shoulder with a well fixed humeral stem.

The glenoid baseplate, standard and locking screws, baseplate post extensions, glenosphere screws and 135/145° reverse adapters are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3. The backside of the baseplate and the post extensions are coated with a plasma sprayed CP Titanium and Hydroxylapatite coating. The glenospheres are manufactured from Co-Cr-Mo conforming to ISO 5832-12. The 135/145° Humeral Cups and standard Humeral Cups are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and UHMWPE conforming to ISO 5834-1 and ISO 5834-2.

Based on the provided text, the device described is the Humelock II Reversible Shoulder System, which is a medical implant, not an AI/software device. Therefore, the questions related to acceptance criteria, study design for AI devices, and performance metrics for AI models are not applicable to this document.

The document is a 510(k) premarket notification summary for a medical device (a shoulder prosthesis), which aims to demonstrate "substantial equivalence" to legally marketed predicate devices, rather than proving performance against specific acceptance criteria for an AI system.

However, I can extract information related to the physical device's "performance" as described in the "Non-Clinical Testing" section, which might be interpreted as "acceptance criteria" for a medical implant, and then address why other points are not applicable.

Here's a breakdown of the requested information based on the provided text, indicating where it's not applicable to this medical implant:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI/Software specific questions:

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

• Not Applicable. This is a physical medical implant device, not an AI/software product, so there is no "test set" in the context of AI model evaluation. The "tests" mentioned are non-clinical biomechanical and material tests.

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 a physical medical implant device. Ground truth, in the AI context of expert consensus, is not relevant here. The "ground truth" for the non-clinical tests would be the established engineering standards and biomechanical principles.

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

• Not Applicable. As there's no "test set" for an AI model, adjudication methods are irrelevant.

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 a physical medical implant device. MRMC studies are for evaluating diagnostic performance with or without AI assistance, which doesn't apply to a shoulder prosthesis.

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

• Not Applicable. This is a physical medical implant device. There is no algorithm or standalone AI performance to evaluate.

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

• Not Applicable in the AI context. For the non-clinical tests, the "ground truth" would be engineering specifications, material properties, and biomechanical stability benchmarks typically verified through laboratory testing against established standards.

8. The sample size for the training set

• Not Applicable. This is a physical medical implant device. There is no AI training set.

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

• Not Applicable. This is a physical medical implant device. There is no AI training set.

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PRCT2 is indicated for use in fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

The PRCT2 is a system of plates and screws intended to be used in the fixation of fractures of the humerus. PRCT2 consists of 5 components:

1. Humeral Plates
2. Diaphyseal Plates
3. Screws (Locking and Standard)
4. Trials
5. Instruments
   All implants and trials in the PRCT2 system are manufactured from medical grade titanium alloy (TA6V ELI) according to ISO 5832-3.

The device in question is a medical device for bone fixation (PRCT2, a system of plates and screws for fractures of the humerus). The provided text describes the 510(k) submission for this device. For medical devices seeking 510(k) clearance, the primary "study" is usually a demonstration of substantial equivalence to a legally marketed predicate device, often through mechanical testing, rather than clinical trials with human subjects as might be seen for AI algorithms.

Here's an analysis based on the provided text, using the requested categories. Please note that several categories related to AI performance, human readers, and ground truth in a clinical context are not applicable to this type of medical device clearance document, which focuses on mechanical performance.

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

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: Not explicitly stated for each test, but implied to be sufficient for mechanical testing according to ASTM standards. Mechanical testing typically involves multiple samples for statistical validity, but the exact number is not provided in this summary.
• Data Provenance: The testing was mechanical bench testing, not clinical data from patients. The location of the testing is not specified, but the applicant (Fx Solutions) is based in France, and the US contact is in Virginia Beach, USA.

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 document describes mechanical bench testing of a bone fixation device, not an AI algorithm that would require expert-established ground truth from clinical data.

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

• Not Applicable. Mechanical testing results are typically quantifiable and do not require expert adjudication in the same way clinical image interpretation or AI output evaluation would. The "ground truth" here is the physical measurement against an established standard.

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 a medical device (bone plate and screw system) clearance, not an AI algorithm. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• The "ground truth" for this study was defined by established engineering standards and specifications (ASTM F382-99 and ASTM F543-13) for mechanical properties of bone plates and screws. The performance of the device was compared against these standards and against a predicate device.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of mechanical bench testing for medical device clearance. This is not an AI algorithm or a statistical model that requires training data.

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

• Not Applicable. As there is no training set for this type of study, this question is not relevant.

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The Humelock II Cemented Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:

1. Proximal humeral fractures
2. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).

The humeral stem and glenoid components of the Humelock II Cemented Shoulder System are intended for cemented use only.

The Humelock II Cemented Shoulder System is a total and hemi-shoulder prosthesis consisting of a humeral stem, a humeral head, a double taper connector, and, when used for total shoulder replacement, a glenoid component.

