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Found 6 results
510(k) Data Aggregation
(234 days)
Anatomic Total Shoulder or Hemi-Shoulder
The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following:
- Osteoarthritis
- Post-traumatic arthrosis
- Focal avascular necrosis of the humeral head
- Previous surgeries of the shoulder that do not compromise the fixation
The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Revision where other devices or treatments have failed.
- Correction of functional deformity.
- Fractures of the humeral head (with Short Humeral Stems)
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate (with Standard or Long Stems)
- Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.
Fixation Methods
The humeral stems are intended for cemented or cementless use. The humeral stemless anchor is intended for cementless use. The glenoid is intended for cemented use only.
Reverse Total Shoulder
The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures to address the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated for conversion from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem.
- A severely painful, disabling, arthritic joint
- Fractures of the humeral head (with Short Humeral Stems)
- Fractures of the proximal humerus (with Standard or Long Stems)
- Revisions of previously failed shoulder joint replacements
Fixation Methods
The humeral stem is intended for cemented or cementless use. The glenoid baseplate components are intended for cementless application with the addition of screw fixation.
The INHANCE™ SHOULDER SYSTEM with a humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures.
The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total, reverse total, or hemi-shoulder replacement procedures.
The Anatomic Total Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem or humeral stemless anchor (titanium alloy), an offset taper adapter (titanium alloy), a humeral head (cobalt-chromium) in combination with a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-linked, VE UHMWPE) glenoid.
The Reverse Total Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem (titanium alloy), a shell (titanium alloy), a liner (Cross-linked, VE UHMWPE) in combination with a glenosphere (cobalt-chromium), baseplate (titanium alloy), peripheral screws (titanium alloy), and either a central screw (titanium alloy) or a central post (titanium alloy).
The Anatomic Hemi-Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem (titanium alloy) an offset taper adapter (titanium alloy), a humeral head (cobaltchromium) (no glenoid component associated).
The provided text describes the regulatory clearance of a medical device, the INHANCE™ Reverse Shoulder System, and does not contain information about the performance of an AI/ML device. Therefore, it is not possible to answer the requested questions about acceptance criteria, study details, and AI performance.
The document focuses on demonstrating "substantial equivalence" of the device to previously cleared predicate devices through non-clinical testing. It explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the INHANCE™ Reverse Shoulder System to the predicate devices."
The non-clinical testing performed includes:
- Range of Motion (RoM) Evaluation: Met established specifications per ASTM F1378.
- Construct Fatigue Testing: Met acceptance criteria per ASTM F1378.
- Construct Loosening and Disassociation: Met acceptance criteria per ASTM F2028-17.
- Biocompatibility Assessments: Found to be biocompatible per ISO 10993-1 and FDA Guidance.
- Porous Structure Characterization: Identical to previously cleared devices.
- Characterization of VE-UHMWPE: Fully characterized in a previous submission (K202716).
- Evaluation of Wear Rate: Wear rate was lower than a predicate device, meeting acceptance criteria.
- MRI Compatibility: Quantitative data obtained per ASTM standards (F2052-15, F2213-17, F2182-19e2, F2119-07).
- Shelf Life Evaluation: A five-year shelf life established per ISO 11607-1 and ISO 11607-2.
- Sterilization Validation: Sterility Assurance Level (SAL) of 10^-9 found per ISO 11137-1 and ISO 11137-2.
These are all engineering and material performance tests for a physical implant, not an AI/ML algorithm or software.
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(231 days)
Aequalis Shoulder Range (except Aequalis for Fracture):
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:
- Degenerative pathologies: arthrosis, rheumatoid arthritis, post-traumatic arthrosis. . Primary and secondary necrosis of the humeral head
- Displaced 4-part upper humeral fracture i
- Humeral head fracture
- Humeral head fracture
Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are i not acceptable · - Revision surgery when other treatments or devices have failed. i
Aequalis monobloc stem is for use with cemented applications and is labeled as such. Aequalis Inditionio stem is for uncemented applications and is labeled as such.
Aequalis Press-Fit stem is for uncemented applications and is labels as such. Aequalis Fress-Fit sich is for uncemented applications ad is labeled as such.
