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Software: The Precision AI Planning Software is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder joint arthroplasty. The software is used to assist in the positioning of shoulder components by creating a 3D bone construct of the joint and allows the surgeon to visualize, measure, reconstruct, annotate and edit presurgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Precision AI Shoulder Guide and Biomodels.

Hardware: The Precision AI Planning System Guides and Biomodels are intended to be used as patient-specific surgical instruments to assist in the intraoperative positioning of shoulder implant components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans. The Glenoid Guide is used to place the k-wire and the Humeral Guide is used to place humeral pins for humeral head resection. The Precision AI Guides and Biomodels are indicated for single use only. The Precision AI Surgical Planning System is indicated for use on adult patients that have been consented for shoulder joint arthroplasty. Both humeral and glenoid guides are suitable for a delto-pectoral approach only. The Precision AI Surgical Planning System is indicated for total and reverse shoulder arthroplasty using the following implant systems and their compatible components: Enovis and Lima.

The Precision AI Surgical Planning System is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing a patient-specific guides and models to transfer the plan to surgery. The subject device is a system composed of the following: The Precision AI Surgical Planning System Software will create a 3D construct/render of the patient's shoulder joint for the surgeon to plan the operatively then create a physical Patient Specific Instrument (or Guide), using 3D printing by selective laser sintering. The patient's CT scan images are the design input for this to be created and are auto segmented via a locked, or static, artificial intelligence algorithm. The surgeon can visualise the deformity of the diseased joint, on this 3D render and CT scan images, and determine the inherent deformity of the joint. They are then able to virtually place the artificial implants in an optimal position to correct the measured deformity for that specific patient. The Precision AI Guides, which are a patient-specific guide and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patient-specific guide and models will be manufactured if the surgeon requests patient-specific guides to transfer the plan to surgery.

The provided text is an FDA 510(k) summary for the Precision AI Surgical Planning System (PAI-SPS). It describes the device and its intended use, but it does NOT contain specific acceptance criteria, detailed study designs, or performance results in terms of metrics like sensitivity, specificity, accuracy, or effect sizes for human reader improvement.

The document states that "Software verification and validation were performed, and documentation was provided following the 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.' This includes verification against defined requirements and validation against user needs." It also mentions that "Design verification and validation testing demonstrated that the PAI-SPS meets all design requirements and is as safe and effective as its predicate device (K233992)."

However, it does not explicitly lay out the acceptance criteria (e.g., "model must achieve 90% accuracy") or the results against those criteria. It focuses more on demonstrating substantial equivalence to a predicate device (PAI-SPS K233992) by showing that the technology and intended use are similar, with the main differences being the addition of compatibility with more implant systems.

Therefore, I cannot fully complete the requested table and answer all questions based solely on the provided text. I will provide information based on what is available and indicate where information is missing.

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

Based on the provided FDA 510(k) summary, the PAI-SPS device is being cleared primarily through demonstrating substantial equivalence to an already cleared predicate device (PAI-SPS, K233992). The key claim for equivalence rests on similar intended use, fundamental scientific technology, design, functionality, operating principles, and materials, with the primary difference being expanded compatibility with additional implant systems.

The document implicitly suggests that the "acceptance criteria" are tied to demonstrating that these technological differences "do not raise any different questions of safety and effectiveness." The studies cited are primarily focused on software verification and validation, ensuring the new compatible implant systems do not negatively impact the established safety and effectiveness.

Here is a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly state quantitative acceptance criteria (e.g., minimum accuracy percentages, specific error bounds) or detailed performance metrics. The performance is largely framed as demonstrating that the device "meets all design requirements and is as safe and effective as its predicate device."

