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Hardware: The BLUEPRINT™ Glenoid Guides are patient-specific drill guides. They have been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.

Software: Blueprint® is a medical device for surgeons. Blueprint® is intended to be used as a pre-surgical planner for shoulder replacement surgery. Blueprint® requires CT scan images showing the anatomical shoulder structure in a DICOM format. Blueprint® allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. Blueprint® allows surgeons to design patient specific instruments and Tornier Perform patient-matched primary reversed glenoid*) based on the pre-surgical plan. Blueprint® leads to the generation of a planning report. Blueprint® is to be used for adult men and women patients only whose bone maturity is reached and should not be used for diagnostic purpose.

BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and Blueprint® (software).

Hardware: The BLUEPRINT ™ Glenoid Guides are patient-specific instruments specially designed to facilitate the implantation of glenoid prostheses. The BLUEPRINT™ Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software Blueprint®.

Software: Blueprint® is a software connected to an Online Management System (OMS). The user interface software is installed on a computer is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (anatomic and reversed). It is intended to help to plan an operation by allowing surgeons to: Plan for shoulder arthroplasty cases, Position and select glenoid and humeral implants, Simulate the prosthetic range of motion, Interact with implants and different computed measurements, Generate information required to design a patient-specific glenoid components when appropriate.

The provided text is a 510(k) premarket notification for the BLUEPRINT™ Patient Specific Instrumentation, which includes both hardware (Glenoid Guides) and software (Blueprint®). While it describes the device, its intended use, and comparison to predicate devices, it does not contain the detailed performance data or acceptance criteria typically found in a study report.

Therefore, I cannot provide the requested information regarding specific acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC study details. The document states that "Technological differences between the subject and predicate software devices are supported by software verification and validation activities. These activities include functional tests, validation and compatibility for new implant integration, as well as the validation and reproducibility of anatomical measures, planning measures, planning features, and segmentation." However, it does not present the results or specific criteria of these activities.

In the absence of a detailed study report within the provided text, I can only state that the document asserts that:

• Differences in design specifications do not raise different questions of safety and effectiveness over the predicate device as demonstrated in validation testing.
• The subject device, the BLUEPRINT™ Patient Specific Instrumentation, does not raise new questions of safety or effectiveness.
• Differences in technological characteristics have been addressed by software verification and validation activities.

To answer your request, a more detailed study report or validation protocol would be necessary.

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Blueprint® Mixed Reality system is indicated for use during Total Shoulder Arthroplasty using Stryker's FDA cleared implants that are also implants cleared for pre-operative planning with the Blueprint® Software. Blueprint® Mixed Reality system is intended to allow surgeons to visualize the Blueprint® 3D preoperative planning intra-operatively. Blueprint® Mixed Reality system is also indicated for stereotaxic surgery to guide the placement of a glenoid pin provided that registration between the patient's anatomical landmarks / surfaces can be established on the preoperative CT based plan. Blueprint® Mixed Reality system is to be only used for skeletally matured adult patients.

The Blueprint® Mixed Reality system is used to intraoperatively display stereoscopic threedimensional images of the Blueprint shoulder arthroplasty preoperative plan and to guide and enable the insertion of a pin following the reaming axis aimed at preparing the glenoid fossa surface to facilitate the placement of the implant. The Blueprint Mixed Reality system allows the user to both see the patient in real-time and their internal boney anatomy displayed on seethrough screens of a head-mounted device (goggles).

The Blueprint Mixed Reality system assists surgeons in visualizing stereoscopic threedimensional images of the patient's boney anatomy and intraoperatively aid by guiding the pin during placement through real-time feedback.

The Blueprint Mixed Reality system is composed of three main components including the HOLOBLUEPRINT software, Microsoft® HoloLens 2 Goggles, and Instrumentation.

The Blueprint Mixed Reality system runs the HOLOBLUEPRINT software application on the Microsoft HoloLens 2 using Microsoft Windows Holographic Operating System. The Blueprint Mixed Reality system leverages the reference device by receiving planned glenoid cases as input for visualizing and guiding the placement of the pin during the shoulder arthroplasty procedure. The digital components of the system interface with specialized surgical instrumentation to enable intra-operative guidance through real-time feedback to the surgeon.

The components of the subject device are as follows:

HOLOBLUEPRINT™ Software
HOLOBLUEPRINT is designed and written by Tornier SAS specifically for use on the Microsoft HoloLens 2 goggles (hardware). The HOLOBLUEPRINT software is to be installed on the hardware to be used by the surgeon as part of the Blueprint Mixed Reality system.

HoloLens 2 goggles (HoloLens 2)
The HoloLens 2 is a Microsoft hardware that runs Microsoft Windows 10 Holographic Operating System. HoloLens 2 is a see-through, mixed reality headmounted smart glasses.

Instrumentations (Instruments)
There are four reusable instruments and one single-use (sterile) instrument designed specifically for use with the Blueprint Mixed Reality system (subject device). The subject device system instruments include a Glenoid Pin Guide, Glenoid Digitizer, Instruments Check Block, Coracoid Clamp, and a Depth Stop Pin (Sterile).