Aequalis for Fracture:
Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral frequres Traumatic or pathologic concilibilis of the since as and displaced 3-or 4-part proximal humeral fractures.
joint, including humeral head fracture and displaced 3-or 4-part pr Revision surgery when other treatments or devices have failed.
Aequalis fracture stem is for cemented use.
Aequalis Reversed Shoulder Prosthesis:
Acqualis Reversed Shoulder Prosthesis is indicated for patients with a functional deltoid The Aequalis Reversed Shoulder Frosthesis is the relief of panin and significant disability
muscle as a total shoulder replacement for the relief off paint and significant Th following arthropathy associated to massive and non repairshe rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rolator colfis also indicated for the prosilent revisions whiles. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.
the bone with 4 screws and is for non-cention interest to be insufficient to bear When during the primary surgery the gions one accure occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw be adapted to the humeral
procedures, the hemi-prosthesis adaptor and the union screw cases in the humeral procedures, the nemi-prosthesis adaptor and the amon before and on reversed hemi-prosthesis.
hemi-prosthesis.
When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears When, in case of revision of a Aequalis Reverse of Aequalis Reversed range again, the to be insufficient to implant a baseptate and the union screw allows for the transformation of the use of the hemi-prosthesis adaptor and the amon serow and is to the morder to avoid the revision of the humeral components.
Aequalis Reversed Fracture Shoulder Prosthesis:
The Aequalis Reversed Fracture Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain or significant disability following arthropathy associated to a grossly deficient rotator cuff joint:
- in case of 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, or
- in case of bone defect in proximal humerus. ।
The Aequalis Reversed Fracture Shoulder Prosthesis is also indicated for prosthetic revisions with a grossly deficient rotator cuff joint when other treatments or devices have failed.
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 Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis.
When, in case of revision of a Aequalis Reversed Fracture Shoulder Prosthesis, the glenoid bone stock appears to be insufficient to implant a base plate and a sphere of Aequalis Reversed range again, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
The Aequalis Reversed Fracture Shoulder humeral stem is used in association with the glenoid components of the Aequalis Reversed Shoulder Prosthesis.
The Aegualis Reversed Fracture Shoulder humeral stem is for cemented use only.
For the Aequalis Fracture Shoulder System:
The usual goal of total shoulder replacement and hemi-arthroplasty of the shoulder is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The Aequalis Shoulder Fracture System is intended to accomplish these goals. With the Aequalis Shoulder Fracture System, the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease or injury. Thus the Aequalis Shoulder Fracture System is intended for use as a total shoulder replacement system, or as a hemi-shoulder. The modular nature of the system allows for the later conversion of a primary hemi-arthroplasty to a total shoulder replacement.
For the Aequalis Reversed Shoulder Prosthesis:
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 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.
For the Aequalis Reversed Fracture Shoulder Prosthesis:
The Aequalis Reversed Fracture Shoulder Prosthesis is intended to relieve pain or significant disability following massive 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 surgery is to restore the shoulder joint to facilitate its working condition and to reduce or eliminate pain. The Aequalis Reversed Fracture 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 and its Aequalis Fracture Shoulder humeral stem-like design allows to facilitate the bone reconstruction and improve the tuberosity healing and fixation.
The Aequalis Reversed Fracture Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.
The present submission corresponds to the following modification:
- Addition of a new coating subcontractor (hydroxyapatite coating): APS Materials, Inc. on . titanium components (stem and baseplate).
All the prostheses of this file are strictly identical to the previously cleared devices except for the coating supplier. The indications for use of each device are not modified.
I am sorry, but the provided text from the FDA 510(k) Premarket Notification for the Aequalis Shoulder Fracture System and related prostheses does not include information about acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets such criteria.
The document is a clearance letter and a summary of safety and effectiveness for a physical medical device (shoulder prostheses). It discusses:
- Device Names: Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture Shoulder Prosthesis.
- Regulatory Information: Regulation number, regulation name, product codes, regulatory class (Class II).
- Indications for Use: Detailed descriptions of the medical conditions for which each type of shoulder prosthesis is intended.
- Device Description: Information on the components, their function, and the surgical goals.