2. Sample Size Used for the Test Set and Data Provenance

• The document does not specify the sample size for any test set (e.g., for software validation or hardware accuracy).
• Data Provenance: Not explicitly stated for specific test sets. Given the company is "Precision AI Pty Ltd" in Australia, and the document discusses "previous cadaver testing and composite bone model testing," it's likely a mix of lab-based/simulated data and potentially some retrospective clinical imaging data for initial AI development/testing, but this is not detailed. The document implies that new testing was not extensively conducted for this submission, relying heavily on the predicate device's prior validation and the minor changes to compatibility.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• The document does not specify the number of experts or their qualifications used to establish ground truth for any test set.
• It mentions that the software allows a "qualified surgeon" to approve pre-surgical plan data, implying that expert surgical review is part of the workflow.

4. Adjudication Method for the Test Set

• The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The focus of this 510(k) is substantial equivalence based on technological similarity and expanded compatibility, not a comparative study against human readers or performance improvement with AI assistance.

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

• The document states that the AI algorithm performs "auto segmentation via a locked, or static, artificial intelligence algorithm." While this indicates a standalone AI component, the document does not provide standalone performance metrics for this AI segmentation. The overall system is described as a "pre-surgical planner" where the surgeon can "visualize, measure, reconstruct, annotate and edit pre-surgical plan data," suggesting a human-in-the-loop workflow.

7. The Type of Ground Truth Used

• For software, the implicit ground truth appears to be expert consensus or approved surgical plans for judging the accuracy of the software's representations and planning capabilities. The document states "The software allows a qualified surgeon to visualize, measure, reconstruct, annotate, edit and approve pre-surgical plan data."
• For hardware, "previous cadaver testing and composite bone model testing" were used, implying physical measurements against a known standard or "true" position established in these models.

8. The Sample Size for the Training Set

• The document does not specify the sample size used for the training set for the AI segmentation algorithm.

9. How the Ground Truth for the Training Set was Established

• The document does not specify how the ground truth for the AI training set was established. It only mentions that the AI algorithm for auto-segmentation is "locked, or static," implying it was trained previously.

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General indications: The LINK Embrace Shoulder System - Reverse Configuration is intended for reverse total shoulder arthroplasty.

Indications: Primary, fracture, or revision total shoulder arthroplasty in a grossly rotator cuff deficient joint with severe arthropathy. A functional deltoid muscle is necessary, and the patient's joint must be anatomically suited to receive the implants.

The Reverse Glenoid Baseplate component is intended for cementless fixation with the addition of bone screws.

The Humeral Stems Standard with CaP (HX) and Short with CaP (HX) are intended for cementless fixation.

The Humeral Stems Standard without CaP (HX) and Short without CaP (HX) are intended for cementless fixation.

The Humeral Fracture Stems and Proximal Bodies are intended for cementless fixation.

The Modular Stems 75mm are intended for cemented or cementless fixation.

The Modular Stems, fully corundum blasted, are intended for cementless fixation.

The Modular Stems, fully polished, are intended for cemented fixation.

This system adds modular humeral stem components to the LINK Embrace Shoulder System – Reverse Configuration, comprised of Proximal Bodies and Modular Stems. The modular Proximal Bodies (Ti6A4V) are available in several sizes and heights. The Proximal Bodies feature a spiked surface, and m-l and a-p holes for suture fixation. The Proximal Bodies feature a proximal modular taper connection for assembly to the existing Reverse Tray components. The Proximal Bodies feature a distal modular taper connection for assembly to a modular stem.

The modular stems (Ti6Al4V) are available in different diameters and lengths as well as different surface options for cemented or cementless fixation.

The provided text is a 510(k) summary for the LINK® Embrace Shoulder System - Reverse Configuration. This document describes a medical device, specifically a shoulder prosthesis, and its substantial equivalence to previously cleared devices. It does not contain information about an AI/ML (Artificial Intelligence/Machine Learning) device or any study that proves such a device meets acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device meets them, as this information is not present in the provided text.

