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The AETOS Shoulder System (when used with the AETOS Humeral Meta Stems) 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 AETOS humeral stems (AETOS Humeral Meta Stems) 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.

When used with the AETOS Humeral Meta Stems, The AETOS Shoulder System is indicated for use as a replacement of shoulder joints disabled by:

• Rheumatoid arthritis
• Non-inflammatory degenerative joint disease
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of other devices if sufficient bone stock remains

The AETOS Shoulder System (when used with AETOS Stemless Humeral Prosthesis) is to be used only in patients with an intact or reconstructable rotator cuff.

When used with AETOS Stemless Humeral Prosthesis, the AETOS Shoulder System is indicated for anatomic total shoulder replacement of shoulder joints disabled by:

• Non-inflammatory degenerative joint disease
• Traumatic arthritis
• Revision of other devices if sufficient bone stock remains

The coated humeral components are intended for uncemented use. The glenoid component is intended for cemented use only.

In Reverse:

The AETOS Shoulder System, when used with AETOS Humeral Meta Stems, 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
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of devices if sufficient bone stock remains

The humeral liner component is indicated for use in the AETOS Shoulder System as a primary reverse total shoulder replacement and for use when converting an anatomic AETOS Shoulder System into a reverse shoulder construct. This facilitates the conversion without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The component is permitted to be used in the conversion from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthroplasty is associated with a massive and non-repairable rotator cuff tear.

The coated humeral stems are indicated for uncemented use. The coated glenoid base plate is intended for cementless application with the addition of screws for fixation.

The AETOS Stemless Humeral Prosthesis subject to this submission is a humeral anchor intended for press-fit fixation as part of an implant construct in anatomic total shoulder arthroplasty for the treatment of skeletally mature individuals with degenerative diseases of the glenohumeral joint.

N/A

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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

Fixation Methods:

The humeral stemless anchor is intended for cementless use. The anatomic glenoid and anatomic hybrid glenoid are intended for cemented use only.

The INHANCE INTACT™ instruments are intended to be used during orthopedic surgery with INHANCE™ Anatomic Stemless Shoulder System. Cases and trays are intended to hold joint reconstruction instruments during the sterilization process and for storage.

The current submission adds INHANCE INTACT™ Instruments to the INHANCE Stemless Anatomic Shoulder System. The implant components of the system are unchanged. The INHANCEINTACT™ Instruments are designed to facilitate a subscapularis sparing total shoulder arthroplasty for the INHANCE™ Anatomic Stemless Shoulder System.

The INHANCETM SHOULDER SYSTEM with a humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures.

The Anatomic Total Shoulder Prosthesis of individually packaged implants: a humeral stemless anchor (titanium alloy), an offset taper adapter (titanium alloy), a humeral head (cobalt- chromium) in combination with an anatomic glenoid (stainless steel x-ray marker pin embedded) or an anatomic hybrid glenoid featuring a metal central post (titanium alloy). All glenoid implants have a Cross-Linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-Linked, VE UHMWPE) bearing surface.

The provided submission does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found for an AI/ML medical device. This document describes a traditional medical device (shoulder joint prosthesis and associated instruments), not an AI/ML-driven diagnostic or therapeutic aid.

Therefore, the requested information elements (acceptance criteria table, sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and training set ground truth establishment) are not applicable or extractable from this 510(k) summary for an AI/ML device.

Here's a breakdown of what the document does state about testing and equivalence, in the context of a traditional medical device:

The submission focuses on demonstrating substantial equivalence of the "INHANCE INTACT™ Instruments" to predicate devices (K203108 and K212933) for use with the existing "INHANCE™ Anatomic Stemless Shoulder System."