- Materials: Specifically mentions titanium alloy (Ti6Al4V) and hydroxyapatite coating, and a new coating subcontractor (APS Materials, Inc.).
- Predicate Devices: Lists previously cleared devices to which the current devices are compared for substantial equivalence.
There is no mention of:
- AI/Machine Learning: No algorithm, software, or AI component is described.
- Acceptance Criteria for AI Performance: No metrics like sensitivity, specificity, AUC, or other performance thresholds are stipulated.
- Clinical Study for AI Validation: No details of a study with a test set, ground truth establishment, expert adjudication, or MRMC studies are present.
- Training Data: No information on training sets for an AI model.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI/SaMD device meets them based on the provided text. The document pertains to the clearance of traditional orthopedic implants.
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(107 days)
Cemented Acqualis 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 hemi-prosthesis 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 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.
Uncemented Acqualis 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 cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. The humeral components are for non-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 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 into 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 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 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 present device modification submission consists of:
- the addition of humeral stems with hydroxylapatite coating,
- the addition of 2 sizes of metaphyses with hydroxylapatite coating, •
- the update of the Aequalis Reversed Shoulder Prosthesis indications for use. .
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.
The document is a 510(k) premarket notification for the "Aequalis Reversed Shoulder Prosthesis," a traditional medical device (implantable shoulder prosthesis). It focuses on demonstrating substantial equivalence to predicate devices, not on evaluating the performance of an AI/ML algorithm.
Therefore, I cannot provide the requested information, which includes:
- Acceptance criteria table
- Sample size and data provenance for test sets
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone algorithm performance
- Type of ground truth used
- Sample size for training set
- Ground truth establishment for training set
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(28 days)
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 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.
The provided document is a 510(k) premarket notification summary for a medical device, the DePuy Delta Xtend™ Reverse Shoulder System. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed study results against specific acceptance criteria for performance.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets them, in the context of an AI/algorithm-driven device.
The questions you've asked (about acceptance criteria, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) are typically relevant for the regulatory review of AI/ML-enabled medical devices or diagnostic tools. The DePuy Delta Xtend™ Reverse Shoulder System is a physical orthopedic implant and its 510(k) submission process does not involve the types of performance studies you're inquiring about for AI-based systems.
To directly answer your request based on the provided text, while acknowledging it doesn't fit the AI/ML framework of your questions:
1. A table of acceptance criteria and the reported device performance
- Response: Not applicable. The document does not define explicit "acceptance criteria" in terms of statistical performance metrics (e.g., sensitivity, specificity, AUC) or report device performance against such metrics. The basis for clearance is "substantial equivalence" to predicate devices, meaning the device is considered as safe and effective as a legally marketed device.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Response: Not applicable. This document does not describe a clinical performance study with a test set. Substantial equivalence for this type of device is typically demonstrated through bench testing (e.g., mechanical properties, wear), biocompatibility testing, and comparison of design, materials, and intended use to predicate devices, not through performance metrics on a clinical test set.
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)
- Response: Not applicable. No clinical test set or ground truth establishment by experts is described in this regulatory submission for a physical implant.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Response: Not applicable. No clinical test set or expert adjudication is described.
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
- Response: Not applicable. This device is a physical orthopedic implant, not an AI-assisted diagnostic tool. Therefore, MRMC studies are irrelevant to its regulatory clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Response: Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Response: Not applicable. No ground truth is established as part of this type of regulatory submission for a physical orthopedic implant.
8. The sample size for the training set
- Response: 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
- Response: Not applicable. No training set or ground truth establishment for a training set is relevant to this device.
In summary, the provided document is a 510(k) premarket notification for an orthopedic implant. It demonstrates substantial equivalence to existing devices based on characteristics like indications for use, materials, design, and manufacturing processes, rather than through clinical performance studies against specific quantitative acceptance criteria or the use of AI/ML algorithms.
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(88 days)
The Aequalis Reversed Fracture Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain or significant disability following arthropathy associated to a grossly deficient rotator cuff joint :
- in case of 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, or
- in case of bone defect in proximal humerus. .
The Aequalis Reversed Fracture Shoulder Prosthesis is also indicated for prosthetic revisions with a grossly deficient rotator cuff joint when other treatments or devices have failed.