The document focuses on:

• Device Description: A shoulder joint replacement system, specifically an update adding modular humeral stem components.
• Indications for Use: When and for whom the device is intended.
• Comparison to Predicate Devices: Demonstrating that the new device is "substantially equivalent" to existing, legally marketed devices, primarily by comparing materials,
  sterilization, packaging, and general design principles.
• Performance Testing: Mentioning non-clinical performance tests (Range of Motion analysis, Fatigue testing with Fretting/Corrosion assessment, and post-fatigue disassembly tests)
  to show mechanical safety and performance, but these are for the physical implant, not an AI component.
• No Clinical Testing: Explicitly states that clinical performance testing was not required to demonstrate substantial equivalence for this device.

In summary, the provided text describes a conventional physical medical implant, not an AI/ML-driven device.

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The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.

The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:

• non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• . inflammatory degenerative joint disease such as rheumatoid arthritis;
• treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
• revision of a failed primary implant; in case of SMR Short Stems only if sufficient bone stock remains); .
• cuff tear arthropathy (CTA Heads only); .
• glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only). .

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator coff deficient joint with severe arthropathy (disabled shoulder). The patients joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs are intended for cemented and uncemented use as specified in the following table.

In the Anatomic shoulder the humeral consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.

The Anatomic glenoid construct consists of an all polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct. On the glenoid side, the fixation of the all polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.

The SMR 140° Reverse Humeral Bodies (SMR 140° Reverse Humeral Body, SMR 140° Short Reverse Humeral Body, SMR 140° Finned Reverse Humeral Body) are manufactured from Ti6Al4V alloy (ASTM F1472 - ISO 5832-3); they are for tapercoupling with previously cleared Humeral extension (K113523), SMR CTA Head Adaptor for Reverse Humeral Body (K131112), Reverse Liners (K110598, K142139) and Humeral stems (K100858, K101263, K111212, K191963).

This document is a 510(k) premarket notification for the SMR 140° Reverse Humeral Body, a component of a shoulder replacement system. As such, it does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria.

The document describes a medical device (SMR 140° Reverse Humeral Body for shoulder replacement) and its substantial equivalence to predicate devices, supported by non-clinical mechanical testing. It explicitly states that clinical testing was not necessary to demonstrate substantial equivalence.

Therefore, the requested information points regarding AI acceptance criteria and studies (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, ground truth type for training/test sets, and training sample size) are not applicable to this document.

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The SMR CTA Humeral Heads are intended for use with cemented and uncemented SMR humeral body - humeral stem assemblies in total or hemi- shoulder joint arthroplasty. The glenoid is intended for cemented use only. Total and hemi-shoulder replacement utilizing the CTA head is indicated for patients suffering from disability due to:

• . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• . Inflammatory degenerative joint discase such as rheumatoid arthritis;
• . Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
• . Cuff tear arthropathy.

The SMR CTA Humcral Heads (cleared via 510(k): K110847) are intended for use with a humcral body - humeral stem assembly in total or hemi-shoulder joint arthroplasty. The CTA heads are coupled with the humeral bodies by means of an adaptor taper. When used in total shoulder replacement, the SMR CTA Humeral Heads are coupled with glenoid components.

The SMR CTA Humeral Heads were cleared in K110847 for use with the humeral stems, humeral bodics, adaptor tapers and glenoid components cleared in K100858, K101263 and K113254.

This submission is to modify the labeling for the SMR CTA Humeral Heads to add the SMR Reverse Humeral Bodies, cleared via K110598, as additional compatible components. An adaptor for the reverse humeral body is being added to allow coupling between the SMR CTA Humeral Heads and the SMR Reverse humeral body. When used with the CTA Humeral Heads, the SMR Reverse Humeral Bodies are intended for anatomic shoulder replacement.

Acceptance Criteria and Device Performance Study for SMR CTA Humeral Heads

The provided document describes a 510(k) submission for a modification to the labeling of the SMR CTA Humeral Heads to include SMR Reverse Humeral Bodies as compatible components. This is a special 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a predicate device for a minor change, rather than proving primary effectiveness for a novel device. As such, the "acceptance criteria" here refer to demonstrating equivalence in critical physical characteristics, not clinical performance metrics like sensitivity or specificity.