Key points from the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section:

• No AI/ML Component: The device is a traditional orthopedic implant system and instruments. There is no mention of algorithms, AI, machine learning, or software functionality that would require performance metrics like sensitivity, specificity, or AUC against a ground truth.
• Implant Components Unchanged: The implant components of the INHANCE Shoulder System are identical to those of the predicate device.
• Focus on Instruments: The submission is primarily for the "INHANCE INTACT™ Instruments," which are new designs intended to facilitate a subscapularis sparing total shoulder arthroplasty.
• Non-Clinical Testing Only: "Clinical testing was not required to demonstrate substantial equivalence."
• Types of Non-Clinical Testing:
  • Biocompatibility Assessments: Conducted per ISO 10993-1 and FDA Guidance documents. The devices were found to be biocompatible.
  • Bench Testing: Covered "Design equivalence, equivalence of use of the device, material rationale and biocompatibility evaluation."

Therefore, I cannot populate the requested table and information points as they relate to AI/ML device performance criteria and studies. The provided text does not contain any of that specific kind of information.

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Anatomic Total Shoulder Applications:

· Osteoarthritis

• The patient must be anatomically and structurally suited, as evident by scapula and proximal humerus closure, to receive the implants.

OsseoFit™ Stemless Shoulder humeral components have a porous surface and are indicated for uncemented biological fixation applications.

Compatible Glenoid components are intended to be implanted with bone cement. The porous posts may be inserted without bone cement.

Compatible Convertible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation.

The OsseoFit™ Stemless Shoulder System consists of a stemless humeral head adapter for anatomic total shoulder applications. The OsseoFit humeral implant is an anatomical (left/right specific), asymmetric humeral anchor with six fins whose location, length, and height vary. The OsseoFit humeral implants are available in Onlay and Inlay variants. The Onlay implants sit on top of the prepared bone while the Inlay implants have a dished superior portion with a shorter fin length to sit within the bone. The OsseoFit Humeral Implant also includes anterior suture holes for soft tissue attachment.

The humeral implants are manufactured through additive manufacturing which includes areas of OsseoTi porous technology to allow biological fixation.

The OsseoFit Stemless Shoulder System is intended for cementless applications and is designed to be used with a compatible Identity Shoulder System (K213856) humeral head. The Identity Humeral Head is assembled to the OsseoFit Humeral Head Adapter via a locking taper by a disposable impactor that is packaged together with the head adapter. The Identity heads can be used with a compatible Alliance Glenoid Implant (K191814 and K193180) or Comprehensive Convertible Baseplate liner (K211729).

The provided text describes the regulatory filing for the OsseoFit Stemless Shoulder System, a medical device. It focuses on demonstrating substantial equivalence to existing predicate devices, primarily through non-clinical testing.

However, the document does not contain any information about a study that assesses the device's performance against specific acceptance criteria in terms of algorithm or diagnostic accuracy, or human reader improvement with AI assistance. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states "Clinical Tests: None Provided." The non-clinical tests listed are related to the mechanical and material properties of the device (e.g., fatigue testing, micromotion testing, MRI compatibility, porous coating characterization, manufacturing validation), not to an AI component or a diagnostic performance study.

Therefore, I cannot provide details on:

1. A table of acceptance criteria and the reported device performance: This information is not present as there's no mention of a performance study in the context of diagnostic accuracy or AI.
2. Sample size used for the test set and the data provenance: No such test set or data are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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: The document clearly states "Clinical Tests: None Provided." There is no mention of an AI component or human reader study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No algorithm or standalone performance is discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in this context.
8. The sample size for the training set: Not applicable as there's no mention of an AI model or training.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a medical implant, focusing on its mechanical, material, and design characteristics relative to predicate devices. It does not contain information about studies measuring diagnostic performance, AI performance, or human reader effectiveness with AI assistance.

