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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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SYSTEM INTENDED USE :

The Aequalis Ascend Flex Shoulder System is intended for use as:

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 Ascend Flex System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.

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 cuff, where it is intended to provide increased mobility and stability 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. ostoorthritis 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 a 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.

Notes:

• All components are single use.
• The coated humeral stem is intended for cemented or cementless use
• The non-coated humeral stem is for cemented use only.
• The all-poly glenoid components are intended for cemented use only
• The glenoid sphere implant is anchored to the bone with screws and is for non-cernented fixation.
• Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.

Indications For Use: Device Name: Aequalis Reversed Shoulder Prosthesis

Cemented Aequalis Reversed prosthesis:

It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated with the massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemiprosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.

When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemiprosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

Uncemented Aequalis Reversed prosthesis:

It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cufftear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cufftear. The humeral components are for uncemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

When during the primary surgery the glenoid stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis.

When, in case of revision of an Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemiprosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

Note:

• Titanium glenoid spheres are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium glenoid sphere is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.

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 Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. 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 or titanium) 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 compatible with Aequalis Reversed glenoid implants (consisting of a sphere, a baseplate and screws). The reversed adapter consists of two components: a titanium tray and a UHMWPE reversed insert which includes a titanium locking ring.

This submission corresponds to the addition of new reversed inserts Aequalis Ascend Flex and glenoid spheres Aequalis Reversed II in diameter 33 mm and 39 mm compatible with each other. The indications for use, the materials, the manufacturing principle, the method of fixation, the packaging and the sterilization process of the pending reversed insert and glenoid spheres are identical or equivalent to the predicate devices.

The provided text describes a 510(k) premarket notification for shoulder prosthesis devices, specifically the "Aequalis™ Ascend™ Flex Shoulder System" and "Aequalis Reversed Shoulder Prosthesis." This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical performance studies with specific acceptance criteria and ground truth establishment as is common for novel diagnostic or AI-driven devices.

Therefore, the information you've requested regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for device performance in the context of a new clinical study is not present in this document. This document focuses on demonstrating that the new devices are essentially the same as previously approved devices.

Here's an analysis of the provided text based on your request, highlighting what is (and isn't) present:

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

• Not present in the traditional sense. For a 510(k) submission, the "acceptance criteria" are typically met by demonstrating that the new device has "substantially equivalent" technological characteristics and uses as the predicate devices. The "reported device performance" is not from a new clinical study with specific metrics, but rather inferred from the known performance of the predicate devices.
• The document presents tables comparing the "Main features or system characteristics" of the pending devices to their predicates (pages 8-9). This is the closest equivalent to "performance comparison" in this context.

Table of Comparative Characteristics (from document, indicating "performance" by equivalence):

"Acceptance Criteria" for a 510(k) in this context: The device is considered to meet "acceptance criteria" if the FDA determines it is "substantially equivalent" to predicate devices. This is based on:
* Same intended use.
* Similar indications for use.
* Equivalent major technological characteristics (materials, biomechanical features, fixation means, prosthetic dimensions).

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

• Not applicable/Not present. This document does not describe a clinical performance study with a test set of data. The submission is based on engineering design, material specifications, and comparison to existing devices.

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

• Not applicable/Not present. No ground truth establishment from expert review is described for this type of submission.

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

• Not applicable/Not present.

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/Not present. This device is a physical shoulder prosthesis, not an AI-driven diagnostic tool.

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

• Not applicable/Not present. This device is a physical shoulder prosthesis, not a software algorithm.

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

• Not applicable/Not present.

8. The sample size for the training set

• Not applicable/Not present.

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

• Not applicable/Not present.

In summary, the provided document is a 510(k) summary for a medical device (shoulder prosthesis), which focuses on demonstrating substantial equivalence to predicate devices through technical comparisons rather than clinical performance studies involving test sets, expert ground truth, or AI performance metrics.

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The Aequalis Ascend Flex Shoulder System is intended for use as:

• 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 Ascend Flex Shoulder System also allows for conversions from anatomic to reverse shoulder . prosthesis in case of revision.

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 intect or reconstructable rotator cuff, where it is intended to provide increased mobility and stability 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 .