1. Table of Acceptance Criteria and Reported Device Performance

• The taper coupling for the SMR reverse humeral bodies and liners cleared via K110598 (predicate)
• The taper coupling for the SMR CTA Humeral Heads and adaptors cleared via K110847 (predicate) | A print review was conducted. The comparisons indicate that the adaptor tapers for the coupling of the reverse humeral bodies and the CTA heads are equivalent in dimensions and tolerances to the predicates. |
  | Fretting / Corrosion Risk | The SMR CTA Humeral Head / SMR Reverse Humeral Body adaptor must not introduce new risks of fretting or corrosion compared to the predicate devices. | A review of previously conducted fretting / corrosion testing was performed. This review indicates that the SMR CTA Humeral Head / SMR Reverse Humeral Body adaptor does not introduce new risks of fretting or corrosion. |
  | Substantial Equivalence | Demonstrating that the modified SMR CTA Humeral Heads (with SMR Reverse Humeral Bodies as compatible components) are substantially equivalent to the predicate devices (SMR CTA Humeral Heads cleared in K110847 and SMR Reverse Shoulder System cleared in K110598) based on similarities in indications, intended use, design, materials, surface finishing, and method of manufacture. | Limacorporate believes that the devices are substantially equivalent based on similarities in indications, intended use, design, materials, surface finishing, method of manufacture, and the conducted print review comparing taper dimensions and tolerances. The FDA concluded that the device is substantially equivalent for the stated indications for use. |

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the traditional sense of a clinical or retrospective data set. The "test set" consisted of the design specifications (prints) for the new adaptor and the previously cleared components.
• Data Provenance: The data provenance is internal to the manufacturer (Limacorporate S.p.A.), based on their design documentation and previous testing records. It is retrospective in the sense that it relies on existing design data and prior test results. The country of origin for the manufacturing and design is Italy.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not explicitly stated as a separate team of external experts. The "ground truth" for the design specifications and testing results would have been established by the engineering and quality assurance teams at Limacorporate S.p.A. who are responsible for device design, manufacturing, and regulatory compliance.
• Qualifications of Experts: Assumed to be qualified engineers and technical personnel with expertise in orthopedic implant design, material science, mechanical testing, and regulatory requirements for medical devices. Specific experience levels are not provided in this summary.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable in a clinical context. The "adjudication" in this non-clinical submission would be the internal review and approval process by Limacorporate's technical and regulatory teams, followed by FDA's review for substantial equivalence. The print review and review of existing test data constitute the evidence presented for this "adjudication."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was done. Clinical testing was explicitly stated as "not necessary to demonstrate substantial equivalence" for this specific modification. This is common for special 510(k)s where changes are minor and do not impact clinical performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No standalone study was done. This is not an AI or algorithm-based device, but a mechanical orthopedic implant. Therefore, "standalone performance" in the context of an algorithm is not relevant. The performance evaluated was solely on the physical compatibility and predicted mechanical integrity of the component interface.

7. Type of Ground Truth Used

• The "ground truth" for this submission was based on engineering specifications and established mechanical testing protocols.
  • For taper dimensions and tolerances: ground truth was the validated design prints and specifications for each component.
  • For fretting/corrosion risk: ground truth was established by previously conducted and validated fretting/corrosion testing results from the predicate devices.

8. Sample Size for the Training Set

• Not applicable. This device is a mechanical implant, not a software algorithm that requires a "training set" in the machine learning sense. The engineering design and manufacturing processes are developed based on established biomechanical principles and material science, not statistical training data.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As a mechanical device, there is no "training set" or "ground truth for a training set" as would be found in AI/ML applications. The design and validation are based on engineering standards, material properties, and mechanical test results.

