(237 days)
ARROW® Humeral stems size 6 and 16, depending on the components used, are designed for:
SIMPLE HUMERAL PROSTHESIS:
- Fracture dislocation or complex four part fracture of the proximal humerus
- Humeral head necrosis without injury to the glenoid cavity.
- Extensive humeral head cartilage damage without injury to the glenoid cavity
- Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
- Rheumatoid polyarthritis with thin rotator cuff.
- Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.
TOTAL ANATOMICAL PROSTHESIS (CEMENTED GLENOID IMPLANT WITH 4 PEGS):
- Centred glenohumeral osteoarthritis with functional rotator cuff
- Rheumatoid polyarthritis with functional rotator cuff
- Fracture sequela, functional rotator cuff with glenoid injury.
REVERSE PROSTHESIS:
The ARROW Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cemented or cementless application while the metal-back glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.
The ARROW® Humeral stems are composed of two stems size 6 and 16. These devices are designed to articulate with ARROW® anatomical shoulder system cleared in K093599 and ARROW® reverse shoulder system cleared in K112193.
ARROW® Humeral stems size 6 and 16 are intended to be implanted using the dedicated instrumentation supplied by the manufacturer. This instrument set is common for all the configurations of prosthesis (and identical to those for ARROW® anatomical (K093599) and reverse shoulder system (K112193).
The provided document is a 510(k) premarket notification for the ARROW® Humeral stems size 6 and 16. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics for an AI/device would not be found in this type of regulatory submission.
However, I can extract the information that is present concerning performance and testing:
1. A table of acceptance criteria and the reported device performance
The document mentions that the general acceptance criteria for a 510(k) submission are based on demonstrating "substantial equivalence" to legally marketed predicate devices. This is achieved by showing similarities in:
- Intended use
- Indications for use
- Technological characteristics (materials, sizes, design features)
- Performance (mechanical tests)
- Safety and effectiveness
Regarding device performance, the document states:
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (ARROW® Humeral stems size 6 and 16) |
|---|---|
| Same intended use | Substantially equivalent |
| Substantial similar indications for use | Substantially similar |
| Same materials (titanium alloy) | Confirmed |
| Similar ranges of sizes | Confirmed |
| Design features similarities | Confirmed |
| Mechanical performance equivalent to predicate devices | "After the testing was completed, it was determined that the ARROW® Humeral stems size 6 and 16 performances were substantially equivalent to those of the selected predicate devices." |
| Risks to health addressed | "Risks to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission references "mechanical tests" but does not detail the sample size or setup of these tests. This is a premarket notification for a medical implant, which typically relies on bench testing and comparison to predicate devices, not clinical trials with human subjects in the same way an AI/software device would.
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 applicable to this document. The "ground truth" for this type of device is established through engineering and biomechanical standards, material specifications, and performance against established benchmarks for similar devices, not through expert consensus on interpretation or pathology of an image/data set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to this document. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish a "ground truth" for diagnostic or predictive device performance.
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
This information is not applicable to this document. MRMC studies are relevant for AI-powered diagnostic aids, not for physical medical implants like the ARROW® Humeral stems.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable to this document. This device is a physical implant; there is no "algorithm only" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this physical implant, the "ground truth" for performance is based on engineering and biomechanical standards, material specifications, and comparative mechanical testing against legally marketed predicate devices. The document implies compliance with Good Manufacturing Practices and quality assurance processes.
8. The sample size for the training set
This information is not applicable to this document. Training sets are relevant for AI/machine learning models, not for physical medical implants.
9. How the ground truth for the training set was established
This information is not applicable to this document for the reasons stated above.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2015
Fournitures Hospitalières industrie Ms. Patricia Donnard General Manager 6 Rue Nobel, Z.I. de Kernévez 29000 Quimper France
Re: K150568
Trade/Device Name: ARROW® Humeral stems size 6 and 16 Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis. Regulatory Class: Class II Product Code: PHX, KWT, HSD Dated: September 30, 2015 Received: October 5, 2015
Dear Ms. Donnard:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Patricia Donnard
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use Statement
510(k) Number (if known): K150568
Device Name:
ARROW® Humeral stems size 6 and 16.
This device is composed of the following elements: Two stems size 6 and 16. These devices are designed to articulate with ARROW® anatomical shoulder system cleared in K093599 and ARROW® reverse shoulder system cleared in K112193.
Indications for Use: ARROW® Humeral stems size 6 and 16, depending on the components used, are designed for:
SIMPLE HUMERAL PROSTHESIS:
- Fracture dislocation or complex four part fracture of the proximal humerus
- Humeral head necrosis without injury to the glenoid cavity.
- Extensive humeral head cartilage damage without injury to the glenoid cavity
- Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
- Rheumatoid polyarthritis with thin rotator cuff.
- Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.
TOTAL ANATOMICAL PROSTHESIS (CEMENTED GLENOID IMPLANT WITH 4 PEGS):
- Centred glenohumeral osteoarthritis with functional rotator cuff
- Rheumatoid polyarthritis with functional rotator cuff
- Fracture sequela, functional rotator cuff with glenoid injury.
