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The Aequalis Reversed Shoulder Prosthesis 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 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 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 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 hemi-prosthesis 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.

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. In this case, the rotator muscles of the shoulder (supraspinatus, teres minor and long head of the biceps) are no more useful for mobility, and only the dettoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional. Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition And to reduce or eliminate pain. The Aegualis Reversed Shoulder Prosthesis is intended to accomplish these goals. Is reversed design allows to medialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm.

The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.

The present device modification submission consists in the following changes:

1ª change: addition of components in order to have the possibility to use multidirectional screws with the glenoid baseplate

2 types of components are added to the components of the Aequalis Reversed Shoulder prosthesis:

• Multidirectional screws in various length, l
• Specific glenoid baseplate for multidirectional screws.
• 244 change: addition of "fish-scales" on the peg of the humeral insert
• 314 change: modification of packaging of polyethylene components

The indications for use already covered by the previous 510(k) clearance are not modified.

The provided document is a 510(k) premarket notification for the "AEQUALIS Reversed Shoulder Prosthesis". This document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study with acceptance criteria and device performance evaluation in the typical sense of a clinical trial or performance study for a new, novel device.

Therefore, the information requested about acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not available within this type of regulatory submission.

Here's why and what information is present:

• 510(k) Premarket Notification: This is a regulatory pathway used to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. The primary goal is to show that the device has the same intended use and the same technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness.
• Focus on Equivalence: The document lists the predicate devices (K030941, K041873, K952928, K991585, K021478) and outlines modifications to an already cleared device (addition of multidirectional screws, "fish-scales" on the humeral insert peg, and packaging modifications). The safety and effectiveness are largely inferred from the predicate devices and the nature of the minor modifications.
• Lack of Performance Study Details: A 510(k) submission typically does not include extensive clinical studies or performance data comparing the device against specific acceptance criteria for efficacy or diagnostic performance, especially for modifications to an existing, cleared device like this one. Such studies are more common for novel devices or those requiring a PMA (Premarket Approval).

Information that CAN be extracted:

1. Device Name: AEQUALIS Reversed Shoulder Prosthesis
2. Regulatory Pathway: Special 510(k)
3. Indications for Use: For patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated with massive and non-repairable rotator cuff-tear, and for prosthetic revisions with massive and non-repairable rotator cuff-tear.
4. Device Description (Changes):
   • Addition of components for multidirectional screws with the glenoid baseplate.
   • Addition of "fish-scales" on the peg of the humeral insert.
   • Modification of polyethylene component packaging.
5. Materials: UHMWPE, Titanium alloy.

Conclusion:

Based on the provided document, which is a 510(k) Summary of Safety and Effectiveness for a medical device (specifically an orthopedic implant modification), the requested information regarding acceptance criteria, specific performance studies, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies is not present. This type of submission relies on demonstrating substantial equivalence to predicate devices rather than presenting de novo clinical or performance study data against defined acceptance criteria.

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The Aequalis Reversed Shoulder Prosthesis 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 non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear.

The Aequalis Reversed Shoulder Prosities humeral component is intended for cemented use only and the glenoid component is intended for non cemented use with 4 screws for fixation.

When during the primary surgery the glenoid stock appears to be insufficient to bear the reversed glonoid 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 Reversed prosthesis in to a non reversed hemi-prosthesis.

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

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. In this case, the rotator muscles of the shoulder (supraspinatus, teres pinor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional. Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition and to reduce or eliminate pain. The Aequalis Reversed Shoulder Prosthesis is intended to accomplish these goals. Its reversed design allows to mcdialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm.

The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.

The present device modification submission consists in the addition of components to the Aequalis Reversed Soulder prosibesis in order to have the possibility to transform the Aequalis Reversed Soulder Prosthesis in a standard hemi or total prosthesis in some clinical cases encountered during the surgical procedure.

The present Device Modification submission corresponds to the addition of 3 components of the Aequalis Reversed Shoulder prosthesis:

• Hemi-prosthesis adaptor diameter 36 mm, -
• Hemi-prosthesis adaptor diameter 42 mm, -
• Adaptor metaphysis union screw.

The provided document is a 510(k) premarket notification for a medical device, specifically the AEQUALIS Reversed Shoulder Prosthesis, and does not contain any information about acceptance criteria or a study proving that a device meets such criteria.

This document describes:

• The device name, classification, and submitter information.
• A description of the device and its intended use.
• Materials used in its construction.
• Indications for use for the original device and the added components.
• A letter from the FDA determining substantial equivalence to predicate devices, thus allowing the device to be marketed.