The humeral stem is manufactured from Ti-6A1-4V alloy conforming to ISO 5832-3 and is available in diameters of 6-15mm. The humeral stem incorporates a female taper for attachment of the double taper connector, which connects to the humeral head.

The double taper connector is manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3. One size is available and is compatible with all sizes of humeral stems and humeral heads.

The humeral head is manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12 and is available in diameters of 39 - 50mm in centered and offset styles. A female taper allows attachment to the double taper connector, which connects to the humeral stem.

The glenoid component is manufactured from ultra high molecular weight polyethylene (UHMWPE) conforming to ISO 5834-2. It is available in sizes extra small, small, medium, and large. The glenoid component features two pegs for cemented fixation to the glenoid bone. Each peg contains a radiopaque marker manufactured from tantalum conforming to ASTM F560.

The current submission adds bone graft cutting and manipulating instruments and graft trials to the Humelock II Shoulder System.

Bone graft cutting and manipulating instruments and graft trials may be used to cut bone graft from the humeral head and position it around the humeral stem. The bone graft can be used to help position and consolidate the tuberosities in cases with proximal bone loss.

The provided document, K140071, describes a 510(k) premarket notification for the Humelock II Cemented Shoulder System. It explicitly states that "Clinical testing was not necessary to determine substantial equivalence between the Humelock II Cemented Shoulder System and the predicate shoulder systems."

Therefore, based on the provided document, there is no information available regarding acceptance criteria or a study proving the device meets those criteria, as no clinical testing was performed for substantial equivalence.

The document details the device's components, materials, intended use, and a comparison to predicate devices, but lacks any description of a performance study involving a test set, expert readers, ground truth, or statistical analysis.

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The Humelock II Cementless Shoulder System is indicated for use in hemi shoulder replacement for fractures of the proximal humerus. The Humelock II Cementless Humeral Stem is intended for use with two cortical screws and is intended for cementless use only.

The Humelock II Cementless Shoulder System is a hemi-shoulder prosthesis consisting of a humeral stem, a humeral head, a double taper connector, cortical bone screws and an optional protector and hex screw to prevent bone ingrowth into the threaded hole in the proximal stem.

The humeral stem is manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3. The distal end of the humeral component is cylindrical with a grit blasted surface and two unthreaded screw holes oriented in the anterior / posterior direction for fixation using bone screws.

The proximal portion of the humeral component has a plasma sprayed commercially pure Titanium (CP Ti) coating and a hydroxyapatite (HA) coating. A hole in the proximal portion of the humeral component allows attachment to instrumentation designed to provide correct positioning (height and retroversion) of the implant. The humeral stem is available in sizes 8 - 15.

The humeral stem incorporates a female taper for attachment of the double taper connector, which connects to the humeral·head.

The double taper connector is manufactured from Ti-6A1-4V allor conforming to ISO 5832-3. One size is available and is compatible with all sizes of humeral stems and humeral heads. The double taper connector has a male taper on each end and is used to connect the humeral head to the humeral stem. An impactor / extractor hole is incorporated into the proximal end of the connector.

The humeral head is manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12 and is available in diameters of 39 - 54mm in centered and offset styles. The offset of the taper allows the head to be rotated relative to the cut surface of the humerus to provide optimal coverage of the bone. A female taper allows attachment to the double taper connector, which connects to the humeral stem.

The cortical bone screws are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and are available with a diameter of 4.5mm in lengths of 18 - 40mm in 2mm increments.

The screw hole protector and hex screw are manufactured from Ti-6Al-4V alloy conforming to Ti-6Al-4V alloy conforming to ISO 5832-3.

The provided text describes the Humelock II Cementless Shoulder System, a hemi-shoulder replacement system. The document is a 510(k) summary submitted by Fx Solutions to the FDA, demonstrating substantial equivalence to predicate devices. It focuses on the mechanical testing performed to support this claim in lieu of clinical testing.

Here's the information requested based on the provided text:

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

The document does not explicitly state numerical acceptance criteria for the mechanical tests or reported device performance in a quantitative manner. It describes the types of tests conducted and their purpose.

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 mentions "Mechanical testing" was conducted. This refers to non-clinical, in-vitro laboratory testing of device components, not clinical studies involving human patients. Therefore, terms like "test set," "data provenance," "retrospective or prospective," "country of origin," and "sample size" in relation to human data are not applicable here. The "sample size" for the mechanical tests would refer to the number of physical device units or components tested, which is not specified.

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. As described above, this submission relies on non-clinical mechanical testing, not clinical data requiring expert evaluation for ground truth.

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

Not applicable. This submission relies on non-clinical mechanical testing, not clinical data requiring adjudication.

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 submission relies on non-clinical mechanical testing. There is no mention of AI or human readers.

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

Not applicable. This submission relies on non-clinical mechanical testing. There is no mention of an algorithm or AI.

