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EMPOWR Dual Mobility (Metal Liner and Poly Bearing) is indicated as part of a total hip replacement for patients suffering from pain and dysfunction due to:

• Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
• Revision of previously failed total hip arthroplasty
• Dislocation risks
• To be used for uncemented applications

EMPOWR Dual Mobility (Metal Liner and Poly Bearing) introduces a modular dual mobility bearing to the current acetabular system. The benefit of the new system is enhanced stability due to a larger femoral head with more ROM for a given cup size than the previously cleared single articulation liners. Bearings are offered in nominal OD sizes of 38-58mm compatible with previously cleared cups.

The subject bearing includes a Metal Liner made of CoCr alloy that locks to the cup with a modular taper junction and a Poly Bearing (Head) made from highly crossed linked UHMWPE infused with Vitamin E that captures an Inner Head made of ceramic or CoCr. The bearing provides two articulating surfaces. The Poly Bearing component articulates inside the Metal Liner and the permanently captured Inner Head articulates inside the Poly Bearing. The two articulations can occur independently or simultaneously.

The provided text is a 510(k) summary for the EMPOWR Dual Mobility Metal Liner and Poly Bearing. This document indicates that clinical testing was not required for this device. Therefore, the comprehensive information regarding acceptance criteria and a study proving device performance as requested cannot be extracted from this document, as such a study was not performed or submitted for this regulatory clearance.

However, I can provide the available information:

1. A table of acceptance criteria and the reported device performance:
   Since no clinical study was required or performed, there is no "reported device performance" in terms of clinical outcomes or specific acceptance criteria for clinical efficacy. The device's substantial equivalence was based on non-clinical mechanical testing.

   Acceptance Criteria (Non-Clinical)	Reported Device Performance (Non-Clinical)
   Demonstrated ability to perform under expected conditions for: Wear Testing, Metal Liner Disassembly, Head Disassembly, Metal Liner Corrosion, Impingement Testing, Range of Motion.	Mechanical testing demonstrated the device's ability to perform under expected conditions for all listed tests.
   Pyrogen limit specifications met.	Device testing assures pyrogen limit specifications are met via Kinetic Chromogenic method for bacterial endotoxin testing.

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, as no clinical test set was used. Non-clinical testing would involve physical prototypes or samples rather than patient data.

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, as no clinical test set was used requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as no clinical test set was used.

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 physical medical implant (hip replacement component), not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device is a physical medical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not applicable, as no clinical study or patient data requiring ground truth was used for this submission. The "ground truth" for non-clinical mechanical testing would be the engineering specifications and performance expectations.

8. The sample size for the training set:
   Not applicable, as no AI algorithm or clinical training set was used.

9. How the ground truth for the training set was established:
   Not applicable, as no AI algorithm or clinical training set was used.

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Joint replacement is indicated for patients suffering from disability due to:

• · noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
• rheumatoid arthritis:
• · correction of functional deformity;
• · femoral fracture.

This device may also be indicated in the salvage of previously failed surgical attempts.

This device is indicated for cementless use.

The DJO Acetabular System allows for the total replacement of the acetabulum. The system consists of porous coated titanium acetabular cups, bone screws for use with the cups, and acetabular liners manufactured from highly crossed linked polyethylene with Vitamin E. It is designed for compatibility with currently cleared DJO stems and femoral heads.

This looks like a 510(k) summary for a medical device that does not involve AI. Therefore, most of the questions about acceptance criteria, study design, ground truth, and expert involvement are not applicable in the context of AI/ML devices.

Here's a breakdown based on the provided document:

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

The provided document describes a traditional medical device (hip implant) and does not specify quantitative acceptance criteria in the way you would expect for an AI/ML device (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly that the device performs equivalently to the predicates in non-clinical mechanical testing.

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

This device clearance did not involve clinical testing as stated: "Clinical Testing: Clinical testing was not required". Therefore, there is no "test set" of patient data in the context of an AI/ML study. The "testing" referred to is mechanical testing of the physical device components. The document does not specify sample sizes for these mechanical tests, nor is data provenance (country, retrospective/prospective) relevant here.

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, as no clinical testing or AI/ML ground truth was established by experts.

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

Not applicable, as no clinical testing or AI/ML ground truth was established.

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 physical hip implant device, not an AI/ML diagnostic or assistive tool.

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

Not applicable. There is no algorithm.

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

Not applicable. For mechanical testing, the "ground truth" is typically defined by engineering specifications, material properties, and comparison to predicate device performance under controlled laboratory conditions, rather than clinical outcomes or expert consensus on a diagnosis.

8. The sample size for the training set

Not applicable. There is no AI/ML model to train.

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

Not applicable. There is no AI/ML model to train.

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The Reverse® Shoulder Prosthesis (RSP®) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy, a previously failed joint replacement with a grossly rotator cuff deficient shoulder 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 glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

The Reverse® Shoulder Prosthesis Monoblock is indicated for patients with a functional deltoid muscle with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint:

• · In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder, including humeral head fracture or displaced 3- or 4-part fractures of proximal humerus. (For cemented implantation only)
• In cases of bone defect in proximal humerus.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s).

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented or cementless use.

The RSP system is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulations fits into a metal cup that is joined to the humeral stem. The components included in this system are a glenoid bead, a humeral stem. The component baseplate, and baseplate screws. The standard RSP system consists of a modular components which include a humeral stem, humeral socket inset, glenoid baseplate, glenoid baseplate, which screws. The RSP Monoblock stem includes a bument test glenoid baseplate, glenoid he screws. The RSP Monoblock socket hiser, greend baseplate, glenoid baseplate, and humeral socket and humeral socket

The modification outlined in this application consists of an addition of a humeral socket insert infused with pure liquid pharmaceutical grade alpha-tocopheral into the material.

I am sorry, but the provided text does not contain information on acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA regarding a shoulder prosthesis, focusing on its substantial equivalence to previously marketed devices. It outlines the device details, indications for use, and a list of non-clinical testing performed, but it explicitly states "Clinical Testing: None provided."

Therefore, I cannot extract any information to fulfill your request regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
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 performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. Method for establishing ground truth for the training set.

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