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In Anatomic:
The AETOS Shoulder System (when used with the AETOS Humeral Meta Stems) 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 AETOS humeral stems (AETOS Humeral Meta Stems) and head may be used by themselves, as a hemiarthroplasty, if the natural dlenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. When used with the AETOS Humeral Meta Stems, The AETOS Shoulder System is indicated for use as a replacement of shoulder joints disabled by:

• Rheumatoid arthritis
• · Non-inflammatory degenerative ioint disease
• · Correction of functional deformity
• · Fractures of the humeral head
• · Traumatic arthritis
• Revision of other devices if sufficient bone stock remains

The AETOS Shoulder System (when used with AETOS Stemless Humeral Prosthesis) is to be used only in patients with an intact or reconstructable rotator cuff.

When used with AETOS Stemless Humeral Prosthesis, the AETOS Shoulder System is indicated for anatomic total shoulder replacement of shoulder joints disabled by:

• · Non-inflammatory degenerative joint disease
• · Traumatic arthritis
• Revision of other devices if sufficient bone stock remains

The coated humeral components are intended for uncemented use. The glenoid component is intended for cemented use only.

In Reverse:
The AETOS Shoulder System, when used with AETOS Humeral Meta Stems, 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
• · Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• · Revision of devices if sufficient bone stock remains

The humeral liner component is indicated for use in the AETOS Shoulder System as a primary reverse total shoulder replacement and for use when converting an anatomic AETOS Shoulder System into a reverse shoulder construct. This facilitates the conversion without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The component is permitted to be used in the conversion from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthroplasty is associated with a massive and non-repairable rotator cuff tear.

The coated humeral stems are indicated for uncemented use. The coated glenoid base plate is intended for cementless application with the addition of screws for fixation.

Note: All implant components are single use.

The AETOS Stemless Humeral Prosthesis subject to this submission is a humeral anchor intended for press-fit fixation as part of an implant construct in anatomic total shoulder arthroplasty for the treatment of skeletally mature individuals with degenerative diseases of the glenohumeral joint.

This FDA submission (K240716) for the AETOS Shoulder System Stemless Humeral Prosthesis does not describe an AI/ML medical device. Therefore, it does not include information on acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies that are typically associated with the evaluation of AI/ML software.

The submission focuses on the substantial equivalence of a new medical implant (a stemless humeral prosthesis) to previously cleared predicate devices. The evaluation criteria for this type of device are primarily based on non-clinical performance data, such as:

• Construct fatigue and corrosion resistance assessment
• Post-fatigue stability
• Static disengagement
• Dynamic stability / loosening
• Bone volume and contact analysis

The document explicitly states: "Clinical performance data were not necessary to demonstrate substantial equivalence of the subject device." This confirms that a clinical study, which would typically involve human readers or an AI algorithm, was not conducted or required for this submission.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance as it pertains to an AI/ML medical device, because this submission is for a physical orthopedic implant and does not involve AI/ML.

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The SMR Stemless Anatomic is indicated for total primary or revision shoulder joint replacement in patients suffering from disability due to:

· non-inflammatory degenerative joint disease including osteoarthritis;

• revision of previous surgeries of the shoulder that do not compromise the fixation (such as a failed SMR resurfacing implant);

· glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only).

The SMR Stemless Anatomic is intended for uncemented use.

The SMR Stemless Anatomic is a modular system comprised of a stemless core and humeral head adaptor taper. The modular components are available in various sizes and are interchangeable allowing for independent sizing and positioning. The SMR humeral heads were previously cleared (K161476, K100858), and the SMR Stemless Anatomic is compatible with the previously cleared Cemented SMR metal back Glenoid Components (K113254, K133349, K143256), Cemented SMR all polyethylene glenoid components (K100858, K130642, K153722), and SMR TT Hybrid Glenoid System (K163397).

This document is a 510(k) clearance letter from the FDA for a medical device called the "SMR Stemless Anatomic." It's not a study report of an AI/ML powered medical device, and therefore does not contain the information requested in the prompt regarding acceptance criteria, study methodologies for AI performance, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML product.

