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The DePuy Synthes DELTA XTEND™ Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with:
• severe arthropathy and/or;
• a previous failed joint replacement and/or;
• fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory

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

DELTA XTEND™ Hemi-Shoulder Replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed DELTA XTEND™ Reverse Shoulder. Porous-coated epiphysis are indicated for use in total shoulder replacement only.

The metaglene component is either HA coated or porous-coated and is intended for cementless use with the addition of screws for fixation. Central screws can only be used with the porous-coated metaglenes and are required to be used with porous-coating augmented metaglenes.

The modular humeral stem is HA coated and is intended for cementless use. The HA coated humeral epiphysis is intended for cementless use. The porous-coated epiphysis is intended for cementless use.

All other metallic components are intended for cemented use only.

The DELTA XTEND Reverse Shoulder System consists of humeral stems, modular epiphysis, humeral spacers, humeral cups, glenospheres, metaglenes and metaglene screws used for reverse shoulder arthroplasty. Humeral heads can be used in hemi-shoulder arthroplasty in place of the humeral cup and glenoid components.

The metaglenes are available in various design configurations including standard and augmented designs. The metaglenes allow for the placement of a central screw down the center of the post. A separate collet component is inserted into the metaglene post to receive the locking screw of the glenospheres.

The provided text describes a 510(k) premarket notification for a medical device, the DELTA XTEND Reverse Shoulder System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study or AI-driven performance metrics.

Therefore, the requested information about acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), and training set details for AI/algorithm performance are not applicable to this 510(k) submission.

This submission is for a mechanical medical device (shoulder prosthesis), not a diagnostic or AI-based device that would typically undergo studies with the kind of performance metrics and ground truth establishment outlined in the request. The "Performance Data" section lists various mechanical tests (e.g., Pullout Evaluation, Fatigue Evaluation, Micromotion Evaluation), which are standard for orthopedic implants to demonstrate their physical properties and durability, ensuring they are comparable to existing, legally marketed devices.

Here's why the queried information is not present in the provided text:

• Acceptance Criteria & Reported Performance Table: The document doesn't provide numerical acceptance criteria for clinical performance (like sensitivity/specificity for a diagnostic device) or reported performance against such criteria. Instead, it demonstrates equivalence through design, materials, and mechanical testing.
• Sample Size & Data Provenance (for test/training sets): These are relevant for clinical trials or AI model validation datasets. For a 510(k) for a mechanical implant, the "sample size" would refer to the number of devices or test specimens used in engineering bench testing, not patient data for algorithm training/testing. Such detailed numbers are typically found in the full technical reports submitted to FDA, not in the summary document.
• Expert Ground Truth, Adjudication, MRMC, Standalone Performance: These concepts are specific to diagnostic devices, especially those involving image interpretation or AI algorithms where human readers' performance is augmented or replaced. They are not applicable to the evaluation of a shoulder prosthesis itself.
• Type of Ground Truth: For this device, the "ground truth" would be established through engineering specifications, material science, biomechanical principles, and the established performance of predicate devices. There wouldn't be "expert consensus" or "pathology" in the sense of diagnosing a condition; rather, it refers to engineering and clinical consensus on mechanical properties and surgical outcomes.
• Training Set Sample Size & Ground Truth Establishment: Again, these are AI/machine learning terms and do not apply to this type of device submission.

In summary, the provided document is a regulatory submission for a physical implant, not an AI/diagnostic device. The "study" referenced in the document (under "Performance Data") refers to benchtop mechanical and material testing, performed to demonstrate that the device is as safe and effective as its predicate devices, rather than a clinical study evaluating diagnostic accuracy or human performance improvement.

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The DELTA XTEND™ Reverse Shoulder System is intended for use in total or hemi-shoulder arthroplasty procedures in patients with non-functional rotator cuffs, with or without bone cement. HA components are for cementless use only.

The DELTA XTEND™ Reverse Shoulder System is indicated for use in treatment of a grossly deficient rotator cuff joint with: severe arthropathy and/or; a previous failed joint replacement and/or: fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory 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. DELTA XTEND™ Reverse Shoulder System hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed DELTA XTEND™ Reverse Shoulder System. The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. All other metallic components are intended for cemented use only.

The DELTA XTEND™ Reverse Shoulder System is currently cleared and marketed by DePuy Synthes and is comprised of multiple humeral and glenoid implant components. These are provided as separate, standalone devices and may be used in conjunction to form a total shoulder prothesis. This submission is pertinent to only those system components which are HA coated: Humeral Implants: Modular humeral stems Modular epiphysis Glenoid Implants: Metaglenes

The provided text is a 510(k) Summary for the DELTA XTEND™ Reverse Shoulder System. It outlines the device, its intended use, and its substantial equivalence to previously cleared predicate devices.

However, the primary purpose of this submission (as stated in section 510(K) SUMMARY) is "to extend the current approved shelf life of 5 years to 10 years" of the DELTA XTEND™ Reverse Shoulder System.

Therefore, the performance data provided focuses solely on testing related to shelf-life extension, specifically regarding the HA coating on shelf-aged products. There is no information within this document about acceptance criteria or studies related to AI-powered medical devices, human reader improvements with AI assistance, or algorithm-only performance.

The document explicitly states:
"NO CLINICAL TESTS WERE CONDUCTED TO DEMONSTRATE SUBSTANTIAL EQUIVALENCE."

Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria, study details (sample sizes for test/training sets, data provenance), expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI device, as this documentation pertains to a traditional medical device (shoulder replacement system) and not an AI/ML device.

