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510(k) Data Aggregation
(86 days)
The WMT Modular Shoulder is indicated for use in shoulder arthroplasty for reduction or relief of pain and/or improved shoulder function in skeletally mature patients with sufficient and satisfactory bone stock to support the prosthesis with the following conditions:
Indications for Use:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis or post-traumatic arthritis;
- Revision where other devices or treatments have failed;
- Correction of functional deformity;
- Treatment of acute fracture of the humeral head unmanageable using other treatment methods; and
- Cuff tear arthroplasty.
Hemi-shoulder replacement is also indicated for:
- Ununited humeral head fractures; and
- Avascular necrosis of the humeral head.
The humeral stem may be implanted by press-fit or cement fixation.
The WMT ULTRA-FITTM Modular Shoulder System consists of three main components: humeral stem, humeral head, and glenoid implants. All heads will be interchangeable with all stems, and glenoids will be matched to humeral heads. The glenoids will be available in two designs: The 3M-like glenoids are identical in intended use, type of interface, material, and design features to the 3M glenoid component submitted under 3M Modular Shoulder System (Table 1: K920362, SE 07/22/1993) currently distributed by WMT; and the WMT ULTRA-FITTM Glenoids that are described below.
The WMT ULTRA-FIT™ Humeral Stems will be available in four options:
- Press-fit slotted stems (4): 10,12,14,16mm X 125mm
- Cemented or press-fit non-slotted stems (7): 6, 8, 10, 12, 14, 16mm X 125mm; . 6mm X110mm
- Standard revision stems (4): 6, 8, 10, 12mm X 175mm
- Long revision stems (4): 6, 8, 10, 12mm X 225mm
The WMT ULTRA-FITTM Humeral Heads will be available in:
- 5 radii of curvature: 20, 22, 24, 26, and 28mm
- 3 heights: standard (defined by 155° to 160° arc), +3mm, and -3mm
The WMT ULTRA-FIT™ Glenoids will be available in:
- 6 radii of curvature (Keeled)
This 510(k) summary for the WMT ULTRA-FIT™ Modular Shoulder System does not contain the kind of detailed information about acceptance criteria and study design that would be found in a study proving a device meets acceptance criteria, especially not for an AI/ML device.
Here's why and what information is missing:
This document is a 510(k) Summary of Safety and Effectiveness, which is a premarket submission to the FDA for medical devices. The primary purpose of a 510(k) is to demonstrate substantial equivalence to a predicate device already legally marketed in the U.S., not to prove performance against specific acceptance criteria through a detailed clinical or performance study in the way an AI/ML device would.
The document primarily focuses on:
- Intended Use and Indications for Use: Stating what the device is for.
- Device Description: Explaining its components and variations.
- Substantial Equivalence Argument: Comparing it to legally marketed predicate devices (other modular shoulder systems) based on intended use, materials, type of interface, and design features.
Therefore, the requested information about acceptance criteria, study sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI/ML context is not present in this document.
To answer your request, here's what we can infer and what is explicitly missing from the provided text:
Acceptance Criteria and Device Performance
Since this is a 510(k) for a traditional medical device (shoulder prosthesis), the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The "performance" is considered equivalent to those predicates based on design and material similarities, rather than through specific quantitative metrics presented in this summary.
| Acceptance Criteria (Implied for 510(k) Submission) | Reported Device Performance (Implied from Substantial Equivalence Basis) |
|---|---|
| Substantial Equivalence to Predicate Devices: | |
| - Intended Use | Meets: Indications for Use are listed as substantially equivalent to cleared total shoulder systems (Table 1). |
| - Material | Meets: Stated as substantially equivalent to competitive devices. |
| - Type of Interface | Meets: Stated as substantially equivalent to competitive devices. |
| - Design Features | Meets: Stated as substantially equivalent to competitive devices. |
| Safety and Effectiveness | Meets: "Adequately supported by the substantial equivalence information, materials data, and testing results provided, within this Premarket Notification." (Detailed testing results are not in this summary). |
Missing Information (as it pertains to an AI/ML device study)
The following information, relevant for evaluating an AI/ML device's performance against detailed acceptance criteria, is not available in this 510(k) summary because it's for a traditional device demonstrating substantial equivalence:
- Sample size used for the test set and the data provenance: Not applicable/Not provided. The 510(k) doesn't describe a specific "test set" in the context of an AI/ML algorithm's performance evaluation. The data supporting substantial equivalence would likely come from design verification/validation testing for the physical device (e.g., mechanical testing, biocompatibility), not a clinical data set for algorithm evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth establishment is not described for this type of device submission.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an implant, not an AI diagnostic or assistance tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided.
- The sample size for the training set: Not applicable/Not provided.
- How the ground truth for the training set was established: Not applicable/Not provided.
In essence, this document is a regulatory filing for a physical medical implant (a shoulder replacement system), and thus the framework for evaluating and describing an AI/ML diagnostic or assistive device's performance against acceptance criteria does not apply here. The "proof" for this device lies in its demonstrated equivalence to already approved predicate devices.
