(191 days)
Addresses proximal fractures when used with interlocking screws and arthritis of the shoulder joint.
The Acumed Modular Shoulder System is a semi-constrained modular component designed to address proximal fractures when used with interlocking screws and arthritis of the shoulder joint to with or without bone cement. It incorporates a cobalt chrome modular head, a titanium body, and a selles of the components may be mixed and matched in order to best duplicate the patient's anktomy. Several strategic holes for suturing are in the body the surgeon to tie down the greater- and lesser-tuberosities, which are frequently displaced during these types of fractures. Interlocking screws identical to those cleared by K942340 Cortical Boxe Screws are intended to provide rotational interlocking with the stems are cannulated and are intended to facilitate placement of the component over a previously inserted gtride wire. The component sizing and the geometrical placement of the head and stem are intended to allow the surgeon to duplicate the anatomic posterior offset in the humeral head. Targeting instrumentation is provided to allow accurate of the screws through the component.
The provided text is a 510(k) summary for a medical device called the "Acumed Modular Shoulder System." This document is for a shoulder implant (prosthetic device), not an AI/ML-based device. Therefore, the questions related to AI/ML device performance (such as sample size for test sets, experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable to this document.
The document focuses on demonstrating substantial equivalence to previously approved predicate devices, primarily the Atlas Modular Shoulder (K961260) and the Select Shoulder System (K962224). The manufacturer's claim of safety and effectiveness is based on these similarities.
Here's the relevant information that can be extracted:
1. Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable way typically seen for AI/ML performance. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The "performance" described is in terms of the device's design, materials, and intended use being similar to existing, legally marketed devices.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as presented in the 510(k) summary) |
|---|---|
| Similarity in Design: Components (head, body, stem), features (suturing holes), tapered stem. | "This device is most similar in design to the Atlas Modular shoulder in that both devices consist of a head, body, and stem components, have holes for suturing, and have a Morse tapered stem." |
| "The component sizing and the geometrical placement of the head and stem are intended to allow the surgeon to duplicate the anatomic posterior offset in the humeral head." | |
| "Interlocking screws identical to those cleared by K942340 Cortical Boxe Screws are intended to provide rotational interlocking with the stems are cannulated and are intended to facilitate placement of the component over a previously inserted gtride wire." | |
| "Targeting instrumentation is provided to allow accurate of the screws through the component." | |
| Similarity in Material: Construction materials. | "All the devices mentioned above are manufactured from similar materials..." (referring to Atlas Modular Shoulder and Intermedics Select Shoulder). |
| "It incorporates a cobalt chrome modular head, a titanium body..." | |
| Similarity in Intended Use: Addresses proximal fractures and arthritis of the shoulder joint. | "The Acumed Modular Shoulder System is a semi-constrained modular component designed to address proximal fractures when used with interlocking screws and arthritis of the shoulder joint to with or without bone cement." |
| "All the devices mentioned above... have the same intended use." | |
| Adequate Locking Strength: The taper selected provides sufficient strength. | "Test data provided concludes that the taper selected for the Acumed Modular Shoulder System will provide adequate locking strength for this application." (No specific quantitative data for locking strength is provided in this summary). |
| Sterility Assurance: Device can be sterilized to appropriate levels. | "Sterility is achieved by a minimum of 2.5 megarads gamma radiation. Verification of sterlity is performed using the AAMI - Method 1. Sterllity assurance level is 10⁻⁶." |
| "On file at Acumed is data which shows that the instrumentation and implant can be successfilly steam sterilized under specific process parameters which will obtain a resulting SAL of 10⁻⁴." | |
| Safety and Effectiveness: Expected to be similar to predicate devices based on the above similarities. | "Based on the similarities between the Acumed Modular System and the predicate devices studied, the safety and effectiveness of the Acumed Modular System is expected to be similar to the prodicate devices mentioned above." |
2. Sample size used for the test set and the data provenance: Not applicable (this is not an AI/ML device study). The "test set" would be the device itself undergoing various engineering tests (e.g., sterilization, taper strength), but specific sample sizes for such tests are not detailed in this summary.
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 (e.g. 2+1, 3+1, none) 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: Not applicable (this is not an AI/ML device).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this type of device, "ground truth" relates to engineering and biocompatibility standards. The document mentions:
* Engineering Test Data: "Test data provided concludes that the taper selected for the Acumed Modular Shoulder System will provide adequate locking strength..." (specifics not detailed).
* Sterility Verification: "Verification of sterlity is performed using the AAMI - Method 1. Sterllity assurance level is 10⁻⁶."
* Similarity to Predicate Devices: The primary "ground truth" for regulatory approval here is the demonstrable substantial equivalence to devices already proven safe and effective through their market history.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.