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

• 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 Shoulder System total shoulder replacement and for transformation of the Aequalis Ascend Flex Shoulder System into a 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 cufftear.

The Aequalis Ascend Flex Shoulder System consists of:

• In a 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 UHM WPE 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.
  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 present device submission corresponds to modifications made to the version of the device cleared in 510(k) K121493 (most recent) and K112615.

This document is a 510(k) premarket notification for the Tornier Aequalis™ Ascend™ Flex Shoulder System. It focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than describing a study to prove acceptance criteria for a new device's performance in a clinical setting.

Therefore, the information regarding acceptance criteria and a study proving device performance as it would typically be presented for a diagnostic or AI-based device is not present in this document. This document describes a medical implant where "acceptance criteria" are related to mechanical and material performance and "proof" comes from non-clinical testing and comparison to existing devices.

Here's a breakdown of what is available based on your request, adapted to the context of a medical implant submission:

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

The document does not provide a formal table of explicit acceptance criteria with numerical performance results in the way a diagnostic device would (e.g., sensitivity, specificity). Instead, "acceptance criteria" are implied by the non-clinical tests performed, demonstrating the device's mechanical integrity and material properties meet established standards, and its design is comparable to predicates.

The "reported device performance" is summarized as:

• Non-clinical testing: "stem strength evaluation in Anatomic/Reverse configurations; taper evaluation; reverse adapter evaluation; head glenoids mismatch evaluation; system range of motion evaluation; and Titanium Plasma Spray coating validation per FDA guidance."
• Conclusion: "The results of these nonclinical tests allow us to conclude that the Aequalis Ascend Flex Shoulder System described in this submission is substantially equivalent and as safe and effective as the predicate device."

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

This information is not applicable and not provided. The "test set" here refers to the physical devices (prototypes or production samples) that underwent non-clinical mechanical and material testing, not a dataset of patient information. The document focuses on demonstrating physical and functional equivalence to predicate devices through engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of device submission. Ground truth is not established by human experts in the context of mechanical testing of an implant; rather, it's defined by engineering specifications, material standards, and biomechanical principles.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of patient data, not for the mechanical testing of an implant.

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 is not applicable. This device is a shoulder implant, not a diagnostic or AI-assisted system. No MRMC study was conducted.

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

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

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

For this type of device (a medical implant), the "ground truth" for proving performance would be based on:

• Engineering specifications and standards: Adherence to established mechanical, material, and biocompatibility standards (e.g., ISO standards for implants, FDA guidance for specific tests).
• Biomechanical principles: Ensuring the device functions appropriately within the human biomechanical system.
• Material properties: Verifying that the materials used meet the required strength, durability, and biocompatibility criteria.
• Predicate device performance: The "ground truth" for substantial equivalence is often the known safety and effectiveness profile of the legally marketed predicate device(s).

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of an implant's mechanical and material testing.

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

This is not applicable.

Summary of the K122698 Submission:

The document describes the Tornier Aequalis™ Ascend™ Flex Shoulder System, an implant intended for shoulder joint replacement in various configurations (anatomic and reverse).

The primary method for demonstrating its "acceptance" and safety/effectiveness for market clearance is substantial equivalence to previously cleared predicate devices (Tornier Inc. Ascend Shoulder System K121493 and Tornier Inc. Aequalis Ascend Modular Reverse Shoulder System K112615, with K120739 as a reference).

The studies referenced are non-clinical tests designed to show that the modified device performs comparably to its predicates and meets necessary engineering and material standards. These tests include:

• Stem strength evaluation (in Anatomic/Reverse configurations)
• Taper evaluation
• Reverse adapter evaluation
• Head glenoids mismatch evaluation
• System range of motion evaluation
• Titanium Plasma Spray coating validation per FDA guidance.

The document states that the "results of these nonclinical tests allow us to conclude that the Aequalis Ascend Flex Shoulder System described in this submission is substantially equivalent and as safe and effective as the predicate device." This indicates that the "acceptance criteria" were met through these engineering and material tests, demonstrating that the device functions as intended and is as safe and effective as the predicate devices.

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