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Intended Use: The Incompass Total Ankle System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.

Indications for Use: The Incompass Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The Incompass Total Ankle is additionally indicated for patients with a failed previous ankle surgery.

Incompass™ Total Ankle System is a total ankle replacement system consisting of implants and instruments.

Incompass™ Total Ankle System will harmonize the Infinity™ and Inbone™ Total Ankle Systems into one comprehensive system consisting of modular stemmed and low-profile pegged tibial trays, tibial inserts, and talar domes. The harmonized system is facilitated by sharing the same tibial resection geometry between the pegged and the stemmed tibial tray designs.

The provided text is a 510(k) clearance letter for the Incompass Total Ankle System. It outlines the device's indications for use, its classification, and declares its substantial equivalence to predicate devices based on non-clinical evidence.

However, the clearance letter explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."

This means that the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment (which are typical for studies proving a device meets acceptance criteria, especially for AI/ML-based devices or those requiring clinical trials) is not included in this document. The clearance was based on non-clinical performance bench testing to demonstrate substantial equivalence in wear, articular stability, lock detail, manufacturing processes, static strength, fatigue strength, fretting, corrosion, and MRI safety, rather than clinical efficacy studies.

Therefore, I cannot provide the requested information from this document. If this were a submission for a device that required clinical performance data to demonstrate safety and effectiveness (e.g., an AI/ML device), this section would typically contain summaries of those studies.

Based on the provided document, here's what can be inferred or explicitly stated regarding the acceptance criteria and study proving adherence to them:

The device in question is a Total Ankle System, a type of orthopedic implant, not an AI/ML-based device or one that underwent a clinical efficacy study for its 510(k) clearance.

The "study" that proves the device meets acceptance criteria, in this context, refers to non-clinical performance bench testing.

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

Since no clinical efficacy study was conducted for this 510(k) clearance, there's no data to populate such a table detailing clinical performance metrics (like sensitivity, specificity, or human reader improvement).

The acceptance criteria for this device were related to substantial equivalence through bench testing. The document states:

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

• Sample Size: Not specified in the document, as it refers to engineering and materials testing (bench testing) rather than a dataset of patient cases. For bench testing, "samples" would refer to the number of devices or components tested.
• Data Provenance: Not applicable in the context of clinical patient data (e.g., country of origin, retrospective/prospective), as the evidence was non-clinical bench testing. The testing would have been conducted in a laboratory setting.

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

• Not applicable. Ground truth as typically defined for AI/ML or clinical studies (e.g., expert consensus on medical images) was not established. The "ground truth" for bench testing is determined by engineering standards, material science principles, and established testing methodologies.

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

• Not applicable. This is relevant for studies involving human reviewers or AI output, not for materials and mechanical bench testing.

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

• No. This type of study is specifically for AI/ML-assisted diagnostic devices. The Incompass Total Ankle System is a physical medical implant.

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

• No. This is relevant for AI/ML algorithms.

7. The type of ground truth used:

• The "ground truth" for this clearance was established through engineering standards, material specifications, and validated bench testing protocols comparing the device's physical and mechanical properties against those of legally marketed predicate devices. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable. This device is not an AI/ML algorithm.

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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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In Anatomic:
The Tornier Perform Humeral System - Fracture combined with a humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement.
The Tornier Perform Humeral System - Fracture is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, stability, and to relieve pain.
The Tornier Perform Humeral System - Fracture is indicated for use as a replacement of shoulder joints disabled by: • Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral head fracture and displaced 3-or 4-part proximal humeral fractures
· Fracture sequelae

• Revisions where adequate fixation can be achieved and adequate bone stock remains after final reconstruction
  Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients without a suspected material sensitivity to cobalt alloy.
  All components are single use. The fracture stems are intended for cementless use. In cementless use, the fracture stems are intended for use with or without cortical screws. In a total shoulder arthroplasty, the Tornier Perform Humeral System - Fracture is intended to be used with cemented polyethylene glenoid components.

In Reverse:
The Tornier Perform Humeral System - Fracture combined with a reverse insert is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by: • 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
• Proximal humerus bone defect
· Fracture sequelae
• Revisions where adequate fixation can be achieved and adequate bone stock remains after final reconstruction
The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed fracture stem for patients with a functional deltoid muscle.
All components are single use. The fracture stems are intended for cementless use. In cementless use, the fracture stems are intended for use with or without cortical screws. The Tornier Perform Humeral System – Fracture is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.

The Tornier Perform Humeral System – Fracture is a convertible humeral fracture system for anatomic, reverse, and hemiarthroplasty of the shoulder. The system also allows for conversion from an anatomic to a reverse shoulder prosthesis in the case of revision. The Tornier Perform Humeral System - Fracture is implanted with existing Tornier glenoid systems for total anatomic and reverse shoulder arthroplasty.
The Tornier Perform Humeral System – Fracture includes titanium fracture stems, titanium couplers, titanium spacers and titanium screws. The system is compatible with commercially available Perform humeral heads and reversed inserts. The system also includes reusable instruments used to implant the shoulder prosthesis.

This document is a 510(k) premarket notification for a medical device (Tornier Perform Humeral System - Fracture), not a study evaluating an AI device's performance. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes for AI model training and testing is not applicable.

The document describes the device, its indications for use, and a comparison to predicate devices. It states that no clinical studies were performed to prove the device meets acceptance criteria. Instead, non-clinical performance testing was conducted to demonstrate substantial equivalence to predicate devices.