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

The "ground truth" for the non-clinical mechanical testing would be the physical properties and performance observed during the tests (e.g., maximum load before failure, fatigue life, adhesion strength of coatings) as measured by calibrated equipment according to predefined test protocols and engineering standards (e.g., ISO standards mentioned for materials). There is no "expert consensus" or "pathology" in this context.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is a traditional medical device submission based on mechanical testing and substantial equivalence, not an AI/ML device requiring training data.

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

Not applicable. There is no "training set" or corresponding ground truth as this is not an AI/ML device.

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The Humelock II Cemented Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:

1. Proximal humeral fractures
2. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).
   The humeral stem and glenoid components of the Humelock II Cemented Shoulder System are intended for cemented use only.

The Humelock II Cemented Shoulder System is a total and hemi-shoulder prosthesis consisting of a humeral stern, a humeral head, a double taper connector and, when used for total shoulder replacement, a glenoid component.
The humeral stem is manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and is available in diameters of 6-15mm. The distal end of the humeral stern is cylindrical with a polished surface. The proximal portion of the humeral stem has a grit blasted surface.
The humeral stem incorporates a female taper for attachment of the double taper connector, which connects to the humeral head.
The double taper connector is manufactured from Ti-6A1-4V alloy conforming to ISO 5832-3. One size is available and is compatible with all sizes of humeral stems and humeral heads. The double taper connector has a male taper on each end is used to connect the humeral head to the humeral stem. An impactor / extractor hole is incorporated into the proximal end of the taper.
The humeral head is manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12 and is available in diameters of 39 - 54mm in centered and offset styles. The offset of the taper allows the head to be rotated relative to the cut surface of the humerus to provide optimal coverage of the bone. A female taper allows attachment to the double taper connector, which connects to the humeral stem.
The glenoid component is manufactured from ultra high molecular weight polyethylene (UHMWPE) conforming to ISO 5834-2. It is available in sizes extra small, small, medium, large and extra large. The glenoid component features two pegs for cemented fixation to the glenoid bone. Each peg contains a radiopaque marker manufactured from tantalum conforming to ASTM F560.

The provided document is a 510(k) summary for the Humelock II Cemented Shoulder System, which is a medical device for shoulder replacement. It describes the device, its intended use, and the basis for its substantial equivalence to predicate devices. However, this document does not contain information related to software or AI-based devices, and therefore, it does not include acceptance criteria for algorithm performance or a study demonstrating such performance.

The "Non-Clinical Testing" section mentions mechanical testing conducted to demonstrate the stability of the modular connection and characterization data for the UHMWPE. The "Clinical Testing" section explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the Humelock II Cemented Shoulder System and the predicate shoulder systems."

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study for an AI/software device based on the provided text. The questions are not applicable to the content of this 510(k) summary.

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The Humelock Cemented Shoulder Prosthesis is indicated for use in hemi-shoulder replacement to treat:

1. Proximal humeral fractures
2. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).
   The Humelock Cemented Shoulder Prosthesis is intended for cemented use only.

The Humelock Cemented Shoulder Prosthesis is a hemi-shoulder prosthesis consisting of a humeral stem and a humeral head.
The humeral stem is manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and is available in diameters of 6-15mm. The distal end of the humeral stem is cylindrical with a polished surface. The proximal portion of the humeral stem has a grit blasted surface.
The humeral stem incorporates a male taper for attachment of the humeral head.
The humeral head is manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12 and is available in diameters of 39 - 50mm with heights of 14 - 19mm in centered and offset styles. The offset of the taper allows the head to be rotated relative to the cut surface of the humerus to provide optimal coverage of the bone. A female taper allows attachment to the humeral stem.

The provided text describes a medical device, the Humelock Cemented Shoulder Prosthesis, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance metrics, or any studies involving a "test set" with ground truth established by experts or a multi-reader multi-case (MRMC) comparative effectiveness study.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets them from the given input.

Here's a breakdown of why the requested information cannot be extracted:

• No Acceptance Criteria or Performance Metrics: The document focuses on device description, intended use, and substantial equivalence, not on specific performance targets (e.g., accuracy, sensitivity, specificity) or any numerical results of performance.
• No "Study" in the context of performance: The "Non-Clinical Testing" section mentions "Mechanical testing was conducted to demonstrate the stability of the modular connection between the modular heads and the humeral stem." This is a mechanical engineering test, not a clinical study involving human readers, images, or ground truth.
• "Clinical Testing: Clinical testing was not necessary...": This explicitly states that clinical testing (which would typically involve test sets, experts, and ground truth) was not conducted for substantial equivalence.
• Absence of AI/Algorithm: The device is a physical prosthetic. There is no mention of an algorithm or AI component, making questions about standalone algorithm performance or human-in-the-loop performance irrelevant to this document.

In summary, the provided content is a 510(k) summary for a physical medical device (a shoulder prosthesis), which does not involve the types of studies or criteria normally associated with evaluating AI/ML-based diagnostic devices. Therefore, a table of acceptance criteria and device performance, details on test sets, expert ground truth, MRMC studies, or standalone algorithm performance cannot be extracted.

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