The subject device is compatible with all Tornier (Stryker) commercially FDA-cleared glenoid implants (Except Patient Matched Implants) available in the reference device (K211359). The compatibility of implants with the reference device was validated and verification was performed for glenoid guidance and visualization of the patient's boney anatomy.

The provided document is a 510(k) premarket notification for the Blueprint Mixed Reality system. It describes the device's indications for use, technological characteristics, and non-clinical performance evidence to demonstrate substantial equivalence to a predicate device.

Based on the content, here's a description of the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily focused on the accuracy and repeatability of the system, and that the software performs as per requirements and specifications. The document states that the system was validated through cadaver testing to demonstrate its accuracy and establish performance equivalency to the predicate device.

Study Details:

1. Sample Size and Data Provenance:

   • Test Set Sample Size: The document mentions "cadaver testing" and "simulated use cases" for validation. It does not specify the numerical sample size (e.g., number of cadavers or simulated cases) used for the test set.
   • Data Provenance: The document does not explicitly state the country of origin of the data. The company is based in France, but the testing locations are not specified. The studies were non-clinical, involving cadavers and simulated use. It is a prospective study in the sense that the testing was performed specifically to evaluate this device.

2. Number of Experts and Qualifications:

   • The document does not provide details on the number of experts used or their specific qualifications (e.g., "radiologist with 10 years of experience") for establishing ground truth or evaluating performance. The testing involved "cadaver testing" and "simulated use cases," implying technical personnel or surgeons would be involved in assessing accuracy, but their roles and expertise are not elaborated upon.

3. Adjudication Method for the Test Set:

   • The document does not specify an adjudication method (e.g., 2+1, 3+1) for the test set. Given it's a technical accuracy and performance study on a medical device system, it's more likely that technical measurements and predefined tolerance limits were used for "ground truth" rather than subjective expert consensus requiring adjudication.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not explicitly done. The document states, "Clinical testing was not deemed necessary for the determination of substantial equivalence." The evaluation was based on non-clinical performance evidence (bench testing, system accuracy validation through cadaver testing, functional and performance testing, software verification/validation). Therefore, there is no reported effect size of how much human readers improve with AI vs. without AI assistance.

5. Standalone (Algorithm Only) Performance:

   • Yes, a form of standalone performance was assessed. The "Bench Testing conducted to demonstrate the HOLOBLUEPRINT™ software performs as per the systems requirements and specifications" can be considered an assessment of the algorithm's performance in isolation from the full human-in-the-loop use case, focusing on its computational accuracy and adherence to specifications. The "System Accuracy Validation... through cadaver testing" also evaluates the system's (including the software) ability to provide accurate guidance measurements, independent of a specific surgeon's subjective interpretation (though a surgeon would utilize the output).

6. Type of Ground Truth Used:

   • The ground truth for the accuracy studies (cadaver testing) would likely be established through highly precise measurements using a gold-standard reference system (e.g., coordinate measuring machine, highly accurate optical tracking system, or direct physical measurements) to verify the device's reported position and orientation accuracy against the true anatomical features. For software performance, the ground truth would be defined by the pre-defined system requirements and specifications.

7. Training Set Sample Size:

   • This document describes the validation of a medical device system, not specifically a machine learning model where a distinct "training set" for an AI algorithm would be relevant. While the system incorporates "HOLOBLUEPRINT™ Software," the text does not indicate that this software is an adaptive AI model requiring a separate training phase with a specific data set size. Therefore, no sample size for a training set is provided or implied.

8. How Ground Truth for Training Set was Established:

   • Given that the document does not describe the use of an adaptive AI model with a training set, the concept of establishing ground truth for a training set is not applicable here. The software validation is against pre-defined specifications and requirements, not against an annotated training dataset for learning.

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The Tornier Pyrocarbon Humeral Head associated with the Tornier Flex Stem is indicated for use as a replacement of deficient humeral heads disabled by:

• Non-inflammatory degenerative joint diseases (osteoarthritis, avascular necrosis) .
• . Traumatic arthritis.

The Tornier Pyrocarbon Humeral Head Shoulder Prosthesis, combined with the Tornier Flex Humeral Stem, are to be used only in patients with an intact or reconstructable rotator cuff and if the native glenoid surface is intact or sufficient, where they are intended to increase mobility, stability, and relieve pain.

Note: The coated humeral stem is intended for cementless use. The noncoated humeral stem is for cemented use only

The Tornier Pyrocarbon Humeral Head is a prescription use device that is comprised of the pyrolytic carbon (pyrocarbon) articulating surface and a cobalt chromium alloy double taper neck. The humeral head is provided pre-assembled to the double taper to the end user and is compacted onto 510(k) cleared compatible humeral stems (K151293) for replacement of deficient humeral heads disabled by noninflammatory arthritis, or traumatic arthritis. The pyrocarbon articulating surface is made of a graphite substrate core, coated with a layer of pyrolytic carbon deposited onto the substrate via chemical vapor deposition. The pvrocarbon articulating surface is pressed into the cobalt chromium alloy double taper neck during the manufacturing process, is provided as a singular construct to the end user, and is not intended to be disassembled by the end user. Compatible monoblock humeral stems are available in titanium plasma spray coated or uncoated versions. The humeral stems are designed with a female taper connection to accept the mating male taper connection of the pyrocarbon humeral heads.