The document discusses performance testing for a mechanical orthopedic implant, specifically a shoulder joint prosthesis, covering aspects like fatigue, micromotion, and pull-out strength. It also mentions "Clinical Data" related to the device's success in patients, comparing it to a predicate device. This is a traditional medical device clearance, not an AI/ML software as a medical device (SaMD) or AI-powered medical device.

Therefore, I cannot extract the requested information (table of acceptance criteria with AI performance, sample sizes for AI test sets, expert details for AI ground truth, MRMC studies, etc.) from this document. The concepts and methodologies described in the prompt are specific to the evaluation and clearance of AI/ML-driven medical devices, which this document does not concern.

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The nucleus, humeral head coupler and humeral head are used in conjunction with a glenoid implant as a total replacement.

The Tornier Perform® Humeral System - Stemless is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide mobility, stability, and to relieve pain. The Tornier Perform Humeral System -Stemless is indicated for use as a replacement of shoulder joints disabled by:

• · Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
• · Post-traumatic arthritis

Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients without a suspected material sensitivity to cobalt alloy.

All components are single use and intended for cementless use.

The Tornier Perform Humeral System - Stemless is intended to be used with cemented polyethylene glenoid components, in an anatomic total shoulder arthroplasty.

The Tornier Perform Humeral System - Stemless is metaphyseal humeral system intended for anatomic total shoulder arthroplasty. The Perform Humeral System - Stemless is implanted with existing Tornier anatomic glenoid systems.

The Tornier Perform Humeral System – Stemless includes new titanium nucleus components and previously-cleared modular humeral heads (K201315). The system also includes reusable instruments used to implant the shoulder prosthesis.

The provided document is a 510(k) premarket notification for a medical device, the Tornier Perform Humeral System - Stemless. This type of submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than clinical studies proving acceptance criteria through device performance.

Therefore, the requested information on acceptance criteria and a study proving the device meets those criteria, specifically concerning human performance, is largely not applicable to this document. The document explicitly states: "No clinical studies were performed."

However, I can extract information about the non-clinical testing performed to demonstrate substantial equivalence, which serves a similar purpose in the context of a 510(k) by showing the device performs comparably to an already cleared device.

Here's a breakdown of the available information based on your request:

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

Since no clinical studies were performed to establish performance against pre-defined acceptance criteria in terms of human-in-the-loop performance or diagnostic accuracy, such a table cannot be created from this document. The document focuses on demonstrating substantial equivalence to an existing predicate device through non-clinical performance testing.

The types of "performance" mentioned are related to mechanical and material properties:

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. No "test set" in the context of clinical or AI performance evaluation was used. The testing was non-clinical (laboratory/mechanical).

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

Not applicable. No "ground truth" for a test set based on expert review was established or required for this type of submission focused on mechanical device equivalence.

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

Not applicable. No "test set" requiring adjudication by experts 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 is a mechanical orthopedic implant, not an AI-assisted diagnostic or therapeutic device that would involve human "readers" or AI assistance in that context.

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

Not applicable. This is a mechanical orthopedic implant, not an algorithm or AI.

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

Not applicable. The "ground truth" for the non-clinical tests would have been established engineering specifications, material standards, and performance of the predicate device.

8. The sample size for the training set:

Not applicable. This is a mechanical orthopedic implant, not an AI or algorithm that requires a training set.

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

Not applicable.

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The Shoulder Innovations Total Shoulder System with Humeral Stemless is intended for use as an orthopedic implant for total shoulder arthroplasty to treat severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis.

The Shoulder Innovations Total Shoulder System components are intended for single use only.

The Humeral Stemless components are indicated for press-fit, un-cemented use. The glenoid component is intended for cemented fixation only.

The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads that articulate with a glenoid component. The humeral stems are collarless, as the humeral head acts as the collar, and manufactured from Titanium Alloy (Ti-GAL-4V) conforming to ASTM F136 with fins to provide rotational stability and are coated with a rough, porous coating. The stems have a female Morse-type taper to interface with the modular humeral heads. The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a male Morse-type taper to interface with the humeral stems.

