Smart SPACE Shoulder System instrumentation consists of patient-specific 3D positioners. They have been specially designed to assist in the intraoperative positioning of shoulder components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.

Smart SPACE Shoulder Planner software

Smart SPACE Shoulder Planner software is a medical device for surgeons composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.

Device Description

The Smart SPACE Shoulder System consists of the Smart SPACE Shoulder Planner software and 3D Positioners which assist the user in planning reverse and anatomic total shoulder arthroplasty and gives the user the ability to translate the surgical plan intraoperatively using 3D positioners for glenoid K-wire placement and humeral head resection.

AI/ML Overview

The provided text is a 510(k) summary for the "Smart SPACE Shoulder System," a medical device used for pre-surgical planning in shoulder orthopedic surgery and for creating patient-specific 3D positioners.

After reviewing the document, it's clear that the included text does not contain the specific information requested regarding acceptance criteria and a detailed study proving the device meets those criteria, especially in the context of an AI/algorithm-based device as implied by the request's structure (e.g., "human readers improve with AI vs without AI assistance," "standalone algorithm only").

The document focuses on the regulatory submission process, comparison to a predicate device, and general performance data (sterilization, biocompatibility, software verification, mechanical, and a cadaveric study for the 3D positioners).

Here's a breakdown of what can be extracted and what information is missing based on your specific questions:

Information Present (or implied):

Device Name: Smart SPACE Shoulder System
Device Type: Pre-surgical planning software and patient-specific 3D positioners for shoulder arthroplasty.
Regulatory Class: Class II (Product Codes: OHE, KWS, MBF)
Performance Data Mentioned (but lacking detail for acceptance criteria):
- Sterilization & Shelf-life Testing
- Biocompatibility Testing (ISO 10993-1)
- Software Verification and Validation Testing (IEC 62304 and FDA guidance documents: General Principles of Software Validation, Off-The-Shelf Software Used in Medical Devices, Cybersecurity for Networked Medical Devices Containing Off-the-Shelf Software, Postmarket Management of Cybersecurity in Medical Devices, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices)
- Mechanical and Acoustic Testing (not applicable for this submission)
- Animal Study (not required)
- Clinical Studies (Performed on cadaveric specimens, focused on accuracy and precision of humeral head cut using the 3D Positioner. Stated that the device "performs as well as existing traditional instrumentation" and "translated the humeral head resection in a more accurate and precise manner compared to traditional instrumentation.")

Information NOT Present (or not in sufficient detail to answer your specific questions):

The bulk of your questions relate to AI/algorithm performance studies, which are not described in this 510(k) summary. The "Smart SPACE Shoulder Planner software" is described as a "pre-surgical planner" that allows surgeons to "visualize, measure, reconstruct, annotate and edit anatomic data" and "design shoulder patient-specific instrumentation." While this involves computational processing, the document does not depict it as an AI/ML algorithm that requires the types of performance studies you've outlined for diagnostic or AI-assisted interpretation tasks.

Specifically, the following cannot be answered from the provided text:

A table of acceptance criteria and the reported device performance: No specific, quantified acceptance criteria (e.g., X% sensitivity, Y% specificity, Z mm accuracy) are provided for the software or the 3D positioners' performance in the summary, other than a general statement about the cadaveric study demonstrating "accuracy and precision" and performing "as well as existing traditional instrumentation."
Sample sized used for the test set and the data provenance: The cadaveric study is mentioned, but the number of cadavers/cases used is not specified. Data provenance (country, retrospective/prospective) is not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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 done/Not described. The device is a planning tool and guide, not an AI diagnostic assistant for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not done/Not described for an AI algorithm. The software is a planning tool for surgeons. The cadaveric study assessed the 3D positioner's performance in executing a plan.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the cadaveric study, the "ground truth" for the humeral head cut would likely be based on physical measurements against a predefined surgical plan, but the method is not detailed.
The sample size for the training set: This refers to AI model training. Since an AI model is not described, training set size is not applicable.
How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a regulatory submission summary for a medical device that includes software for surgical planning and 3D printed guides. It does not present data in the format of an AI/ML performance study as detailed in your questions. The performance data mentioned (cadaveric study) relates to the physical accuracy of the 3D positioners in aiding a surgical cut, not the diagnostic performance or AI-assisted interpretation of medical images.

Summary

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TechMah Medical LLC Mary Vater Regulatory Consultant Medical Device Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury, Vermont 05738 USA

December 28, 2020

Re: K202454

Trade/Device Name: Smart SPACE Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: OHE, KWS, MBF Dated: December 1, 2020 Received: December 1, 2020

Dear Mary Vater:

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 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.

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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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 (QS) 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-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorywebsite the DICE assistance/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 Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202454

Device Name Smart SPACE Shoulder System

Indications for Use (Describe) Smart SPACE Shoulder 3D Positioners

Smart SPACE Shoulder Planner software

Smart SPACE Shoulder Planner software is a medical device for surgeons composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.

Smart SPACE Shoulder Planner software runs on standard personal and business computers running Microsoft Windows operating system.

The software supports DICOM standard to import the CT scan (Computed Tomography) images of the patient. Only CT scan modality can be loaded with the Smart SPACE Shoulder Planner software.

Smart SPACE Shoulder Planner software allows the surgeon to visualize, measure, reconstruct, annotate and edit anatomic data.