The provided text describes the acceptance criteria and a clinical study that proves the Tornier Pyrocarbon Humeral Head device meets these criteria. However, it does not detail a study involving AI or human readers for diagnostic image analysis. Instead, the "study" referenced is a clinical trial evaluating the safety and effectiveness of a medical implant.

Therefore, many of the requested points related to AI model evaluation, such as "number of experts used to establish ground truth," "adjudication method," and "MRMC comparative effectiveness study," are not applicable to this document's content.

I will provide the information that is available in the document regarding the acceptance criteria and the clinical study of the implant.

Acceptance Criteria and Device Performance for Tornier Pyrocarbon Humeral Head (Hemiarthroplasty Implant)

The acceptance criteria for this medical device are primarily defined through bench testing (non-clinical performance) and clinical study endpoints (safety and effectiveness in patients).

1. Table of Acceptance Criteria and Reported Device Performance

A. Bench Testing (Non-Clinical Mechanical Performance)

B. Clinical Performance (Primary Endpoint for Clinical Success at 24 Months)

1. Change in Constant score is ≥ 17;
2. No revision surgery;
3. No radiographic evidence of system disassembly or fracture;
4. No system-related serious adverse event. | Composite Clinical Success (CCS):

• Intent to Treat (ITT): 82.7%
• Per Protocol (PP): 87.9%

Component Success Rates:

• Free of Revision: 98.1% (154/157)
• Constant Score improved 17+ points (among those with evaluable scores): 84.6% (121/143)
• Free of disassembly or fracture: 100.0% (157/157)
• Free of device related SAE: 96.8% (152/157) | Composite Clinical Success (CCS):
• Intent to Treat (ITT): 66.8%
• Per Protocol (PP): 63.1%

Component Success Rates:

• Free of Revision: 94.7% (160/169)
• Constant Score improved 17+ points (among those with evaluable scores): 73.1% (49/67)
• Free of disassembly or fracture: 100.0% (169/169)
• Free of device related SAE: 94.7% (160/169) |

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

• Sample Size (Test Set):
  • Pyrocarbon (Investigational) Group: 157 subjects enrolled.
  • Control Group: 169 subjects selected after Propensity Score (PS) matching from a historical dataset.
• Data Provenance:
  • Pyrocarbon Group: Prospective, multi-center, single-arm investigational study (IDE G140202 - Pyrocarbon IDE Study). Data collected from 18 sites within the US.
  • Control Group: Retrospective, derived from the Aequalis Post-Market Outcomes Study dataset. The exact country of origin for the Aequalis dataset is not explicitly stated, but given context with US-based clinical trials, it is likely also primarily US data or from similar western healthcare systems.

3. Number of Experts and Qualifications for Ground Truth

This question is not applicable as the document describes a clinical trial for a medical implant, not an AI model requiring human expert labeling of data. The "ground truth" for the clinical study is the patient's actual clinical outcome, measured through direct observation (e.g., revision surgery, radiographic findings) and patient-reported outcomes (e.g., Constant score changes).

4. Adjudication Method for the Test Set

This question is not applicable in the context of diagnostic performance evaluation for an AI model. For the clinical study of the implant:

• The primary endpoint was a composite outcome, objectively defined.
• "Unanticipated Adverse Device Effects" were determined by an independent medical monitor.
• Clinical data collection and evaluation would have followed standard clinical trial protocols, typically involving investigators at sites and a data monitoring committee. Explicit "adjudication" in the sense of resolving disagreements among multiple human readers of image data is not relevant here.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specific to evaluating the diagnostic performance of AI or other tools when used by human readers (e.g., radiologists interpreting images). The study described is a clinical trial comparing a new implant to a historical control.

6. If a Standalone (Algorithm Only) Performance Study was done

No, this question is not applicable as the document is about a physical medical implant, not an AI algorithm. Its "standalone performance" is demonstrated through bench testing (mechanical performance, biocompatibility, sterility) rather than diagnostic accuracy.

7. The Type of Ground Truth Used

For the clinical study:

• Clinical Outcomes Data: This includes hard endpoints such as occurrence of revision surgery, radiographic evidence of system disassembly or fracture, and presence of system-related serious adverse events.
• Patient-Reported Outcomes (PROs): These are quantitative measures of patient experience and function, such as the Constant score, ASES score, SANE, EQ-5D, and VAS pain scale. Improvement in these scores contributes to the definition of "success."

For the bench testing:

• Direct Measurement/Observation: Mechanical properties are empirically measured (e.g., force to cause disassembly, visual inspection for cracks, measured ROM).
• Comparative Data: For some tests without absolute acceptance criteria (e.g., taper disassembly, fretting/corrosion, third-body wear), performance was compared to another cleared humeral head with the same intended use.

8. The Sample Size for the Training Set

This question is not applicable as the document describes a physical medical device (implant) and its clinical evaluation, not an AI model that requires a "training set" of data in the machine learning sense. The "training" for this device would refer to its manufacturing process and quality control, and the "data" is the clinical and bench testing data.

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

This question is not applicable for the reasons stated above.

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Hardware: The BLUEPRINT™ Glenoid Guides are patient-specific drill guides. They have been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.