The glenoid components of the Total Shoulder System are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE) with a pegged design intended for cemented fixation.

This submission adds Humeral Stemless Implants to the Shoulder Innovations Total Shoulder System. The Humeral Stemless Implants are similar to the previously cleared humeral short stems (K173824), except that the Humeral Stemless Implants do not include the stem. The Humeral Stemless Implants have fins to provide rotational stability and a female Morse-type taper to interface with modular humeral heads, identical to the humeral short stems (K173824). The Humeral Stemless Implants are manufactured from Titanium Alloy (Ti-6Al-4V) conforming to ASTM F136 with a proximal porous coating of commercially pure titanium according to ASTM F67.

The Humeral Stemless Implants are for press-fit, uncemented use. All Humeral Stemless Implants are compatible with the previously cleared Total Shoulder System humeral heads (K173824) and previously cleared Total Shoulder System glenoid components (K111596 and K192365).

The provided text is a 510(k) premarket notification for a medical device (Shoulder Innovations Total Shoulder System with Humeral Stemless). It outlines the device description, indications for use, and a summary of non-clinical testing and substantial equivalence to predicate and reference devices.

Crucially, it clearly states that "Clinical testing was not necessary to demonstrate substantial equivalence" for this device. This implies that the device's acceptance was based on non-clinical testing and a comparison to already cleared devices, rather than a clinical study evaluating its performance against specific clinical acceptance criteria.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets those criteria, as the document explicitly states no clinical study was performed for this specific submission to demonstrate substantial equivalence.

The provided text does not contain the information requested regarding acceptance criteria related to a clinical study proving device performance. There is no information about:

1. A table of acceptance criteria and reported device performance: No clinical performance metrics or predefined acceptance thresholds are mentioned.
2. Sample size used for the test set and data provenance: No clinical test set.
3. Number of experts used to establish ground truth and their qualifications: Not applicable, as no clinical ground truth was established from expert readings.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: No such study was conducted.
6. Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
7. Type of ground truth used: No clinical ground truth was used.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
9. How ground truth for the training set was established: Not applicable.

The document focuses on non-clinical testing (lever out, pull out, torque out, and fatigue testing) to demonstrate substantial equivalence based on mechanical properties and design similarity to predicate devices, rather than clinical efficacy or diagnostic performance.

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The Stemless Shoulder System is comprised of modular humeral heads to be used in total shoulder arthroplasty.

The Stemless Shoulder System is indicated for a severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis.

The Stemless humeral components are intended for press-fit fixation without the use of bone cements are intended only for use with bone cement.

The GLOBAL ICON Stemless Shoulder System includes cobalt-chromium alloy humeral heads that mate with titanium alloy anchor plates. The anchor plates include four grooved peripheral legs which are seated in the proximal humerus, and hydroxyapatite coating on all bone- contacting surfaces.

The document describes the GLOBAL ICON Stemless Shoulder System, a medical device for total shoulder arthroplasty. It details the device's indications for use, technological characteristics, and a summary of non-clinical and clinical tests conducted to demonstrate substantial equivalence to predicate devices.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the GLOBAL ICON Stemless Shoulder System were based on a composite success endpoint at 24 months post-operative in a clinical study. The criteria and reported performance are summarized in the table below:

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The clinical study included 128 subjects for the 24-month interim data analysis.
• Data Provenance: The document does not explicitly state the country of origin for the data. However, it is a submission to the U.S. Food & Drug Administration (FDA), indicating the device is intended for the U.S. market. The study is described as having "interim 24-month data," which suggests it is a prospective study (following subjects forward in time).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

The document does not provide details on the number or qualifications of experts used to establish ground truth for the test set. It mentions "Radiographs indicate" and "adjusted Constant-Murley score," suggesting these assessments were made by healthcare professionals, but specific qualifications (e.g., radiologist with X years of experience) or the number of such experts are not specified.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical outcomes or radiological assessments in the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document presents a clinical study evaluating the device's performance directly, not a comparative effectiveness study involving human readers with and without AI assistance for interpretation. The device itself is a physical medical implant, not an AI diagnostic tool.

