(266 days)
The MyShoulder guides are intended to be used as guides specifically designed for the anatomy of a single patient. The humeral guide is used to define the level and orientation of the humeral head resection cut. The glenoidal guide is used to position and orient the K-wire that will subsequently guide the glenoidal reaming.
Both anatomical and reverse total joint configurations are acceptable.
Both humeral and glenoid guides are suitable for a delto-pectoral approach only.
MyShoulder Patient-Matched Guides are intended for use with Medacta Shoulder System and its cleared indications for use.
MyShoulder Patient-Matched Guides are intended for single use only.
The MyShoulder" Placement Guides are patient specific surgical instruments that allow for guided shoulder implants placement of both Medacta Shoulder Reverse System (K170452) and Medacta Anatomic Shoulder Prosthesis (K170910) and the additional products cleared under K181826 (Glenoid Polyaxial Non-locking screws), K180089 (Short Humeral Stem) and K171058 (Threaded Glenoid Baseplate).
The MyShoulder™ Placement guides uses the patient's CT Scan to perform a 3D planning of the glenohumeral joint replacement surgery. Then, following this planning the humeral and glenoidal guides are created. The MyShoulder™ Placement guides are anatomical guides for a single patient anatomy.
The MyShoulder™ Placement guides subject of this submission are comprised of the following products:
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- MyShoulder™ humeral guide: it will allow to perform an accurate humeral resection
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- MyShoulder™ glenoidal guide: it will provide a precise alignment reference that will guide the glenoidal reaming and final implant positioning.
The MyShoulder™ Placement guides are manufactured from medical grade nylon for sintering (Polyamide PA 12) which is identical to Medacta reference device MySpine Pedicle Screw Placement Guides (132788). The MyShoulder™ Placement guides are single use, external communicating devices with limited (
The provided text does not contain detailed acceptance criteria or the full study that explicitly demonstrates the device meets specific numerical acceptance criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone performance study with detailed acceptance criteria and results.
However, I can extract information related to the performance data provided to support substantial equivalence.
Here's a breakdown of the available information, addressing each point as much as possible:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for various performance metrics, nor does it provide a table of reported device performance against such criteria. It mentions "testing was conducted according to written protocols with acceptance criteria," but these specific criteria and their corresponding results are not detailed in this summary.
The "Performance Data" section lists several non-clinical studies:
- Characterization Tests:
- Cadaver Lab Test Report 1
- Surgical Evaluation Test Report 2
- MyShoulder accuracy and positioning variability cadaver test Test Report 4
- MyShoulder accuracy test Test Report 5
- Performance Tests:
- Effects of the Sterilization on the geometry of the MyShoulder Glenoidal Guide -Test Report 3
- Wear Test, according to RPO-01.028.009
Without access to these specific test reports (numbers 1-5 and RPO-01.028.009), the detailed acceptance criteria and reported performance cannot be provided. The general statement is that "Risks were identified based on the proposed design and testing was conducted to mitigate those risks."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Cadaver Lab Test Report" and "MyShoulder accuracy and positioning variability cadaver test." This indicates the use of cadaveric samples for testing. The number of cadavers or individual samples used in these tests is not specified.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective in a clinical sense, as no clinical studies were performed. The "cadaver" tests would be considered prospective for the device evaluation.
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)
This information is not provided in the document. The studies listed are non-clinical (cadaver and performance tests). While surgeons might have been involved in the "Surgical Evaluation Test Report" or "Cadaver Lab Test Report," their number and qualifications are not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided as the studies are non-clinical performance and characterization tests on cadavers and materials, not diagnostic interpretation or clinical outcome studies requiring adjudication.
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
No MRMC study was done. The device is "MyShoulder™ Placement Guides," which are patient-specific surgical instruments for guiding shoulder implant placement. This is not an AI-based diagnostic tool for interpretation by human readers, so an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a physical surgical guide. The "planning" step involves using a patient's CT scan to perform a 3D planning of the joint replacement surgery, and then the guides are created based on this planning. This implies a human-in-the-loop process for surgical planning, followed by the physical device. The listed non-clinical studies evaluate the accuracy and performance of these physical guides. Therefore, a "standalone algorithm only" performance is not directly applicable to this type of device in the typical sense of AI algorithms. The accuracy tests (e.g., "MyShoulder accuracy test") would be evaluating the performance of the guide itself in achieving its intended surgical goal based on the planning.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "MyShoulder accuracy and positioning variability cadaver test" and "MyShoulder accuracy test," the ground truth would likely be established by precise measurements of the actual resection planes, K-wire positioning, or implant placement relative to the pre-operative 3D plan on the cadaveric specimens. This would typically involve physical measurements using highly accurate instruments, compared against the pre-operative 3D plan. It is not expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set
The document states that the "MyShoulder™ Placement guides uses the patient's CT Scan to perform a 3D planning of the glenohumeral joint replacement surgery." This suggests that each guide is patient-specific and generated individually. There is no mention of a "training set" in the context of an algorithm learning from a large dataset. The customization is based on an individual patient's CT scan. If there are underlying algorithms or software used for the 3D planning itself, the training data for that specific software is not detailed in this submission.
9. How the ground truth for the training set was established
As there is no "training set" described in the context of a machine learning algorithm for the device itself, this question is not applicable as presented. The process involves creating a custom guide for each patient based on their individual CT scan and a 3D planning process.
§ 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.”