Software: BLUEPRINT™ 3D Planning Software is a medical device for surgeons. BLUEPRINT™ 3D Planning Software is intended to be used as a pre-surgical planner for shoulder orthopedic surgery. BLUEPRINT™ 3D Planning Software requires CT scan images showing the anatomical shoulder structure in a DICOM format. BLUEPRINT™ 3D Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. BLUEPRINT™ 3D Planning Software allows surgeons to design patient specific guides based on the pre-surgical plan. BLUEPRINT™ 3D Planning Software leads to the generation of a planning report. BLUEPRINT™ 3D Planning Software is to be used for adult men and women only whose bone maturity is reached and should not be used for diagnostic purpose.

BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and BLUEPRINT™ 3D Planning Software (software).

Hardware: The BLUEPRINT IM Glenoid Guides are patient-specific instruments specially designed to facilitate the implantation of WRIGHT-TORNIER glenoid prostheses. The BLUEPRINT™ Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software BLUEPRINT™ 3D Planning Software.

Software: BLUEPRINT™ 3D Planning Software is a software connected to an Online Management System (OMS). The user interface software is installed on a computer is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (anatomic and reversed). It is intended to help to plan an operation by allowing surgeons to: Plan for shoulder arthroplasty cases, Position and select glenoid and humeral implants, Simulate the prosthetic range of motion, Interact with implants and different computed measurements, Design a patient specific guide for the glenoid component when appropriate.

The provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to Tornier SAS, indicating clearance for their BLUEPRINT™ Patient Specific Instrumentation.

It describes the device, its intended use, comparison to predicate devices, and a general statement about performance data and verification/validation testing. However, it does not detail:

1. Specific acceptance criteria values.
2. Reported device performance metrics.
3. Sample sizes for test or training sets.
4. Data provenance.
5. Number or qualifications of experts.
6. Adjudication methods.
7. MRMC study results or effect sizes.
8. Standalone algorithm performance.
9. Type of ground truth or how it was established for training/test sets.

The text states: "Technological differences between the subject and predicate software devices are supported with verification and validation evaluations. The operating principle of the subject device is the same as that of the predicate device." and "The differences in design specifications do not raise new questions of safety and effectiveness over the predicate device as demonstrated in validation testing." These are general statements about the testing performed, but no specific study details are provided.

Therefore, I cannot fulfill your request for the detailed table and study information based solely on the provided text.

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IN ANATOMIC:
The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.

The Aequalis Ascend Flex Shoulder System is to be used only in patients with an intact or reconstructable rotator ouff. where it is intended to provide increased mobility and to relieve pain. The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints disabled by:

• Rheumatoid arthritis with pain
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of other devices if sufficient bone stock remains

IN REVERSE:
The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

• Rheumatoid arthritis
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of the devices if sufficient bone stock remains.

The reversed adapter is indicated for use as components of the Aequalis Ascend Flex Shoulder System total shoulder replacement and for transformation of the Aequalis Ascend Flex Shoulder System into reverse shoulder prosthesis without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The components are permitted to be used in the transformation from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthropathy is associated with a massive and non-repairable rotator cuff-tear.

The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear.

The Aequalis Reversed Shoulder System is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthroplasty. It is a semi-constrained system composed of a humeral and a glenoid parts.

The Aequalis Ascend Flex Shoulder System consists of:

• In an Anatomic configuration: a titanium humeral stem offered in Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a compatible humeral head (CoCr) with a compatible UHMWPE Aequalis glenoid; or UHMWPE Affiniti Anatomic glenoid. The Aequalis Ascend Flex Shoulder System stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid, as a total shoulder joint replacement.
• In a Reversed configuration: a titanium humeral stem offered in Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a reversed adapter with compatible Aequalis Reversed glenoid implants. The reversed adapter is comprised of two components: a titanium tray and a UHMWPE reversed insert. The Aequalis Reversed glenoid implants is comprised of four components: Baseplate: made from Titanium; Glenoid sphere: made from of CoCr; Screw (baseplate/to glenoid sphere): made from CoCr and Fixation screws: made from Titanium.

This submission corresponds to the addition of 135° & 140° reversed final angle combinations and the Inlay technique, in addition to the existing 145° angle without any change in the implants design.

This FDA 510(k) summary describes a modification to an existing device, the Aequalis™ Ascend™ Flex Shoulder System. The submission adds new reversed final angle combinations (135° & 140°) and an "Inlay" surgical technique to the existing system. The document explicitly states that clinical studies were not required to demonstrate substantial equivalence, relying instead on non-clinical performance testing. Therefore, the information typically requested about acceptance criteria, study design, and performance metrics for a clinical study is not available in these documents.

Here's a breakdown of the available information based on your request, with explicit notes about what is not provided due to the nature of this 510(k):

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

• No specific acceptance criteria or reported device performance metrics from a clinical study are provided.
• The document states that "Non-clinical bench testing and process validations were performed to demonstrate substantial equivalence... Fatigue test in anatomic and reversed configuration." This implies that the acceptance criteria would be related to mechanical properties (e.g., fatigue strength) and met by the test results, but the specific criteria and performance values are not detailed in this summary.