6. Standalone Performance Study (Algorithm Only)

No. The device is a surgical implant (GLOBAL ICON Stemless Shoulder System), not an algorithm or AI software. Therefore, a standalone (algorithm only) performance study is not applicable. The clinical study evaluates the performance of the implanted device in human subjects.

7. Type of Ground Truth Used

The ground truth for the clinical study was established using a combination of:

• Radiological assessment: To determine the presence or absence of continuous radiolucent lines around the humeral component.
• Clinical outcome scores: Specifically, the adjusted Constant-Murley score, which is a functional assessment used in shoulder arthroplasty.
• Device integrity/removal data: Tracking whether the humeral component was removed for any reason.
• Adverse event reporting: Documentation of device-related serious adverse events.

8. Sample Size for the Training Set

The document describes a clinical study for device approval, not an algorithm's development. Therefore, there is no mention of a "training set" in the context of machine learning. The 128 subjects are part of the clinical evaluation for the device's performance.

9. How the Ground Truth for the Training Set Was Established

As this is not a study involving an AI algorithm that requires training data, the concept of establishing ground truth for a "training set" is not applicable to this document. The clinical study evaluated the device's performance in patients.

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The Ignite Stemless Anatomic Shoulder Prosthesis is intended for use in total shoulder replacement procedures to address the following:

• · Osteoarthritis;
• Posttraumatic arthrosis;
• · Focal avascular necrosis of the humeral head;
• · Previous surgeries of the shoulder that do not compromise the fixation.

The Ignite Stemless Anatomic Shoulder System is total shoulder arthroplasty system consisting of stemless humeral implants (multiple sizes), offset taper adapter, humeral heads (38 - 57mm diameters), and glenoid components (multiple sizes).

The anatomic stemless humeral construct consists of an additively manufactured Ti-6A1-4V Stemless Humeral Implant, a wrought Cobalt-Chromium Humeral Head, and a wrought Ti-6Al-4V Taper Adapter. The all-poly Anatomic Glenoid consists of a Highly Crosslinked Alpha-Tocopherol (Vitamin-E) infused Ultra-High-Molecular-Weight-Polyethylene articulation surface. This device also has a 316L stainless steel pin pressed into it as an x-ray marker.

The system is provided with a set of instruments designed for preparation of the implant site and insertion of the implants into bone.

The provided text describes the "Ignite Stemless Anatomic Shoulder System" and its FDA 510(k) clearance. This document pertains to a medical device (shoulder prosthesis) and not an AI/ML powered device. Therefore, many of the requested fields regarding acceptance criteria and study design for AI/ML devices are not applicable.

Here's the information that can be extracted or noted as not applicable based on the provided text:

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

Since this is a physical medical device clearance, the "acceptance criteria" are typically related to mechanical performance, material properties, and biocompatibility rather than AI/ML performance metrics like accuracy, sensitivity, or specificity. The text states that "acceptance criteria were met" for various tests.

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. The clearance is for a physical medical device, not an AI/ML system. Testing involved mechanical and material evaluations, not data sets for AI/ML.

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. Ground truth as typically defined for AI/ML (e.g., expert labels on images) is not relevant to the mechanical and material testing performed for this device.

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

Not applicable. Adjudication methods are relevant for resolving discrepancies in expert labeling or diagnoses for AI/ML output, not for physical device testing.

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-assisted device.

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

Not applicable. This is not an AI algorithm.

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

For a physical device like a shoulder prosthesis, "ground truth" would relate to accepted engineering standards, material properties, and biological responses.

