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.

Device Description

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:

1. MyShoulder™ humeral guide: it will allow to perform an accurate humeral resection
1. 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 (<24 hours) contact duration and are provided in non-sterile version only.

AI/ML Overview

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.

Summary

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December 13, 2019

Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street MEMPHIS TN 38118

Re: K190738

Trade/Device Name: MyShoulder Placement Guides Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX, KWS, HSD, MBF Dated: November 13, 2019 Received: November 14, 2019

Dear Chris Lussier:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Michael C. Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K190738

Device Name MyShoulder™ Placement Guides

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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2.0 510(k) Summary

K190738

I. Submitter

Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66

Contact Person: Stefano Baj, Regulatory and Compliance Director, Medacta International SA Date Prepared: Mar 21, 2019 Date Revised: November 13, 2019

II. Device

Device Proprietary Name:	MyShoulder™ Placement Guides
Common or Usual Name:	Shoulder Prosthesis System
Classification Name:	Shoulder joint metal/polymer semi-constrained cemented prosthesis
Primary Product Code:	PHX
Secondary Product Code:	KWS, HSD, MBF
Regulation Number:	21 CFR 888.3660, 21 CFR 888.3690, and 21 CFR 888.3670
Device Classification	II

III. Predicate Device

Substantial equivalence is therefore claimed to the following devices:

Primary Predicate: BLUEPRINT Patient Specific Instrumentation (K143374), Wright-Tornier
Reference Device: A
Anatomic Shoulder Prosthesis (K170910), Medacta International SA
Shoulder Reverse System (K170452), Medacta International SA ●
MySpine Pedicle Screw Placement Guides (132788), Medacta International SA ●

IV. Device Description

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The MyShoulder™ Placement guides subject of this submission are comprised of the following products:

1. MyShoulder™ humeral guide: it will allow to perform an accurate humeral resection
1. 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 substantially equivalent to BLUEPRINT Patient Specific K143374), Wright-Tornier, Medacta reference devices Shoulder Reverse System (K170452) Anatomic Shoulder Prosthesis (K170910), and MySpine Pedicle Screw Placement Guides (132788).

V. Indications for Use

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.

VI. Comparison of Technological Characteristics

MyShoulder glenoid guides are substantially equivalent to Wright-Tornier BLUEPRINT Patient Specific Instrumentation (K143374) for what concerns indications for use, contraindications, design, material and manufacturing process.

MyShoulder guides have substantially equivalent indications for use and contraindications of the reference predicate devices Medacta Shoulder Reverse System (K170452) and Medacta Anatomic Shoulder Prosthesis (K170910).

The technological characteristics including materials, contact duration, software, manufacturing process, device usage, packaging, labeling, and shelf-life of the MyShoulder™ Placement guides are similar to those of the reference device MySpine Pedicle Screw Placement Guides (132788).

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The safety and effectiveness of the MyShoulder™ Placement guides are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

Performance Data VII.

Risks were identified based on the proposed design and testing was conducted to mitigate those risks. Based on the risk analysis, testing was conducted according to written protocols with acceptance criteria. The following performance data was provided in support of the substantial equivalence determination:

Non-Clinical Studies:

. Characterization Tests
- Cadaver Lab Test Report 1; o
- Surgical Evaluation Test Report 2; and o
- MyShoulder accuracy and positioning variability cadaver test Test Report 4 o
- MyShoulder accuracy test Test Report 5 o
Performance Tests ●
- o Effects of the Sterilization on the geometry of the MyShoulder Glenoidal Guide -Test Report 3
- Wear Test, according to RPO-01.028.009 o

Clinical Studies:

No clinical studies were conducted. .

VIII. Conclusion

Based on the above information, the MyShoulder™ Placement guides are substantially equivalent to the identified predicate and reference devices.

Substantial equivalence has been demonstrated through a comparison of indication for use, design, and technological characteristics, as well as performance evaluations. The MyShoulder™ Placement guides are as safe and effective as the predicate device BLUEPRINT Patient Specific Instrumentation (K143374), Wright-Tornier and the reference devices Medacta Shoulder Reverse System (K170452), Medacta Anatomic Shoulder Prosthesis (K170910) and MySpine Pedicle Screw Placement Guides (K132788).

Regulation Number and Section

§ 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.”