Since the document provided is a 510(k) submission, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and results. The content is primarily descriptive and regulatory in nature. Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies from this particular text.

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The Aegualis Reversed Shoulder Prosthesis is indicated for patients, with a functional deltoid I ho requare to rever sou box replacement for the relief of pain and significant disability following arthropathy associated to massive non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear.

The Aegualis Reversed Shoulder Prosthesis humeral component is intended for cemented use only and the glenoid component is intended for non cemented use with 4 screws for fixation.

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. In this case, the rotator muscles of the shoulder (supraspinatus, infraspinatus, teres minor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional. Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition and to reduce or eliminate pain. The Aequalis Reversed Shoulder Prosthesis is intended to accomplish these goals. Its reversed design allows to medialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm.

The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.

The humeral component:

The humeral part is made of 3 parts consisting of interchangeable stems, metaphysis , and inserts, that may be assembled in different configurations thus accommodating a large variation in patient size and anatomy.

The metaphyseal parts are fixed to the stem by a screwing fixation secured by a polyethylene breaking system. A lateralization spacer can be added to the humeral metaphysis in order to vary the lateralization.

The inserts are impacted on to the conic shape of the metaphysis. A polyethylene peg guides it in the correct position.

The stems are made of cobalt-chrome in 4 diameters The metaphyseal parts are manufactured from cobalt-chrome, in 2 sizes. The inserts are available in polyethylene in 6 sizes. The lateralization spacers are made of cobalt-chrome and are available in 2 sizes.

The glenoid component:

The glenoid part is composed of a base made of titanium alloy, on which is impacted a sphere of chrome cobalt. The assembly is secured by a central and internal screw. The sphere is available in two diameters congruent with the humeral insert.

The metallic base of the glenoid is fixed to the bone by using 4 compression screws for fixation.

The provided text is a 510(k) summary for the Tornier S.A. Aequalis Reversed Shoulder Prosthesis. It describes the device, its intended use, materials, and provides a substantial equivalence determination from the FDA. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert adjudication in the context of proving the device meets specific performance criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific acceptance criteria that would fall under the categories requested in your prompt. The "Standards / Testing" section only lists material and sterilization standards, not performance criteria for the device's clinical efficacy or safety beyond material biocompatibility.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This information is typically found in clinical study reports, scientific publications, or more detailed regulatory submissions (like a PMA) that are not part of this 510(k) summary.

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A Delta Total shoulder prosthesis is indicated for use in: Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional Deltoid muscle is necessary to use the device.

The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. All other components are intended for cemented use only.

The Delta Shoulder prosthesis is a modular total shoulder prosthesis that was designed specifically for use in patients with non-functional rotator cuffs. The articulation of this design is "inverted" compared to traditional total shoulder prosthesis. Unlike traditional total shoulder prosthesis, the Delta Shoulder is designed such that the "ball" of the articulation is incorporated into the glenoid prosthesis, and the "cup" of the articulation is incorporated in the humeral prosthesis. The distal surface of the metaglene components are coated with a hydroxyapatite coating (HA) and are intended to be used with 4 metaglene screws for fixation.

This 510(k) submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically associated with AI/ML-based medical devices.

Instead, this document pertains to a traditional medical device (a shoulder prosthesis) and focuses on demonstrating substantial equivalence to legally marketed predicate devices, as required for 510(k) clearance by the FDA. This regulatory pathway does not typically involve the kind of performance metrics, clinical studies, or AI/ML-specific validation often seen in submissions for software-as-a-medical-device (SaMD) or AI-enabled devices.

Here's why the requested information cannot be fully provided based on the given text:

• Device Type: The "Delta Shoulder" is a physical medical implant (a shoulder prosthesis), not an AI/ML diagnostic or prognostic tool. Therefore, the concept of "device performance" in terms of accuracy, sensitivity, or specificity against ground truth, as would be relevant for AI, does not apply in the same way.
• Regulatory Pathway: The 510(k) pathway for traditional devices primarily involves demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing indications for use, design, materials, sterilization, packaging, and often includes bench testing (e.g., mechanical strength, wear) and sometimes animal studies, but generally not human clinical trials with performance metrics against a defined ground truth as would be done for an AI algorithm.
• Content of the Document: The provided text is a 510(k) summary and the FDA clearance letter. It describes the device, its indications for use, identifies predicate devices, and states that substantial equivalence was determined based on "detailed device description, design rationale, product testing, literature and conformance with voluntary performance standards." However, it does not detail the specific "product testing" or "voluntary performance standards" in a way that allows for the extraction of acceptance criteria and reported performance metrics in the format requested for AI/ML devices.

