(86 days)
The OS2®-C Compression Staples are indicated for fixation of arthrodesis, osteotomies and fractures in hand or foot surgery.
The number and size of the OS2®-C Compression Staples must be adapted to the indication.
The OS2®-C Compression Staple is an osteosynthesis staple, enabling a constant and reproducible compression.
The OS2®-C Compression Staple is available in multiple lengths and interaxis. It is delivered sterile, ready to use, pre-assembled on its inserter.
The implant is manufactured from PEEK-OPTIMA®, polymer from Invibio®, and is designed for single use only.
Sizes:
The OS2®-C Compression Staple is available in various interaxis from 11mm to 15mm.
Material:
The OS2®-C Compression Staple is manufactured from PEEK according to standard ASTM F2026.
It does not have any coating.
Single use:
The OS2®-C Compression Staple is designed for single use only.
Sterilization:
The OS2®-C Compression Staple is supplied sterile, using gamma irradiation.
Place of use:
The OS2®-C Compression Staple is indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained.
The provided text primarily concerns the 510(k) premarket notification for the OS2®-C Compression Staple, a medical device. This document details the regulatory approval process and comparison to predicate devices, rather than describing an AI/ML powered medical device. As such, the information typically requested for AI/ML powered devices, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity), sample sizes for test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not present.
The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, a requirement for 510(k) clearance.
Here's an analysis based on the information that is provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table of "acceptance criteria" in the context of an AI/ML algorithm's performance metrics (like accuracy, F1-score, etc.). Instead, the "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to predicate devices through various comparisons and mechanical testing. The reported "device performance" is therefore related to its mechanical properties and biocompatibility, not diagnostic or predictive accuracy.
| Acceptance Criteria (Implied for 510(k)) | Reported Device Performance |
|---|---|
| Similar Intended Use: OS2®-C Compression Staples indicated for fixation of arthrodesis, osteotomies, and fractures in hand or foot surgery. | The OS2®-C Compression Staples have the same indications for use as the predicate devices: "fixation of arthrodesis, osteotomies and fractures in hand or foot surgery." |
| Similar Technological Characteristics: Same intended use and design basis as predicates. | Design: Partially similar design to predicate devices (Integra / Newdeal UNI-CLIP, Memometal Easyclip, Biotech International / EOS Eleos Memory Staple). Differences in design are stated not to affect Safety and Effectiveness. Material: Manufactured from PEEK-OPTIMA® (polymer from Invibio®) according to ASTM F2026, which is the same raw material as the Smith and Nephe Bioraptor 2.3 PK suture anchor (predicate). Equivalent Size Range: Similar range size to Biotech International Eleos Memory Staple, Integra / Newdeal UNI-CLIP, and Memometal Easyclip. |
| Similar Principles of Operation: Operate similarly to predicate devices. | The document states "principles of operation are substantially equivalent to those of predicate devices." (No further operational details provided beyond being a compression staple for bone fixation). |
| Acceptable Performance Data (Mechanical): Mechanical properties comparable to predicate devices. | Performance assessment was made through mechanical comparison with predicate devices according to ASTM F564-06. The OS2®-C Compression Staple has similar mechanical properties when compared to the Biotech International Eleos Memory Staple (K112794). Results of testing performed indicated that the implants performed as expected for each test. |
| Biocompatibility: Safe for long-term implantation. | The implant is manufactured from PEEK-OPTIMA®, a polymer compliant with ASTM F2026. This material is widely accepted for biocompatibility in long-term implantation. (No specific biocompatibility study described in this summary, but implied by material choice and substantial equivalence). |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of AI/ML testing. For mechanical testing, the sample size would refer to the number of staples tested according to ASTM F564-06. This number is not provided in the summary.
- Data Provenance: Not applicable in the context of AI/ML testing. The mechanical testing would have been conducted in a laboratory.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the device is not an AI/ML algorithm requiring expert-established ground truth for diagnostic or predictive performance. The ground truth for mechanical testing is based on engineering standards and measurements.
4. Adjudication method for the test set:
- Not applicable for the type of device and testing described.
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:
- Not applicable as the OS2®-C Compression Staple is a physical medical device, not an AI/ML system to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as the OS2®-C Compression Staple is a physical medical device, not an algorithm.
7. The type of ground truth used:
- For the mechanical testing, the "ground truth" would be the specifications and performance characteristics defined by the applicable ASTM standard (ASTM F564-06) for metallic bone fixation devices.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
In summary: The provided document is a 510(k) clearance letter for a physical medical device. It focuses on demonstrating substantial equivalence through comparison of intended use, technological characteristics (design, material, size), principles of operation, and mechanical performance with legally marketed predicate devices. The required information for AI/ML-powered device submissions, as outlined in your prompt, is not relevant to this document or device type.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of an eagle or bird with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 18, 2016
In2Bones SAS % Dr. Norman Estrin, Ph.D. Managing Partner Estrin Consulting Group LLC 9109 Copenhaver Drive Potomac, Maryland 20854
Re: K153395
Trade/Device Name: OS2® -C Compression Staple Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: November 22, 2015 Received: November 24, 2015
Dear Dr. Estrin:
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{1}------------------------------------------------
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K153395
Device Name
OS2®-C Compression Staple
Indications for Use (Describe)
The OS2®-C Compression Staples are indicated for fixation of arthrodesis, osteotomies and fractures in hand or foot surgery.