REVERSE PROSTHESIS:
The ARROW Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cemented or cementless application while the metal-back glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.
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5. 510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance to the requirements of SDMA 1990 and 21 CFR 807.92.
Date prepared: February 27th 2015
The assigned 510(k) number is: K150568
| 5-1. Applicant: | Fournitures Hospitalières industrie6 Rue Nobel, Z.I. de Kernévez29000 QUIMPER - FRANCETel: (+33) 2.98.55.68.95Fax: (+33) 2.98.53.42.13 |
|---|---|
| ----------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------- |
- Franck HUNT, General Manager 5-2. Company Contact: Tel: (+33) 2.98.55.68.95
- 5-3. Product :
| Trade name: | ARROW® Humeral stems size 6 and 16. |
|---|---|
| Common name: | Shoulder prosthesis |
| Classification: | ARROW® Humeral stems size 6 and 16 are included in the following classifications:-Shoulder joint metal/polymer semi-constrained cemented prosthesisProduct code: PHXRegulation: 21 CFR 888.3660Class: II-Shoulder joint metal/polymer non-constrained cemented prosthesisProduct code: KWTRegulation: 21 CFR 888.3650Class: II-Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesisProduct code: HSDRegulation: 21 CFR 888.3690Class: II |
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5-4. Predicate/ Legally Marketed Devices:
The ARROW® Humeral stems are substantially equivalent to the following legally marketed devices:
| Manufacturer: | Fournitures Hospitalières industrie |
|---|---|
| Device Trade Name: | ARROW® Anatomical Shoulder System |
| 510 (K): | K093599 |
| Manufacturer: | Fournitures Hospitalières industrie |
| Device Trade Name: | ARROW® Reverse Shoulder System |
| 510 (K): | K112193 |
| Manufacturer: | Exactech, Inc. |
| Device Trade Name: | Exactech Equinoxe® Shoulder System |
| 510 (K): | K042021 / K061454 |
| Manufacturer: | Exactech, Inc. |
| Device Trade Name: | Exactech Equinoxe® Reverse Shoulder System |
| 510 (K): | K063569 / K073688 |
5-5. Device Description:
The ARROW® Humeral stems are composed of two stems size 6 and 16. These devices are designed to articulate with ARROW® anatomical shoulder system cleared in K093599 and ARROW® reverse shoulder system cleared in K112193.
ARROW® Humeral stems size 6 and 16 are intended to be implanted using the dedicated instrumentation supplied by the manufacturer. This instrument set is common for all the configurations of prosthesis (and identical to those for ARROW® anatomical (K093599) and reverse shoulder system (K112193).
5-6. Indications for Use/ Intended Use:
• Indications for use
As stated in the Indications for Use section and on the product related labeling (instructions for use and commercial documents):
ARROW® Humeral stems size 6 and 16, depending on the components used, are designed for:
SIMPLE HUMERAL PROSTHESIS:
- Fracture dislocation or complex four part fracture of the proximal humerus i
- Humeral head necrosis without injury to the glenoid cavity.
- Extensive humeral head cartilage damage without injury to the glenoid cavity i
- Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid i implant.
- Rheumatoid polyarthritis with thin rotator cuff. ।
- । Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.
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TOTAL ANATOMICAL PROSTHESIS (CEMENTED GLENOID IMPLANT WITH 4 PEGS):
-
- Centred glenohumeral osteoarthritis with functional rotator cuff
- Rheumatoid polyarthritis with functional rotator cuff
- Fracture sequela, functional rotator cuff with glenoid injury.
REVERSE PROSTHESIS:
The ARROW Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cemented or cementless application while the metal-back glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.
. Intented use
All the implants of shoulder prosthesis are used for primary or revision surgeries.
The humeral stem Ø6 is intended for cemented application. The other humeral stems are for cemented or cementless application.
5-7. Comparison of Technological Characteristics:
The ARROW® Humeral stems size 6 and 16 and the above selected predicate devices have the same intended use and substantial similar indications for use and share the following similarities:
- they are made out of the same materials (titanium alloy), ।
- they are available in similar ranges of sizes, ।
- they bear design features similarities. ।
5-8. Performances:
The ARROW® Humeral stems size 6 and 16 were tested with mechanical tests. After the testing was completed, it was determined that the ARROW® Humeral stems size 6 and 16 performances were substantially equivalent to those of the selected predicate devices.
Risks to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations.
5-9. Substantial Equivalence:
The substantial equivalence of our products, when compared to the selected predicate devices, has been established following the commercial documents, 510(k) submission's information as well as conformance to standards in force.
The analysis of these technical data allows us to submit the ARROW® Humeral stems size 6 and 16 as being substantially equivalent to the already cleared predicate devices selected to draw a comparison.
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5-10. Conclusion:
Following the examination of all the above mentioned information, we believe that the ARROW® Humeral stems size 6 and 16 are substantially equivalent to the selected predicate devices in terms of intended use, ranges of sizes, materials, performances, safety and effectiveness.
§ 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.”