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(72 days)
The WMT Modular Shoulder System, humeral head and stem, is intended to be used for total or hemi-arthroplasty. When used for total shoulder arthroplasty, the subject components are to be used with shoulder artill oplaar glenoid components cleared in K920362 or with 3M Neer IITM Shoulder (K895226, SE 11/3/89) compatible glenoid components.
Indications for Use:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- Revision where other devices or treatments have failed;
- Correction of functional deformity;
- Treatment of acute fracture of the humeral-head unmanageable using other treatment methods; and
- Cuff tear arthroplasty.
Hemi-shoulder replacement is also indicated for:
- Ununited humeral head fractures; and
- Avascular necrosis of the humeral head.
The humeral stem may be implanted by press-fit or cement fixation.
The WMT Modular Shoulder System includes humeral heads in five sizes. A regular length and long length humeral stem are available in identical diameters. Both humeral stems have four proximal flanges: one lateral, two anterior/posterior and one medial. The lateral flange has three suture holes and the anterior/posterior fins have one suture hole each. Both the regular and long stems are manufactured from titanium alloy (ASTM F 136). The heads are manufactured from cobalt chrome (ASTM F 1537, warm worked or ASTM F 799).
The provided text is a 510(k) summary for the WMT Modular Shoulder System. It describes the device, its intended use, indications for use, and a summary of testing. However, it does not contain information about acceptance criteria, detailed study designs, or specific performance metrics that would be used to prove a device meets acceptance criteria in the context of an AI/ML medical device.
The "Testing Summary" section states: "The WMT Modular Shoulder System was declared substantially equivalent to the predicate device. Mechanical test data demonstrated that the material and subject device design meet the strength requirements of the predicate device."
This statement indicates that mechanical testing was performed to demonstrate that the physical and design properties of the shoulder system are comparable to a previously cleared predicate device. It doesn't present a clinical study with quantifiable performance metrics, acceptance criteria, or ground truth as would be expected for an AI/ML device.
Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies in the context of an AI/ML device from this document.
If this were an AI/ML device submission, the document would typically include:
- Acceptance Criteria Table: Specific thresholds for metrics like sensitivity, specificity, AUC, F1-score, accuracy, etc.
- Reported Device Performance: The actual measured values from the study for those metrics.
- Sample Size and Data Provenance: Details about the test set, including its size, origin (e.g., country), and whether it was retrospective or prospective.
- Ground Truth Experts: Number and qualifications of experts who established the ground truth.
- Adjudication Method: How disagreements among experts were resolved.
- MRMC Study: Information on comparative effectiveness studies, including effect sizes.
- Standalone Performance: If the algorithm was evaluated without human intervention.
- Type of Ground Truth: Whether pathology, consensus, or other methods were used.
- Training Set Details: Sample size and how ground truth was established for the training data.
Since this is a submission for a mechanical orthopedic implant, these types of details are not present.
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(113 days)
Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, theumatoid, or traumatic disease of the glenohumeral joint; ununited humeral head fractures of long duration; irreducible 3- and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. Humeral heads with heights greater than 27 mm may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional nonconstrained arthroplasty is not acceptable.
The New Zimmer Shoulder features modular and monoblock cobalt-chrome alloy humeral stems intended for use with or without cement in total shoulder arthroplasty. The cobaltchrome alloy humeral heads feature female Morse-type tapers which facilitate assembly with the modular humeral stems. The keeled glenoid component is manufactured from UHMWPE. It is intended for cemented use only.
The provided text describes a 510(k) submission for the "New Zimmer Shoulder System." This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria or specific numerical performance metrics for the New Zimmer Shoulder System. Instead, it states:
| Criterion | Reported Performance |
|---|---|
| Taper performance | "demonstrated that the New Zimmer Shoulder System is safe and effective and substantially equivalent to predicate devices." |
| Glenoid component performance | "demonstrated that the New Zimmer Shoulder System is safe and effective and substantially equivalent to predicate devices." |
2. Sample Size for the Test Set and Data Provenance
The document does not provide details on the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The "Performance Testing" section states that "Testing performed on the taper and the glenoid component demonstrated that the New Zimmer Shoulder System is safe and effective and substantially equivalent to predicate devices," but it does not specify what type of testing or how many samples were involved.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the use of experts to establish ground truth or their qualifications. The testing described appears to be device-specific mechanical or functional testing rather than clinical evaluation requiring expert consensus on patient data.
4. Adjudication Method for the Test Set
No adjudication method is mentioned, as there is no indication of human-reviewed test sets or expert evaluations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence through component testing, not direct comparison of human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the device is a physical shoulder joint prosthesis, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device would be based on engineering specifications, material science standards, and biomechanical parameters that define the safety and effectiveness of the components (taper and glenoid). The summary indicates that the testing demonstrated "safe and effective and substantially equivalent to predicate devices," implying that the performance was measured against established standards for shoulder prostheses.
8. Sample Size for the Training Set
This is not applicable as the device is a physical shoulder prosthesis, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as the device is a physical shoulder prosthesis, not an AI algorithm.
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