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The Delta Xtend Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with: · severe arthropathy and/or; · a previously failed joint replacement and/or: · fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed Delta Xtend Reverse Shoulder. The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. The modular humeral stem and humeral epiphysis components are HA coated and intended for cementless use. All other metallic components are intended for cemented use only.

The Delta Xtend Reverse Shoulder System consists of humeral stem, modular epiphysis, humeral spacer, humeral cup, glenosphere, metaglene and metaglene screws. The glenosphere and metaglene are used for total reverse shoulder arthroplasty. The humeral spacer can be added between the epiphysis and the humeral cup if necessary. Humeral head can be used in hemi-shoulder arthroplasty in place of the humeral cup and glenoid components.

The provided document pertains to the 510(k) premarket notification for the DePuy Delta Xtend™ Reverse Shoulder System, specifically for the addition of lateralized glenosphere components. This document is a regulatory submission for a medical device (a shoulder prosthesis), NOT an AI/ML medical device. Therefore, the information requested regarding acceptance criteria and study proving device performance for an AI/ML device (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth sources) is not applicable here.

The document discusses the substantial equivalence of the new components to predicate devices based on:

1. Biocompatibility: Confirmed per ISO10993-1.
2. Range of Motion: Theoretical simulated range of motion analyses showed an increase compared to the predicate non-lateralized glenosphere.
3. Glenoid Loosening/Disassociation: A study demonstrated substantial equivalency of glenoid fixation performance to the predicate.

The document explicitly states:

• "Summary of animal study: Animal study was not necessary."
• "Summary of clinical study: Clinical study was not necessary."

This indicates that clinical trials or studies that would involve human patient data, ground truth establishment by experts, or detailed statistical analysis of performance (as would be typical for AI/ML device validation) were not required for this specific 510(k) submission, as it focused on demonstrating substantial equivalence through non-clinical performance and design comparisons.

Therefore, I cannot extract the information required for an AI/ML device's acceptance criteria and study results from this document.

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The Delta Xtend Reverse Shoulder prosthesis is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff 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.

In cases of bone defects in the proximal humerus, the monobloc implant should be used and then only in cases where the residual bone permits firm fixation of this implant.

Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for revision of a previously failed Delta Xtend Reverse Shoulder.

The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation.

The modular humeral stem and epiphysis components are HA coated and intended for cementless use.

All other components are for cemented use only.

The Delta Xtend Reverse Shoulder prosthesis is intended for use in total or hemi shoulder arthroplasty procedures in patients with non-functional rotator cuffs, with or without bone cement. HA coated components are for cementless use only.

The Delta Xtend Reverse Shoulder System is a modular shoulder prosthesis designed for use in patients with non-functional rotator cuffs.

I am sorry, but based on the provided text, there is no information about acceptance criteria, reported device performance, sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details. This document is a 510(k) premarket notification letter and summary for a medical device (DePuy Delta Xtend Reverse Shoulder System), which primarily focuses on establishing substantial equivalence to existing predicate devices based on design, materials, and intended use, rather than presenting detailed study results for performance metrics.

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Intended Use: The Delta Xtend™ Reverse Shoulder prosthesis is intended for use in total or hemi shoulder arthroplasty procedures in patients with non-functional rotator cuffs.

Indications for Use: The Delta Xtend™ Reverse Shoulder prosthesis is intended for use as total shoulder or hemi-shoulder replacement. Delta Xtend™ Reverse Shoulder prosthesis is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff 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. In cases of bone defects in the proximal humerus, the monobloc implant should be used and then only in cases where the residual bone permits firm fixation of this implant. Delta Xtend™ hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively. The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. All other components are for cemented use only.

The Delta Xtend™ Reverse Shoulder System is a modular shoulder prosthesis designed for use in patients with non-functional rotator cuffs.

This document pertains to a 510(k) premarket notification for the Delta Xtend™ Reverse Shoulder System. It is a regulatory submission for a medical device and, as such, does not contain information about clinical studies with acceptance criteria, sample sizes, expert involvement, or specific performance metrics in the way a clinical trial report would.

The provided text describes the device, its intended use, indications for use, and establishes substantial equivalence to previously cleared predicate devices. It also includes the FDA's clearance letter.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and the reported device performance: This document does not present acceptance criteria or detailed performance data from a clinical or analytical study. The basis for clearance is substantial equivalence to predicate devices, not meeting specific performance thresholds in a new study.
2. Sample size used for the test set and the data provenance: No new test set data is described. The clearance is based on 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 as no new test set requiring ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
6. If a standalone performance study was done: No standalone algorithm performance study is indicated. This is a physical medical device (shoulder prosthesis), not an AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information related to the device and its clearance:

• Device Name: Delta Xtend™ Reverse Shoulder System
• Classification: Class II
  • 21 CFR 888.3660: Shoulder Prosthesis, Semi-Constrained, Metal/Polymer Cemented
  • 21 CFR §888.3690: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
• Intended Use/Indications: Total or hemi-shoulder arthroplasty in patients with non-functional rotator cuffs, severe arthropathy, or previous failed joint replacement with a grossly deficient rotator cuff joint. Also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively. Requires a functional deltoid muscle.
• Basis of Clearance: Substantial equivalence to predicate devices:
  • DePuy Delta CTA Reverse Shoulder System (K021478)
  • DePuy Delta CTA Head (K062116)
  • DePuy Global Advantage Shoulder System (K992065)
  • DePuy Global Advantage CTA Head (K000575)

The 510(k) process for this device relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring new clinical studies to meet pre-defined performance acceptance criteria.

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