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The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy. 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 components are intended for use in cemented and uncemented applications, as specified in the following table:

The SMR Reverse Shoulder System consists of a humeral stem, a reverse humeral body, a reverse liner, a metal-back glenoid, a glenosphere and a connector with screw. Bone screws are used for the fixation of the metal-back glenoid to the scapula. Humeral stems are provided for both cemented (cleared via 510(k): K100858) and cementless (cleared via 510(k): K101263) fixation as well as reverse humeral bodies (object of this submission). The SMR Reverse Shoulder System metal back glenoids and glenospheres are intended for uncemented press-fit use only with the addition of screws for fixation. Two designs of humeral stems are available: the first one (cleared via 510(k): K100858) is intended for cemented use only while the second one (cleared via 510(k): K101263) is intended for uncemented use. The stems are provided with a male Morse taper to allow coupling with the reverse humeral bodies. All reverse humeral bodies for SMR Reverse Shoulder Systems are made from Ti6Al4V (ASTM F1472 - ISO 5832-3). They are intended to be coupled by means of a Morse taper with the humeral stem; further stabilization is achieved with a screw that joins the humeral body to the stem. SMR reverse humeral bodies have a fixed cervico-diaphyseal angle of 150° to provide the correct varus-valgus alignment of the joint. The humeral body has a female taper for coupling with the reverse liner. Two versions of the SMR reverse liners are available: standard (available in Standard and Short sizes) and finned for trauma applications (fins with holes for tuberosities reconstruction provided). Reverse liners are made from standard ultra-high molecular weight polycthylene (ASTM F648 - ISO 5834-2); they are coupled via the internal tapcr of the reverse humeral bodies. Two designs of reverse liners are available: standard and retentive (characterized by deeper spherical concavity, higher lateral rim to provide a larger articulating surface and greater congruency between the liner and the glenosphere than the standard liners). Three thicknesses are available: STD, +3mm and +6mm. As reported for standard liners, the choice of the thickness is made by the surgeon to ensure the appropriate tension and prevent laxity in the joint. Metal-backed glenoids are made from Ti6Al4V (ASTM F1472 - ISO 5832-3). The surface of the metal-backed glenoid which comes in contact with bone is coated with Ti plasma spray coating. These devices are intended to be press-fitted into a hole drilled into the glenoid cavity during surgery; the peg surface has several wings to aid in fixation. Metal backed glenoids are available in four sizes (small-R, Small, Standard and Large). The plate has curved surfaces to adapt to the spherical shape of the glenoid cavity. The plate is provided with holes to allow the insertion of screws to fix the device in the glenoid cavity: Small-R, Small and Standard glenoids have two holes while the Large size has four holes. Glenospheres are made from CoCrMo alloy that conforms to ASTM F1537 - ISO 5832-12. Two different designs are available: a standard glenosphere that can be centered with respect to the glenoid component or eccentrical glenosphere to provide offset. Both designs have a spherical shape of 36mm diameter and articulate with the standard UHMWPE liners of the humeral body. Glenospheres are intended to be coupled to the metal-back glenoid through the use of a connector manufactured of Ti6Al4V (ASTM F1472 - ISO 5832-3). It incorporates a double male taper: one side is connected to the glenosphere while the other is coupled with the glenoid component. To increase the solidity of the system, a screw is used to link the glenosphere to the glenoid component. The screw is inserted through a hole on the surface of the glenosphere, passing through the internal cavity of the connector and then screwed to the metal-backed liner. Two types of connectors are used depending on the metal backed glenoid component: Small-STD and Small-R.

This document describes the SMR Reverse Shoulder System, a medical device for shoulder replacement. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML-based medical device.

The provided text is a 510(k) premarket notification summary for a physical medical device (a shoulder implant system). It focuses on:

• Device Description: The components and materials of the SMR Reverse Shoulder System.
• Intended Use: The medical conditions and patient types for which the device is indicated.
• Predicate Devices: Other similar devices already on the market that establish substantial equivalence.
• Non-Clinical Testing: Mechanical and wear testing performed on the physical components (e.g., fatigue strength, wear of liners and glenospheres). This testing is to ensure the physical components meet performance requirements, not an AI algorithm.
• Clinical Testing: Explicitly states, "Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Reverse Shoulder System to the predicate device(s)."

Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device from this document. The document pertains to a traditional orthopedic implant, not an AI-powered diagnostic or assistive tool.

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