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

• Not applicable. Since clinical studies were not performed, there is no "test set" in the context of human subjects or patient data.
• For the non-clinical bench testing (fatigue testing), the sample size of the devices tested is not specified. The data provenance would be laboratory testing.

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

• Not applicable. No clinical ground truth was established from a patient test set for this 510(k) submission.

4. Adjudication method for the test set

• Not applicable. No clinical ground truth was established from a patient test set, so no adjudication method was employed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a shoulder prosthesis, not an AI-assisted diagnostic or imaging device. No MRMC study was performed.

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

• Not applicable. This device is a medical implant, not an algorithm, and does not have a "standalone" or "human-in-the-loop" performance in the context of AI.

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

• Not applicable for a clinical ground truth. The "ground truth" for this submission refers to the established safety and effectiveness of the predicate device, which the modified device is compared against. The primary "ground truth" for the new configurations is the demonstration through non-clinical bench testing that they perform equivalently to the predicate.

8. The sample size for the training set

• Not applicable. Since clinical studies were not performed, there is no "training set" in the context of patient data.

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

• Not applicable. As above, no clinical training set was used.

Summary of the study that proves the device meets acceptance criteria (Non-clinical context):

The device (Aequalis™ Ascend™ Flex Shoulder System with new 135° & 140° reversed final angle combinations and Inlay technique) achieves substantial equivalence to its predicate device (Aequalis™ Ascend™ Flex Shoulder System, K122698, K151293) based on non-clinical bench testing.

• Nature of the study: The study involved fatigue testing in both anatomic and reversed configurations.
• Rationale: The submission states, "The new combinations do not raise new issues of safety or effectiveness and are supported by performance testing." It further emphasizes, "The subject device has the same design of implants, the same materials, the same manufacturing principle, the same method of fixation, the same packaging and the same sterilization process as the predicate device."
• Conclusion: The results of the performance testing (specifically, fatigue testing) for the new angle combinations "support substantial equivalence to the current Aequalis Ascend Flex Shoulder System (K122698, K151293)."

Essentially, the "study" was a series of mechanical tests to confirm that the new configurations did not compromise the established mechanical integrity and performance of the existing, cleared device. The specific parameters and results of these fatigue tests are not disclosed in this public 510(k) summary, but the FDA's clearance indicates that these tests were sufficient to demonstrate substantial equivalence.

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Hardware: The BLUEPRINT™ Glenoid Guides are patient-specific drill guides. They have been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.

Software: BLUEPRINT™ 3D Planning Software is a medical device for surgeon composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery. BLUEPRINT™ 3D Planning Software runs on standard personal and business computers running Microsoft Windows or Mac OS operating systems. The software supports DICOM standard to import the CT scan (Computed Tomography) images of the patient. Only CT scan modality can be loaded with BLUEPRINT™ 3D Planning Software. BLUEPRINT™ 3D Planning Software allows surgeon to visualize, measure, reconstruct, annotate and edit anatomic data. It allows surgeon to design glenoid patient-specific guides based on the pre-surgical plan. The software leads to the generation of a surgery report along with a 3D file of the glenoid patient-specific guide. BLUEPRINT™ 3D Planning Software does not include any system to manufacture the glenoid patient-specific guide. BLUEPRINT™ 3D Planning Software is to be used for adult patients only and should not be used for diagnostic purpose.

BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and BLUEPRINT™ 3D Planning Software (software).

Hardware: The BLUEPRINT™ Glenoid Guides are patient-specially designed to facilitate the implantation of WRIGHT-TORNIER glenoid prostheses. The BLUEPRINT™ Glenoid Guides are designed and manufactured based on a pre-operative plan generated by the BLUEPRINTTM 3D Planning Software. All BLUEPRINT™ Glenoid Guides are patient-specific, single use and delivered non-sterile.

Software: BLUEPRINT™ 3D Planning Software is composed of one software component connected to an Online Management System (OMS). The software installed on a computer is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (anatomic and reversed). It is intended to help plan an operation by allowing surgeons to: Position and select glenoid implant, Position and select humeral implant, Display bone density and reaming surface, Simulate the prosthetic range of motion, Design a patient specific guide for the glenoid component.

The provided document is a 510(k) summary for the BLUEPRINT™ Patient Specific Instrumentation (K162800). It describes a medical device system composed of software (BLUEPRINT™ 3D Planning Software) and hardware (BLUEPRINT™ Glenoid Guides) used for pre-surgical planning and intraoperative guidance in shoulder arthroplasty procedures.

However, this document does not contain the specific details required to fully address all points in your request. It refers to previous 510(k) clearances (K143374 and K160555) for validation of the device, but it does not reproduce the detailed acceptance criteria and study results within this summary.

Based on the information available in this document, here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

This document does not explicitly state specific acceptance criteria (e.g., accuracy thresholds for guide placement) or detailed performance results in a table format. It broadly states that "The validation of BLUEPRINT™ Patient Specific Instrumentation (Subject Device System) was already proven via BLUEPRINT™ Patient Specific Instrumentation (K143374) and BLUEPRINT™ Patient Specific Instrumentation (K160555), including polyamide and titanium materials... The performed testing for validation of the design, manufacturing, biocompatibility, sterility, dimensions and the accuracy of the guide are applicable to the subject device."