• Mechanical Testing: Based on established industry standards (e.g., ASTM F1378, ASTM F1044, ASTM F1147, ASTM F1160, ASTM F1978, ASTM F1854, ASTM F2009) and "clinically relevant loading conditions."
• Biocompatibility: Based on ISO 10993-1 and FDA Guidance.
• Sterilization: Based on ISO 11137-1 and ISO 11137-2.
• Shelf Life: Based on ISO 11607-1 and ISO 11607-2.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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The Easytech® Anatomical Shoulder System is in total shoulder repacement to treat a severely painf il and/or disabled joint resulting from osteoarthritis.

The humeral stemless of the Easytech® Anatomical Shoulder is intended for cementless use only. The glencid components of the Easytech® Anatomical Shoulder System are intended for cemented use only.

The patient's joint must be anatomically suited to receive the selected implants and a functional rotator cuff is necessary to use the device.

The Easytech® Anatomical Shoulder is an anatomical shoulder prothesis designed for use in patients with a functional rotator cuff. The Easytech® humeral stemless (Anchor base) is used with a connector, a centered or offset humeral head, and a glenoid for use in an anatomical shoulder configuration.

This system is designed to articulate with a glenoid component for total shoulder arthroplasty. Subject of this submission is the cementless, stemless Humeral Anchor base that is part of the Easytech® Anatomical Shoulder System. The compatible components to complete the system have been cleared previously in K111097, K123814, and K163669.

The Easytech® Anchor base is a stemless prosthesis. The cementless Anchor base is available in diameters of 30 to 38 mm. The Anchor base has a main central post with striaes. In the periphery of the Anchor base, five retentives striaes are positioned to help with the primary fixation. The undersurface of the Anchor base, including the central post and retentive striaes, has a plasma sprayed CPTitanium and Hydroxyapatite coating without the superior surface and the female taper. The Anchor base incorporates a female taper for attachment of compatible components. This component is manufactured in Ti-6AI-4V ELI allov conforming to ISO 5832-3.

The Anchor base can be used with a straight taper connector or a centered spacer manufactured from Ti-6Al-4V ELI alloy conforming to ISO 5832-3, a centered or offset humeral head manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12 and a 2 pegs or 3 or 4 pegs cemented glenoid manufactured from ultra high molecular weight polyethylene (UHMWPE) conforming to ISO 5834-2 for use in an anatomical shoulder configuration.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: 129 patients (from an initial 141; 7 refused data sharing, 5 had non-osteoarthritis diagnoses).
   • Data Provenance: Retrospective, multi-center study conducted at 5 sites in France. This is described as "real-world evidence" reflecting clinical experience by orthopedic surgeons in community and clinic-based practices.

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

   • The document mentions "Independent radiograph review" was conducted, but does not specify the number of experts or their qualifications.

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

   • The document does not specify an adjudication method for the test set. It mentions "Independent radiograph review," suggesting individual assessment, but no mechanism for resolving discrepancies is detailed.

4. 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:

   • No MRMC comparative effectiveness study was done. This study is a clinical efficacy and safety study of a medical device (shoulder prosthesis) in patients, not an AI diagnostic tool's performance with human readers.

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

   • No standalone algorithm performance study was done. This is a study of a physical medical device.

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

   • The ground truth for the clinical success criteria was established using a combination of:
     • Clinical Outcomes Data: Adjusted Constant Score (a standardized patient outcome measure), Range of Motion measurements.
     • Radiographic Review: For migration, subsidence, radiolucencies, and implant integrity.
     • Event-Based Data: Absence of revision surgery, absence of serious adverse device events.

7. The sample size for the training set:

   • Not applicable/Not provided. This refers to a clinical study of a physical medical device, not a machine learning model that requires a training set. The "training" here would be general surgical training and experience.

8. How the ground truth for the training set was established:

   • Not applicable/Not provided. As above, this is for a physical device, not an AI/ML system.

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