(70 days)
When used as a posterior, noncervical hook, and/or sacral/iliac screw fixation system, or as an anterior, thoracic/lumbar screw fixation system, the Moss Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).
When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the Moss Miami Spinal System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Moss Miami System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5 – S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 – S1), and for whom the device system is intended to be removed after solid fusion is attained.
Manufactured from ASTM F-136 implant grade titanium alloy and ASTM F-138 implant grade stainless steel.
The provided text describes the Moss Miami Spinal System Pin Nut (K023804), a spinal fixation device. However, it does not contain specific acceptance criteria or the details of a study that proves the device meets such criteria.
The document is a 510(k) summary and an FDA clearance letter for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through detailed studies.
Here's a breakdown of what can be extracted and what is missing from the provided text, relative to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "Data were submitted to characterize the Moss Miami Spinal System Pin Nut." (No specific performance metrics provided in this document) |
Missing Information:
- Specific numerical or qualitative acceptance criteria (e.g., tensile strength, fatigue life, torque strength, biocompatibility standards).
- Detailed performance results against those criteria. The document only states that "Data were submitted to characterize" the device.
2. Sample Size Used for the Test Set and Data Provenance:
Missing Information. The document mentions "Data were submitted to characterize the Moss Miami Spinal System Pin Nut" but does not provide details about any specific test sets, their sample sizes, or the provenance of any data (e.g., country of origin, retrospective/prospective). This likely refers to mechanical testing data, which typically is conducted in a lab setting, not on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Missing Information. This type of information (expert review, ground truth establishment) is typically relevant for diagnostic or AI-driven devices. As this is a spinal implant, the "ground truth" would be established through mechanical testing standards, rather than expert review of images or clinical cases.
4. Adjudication Method for the Test Set:
Missing Information. Not applicable for a mechanical implant's performance testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Missing Information. Not applicable. The device is a spinal implant, not a diagnostic imaging or AI assistance tool that would involve human readers.
6. Standalone Performance Study:
Present (Implied): The statement "Data were submitted to characterize the Moss Miami Spinal System Pin Nut" implies that some form of standalone performance (mechanical testing) was conducted on the device itself.
Missing Information:
- Details of the standalone performance studies (e.g., type of tests, parameters measured, results).
- Any comparison to a "human-in-the-loop" scenario, as the device is an implant.
7. Type of Ground Truth Used:
Implied: The "ground truth" for a device like this would be established by mechanical testing standards (e.g., ASTM or ISO standards for spinal implants) and material specifications (ASTM F-136, ASTM F-138). The device's materials are explicitly stated: "Manufactured from ASTM F-136 implant grade titanium alloy and ASTM F-138 implant grade stainless steel." This indicates that material properties conforming to these standards would be part of the "ground truth."
Missing Information: Specific details of these mechanical tests and their corresponding "ground truth" (e.g., required fatigue cycles, pull-out strength).
8. Sample Size for the Training Set:
Missing Information. Not applicable. This device is a passive implant; there is no "training set" in the context of machine learning or algorithms.
9. How the Ground Truth for the Training Set Was Established:
Missing Information. Not applicable, as there is no training set.
Summary of what the document does provide:
- Device Name: Moss Miami Spinal System Pin Nut
- Manufacturer: DePuy AcroMed, Inc.
- Date Prepared: August 2, 2002
- Predicate Device: Moss Miami Spinal System Titanium Pin Nut (K010742)
- Intended Use/Indications: Detailed for various spinal conditions, including scoliosis, kyphosis, lordosis, fracture, tumor, spinal stenosis, spondylolisthesis, previously failed fusions, and degenerative disc disease. Specific indications for pedicle screw fixation in skeletally mature patients and severe spondylolisthesis (Grades 3 and 4) at L5-S1.
- Materials: ASTM F-136 implant grade titanium alloy and ASTM F-138 implant grade stainless steel.
- FDA Clearance: K023804 granted on January 23, 2003, based on substantial equivalence to predicate devices.
In conclusion, the provided text is an FDA 510(k) summary and clearance letter, designed to demonstrate substantial equivalence for market clearance. It does not contain the detailed studies or acceptance criteria that would typically be found in a detailed device performance report or scientific publication for a new technology, especially not in the context of AI or advanced diagnostic algorithms. The "performance data" mentioned likely refers to mechanical and material data submitted to the FDA but not elaborated upon in this public summary.
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| K023804 | |||
|---|---|---|---|
| IX. | 510(k) Summary | Page 1 of 2 | |
| SUBMITTER: | DePuy AcroMed, Inc.325 Paramount DriveRaynham, MA 02767 | JAN 23 2003 | |
| CONTACT PERSON: | Lisa A. Gilman | ||
| DATE PREPARED: | August 2, 2002 | ||
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal InterlaminalOrthosis, Spinal Pedicle Fixation | ||
| PROPRIETARY NAME: | Moss Miami Spinal System Pin Nut | ||
| PREDICATE DEVICES: | Moss Miami Spinal System Titanium Pin Nut(K010742) | ||
| INTENDED USE: | When used as a posterior, noncervical hook, and/orsacral/iliac screw fixation system, or as an anterior,thoracic/lumbar screw fixation system, the MossMiami Spinal System is intended to treat scoliosis,kyphosis and lordosis, fracture, loss of stability due totumor, spinal stenosis, spondylolisthesis, a previouslyfailed fusion surgery or degenerative disc disease(i.e., discogenic back pain with degeneration of thedisc confirmed by patient history and radiographicstudies). | ||
| When used as a pedicle screw fixation system of thenoncervical spine in skeletally mature patients, theMoss Miami Spinal System is indicated fordegenerative spondylolisthesis with objectiveevidence of neurologic impairment, fracture,dislocation, scoliosis, kyphosis, spinal tumor, andfailed previous fusion (pseudarthrosis). |
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The Moss Miami Spinal System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5 – S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 – S1), and for whom the device system is intended to be removed after solid fusion is attained.
MATERIALS:
Manufactured from ASTM F-136 implant grade titanium alloy and ASTM F-138 implant grade stainless steel.
PERFORMANCE
DATA:
Data were submitted to characterize the Moss Miami Spinal System Pin Nut.
KO23804 Page 2 of 2
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 2003
Ms. Lisa Gilman Regulatory Affairs Associate DePuy AcroMed. Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K023804
Trade/Device Name: Moss Miami Spinal System Pin Nut Regulation Number: 21 CFR 888.3050, 21 CFR 888.3070 Regulation Name: Spinal interlaminal fixation orthosis; Spondylolisthesis spinal fixation device system; Pedicle screw spinal system Regulatory Class: Class II Product Code: KWP, MNH, MNI Dated: January 6, 2003 Received: January 7, 2003
Dear Ms. Gilman:
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.
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. Lisa Gilman
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milburn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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111. Indications for Use
510(k) Number (if known): _ KO23804
Page 1 of 1
Moss Miami Spinal System Pin Nut Device Name:
Indications For Use:
When used as a posterior, noncervical hook, and/or sacral/iliac screw fixation system, or as an anterior, thoracic/lumbar screw fixation system, the Moss Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies),
When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the Moss Miami Spinal System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Moss Miami System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5 - S1 vertebral ioint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 - S1), and for whom the device system is intended to be removed after solid fusion is attained.
(Please do not write below this line - continue on another page if needer')
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: (Per 21 CFR 801.109) OR Over-The-Counter Use:
Mark A. Milhern
General, Restorative
Number K023804
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.