Here's a breakdown of the information provided in the document as it relates to your request:

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

The document does not provide a formal table of acceptance criteria with corresponding performance metrics for a digital health or AI device. The "performance" described refers to the results of non-clinical engineering tests to demonstrate the device's physical properties and compatibility, rather than clinical efficacy or diagnostic accuracy.

Non-clinical Performance Testing Performed:

• Fatigue testing
• Static taper evaluation
• ASTM F543 screw testing
• Evaluations for compatibility with existing components
• Range of motion analysis
• MRI compatibility evaluation
• Biocompatibility, sterilization, cleaning, endotoxin, packaging, shelf life, and distribution assessments (in accordance with recognized consensus standards).

Reported Device Performance:
The document states: "The results of performance testing for the Tornier Perform Humeral System – Fracture support substantial equivalence to the predicate Aequalis Reversed Fracture Shoulder Prosthesis and Aequalis Shoulder Fracture System (K131231)." This implies that the device performed adequately in these non-clinical tests to be considered comparable to the predicate. Specific quantitative results or acceptance thresholds are not detailed in this summary.

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. No clinical test set. The "testing" referred to是在工程实验室进行的非临床性能测试，而不是对临床数据进行的测试。

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. No clinical test set or ground truth established by experts.

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

Not applicable. No clinical test set.

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 implant device, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

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

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

Not applicable. No clinical ground truth was established as no clinical studies were performed. The "ground truth" equivalent for this device would be engineering specifications and standards for its physical and material properties.

8. The sample size for the training set

Not applicable. This is a medical implant device, not an AI model requiring a training set.

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

Not applicable. No training set for an AI model.

In summary: The provided document is an FDA 510(k) clearance letter and its associated Indications for Use and Device Description/Comparison. It describes a medical implant device that demonstrated substantial equivalence through non-clinical performance testing, not through clinical trials or the evaluation of an AI-powered diagnostic/therapeutic tool. Therefore, the questions related to AI device performance evaluation are not relevant to this document.

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In an anatomic shoulder configuration, the FX V135 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 FX V135 Shoulder is indicated for primary or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with massive and non-repairable rotator cuff tear.

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

The humeral stem of the FX V135 Cementless Shoulder is intended for cementless use only. The glenoid components of the FX V135 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 FX V135 Shoulder Prosthesis is a shoulder replacement system that may be used as a total or hemi shoulder replacement in either an anatomic or a reversed shoulder construct. The new components of this system include the FX V135 cementless humeral stems, the new Humeral Cup 135/145° and a new humeral spacer on the reverse configuration, and on the anatomic configuration, the new humeral stem and new humeral heads.

The Humeral Stem of the FX V135 Shoulder Prosthesis is manufactured from Ti-6AI-4V ELI alloy conforming to ISO 5832-3 and is available in diameters of 10-20mm in the diaphysis dependent upon the epiphyseal size 32, 36, or 40mm. All have a length of 70mm. The distal end of the humeral stem is quadrangular and bead blasted. The proximal portion of the humeral stem has a plasma sprayed commercially pure Titanium (CP-Ti) and Hydroxyapatite (HA) coating.

The FX V135 Humeral Stems incorporate a female taper for attachment of compatible components.

The new FX V135 Humeral Head is available in two versions and are manufactured from CoCrMo alloy conforming to ISO 5832-12. The new FX V135 Humeral Cup 135/145° is available in three sizes, Ø32, Ø36 and Ø40mm. Each size is available in two versions, standard and stability. Each version is available in three heights: +3mm, +6mm; and is compatible with all sizes of FX V135 Humeral Stems. The FX V135 Humeral Cup 135/145º is pre-assembled, one-piece component manufactured from ultra high molecular weight polyethylene (UHMWPE) conforming to ISO5834-2 and Ti-6AI-4V ELI alloy conforming to ISO 5832-3. The new Humeral Cup 135/145° may be used with the new Humeral Spacer +9mm to increase the cup offset.

The FX V135 Humeral Stems can be used with previously cleared components including a taper adapter, a centered or offset humeral head and a 2 peg or 3 or 4 peg cemented glenoid for use in an anatomical shoulder configuration.

For reverse configuration, the FX V135 Humeral Stem can be used with a humeral cup and optional spacer, a centered or eccentric glenosphere with or without a central screw, a glenoid baseplate (with or without a central screw), optional post extensions and standard (compression) or locking bone screws around the periphery of the baseplate. The previously cleared Humeral Cups or the subject Humeral Cup 135/145° mate with the FX V135 Humeral Stem to complete the reverse configuration.

The provided text does not contain information about acceptance criteria for an AI/ML powered device, nor does it describe a study proving such a device meets acceptance criteria.

The document is a 510(k) premarket notification for a FX V135 Shoulder Prosthesis, which is a medical implant (a shoulder replacement system), not an AI/ML powered device. The document details the device description, indications for use, and a comparison to predicate devices to establish substantial equivalence.

Specifically, under the heading "Non-Clinical Testing", it states:
"Range of motion analysis demonstrated substantial equivalence to predicate device. Construct fatigue testing was completed with test constructs completing all cycles with no failures and taper connections remaining firmly fixed. The results of these tests indicate that the performance of the FX V135 Shoulder Prosthesis is adequate for its intended use and substantially equivalent to the predicate device."

And under "Clinical Testing":
"Clinical testing was not necessary to determine substantial equivalence of the FX V135 to the predicate device."

This indicates that the evaluation was based on non-clinical (mechanical) testing for a physical implant, not an AI/ML algorithm. Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for an AI/ML device from this document.

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