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 Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis.
When, in case of revision of a Aequalis Reversed Fracture Shoulder humeral stem, the glenoid bone stock appears to be insufficient to implant a base plate and a sphere of Aequalis Reversed range again, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
The Aequalis Reversed Fracture Shoulder humeral stem is used in association with the glenoid components of the Aequalis Reversed Shoulder Prosthesis.
The Aequalis Reversed Fracture Shoulder humeral stem is for cemented use only.
The Aequalis Reversed Fracture Shoulder Prosthesis is intended to relieve pain or significant disability following massive 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 deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional.
Therefore, the usual goal of surgery is to restore the shoulder joint to facilitate its working condition and to reduce or eliminate pain. The Aequalis Reversed Fracture 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 and its Aequalis Fracture Shoulder humeral stem-like design allows to facilitate the bone reconstruction and improve the tuberosity healing and fixation.
The Aequalis Reversed Fracture Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.
This document is a 510(k) premarket notification for the "Aequalis Reversed Fracture Shoulder Prosthesis." It outlines the device's indications for use, materials, and provides a comparative analysis to predicate devices to establish substantial equivalence.
Based on the provided text, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
This document describes a medical device (Aequalis Reversed Fracture Shoulder Prosthesis) and its substantial equivalence to predicate devices, rather than an AI/software device. Therefore, the concept of "acceptance criteria" as typically applied to performance metrics like sensitivity, specificity, or accuracy for an AI system is not directly applicable here.
Instead, the "acceptance criteria" implicitly referred to are the regulatory requirements for showing substantial equivalence to legally marketed predicate devices, as defined by the FDA's 510(k) process. This involves demonstrating that the new device is as safe and effective as the predicate device(s). The document indicates that the device meets these criteria as the FDA issued a "substantially equivalent letter."
The "reported device performance" is not quantified in terms of clinical outcomes or performance metrics in this document, but rather in terms of its design, materials, and intended use being comparable to existing devices already deemed safe and effective.
| Acceptance Criteria (Implied for 510(k) Clearance) | Reported Device Performance (as per document) |
|---|---|
| Substantial Equivalence to Legally Marketed Predicate Devices | The FDA has determined the device is substantially equivalent for the stated indications for use to legally marketed predicate devices. This implies that the Tornier Aequalis Reversed Fracture Shoulder Prosthesis is considered as safe and effective as the predicate devices. This assessment is based on comparisons in design, materials, and intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document is a regulatory submission for a medical implant (a shoulder prosthesis), not a study evaluating an AI device's performance. Therefore, there is no test set, sample size, or data provenance information related to an AI algorithm's evaluation. The evaluation is based on a comparison to predicate devices, materials testing, and design specifications.
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 this is a medical device submission, not an AI study requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is a medical device submission.
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, as this is a medical device submission, not an AI or software device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a medical device submission, not an AI or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this medical device, the "ground truth" for regulatory clearance is the established safety and effectiveness of the legally marketed predicate devices. The new device demonstrates substantial equivalence by showing similar technological characteristics, materials, and intended use, supported by engineering testing and clinical experience with similar devices, rather than a specific "ground truth" derived from patient data in the context of an AI algorithm validation.
8. The sample size for the training set
Not applicable, as this is a physical medical device submission, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is a physical medical device submission.
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(32 days)
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.
The provided document is a 510(k) premarket notification letter from the FDA regarding the DePuy Delta Xtend Reverse Shoulder System. This document does not contain information about acceptance criteria or a study proving that a device meets those criteria.
Instead, this document focuses on:
- Substantial Equivalence: The FDA's determination that the DePuy Delta Xtend Reverse Shoulder System (specifically the High Mobility Cup) is substantially equivalent to previously cleared devices (Delta Xtend Reverse Shoulder System, K062250 and K071379). This means the FDA believes the new device is as safe and effective as existing legally marketed predicate devices.
- Indications for Use: The medical conditions for which the device is intended.
- Device Description: A brief overview of the device's design and components.
- Regulatory Classification: The device's classification (Class II) and associated regulations.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text. This type of detailed study information is typically found in a clinical study report or a more comprehensive technical document, not in a 510(k) clearance letter.
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