Therefore, many of the requested fields are not applicable or cannot be extracted from this document.

However, I can extract the relevant information regarding the basis for clearance and what's available:

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

• Similarity in Indications for Use: The device is intended for "Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint," requiring an anatomically and structurally suited joint and a functional Deltoid muscle.
• Similarity in Design: Modular total shoulder prosthesis, "inverted" articulation (ball on glenoid, cup on humeral), HA-coated metaglene component for cementless application with screws, other components for cemented use.
• Similarity in Sterilization and Packaging.
• Product Testing: Not detailed, but typically involves mechanical and biocompatibility testing for implants.
• Literature and conformance with voluntary performance standards: Specific standards are not listed but are implied to have been met. |
  | Biocompatibility: | Implied to have been demonstrated through material selection and potentially testing, consistent with predicate devices and voluntary standards. |
  | Mechanical Performance: | Implied to have been demonstrated through "product testing" and "conformance with voluntary performance standards," ensuring the device can withstand physiological loads and wear over its intended lifespan, comparable to predicate devices. This typically includes fatigue, static strength, and wear testing, but specific results or acceptance criteria are not provided in this summary. |

The following points cannot be addressed from the provided text as they are not relevant to a 510(k) submission for a physical implant device in this context:

2. Sample sizes used for the test set and data provenance: No "test set" in the context of AI/ML performance evaluation is discussed. The validation is primarily against predicate devices and design verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI is not established here.
4. Adjudication method for the test set: Not applicable.
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 not an AI-enabled device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI/ML sense. The "ground truth" for a physical implant is typically its ability to function safely and effectively within the human body, assessed through engineering principles, preclinical testing, and post-market surveillance.
8. The sample size for the training set: Not applicable. No AI model is being trained.
9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) submission for a traditional, physical shoulder prosthesis. The "acceptance criteria" and "study" are framed around demonstrating substantial equivalence to existing devices through design comparison, product testing (not detailed here), and adherence to standards, rather than through performance metrics of an AI/ML algorithm against a ground truth.

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The Biomet® Bi-Polar Shoulder System is indicated for use in:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Revision where other devices or treatments have failed
4. Correction of functional deformity
5. Treatment of acute fracture of the humeral head unmanageable using other treatment methods
6. Cuff tear arthroplasty
   This is a single use implant for use with cemented or uncemented humeral components. It is intended for use with Biomet's humeral components previously cleared by the FDA.

The Biomet® Bi-Polar Shoulder Prosthesis is a self-retaining humeral shell that can be used with either the Bi-Angular® humeral prosthesis or the Bio-Modular® humeral prosthesis. In assembling, the liner is place over a modular inner head that is already impacted to an implanted humeral stem. The shell is then placed over the liner and the Ring-Loc lock ring snaps into the outer groove of the liner, which completes assembly of the prosthesis. The shell is available in six spherical diameters, 40 mm, 48 mm, 52 mm, 56 mm and 60 mm. The liner and Ring-Loc® locking ring are modular, i.e. there is only one size of each, and each is used with all six shell sizes.

The provided text describes a medical device submission (K002998) for the Biomet® Bi-Polar Shoulder System. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.

The document is primarily a Notice of Substantial Equivalence from the FDA, indicating that the device is substantially equivalent to a previously marketed predicate device (Biomet® Bi-Polar Shoulder, K991585). This type of FDA clearance (510(k)) focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to establish efficacy and safety from scratch.

Therefore, I cannot provide the requested information. The text does not elaborate on:

1. A table of acceptance criteria and the reported device performance: No such criteria or performance data are presented.
2. Sample size used for the test set and the data provenance: No test set or corresponding data is described.
3. Number of experts used to establish the ground truth... and their qualifications: No ground truth establishment is detailed.
4. Adjudication method: Not applicable as no ground truth establishment is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
6. Standalone (algorithm only without human-in-the-loop performance): This device is a physical shoulder prosthesis, not an algorithm, so this is not applicable.
7. The type of ground truth used: Not applicable as no ground truth assessment is described.
8. The sample size for the training set: Not applicable as this is a physical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

The document mainly focuses on:

• Sponsor and contact information.
• Device name and classification.
• Intended use and device description.
• Potential risks associated with the device (general risks for joint replacement).
• Identification of the predicate device.
• The FDA's official letter of substantial equivalence.
• The Indications for Use statement.

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