SmartSPACE Shoulder System instrumentation consists of a patient-specific 3D positioner. It has been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.

SmartSPACE Shoulder Planner software

SmartSPACE 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.

SmartSPACE 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 SmartSPACE Shoulder Planner software.

SmartSPACE 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.

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

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

Device Description

The SmartSPACE Shoulder System consists of the SmartSPACE Shoulder Planner software and a 3D positioner which assists the user in planning reverse and anatomic total shoulder arthroplasty and gives the user the ability to translate the surgical plan intraoperatively using a 3D positioner for glenoid K-wire placement.

AI/ML Overview

The provided text is a 510(k) Summary for the SmartSPACE Shoulder System, which includes software and a 3D positioner. It describes the device's intended use and compares it to a predicate device, BLUEPRINT Patient Specific Instrumentation (K162800). The summary discusses various performance data but does not outline specific acceptance criteria in a quantitative table or details of a study that explicitly proves the device "meets acceptance criteria" in the way a clinical study typically would for performance metrics like sensitivity, specificity, accuracy, or reader improvement in AI contexts.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through non-clinical studies and verification/validation activities. The "Performance Testing" section serves as the closest equivalent to a study proving the device meets certain criteria, but these are primarily engineering and software validation tests, not a traditional clinical performance study with human readers and ground truth as might be expected for an AI device in a Multi-Reader Multi-Case (MRMC) study.

Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in the available information and explicitly state when information is not present.

Here's the analysis based on the provided document:

Device: SmartSPACE Shoulder System (SmartSPACE Shoulder Planner software and SmartSPACE Shoulder 3D Positioner)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with numerical performance targets and corresponding results for the "SmartSPACE Shoulder System" as a whole system in the context of clinical accuracy or reader performance typically discussed for AI/software devices. Instead, it lists types of validation tests with a general requirement for "compliance" or "should be compliant."

Acceptance Criteria (Stated Goal / Type of Validation)	Reported Device Performance (as stated)
Glenoid Version and Inclination Angle Validation Test (between reference method and software calculation should be compliant)	The version and inclination angle between reference method and the software calculation should be compliant. (Implies compliance achieved, no specific values given)
Patient-Specific Guiding Wire Test (Version angle error, inclination angle error and entry point error should be compliant)	Version angle error, inclination angle error and entry point error should be compliant. (Implies compliance achieved, no specific values given)
Segmentation Accuracy Test (Mean Distance Error in the surgical zone between 3D reconstruction and the reference reconstruction should be compliant)	Mean Distance Error in the surgical zone between 3D reconstruction and the reference reconstruction should be compliant. (Implies compliance achieved, no specific values given)
Cadaver Validation Study (Pre-operative surgical plan compared to post-operative implant position should be compliant)	Pre-operative surgical plan compared to post-operative implant position should be compliant. (Implies compliance achieved, no specific values given)
Software Verification and Validation Testing (in accordance with requirements of IEC 62304)	Conducted in accordance with the requirements of IEC 62304. (Implies successful completion)
Biocompatibility Testing (per ISO 10993-1)	Conducted to ensure the biocompatibility of the materials. (Implies successful completion)
Sterilization & Shelf-life Testing (validate end-user sterilization protocol)	Performed to validate the end-user sterilization protocol. (Implies successful completion)
Human Factors Validation Testing (ensure users able to use software and guide as intended with available instructions for use and training videos)	Underwent Human Factors Validation testing to ensure users were able to use the software and guides as intended with the available instructions for use and training videos. (Implies successful completion)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified quantitatively. The document mentions studies "performed on cadaveric specimen or performed by using patients' data." It does not provide the number of cadavers or patient datasets used for any specific test.
Data Provenance: Not specified (e.g., country of origin). The document mentions "cadaveric specimen" and "patients' data," but does not specify if data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not specified. The document refers to "reference method" in the validation tests but does not detail how this reference or "ground truth" was established, nor does it mention the number or qualifications of any experts involved in defining it for the testing.

4. Adjudication Method for the Test Set

Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned, nor are any effect sizes for human reader improvement. The device's validation is focused on technical accuracy of planning and positioning components, not on aiding human interpretation or diagnosis.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The software component (SmartSPACE Shoulder Planner software) has "standalone" validation in terms of its calculations and functionality (e.g., Glenoid Version and Inclination Angle Validation Test, Patient-Specific Guiding Wire Test, Segmentation Accuracy Test) compared to a "reference method". However, the overall device is an instrumentation system that includes both software for planning and a patient-specific 3D positioner for intraoperative use. The validation tests (e.g., Cadaver Validation Study) involve both components in a practical setting.

7. The Type of Ground Truth Used

The ground truth or "reference method" for the validation tests seems to be based on:

Engineering measurements/calculations (for glenoid angles, guiding wire parameters, segmentation accuracy).
Comparison of pre-operative plans with post-operative implant positions in cadaveric studies.
The document does not indicate the use of pathology or outcomes data as a ground truth, which is typical as this is a surgical planning and guiding system, not a diagnostic one.