It allows the surgeon to design shoulder patient-specific instrumentation based on the pre-surgical plan. The software leads to the generation of a surgical report along with a 3D file of the shoulder patient-specific instrumentation.

Smart SPACE Shoulder Planner software does not include any system to manufacture the shoulder patient-specific instrumentation.

Smart SPACE Shoulder Planner software is to be used for adult patients only and should not be used for diagnostic purposes.

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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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

I.	SUBMITTERTechMah Medical LLC2099 Thunderhead Rd., Suite 302Knoxville, TN 37922Tel: +1.877.725.6920 ext. 104
	Primary Contact Person:Contact Person:Date Prepared:	Mary Vater, 510(k) Consultant; email: mary@fdaecopy.comMohamed R. Mahfouz, Ph.D.August 25, 2020
II.	DEVICEName of Device:Classification Name:	Smart SPACE Shoulder SystemShoulder Arthroplasty Implantation SystemProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Prosthesis,Shoulder, Semi-Constrained, Metal/Polymer Uncemented
	Regulation:Regulatory Class:Product Classification Code:	21 CFR §888.3660 and 21 CFR §888.3670Class IIQHE, KWS and MBF (The device is a planning system andsurgical guides, primary code QHE, intended to be used withdevices in product codes KWS and MBF)
III.	PREDICATE DEVICEPredicate Manufacturer:Predicate Trade Name:	TechMah Medical LLCSmartSPACE Shoulder System

Predicate 510(k): K191247

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

Smart SPACE Shoulder 3D Positioners

Smart SPACE Shoulder system instrumentation consists of patient-specific 3D positioners. They have been specially designed to assist in the intraoperative positioning of shoulder components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.

Smart SPACE Shoulder Planner software

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Smart SPACE Shoulder Planner software is a medical device for surgeons composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.

Smart SPACE Shoulder Planner software runs on standard personal and business computers running Microsoft Windows operating system.

The software supports DICOM standard to import the CT scan (Computed Tomography) images of the patient. Only CT scan modality can be loaded with the Smart SPACE Shoulder Planner software.

Smart SPACE Shoulder Planner software allows the surgeon to visualize, measure, reconstruct, annotate and edit anatomic data.

It allows the surgeon to design shoulder patient-specific instrumentation based on the presurgical plan.

The software leads to the generation of a surgical report along with a 3D file of the shoulder patient-specific instrumentation.

Smart SPACE Shoulder Planner software does not include any system to manufacture the shoulder patient-specific instrumentation.

Smart SPACE Shoulder Planner software is to be used for adult patients only and should not be used for diagnostic purposes.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:

। Indications for Use - The predicate and subject device have equivalent indications for use.
-Materials – The predicate and subject device have the same patient contacting materials of PA 2200.
-Design - The predicate and subject device use the same software technology for the surgical planning and the final design of the 3D positioners.
-Energy Source – The predicate and subject devices' software runs on computers, the guides themselves do not have an energy source.
-Other Design Features - The subject device builds on already approved Smart SPACE shoulder system (K191247 / Predicate). Novel features in this device compared to predicate is the humerus 3D positioner which is a patient specific device that aids the surgeon in the resection of humeral head.
। Performance Testing – The subject and predicate device were primarily validated using non-clinical studies performed on cadaveric specimens. The primary validation method is the same and demonstrate compliance with the same recognized standards, demonstrating equivalence.

PERFORMANCE DATA VII.

The following performance data were provided in support of the substantial equivalence determination.

Sterilization & Shelf-life Testing

Testing was performed to validate the end-user sterilization protocol of the subject device.

Biocompatibility Testing

Biocompatibility testing per ISO 10993-1 was conducted to ensure the biocompatibility of the materials used in the 3D positioners.

Electrical safety and electromagnetic compatibility (EMC)

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Electrical Safety and Electromagnetic Compatibility testing is not applicable for these devices as there is not an energy source beyond that of the computer used with the planning software, which does not pose significant risk to users or patients.

Software Verification and Validation Testing

Software Verification and Validation Testing was conducted in accordance with the requirements of IEC 62304 and the following FDA guidance documents: General Principles of Software Validation, Off-The-Shelf Software Used in Medical Devices, Cybersecurity for Networked Medical Devices Containing Offthe-Shelf Software, Postmarket Management of Cybersecurity in Medical Devices, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

Mechanical and Acoustic Testing

Mechanical and Acoustic Testing was not applicable for this submission because the device is intended to be used as a temporary guide during a surgical procedure without critical mechanical performance testing requirements.

Animal Study

Animal performance testing was not required to demonstrate safety and effectiveness of the device.

Clinical Studies

Clinitod SosiangSPACIDShoplitedSopsCentrationalsFormationStandithondsswalithsoderformed on cadaveric specimens.

Bellege:Recogeners with the executed with the executed humeral head cut using the Smart SPACE Humerus 3D Positioner.

Testing has successfully demonstrated that the subject device performs as well as existing traditional instrumentation currently used for executing the humeral head resection. The subject device translated the humeral head resection in a more accurate and precise manner compared to traditional instrumentation.

VIII. CONCLUSIONS

The Smart SPACE Shoulder System (Subject Device System) described in this section has an equivalent intended use and the same fundamental scientific technology as the cleared SmartSPACE Shoulder System (K191247). Based on the performance data presented for the subject device and predicate device, TechMah Medical concludes that the subject device is substantially equivalent to the predicate device.

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.”