To obtain this information, one would need to access the full 510(k) submissions for K143374 and K160555.

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

This document does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It refers to previous validations but does not provide details about those studies.

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

This information is not present in the provided document.

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

This information is not present in the provided document.

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:

This document does not mention an MRMC comparative effectiveness study or any effect size related to human reader improvement with/without AI assistance. The software is described as a pre-surgical planner to assist surgeons, implying it's a tool, but not explicitly tested in an MRMC setting for diagnostic performance comparison.

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

The document describes the software as a "pre-surgical planner" and the guides as assisting in "intraoperative positioning." This implies a human-in-the-loop scenario where the software aids the surgeon. It does not describe a standalone algorithm performance study.

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

This document does not specify the type of ground truth used for validation. It refers to "accuracy of the guide" being validated, which suggests comparison to a known standard, but the nature of that standard (e.g., CMM measurements, post-operative CT) is not detailed.

8. The sample size for the training set:

This document does not mention any training set size as it concerns the validation of an already proven system. If the AI component (the 3D Planning Software) involved machine learning, this information would typically be in its original clearance or a more detailed technical document.

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

As no training set is mentioned in this document, this information is not available.

In summary:

This 510(k) summary focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed technical report of a new primary clinical validation study with all the requested specifics. To get the requested information, one would need to consult the original 510(k) submissions for K143374 and K160555, as these are the documents indicated as containing the previous validation data.

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The hardware: The Aequalis Glenoid Guides are patient-specific drill guides. They have been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT-scans. Aequalis PerFORM Anatomic Glenoid Guide is used by surgeons to facilitate the placement of the Aequalis PerFORM glenoids and the Aequalis PerFORM + glenoids.

The software: The BLUEPRINT 3D planning software is a medical device for surgeon composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery. BLUEPRINT 3D planning software runs on standard personal and business computers running Microsoft Windows or Mac OS operating systems. The software supports DICOM standard to import the CT-Scan (Computed Tomography) images of the patient. Only CT-Scan modality can be loaded with BLUEPRINT3D planning software. BLUEPRINT 3D planning software allows surgeon to visualize, measure, reconstruct, and annotate anatomic data. It allows surgeon to design patient specific guides based on the presurgical plan. This device is intended for use provided anatomic reference points necessary for positioning of the guide are present on the CT scan. The software leads to the generation of a surgery report along with a 3D file of the patient-specific guide. BLUEPRINT 3D planning software does not include any system to manufacture the guide. BLUEPRINT 3D planning software is to be used for adult patients only and should not be used for Diagnostic purpose.

BLUEPRINT™ Patient Specific Instrumentation is composed of two components: Aequalis Glenoid Guides (hardware) and BLUEPRINT 3D planning software (software). BLUEPRINT™ Patient Specific Instrumentation which includes the Aequalis Glenoid Guides and BLUEPRINT 3D planning software is the responsibility of Tornier is the legal manufacturer for the hardware and the software.

The hardware: The Aequalis Glenoid Guides are patient-specific instruments specially designed to facilitate the implantation of the Aequalis PerFORM shoulder prostheses and the Aequalis PerFORM + shoulder prostheses. The Aequalis Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software BLUEPRINT™ 3D planning software.

The software: BluePrint 3D Planning software is composed of one software component connected to an Online Management System (OMS). The software installed on a computer is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (= total anatomic shoulder replacement). It is intended to help -plan an operation by allowing surgeons to: - position and select the glenoid implant, - design a patient specific pin guide.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set in the "Compare post-operative clinical data with pre-operative plans" study. It also does not specify the country of origin of the data or whether it was retrospective or prospective.

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 used or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

The document does not describe the adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The studies mentioned focus on the device's compatibility and accuracy rather than comparing human reader performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document describes the "BLUEPRINT 3D planning software" as a "medical device for surgeon composed of one software component" intended to "assist in pre-operative surgical planning." This implies a human-in-the-loop scenario, where the software assists the surgeon. The study to "Perform tests of software features when the Aequalis PerFORM+ is selected" verifies the software's functionality and display, which seems to be a standalone test of the algorithm's output within the software environment. However, it's not a standalone performance study in the sense of the algorithm diagnosing or acting without human interpretation or intervention for clinical outcomes.

The "Compare post-operative clinical data with pre-operative plans" study indirectly assesses the software's effectiveness when used by surgeons, but it's still about the overall patient-specific solution, including the guide.

7. The Type of Ground Truth Used

For the study "Compare post-operative clinical data with pre-operative plans to verify the accuracy of the patient-specific solution in Aequalis PerFORM+ configuration", the ground truth is derived from post-operative clinical data, specifically assessing the "correct positioning of the main pin." This suggests an objective measurement from actual surgical outcomes.

For the other two validation methods, "technical, biological, and clinical equivalences" and "no dysfunction of the software features," the ground truth would be based on predefined technical specifications, biological assessments, and functional requirements of the software, as well as presumably expert review of the software's output.

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set for the BLUEPRINT 3D planning software.

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

The document does not provide information on how the ground truth for the training set was established. Since it is pre-surgical planning software, it's possible that historical CT-scans and corresponding surgical outcomes or expert annotations were used, but this is not specified.

