(559 days)
A Delta Total shoulder prosthesis is indicated for use in: Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient 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.
The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. All other components are intended for cemented use only.
The Delta Shoulder prosthesis is a modular total shoulder prosthesis that was designed specifically for use in patients with non-functional rotator cuffs. The articulation of this design is "inverted" compared to traditional total shoulder prosthesis. Unlike traditional total shoulder prosthesis, the Delta Shoulder is designed such that the "ball" of the articulation is incorporated into the glenoid prosthesis, and the "cup" of the articulation is incorporated in the humeral prosthesis. The distal surface of the metaglene components are coated with a hydroxyapatite coating (HA) and are intended to be used with 4 metaglene screws for fixation.
This 510(k) submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically associated with AI/ML-based medical devices.
Instead, this document pertains to a traditional medical device (a shoulder prosthesis) and focuses on demonstrating substantial equivalence to legally marketed predicate devices, as required for 510(k) clearance by the FDA. This regulatory pathway does not typically involve the kind of performance metrics, clinical studies, or AI/ML-specific validation often seen in submissions for software-as-a-medical-device (SaMD) or AI-enabled devices.
Here's why the requested information cannot be fully provided based on the given text:
- Device Type: The "Delta Shoulder" is a physical medical implant (a shoulder prosthesis), not an AI/ML diagnostic or prognostic tool. Therefore, the concept of "device performance" in terms of accuracy, sensitivity, or specificity against ground truth, as would be relevant for AI, does not apply in the same way.
- Regulatory Pathway: The 510(k) pathway for traditional devices primarily involves demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing indications for use, design, materials, sterilization, packaging, and often includes bench testing (e.g., mechanical strength, wear) and sometimes animal studies, but generally not human clinical trials with performance metrics against a defined ground truth as would be done for an AI algorithm.
- Content of the Document: The provided text is a 510(k) summary and the FDA clearance letter. It describes the device, its indications for use, identifies predicate devices, and states that substantial equivalence was determined based on "detailed device description, design rationale, product testing, literature and conformance with voluntary performance standards." However, it does not detail the specific "product testing" or "voluntary performance standards" in a way that allows for the extraction of acceptance criteria and reported performance metrics in the format requested for AI/ML devices.
Therefore, many of the requested fields are not applicable or cannot be extracted from this document.
However, I can extract the relevant information regarding the basis for clearance and what's available:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria Type (Implicit) | Reported Device Performance (Implicit Basis for Substantial Equivalence) |
|---|---|
| Safety and Effectiveness Equivalence: | The Delta Shoulder was deemed substantially equivalent to predicate devices (Biomet Bio-Modular and Bipolar Shoulder, Global Advantage Shoulder). This implies that its safety and effectiveness profile is comparable. The determination was based on: |
- Similarity in Indications for Use: The device is intended for "Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint," requiring an anatomically and structurally suited joint and a functional Deltoid muscle.
- Similarity in Design: Modular total shoulder prosthesis, "inverted" articulation (ball on glenoid, cup on humeral), HA-coated metaglene component for cementless application with screws, other components for cemented use.
- Similarity in Sterilization and Packaging.
- Product Testing: Not detailed, but typically involves mechanical and biocompatibility testing for implants.
- Literature and conformance with voluntary performance standards: Specific standards are not listed but are implied to have been met. |
| Biocompatibility: | Implied to have been demonstrated through material selection and potentially testing, consistent with predicate devices and voluntary standards. |
| Mechanical Performance: | Implied to have been demonstrated through "product testing" and "conformance with voluntary performance standards," ensuring the device can withstand physiological loads and wear over its intended lifespan, comparable to predicate devices. This typically includes fatigue, static strength, and wear testing, but specific results or acceptance criteria are not provided in this summary. |
The following points cannot be addressed from the provided text as they are not relevant to a 510(k) submission for a physical implant device in this context:
- Sample sizes used for the test set and data provenance: No "test set" in the context of AI/ML performance evaluation is discussed. The validation is primarily against predicate devices and design verification.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI is not established here.
- Adjudication method for the test set: Not applicable.
- 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-enabled device that assists human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI/ML sense. The "ground truth" for a physical implant is typically its ability to function safely and effectively within the human body, assessed through engineering principles, preclinical testing, and post-market surveillance.
- The sample size for the training set: Not applicable. No AI model is being trained.
- How the ground truth for the training set was established: Not applicable.
In summary: The provided document is a 510(k) submission for a traditional, physical shoulder prosthesis. The "acceptance criteria" and "study" are framed around demonstrating substantial equivalence to existing devices through design comparison, product testing (not detailed here), and adherence to standards, rather than through performance metrics of an AI/ML algorithm against a ground truth.
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”