The number and size of the OS2®-C Compression Staples must be adapted to the indication.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for IN2BONES. The logo is in a gray oval shape with a white line that curves around the left side of the oval. The text "IN2BONES" is in white, with the "2" in orange.
For In2Bones OS2®-C ComMARY
For In2Bones OS2®-C Compression Staple
| Sponsor identification | In2Bones SAS28 chemin du Petit Bois69130 Ecully – FrancePhone: +33.4.72.29.26.26Fax: +33.4.72.29.26.29 |
|---|---|
| Establishment registrationnumber | 3010470577 |
| Date of preparation | November 20, 2015 |
| Contact person | Norman F. Estrin. Ph.D.Estrin Consulting Group LLC9109 Copenhaver DrivePotomac, MD 20854Phone: (301) 279-2899Email: estrin@yourFDAconsultant.com |
| Authorized Agent in theUnited States | Norman F. Estrin, Ph.D.Estrin Consulting Group LLC9109 Copenhaver DrivePotomac, MD 20854Phone: (301) 279-2899Email: estrin@yourFDAconsultant.com |
| Proprietary Name | OS2®-C Compression Staple |
| Common name | Bone Compression staple |
| Device classificationregulation | 21 CFR 888.3030: Single/multiple component metallic bone fixationappliances and accessoriesClass II |
| Device ProductCode and Panel | JDR: staple, fixation, bone87 orthopedics |
{4}------------------------------------------------
| Device Description | The OS2®-C Compression Staple is an osteosynthesis staple, enabling aconstant and reproducible compression.The OS2®-C Compression Staple is available in multiple lengths andinteraxis. It is delivered sterile, ready to use, pre-assembled on itsinserter.The implant is manufactured from PEEK-OPTIMA®, polymer fromInvibio®, and is designed for single use only.Sizes:The OS2®-C Compression Staple is available in various interaxis from11mm to 15mm.Material:The OS2®-C Compression Staple is manufactured from PEEKaccording to standard ASTM F2026.It does not have any coating.Single use:The OS2®-C Compression Staple is designed for single use only.Sterilization:The OS2®-C Compression Staple is supplied sterile, using gammairradiation.Place of use:The OS2®-C Compression Staple is indicated for use in a hospital, oroutpatient surgery center where sterile field may be created andmaintained. |
|---|---|
| Predicate Devices | Biotech International / EOS Eleos Memory Staple (K112794)Integra / Newdeal UNI-CLIP (K011716)Memometal Easyclip (K070031)Smith and Nephew Bioraptor 2.3 PK suture anchor (K071586) - PEEK |
| Indications for use: | The OS2®-C Compression Staples are indicated for fixation ofarthrodesis, osteotomies and fractures in hand or foot surgery.The number and size of the OS2®-C Compression Staples must beadapted to the indication. |
| Comparison of theindications for use withthe predicate devices: | As with the predicate devices, the OS2®-C Compression Staple isindicated for surgical implantation longer than 30 days in the fixationof bone fractures or for bone reconstruction in hand and foot. |
| Comparison ofTechnologicalcharacteristics | The technological characteristics of the OS2®-C Compression Stapleare the same as the characteristics of predicate devices in terms ofintended use and design. All these implants have the following features:- Insertion into bone: The OS2®-C Compression Staple and allpredicate devices are intended for surgical implantation intobone for longer than 30 days.- Design: The OS2®-C Compression Staple has partially similardesign, when compared to the Integra / Newdeal UNI-CLIP |
| (K011716), Memometal Easyclip (K070031), BiotechInternational / EOS Eleos Memory Staple (K112794) andMemometal Easyclip (K070031); all are compression stapleswith various interaxis and leg lengths in the range. Anydifferences of design from staple to staple do not affect theSafety and Effectiveness of the OS2®-C Compression Staple.Material: The OS2®-C Compression Staple are manufacturedfrom the same raw material when compared to the Smith andNephew Bioraptor 2.3 PK suture anchor (K071586) and meetappropriate ASTM standard.Equivalent size range: The OS2®-C Compression Staple hassimilar range size when compared to the Biotech InternationalEleos Memory Staple (K112794), Integra / Newdeal UNI-CLIP(K011716) and Memometal Easyclip (K070031). | |
| Substantial EquivalenceSummary | The OS2®-C Compression Staple intended use, design, material,technological characteristics and principles of operation aresubstantially equivalent to those of predicate devices, if applicable.The OS2®-C Compression Staple has similar mechanical propertieswhen compared to the Biotech International Eleos Memory Staple(K112794). |
| Summary PerformanceData | Performance assessment for the OS2®-C Compression Staple was madethrough mechanical comparison with predicate devices, animal andclinical testing being considered not applicable.Mechanical testing for both OS2®-C Compression Staple and predicatedevice was performed according to ASTM F564-06.The OS2®-C Compression Staple is substantially equivalent to thepredicate devices identified in the 510(k) submission. |
| CONCLUSION | Based on the evaluations performed, the design and indications ofthe OS2®-C Compression Staple are substantially equivalent to thepredicate devices identified in the 510(k) submission. No newmaterials or processes are used in the development of this implant.In addition, the results of the testing performed by the testlaboratory indicated that the implants performed as expected foreach test.The OS2®-C Compression Staples are acceptable for theapplication. |
{5}------------------------------------------------
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.