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The Salto Talaris ankle prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatic, or degenerative arthritis. Components are intended for cemented use only.

The Salto XT ankle prosthesis is indicated as a total ankle replacement in revision surgeries only for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Components are intended for cemented use only.

The cleared Salto Talaris and the new Salto XT are intended for total ankle replacement. Both are a semiconstrained anatomical design, which reproduces the kinematics of the ankle joint. And both consist of two mating components: a metal tibial base in association with a conforming polyethylene articulating insert, and a metal talar component.

The submission seeks clearance for:

• the addition of new components to the Salto XT (tibial and talar components).
• the addition of a new size and new thicknesses to the cleared range of Salto Talaris tibial inserts.

The tibial inserts are compatible with both Salto Talaris (K060544, K090076, K130533) and the new Salto XT. The new device Salto XT has been designed to be compatible with the cleared and the new Salto Talaris tibial inserts. All Salto XT components are compatible with cleared Salto Talaris components.

The provided document is a 510(k) premarket notification for two medical devices, Salto XT and Salto Talaris ankle prostheses. This document details the FDA's decision of substantial equivalence to predicate devices, but does not describe acceptance criteria for software performance or a study proving that a device meets such criteria.

The document describes non-clinical testing for mechanical performance, such as tibial fatigue, insert locking mechanism strength, talar stability, contact pressure, and wear. These are physical tests of the prosthesis components, not software performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies related to software performance from this document.

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The hardware: The Aequalis Glenoid Guides are patient-specific drill guides. They have been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT-scans. Aequalis PerFORM Anatomic Glenoid Guide is used by surgeons to facilitate the placement of the Aequalis PerFORM glenoids.

The software: The BLUEPRINT 3D planning software is a medical device for surgeon composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery. BLUEPRINT 3D planning software runs on standard personal and business computers running Microsoft Windows or Mac OS operating systems. The software supports DICOM standard to import the CT-Scan (Computed Tomography) images of the patient. Only CT-Scan modality can be loaded with BLUEPRINT 3D planning software. BLUEPRINT 3D planning software allows surgeon to visualize, measure, reconstruct, and annotate anatomic data. It allows surgeon to design patient specific guides based on the presurgical plan. This device is intended for use provided anatomic reference points necessary for positioning of the guide are present on the CT scan. The software leads to the generation of a surgery report along with a 3D file of the patient-specific guide. BLUEPRINT 3D planning software does not include any system to manufacture the guide. BLUEPRINT 3D planning software is to be used for adult patients only and should not be used for Diagnostic purpose.

BLUEPRINT™ Patient Specific Instrumentation is composed of two components: Aequalis Glenoid Guides (hardware) and BLUEPRINT 3D planning software (software). BLUEPRINT™ Patient Specific Instrumentation which includes the Aequalis Glenoid Guides and BLUEPRINT 3D planning software is the responsibility of Tornier. Tornier is the legal manufacturer for the hardware and the software.

The hardware: The Aequalis Glenoid Guides are patient-specific instruments specially designed to facilitate the implantation of the Aequalis PerFORM shoulder prostheses and are exclusively reserved for this use. The Aequalis Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software BLUEPRINT™ 3D planning software.

The software: BluePrint 3D Planning software is composed of one software component connected to an Online Management System (OMS). The software installed on a computer is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (= total anatomic shoulder replacement). It is intended to help to plan an operation by allowing surgeons to: position and select the glenoid implant, design a patient specific pin guide.

This submission seeks clearance for: Hardware: a guide made of Titanium with an orientation hole which allows for controlling rotation of the commercially available implant, AequalisTM PerFORM. Software modified to: Integrate a guide made of titanium, Add a glenoid sphere radius measurement.

The BLUEPRINT Patient Specific Instrumentation device's acceptance criteria and the study proving it are described below.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Sample Size: The document states that studies using cadaver specimens were used for non-clinical testing. However, the exact sample size (number of cadavers) is not specified.
• Data Provenance: The cadaver studies were used for testing, implying prospective data collection for this specific validation. The country of origin of the data is not specified.

3. Number and Qualifications of Experts for Ground Truth:

• The document primarily focuses on validating the device's accuracy in guiding surgical procedures and meeting dimensional specifications. It does not explicitly mention the use of experts to establish a "ground truth" for a test set in the traditional sense of diagnostic AI performance. The ground truth for the "Patient Specific Guiding Wire test" would likely be derived from precise measurements taken during the cadaver studies, ensuring compliance with the device's design specifications. No information about expert qualifications or numbers is provided for this.

4. Adjudication Method for the Test Set:

• No adjudication method is mentioned. The "Acceptable" results for the non-clinical tests suggest that the measurements taken during the studies met predetermined specifications without requiring an adjudication process by multiple reviewers.

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

• No information about a multi-reader multi-case (MRMC) comparative effectiveness study is provided. This device is primarily a surgical planning software and patient-specific instrumentation, not a diagnostic AI intended to assist human readers in image interpretation for improved diagnostic accuracy.

6. Standalone Performance Study:

• Yes, a standalone performance was done. The document outlines "Non-clinical testing" for BLUEPRINT™ Patient Specific Instrumentation to "assess that no new safety or effectiveness questions were raised." This testing includes a "Patient Specific Guiding Wire test" and a "Dimensional test of The titanium guide," both of which evaluate the device's performance based on predefined acceptance criteria without human-in-the-loop performance described. The software's ability to measure in preoperative planning and generate a guide matching patient anatomy was validated using cadaver specimens.