8. The Sample Size for the Training Set

Not applicable/Not specified. The document does not describe the use of machine learning or AI models developed using a training set. This is a software and instrumentation system that relies on pre-programmed algorithms and patient-specific anatomical data derived from CT scans for planning, not a learning algorithm that would require a "training set" in the conventional machine learning sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no machine learning training set is described.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

TechMah Medical LLC % Mary Vater Regulatory Consultant Medical Device Academy, Inc. 345 Lincoln Hill Rd. SHREWSBURY VT 05738

Re: K191247

Trade/Device Name: SmartSPACE Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KWS, MBF, QHE Dated: October 21, 2019 Received: October 21, 2019

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 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 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

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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-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 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) K191247

Device Name SmartSPACE Shoulder System

Indications for Use (Describe) SmartSPACE Shoulder 3D Positioner

SmartSPACE Shoulder Planner software

SmartSPACE 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.

SmartSPACE 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 SmartSPACE Shoulder Planner software.

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

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

SmartSPACE 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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K191247

510(k) SUMMARY

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

l. SUBMITTER TechMah Medical LLC 2099 Thunderhead Rd., Suite 302 Knoxville, TN 37922 Tel: +1.877.725.6920 ext. 104 Contact Person: Mohamed R. Mahfouz, Ph.D.

Date Prepared: May 7, 2019

II. DEVICE
Name of Device:	SmartSPACE Shoulder System
Classification Name:	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedProsthesis, Shoulder, Semi-Constrained, Metal/PolymerUncemented
Regulation:	21 CFR §888.3660 and 21 CFR §888.3670
Regulatory Class:	Class II
Product Classification Code:	QHE, KWS and MBF (The device is a planning system andsurgical guides in product code QHE, intended to be used withdevices in product codes KWS and MBF)
III. PREDICATE DEVICE

Predicate Manufacturer: Tornier SAS Predicate Trade Name: BLUEPRINT Patient Specific Instrumentation Predicate 510(k): K162800

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

SmartSPACE Shoulder 3D Positioner

SmartSPACE Shoulder Planner software

SmartSPACE 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.

Page 1 of 5.

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SmartSPACE 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 SmartSPACE Shoulder Planner software.

SmartSPACE 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.

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

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

Compatible Implant Systems

The following Lima implants are supported by the SmartSPACE Shoulder System:

Device	510(k)
SMR Reverse - Metal Black	K113254
SMR Reverse – TT Metal Back	K133349
SMR Anatomic - Metal Back	K113254
SMR Anatomic – TT Metal Back	K133349
SMR Anatomic - 3 Pegs Glenoid	K130642, K153722
SMR Anatomic - Cemented Glenoid (single peg)	K100858
Hybrid Anatomic	K163397
Hybrid Reverse	K163397

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:

