(89 days)
The Smith & Nephew OSTEORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications: Elbow, Wrist, and Hand (Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicylitis repair), Foot and Ankle (Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy), Hip (Hip capsule repair, Acetabular labrum reattachment), Knee (Extra-capsular repairs: Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs, Vastus medialis obliquous advancement, Iliotibial band tenodesis), Shoulder (Capsular stabilization, Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis).
The device consists of a suture anchor with attached non-absorbable suture(s) preassembled to an insertion device. This device is provided sterile, for single use only.
The document provided is a 510(k) summary for a medical device called the OSTEORAPTOR® Suture Anchor. This is a premarket notification to the FDA for a device that is not an AI/ML powered diagnostic device. Therefore, the questions related to AI/ML specific aspects like training data, test set, ground truth adjudication, MRMC studies, etc., do not apply to this document.
The document indicates that the device's performance was evaluated by demonstrating "substantial equivalence" to legally marketed predicate devices. This is a regulatory pathway for medical devices that are similar to existing ones.
Here's an attempt to answer the relevant questions based on the provided text, while explicitly stating where information is not applicable or unavailable for a non-AI/ML device.
1. A table of acceptance criteria and the reported device performance
For a traditional medical device like a suture anchor, "acceptance criteria" and "reported device performance" are typically defined by demonstrating substantial equivalence to predicate devices through various established engineering and biocompatibility tests, rather than diagnostic performance metrics. The document states:
| Intended Use / Fundamental Scientific Technology | Acceptance Criteria (Implicit) | Reported Device Performance (Claimed) |
|---|---|---|
| Intended Use | Substantially equivalent to predicate devices (BIORAPTOR 2.9 Anchor (K053344) and BIORAPTOR 2.3 PK Anchor (K071586)). | The Smith & Nephew OSTEORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the same indications as the predicate devices (Elbow, Wrist, Hand, Foot, Ankle, Hip, Knee, Shoulder). The FDA's letter states approval "for the indications for use stated in the enclosure." |
| Fundamental Scientific Technology | Substantially equivalent to predicate devices. | "The proposed and predicate anchors are similar in design, operate on the same principles, have the same indications and intended use, and exhibit similar fixation properties." |
| Performance Testing | Demonstrates substantial equivalence in insertion and fixation properties to predicate devices. | "The performance testing conducted demonstrates that the insertion and fixation properties of the OSTEORAPTOR Anchor are substantially equivalent to the predicate devices." (Specific numerical criteria or test results are not provided in this summary, but would be expected in the full 510(k) submission). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable in the context of an AI/ML diagnostic device's test set. For physical medical devices, performance testing involves engineering tests, biocompatibility tests, and potentially cadaveric or animal studies. The 510(k) summary provided does not detail the sample sizes or provenance for these types of tests, only stating that "performance testing was conducted."
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 is not applicable as this is not an AI/ML powered diagnostic device requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as this is not an AI/ML powered diagnostic device.
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 is not applicable as this is not an AI/ML powered device. MRMC studies are used for evaluating diagnostic performance of AI or AI-assisted diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as this is not an AI/ML powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable for a physical medical device. Ground truth refers to the verified correct answer in diagnostic tasks, which is not relevant for a suture anchor's performance assessment. Instead, the "truth" for this device would be established by physical measurements, mechanical properties testing, and biocompatibility standards.
8. The sample size for the training set
This is not applicable as this is not an AI/ML powered device. "Training set" refers to data used to train AI models.
9. How the ground truth for the training set was established
This is not applicable as this is not an AI/ML powered device.