7. Type of Ground Truth Used:

• The ground truth for the "Patient Specific Guiding Wire test" and "Dimensional test of The titanium guide" appears to be based on device specifications and direct physical measurements taken during cadaver specimen studies. For example, for the guiding wire test, the ground truth would be the ideal or intended version angle, inclination angle, and entry point, against which the device's actual performance is measured. Similarly, for the dimensional test, the ground truth is the specified dimensions of the titanium guide.

8. Sample Size for the Training Set:

• No information about a separate training set or its sample size is provided. The document outlines validation studies to assess the device's performance, but it does not detail the development or training of any machine learning components that would typically require a training set. The software mentioned is for pre-operative planning, visualization, measurement, and annotation, and the generation of a 3D file, which might not rely on machine learning in the same way a diagnostic AI would.

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

• Since there is no mention of a training set, there is no information provided on how its ground truth was established.

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IN ANATOMIC:

The Aequalis Fx2 humeral stem combined with the Flex Shoulder System humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.

The Aequalis Fx2 is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and to relieve pain. The Aequalis Ex2 is indicated for use as a replacement of shoulder joints disabled by:

• Rheumatoid arthritis with pain
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the proximal humerus except for size 50mm(1)
• Traumatic arthritis
• Revision of other devices if sufficient bone stock remains except for size 50mm(1)

IN REVERSE:

The Aequalis Fx2 is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

• Rheumatoid arthritis

• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)

• Correction of functional deformity

• Fractures of the proximal humerus except for size 50mm(1

• Traumatic arthritis

• Revision of the devices if sufficient bone stock remains except for size 50mm( ).. The reversed insert is permitted to be used in the transformation from anatomic to reverse Aequalis Fx2 without the humeral stem, and if it is well fixed, during a revision surgery, for patient with a functional deltoid muscle.

The Aequalis Fx2 is a non-constrained prosthesis intended for the total or partial replacement of the gleno-humeral articulation.

The Aequalis Fx2 consists of:

• in an anatomic configuration, a humeral stem compatible with Flex Shoulder System humeral heads (K122698 ; K140082);

or

• in a reversed configuration, a humeral stem and a reversed insert, compatible with Aequalis Reversed/Aequalis Reversed II glenoid implants (K081059; K140478).

The Aequalis Fx2 is intended for use as:

• traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint,

including humeral head fracture and displaced 3-or 4-part proximal humeral fractures,

• in case of bone defect in the proximal part of the humerus,

• a replacement of shoulder joints in primary anatomic or in primary reverse,

• a replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains.

The Aequalis Fx2 also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.

This submission corresponds to the design modification related to the Aequalis Fx2 assembly zone (humeral stems and reversed inserts) compatible only with each other. This design modification does not affect the intended use of the device or alter the fundamental scientific technology of the device. The pending humeral stems are compatible with the cleared Flex Shoulder humeral heads and the pending reversed inserts are compatible with the cleared Aequalis Reversed II glenoid implants. There is no change regarding the material of the pending Aequalis Fx2 humeral stems. The design change related to the pending Aequalis Fx2 reversed inserts does not include a titanium locking ring in contrast to the previously cleared Aequalis Fx2 reversed inserts.

Here's a breakdown of the acceptance criteria and the study information for the Aequalis Fx2 device based on the provided document:

This document is a 510(k) premarket notification for a medical device (Aequalis Fx2), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study on human-in-the-loop performance or diagnostic accuracy. Therefore, many of your requested points related to AI/algorithm performance (standalone performance, MRMC studies, ground truth establishment for training/test sets, expert qualifications) are not applicable to this type of submission.

The "study" described here consists of various engineering and physical tests to demonstrate that the modified device's performance is acceptable and comparable to its predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify a numerical sample size in terms of units tested for each validation method. It refers to "the design modification" and "the pending Aequalis Fx2 humeral stem and reversed insert," implying that these tests were conducted on representative samples of the device components.
• Data Provenance: The tests are described as physical/bench tests conducted by the manufacturer, Tornier S.A.S., which is based in Montbonnot Saint-Martin, France. This is not patient-derived data; it's engineering test data.

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

This information is not applicable. The "ground truth" for these engineering tests is established by industry standards, engineering specifications, and predicate device performance, not by medical experts interpreting data like in a diagnostic study.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations, which is not relevant to the physical testing described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

This information is not applicable. This document is for a shoulder prosthesis and does not involve AI or human reader performance.

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

This information is not applicable. This document is for a physical medical device (shoulder prosthesis) and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for these performance tests is based on:

• Engineering Specifications and Design Requirements: For dimensional comparisons, assembly methods, and convertibility.
• Predicate Device Performance: For tests like Pull-out and Torque testing, where the modified device's performance is compared for equivalence to previously cleared devices (K030941 and K141345).
• Failure Criteria: For fatigue testing ("No failure after the test").

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of an engineering evaluation for a mechanical implant.

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

This information is not applicable for the same reasons as above.

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