	SmartSPACE Shoulder System	BLUEPRINT Glenoid Guidesand 3D Planning Software –K162800	Comments onSubstantialEquivalence
Indications forUse	SmartSPACE Shoulder 3DPositionerSmartSPACE Shoulder Systeminstrumentation consists of a patient-specific 3D positioner. It has beenspecially designed to assist in theintraoperative positioning of glenoidcomponents used with totalanatomic or reverse shoulderarthroplasty procedures usinganatomic landmarks that areidentifiable on patient-specificpreoperative CT scans.	Hardware:The BLUEPRINT™ GlenoidGuides are patient-specific drillguides. They have been speciallydesigned to assist in theintraoperative positioning of glenoidcomponents used with totalanatomic or reversed shoulderarthroplasty procedures usinganatomic landmarks that areidentifiable on patient-specificpreoperative CT scans.Software:	Essentially identicalindications for use.Therefore, SubstantiallyEquivalent.
	SmartSPACE Shoulder Plannersoftware
	SmartSPACE Shoulder Plannersoftware is a medical device forsurgeons composed of one softwarecomponent. It is intended to be usedas a pre-surgical planner forshoulder orthopedic surgery.SmartSPACE Shoulder Plannersoftware runs on standard personaland business computers runningMicrosoft Windows operatingsystem.The software supports DICOMstandard to import the CT scan(Computed Tomography) images ofthe patient. Only CT scan modalitycan be loaded with the SmartSPACEShoulder Planner software.SmartSPACE Shoulder Plannersoftware allows the surgeon tovisualize, measure, reconstruct,annotate and edit anatomic data.It allows the surgeon to designshoulder patient-specificinstrumentation based on the pre-surgical plan.The software leads to the generationof a surgical report along with a 3Dfile of the shoulder patient-specificinstrumentation.SmartSPACE Shoulder Plannersoftware does not include anysystem to manufacture the shoulderpatient-specific instrumentation.SmartSPACE Shoulder Plannersoftware is to be used for adultpatients only and should not be used	BLUEPRINTTM 3D PlanningSoftware is a medical device forsurgeon composed of one softwarecomponent. It is intended to be usedas a pre-surgical planner forshoulder orthopedic surgery.BLUEPRINTTM 3D PlanningSoftware runs on standard personaland business computers runningMicrosoft Windows or Mac OSoperating systems.The software supports DICOMstandard to import the CT scan(Computed Tomography) images ofthe patient. Only CT scan modalitycan be loaded with BLUEPRINTTM3D Planning Software.BLUEPRINTTM 3D PlanningSoftware allows surgeon tovisualize, measure, reconstruct,annotate and edit anatomic data.It allows surgeon to design glenoidpatient-specific guides based on thepre-surgical plan.The software leads to the generationof a surgery report along with a 3Dfile of the glenoid patient-specificguide.BLUEPRINTTM 3D PlanningSoftware does not include anysystem to manufacture the glenoidpatient-specific guide.BLUEPRINTTM 3D PlanningSoftware is to be used for adultpatients only and should not be usedfor diagnostic purpose.
Materials	for diagnostic purposes.Medical grade polyamide	The commercially available	The main patient
	PA2200	BLUEPRINT Glenoid Guidesare manufactured from medicalgrade polyamide(PA 2200) or titanium(Ti6Al4V).	contacting material ofthe guides is the samefor the predicate andsubject device.
Design	The SmartSPACE ShoulderSystem consists of the followingfunctional elements:• SmartSPACE ShoulderPlanner software• SmartSPACE Shoulder 3DPositioner	Surgical Guides and PlanningSoftware	Both subject andpredicate devices haveglenoid guides andpresurgical planningsoftware. Therefore,they are substantiallyequivalent.
Energy Source	Guides (3D positioners) have noenergy source. Software Only,used on user's computer.	Guides have no energy source.Software Only, used on user'scomputer.	SubstantiallyEquivalent
Other Features	Single-UseNon-Sterile	Single-UseNon-Sterile	SubstantiallyEquivalent
PerformanceTesting	The SmartSPACE ShoulderSystem was validated throughnon-clinical studies performed oncadaveric specimen or performedby using patients' data including:- Glenoid Version andInclination Angle ValidationTest - The version andinclination angle betweenreference method and thesoftware calculation shouldbe compliant.- Patient-Specific GuidingWire Test - Version angleerror, inclination angle errorand entry point error shouldbe compliant.- Segmentation Accuracy Test- Mean Distance Error in thesurgical zone between 3Dreconstruction and thereference reconstructionshould be compliant.- Cadaver Validation Study -Pre-operative surgical plancompared to post-operativeimplant position should becompliant.	BLUPRINT Patient SpecificInstrumentation was validatedthrough non-clinical studiesperformed on cadavericspecimen or performed by usingpatients' data including:- Seating Validation Test- Reaming Validation Test- Orientation and DirectionAngles Validation Test- Glenoid Version andInclination Angle ValidationTest- Humeral Head Subluxationand Direction Measure- Patient Specific GuidingWire Test- Segmentation Accuracy Test- Clinical Case Studies	The primary validationmethod was the same.They both requireduse of the software toproduce guides andthen use of the guideson cadavericspecimens.For the subject device,the seating andreaming can beconducted using thecoverage map withinthe software, so thisfeature was validatedthrough softwaretesting.The subject devicedoes not requiresubluxationmeasurement.The subject devicealso underwentHuman FactorsValidation testing toensure users were ableto use the software andguides as intendedwith the availableinstructions for useand training videos

K191247, Page 2 of 5.

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K191247, Page 3 of 5.

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VII. PERFORMANCE DATA

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.

Software Verification and Validation Testing

K191247, Page 4 of 5.

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Software Verification and Validation Testing was conducted in accordance with the requirements of IEC 62304. The subject device also underwent Human Factors Validation testing to ensure users were able to use the software and guide as intended with the available instructions for use and training videos.

Benchtop Performance

The SmartSPACE Shoulder System was validated through non-clinical studies performed on cadaveric specimen or performed by using patients' data including:

। Glenoid Version and Inclination Angle Validation Test - The version and inclination angle between reference method and the software calculation should be compliant.
Patient-Specific Guiding Wire Test - Version angle error, inclination angle error and entry point error should be compliant.
| Segmentation Accuracy Test - Mean Distance Error in the surgical zone between 3D reconstruction and the reference reconstruction should be compliant.
Cadaver Validation Study Pre-operative surgical plan compared to post-operative implant l position should be compliant.

VIII. CONCLUSIONS

The SmartSPACE Shoulder System (Subject Device System) described in this section has an equivalent intended use and the same fundamental scientific technology as the cleared BLUEPRINT Patient Specific Instrumentation (K162800). Based on the performance data presented for the design differences between 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.”