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K082215-
P. 1/2
SECTION IV
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
NOV - 3 2008
as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
OSTEORAPTOR® Suture Anchor
Date Prepared: 04 August 2008
- A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover, MA 01810
B. Company Contact
Julie Acker, RAC Regulatory Affairs Specialist
Phone: (508) 261-3618 FAX: (508) 261-3620
C. Device Name
| Trade Name: | OSTEORAPTOR Suture Anchor |
|---|---|
| Common Name: | Suture Anchor |
| Classification Name: | Fastener, Fixation, Biodegradable, Soft Tissue |
| Product Code: | MAI |
| Regulation Number: | 21 CFR & 888.3030 |
D. Predicate Devices
The Smith & Nephew OSTEORAPTOR Suture Anchor is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: BIORAPTOR 2.9 Anchor (K053344) and BIORAPTOR 2.3 PK Anchor (K071586).
E. Description of Device
The device consists of a suture anchor with attached non-absorbable suture(s) preassembled to an insertion device. This device is provided sterile, for single use only,
. . . .
Smith & Nephew, Inc. Endoscopy Division
Page 10 of 61
OSTEORAPTOR 510(K)
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F. Intended Use
The Smith & Nephew OSTEORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
| Elbow, Wrist, and Hand | Knee |
|---|---|
| Biceps tendon reattachment | Extra-capsular repairs: |
| Ulnar or radial collateral ligament reconstructions | - Medial collateral ligament |
| Lateral epicondylitis repair | - Lateral collateral ligament |
| - Posterior oblique ligament | |
| Foot and Ankle | Patellar realignment and tendon repairs |
| Hallux valgus repairs | - Vastus medialis obliquous advancement |
| Medial or lateral instability repairs/reconstructions | lliotibial band tenodesis |
| Achilles tendon repairs/reconstructions | |
| Midfoot reconstructions | Shoulder |
| Metatarsal ligament/tendon repairs/reconstructions | Capsular stabilization |
| Bunionectomy | - Bankart repair |
| - Anterior shoulder instability | |
| Hip | - SLAP lesion repairs |
| Hip capsule repair | - Capsular shift or capsulolabral reconstruction |
| - Acetabular labrum reattachment | Acromioclavicular separation repairs |
| Deltoid repairs | |
| Rotator cuff tear repairs | |
| Biceps tenodesis |
G. Comparison of Technological Characteristics
The Smith & Nephew OSTEORAPTOR Suture Anchor is substantially equivalent to the predicate anchors. The proposed and predicate anchors are similar in design, operate on the same principles, have the same indications and intended use, and exhibit similar fixation properties.
H. Summary Performance Data
The performance testing conducted demonstrates that the insertion and fixation properties of the OSTEORAPTOR Anchor are substantially equivalent to the predicate devices.
Smith & Nephew, Inc. Endoscopy Division
Page 11 of 61
OSTEORAPTOR 510(K)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle. The text is in all capital letters and is black in color. The eagle is also black and is made up of several curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2008
Smith & Nephew, Inc. Endoscopy Division % Ms. Julie Acker 150 Minuteman Road Andover, Massachusetts 01810
Re: K082215
Trade/Device Name: Osteoraptor™ Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR, HWC, MAI Dated: August 4, 2008 Received: August 6, 2008
Dear Ms. Acker:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
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Page 2 - Ms. Julie Acker
1950 (1992) 1992 (1992) 1992 (1992) 1992 (1992) 1998 (1992) 1999 (1998) 1992 1992 1992 (1992) 1992 1992 (1992) 1992 1992 1992 1992 1992 1992 1992 1992 1992 1992 1992 1992 199
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Kop 2215
510(k) Number (if known):
Device Name: OSTEORAPTOR® Suture Anchor
The Smith & Nephew OSTEORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
Elbow, Wrist, and Hand
Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair
Foot and Ankle
Hallux valgus repairs
Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy
Hip
Hip capsule repair
- Acetabular labrum reattachment
Knee
- Extra-capsular repairs: - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament Patellar realignment and tendon repairs - Vastus medialis obliquous advancement Iliotibial band tenodesis
Shoulder
Capsular stabilization
-
Bankart repair
-
Anterior shoulder instability
-
SLAP lesion repairs
-
Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | /o |
|---|---|
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number
§ 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.