The Micomed Posterior Doublerod System is a pedicle screw system indicated for the treatment of severe spondyloisthesis (Grades 3 and 4) at the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The Micomed Posterior Doublerod System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of deformities of the thoracic, lumbar, and sacral spine: degenerative spondyloisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

When used as a non-pedicle screw fixation system, the Micomed Posterior Doublerod System is also intended for scoliotic, lordotic deformities such as scoliosis, Scheuermann's disease, degernerative disk disease defined as back pain of discogenic origin with degeneration of the disk confirmed by patient history and radiographic studies, and fractures of the posterior thoracolumbar spine from levels T4 to S1.

Device Description

The Micomed Posterior Doublerod System is a low profile, top loading spinal fixation system available in titanium and stainless steel. The system consists of pedicle screws, polyaxial screws*, open and closed hooks, and fluted and threaded rods. A set of instruments is available for use with the Micomed Posterior Doublerod System. * polyaxial screws are only available in titanium

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, specifically the Micomed Posterior Doublerod System. The submission focuses on demonstrating substantial equivalence to predicate devices based on design, intended use, and performance.

However, the document primarily outlines the regulatory approval process and device specifications, and does not contain detailed information about a study proving the device meets specific acceptance criteria in the way a clinical or even a detailed standalone performance study would. The "Testing and Performance" section is brief and refers to biomechanical performance as per an ASTM standard, rather than a comprehensive study with specific acceptance criteria that one would typically associate with AI/software performance.

Therefore, many of the requested elements for describing an acceptance criteria study, especially those related to AI/software performance (e.g., sample sizes for test sets, expert ground truth, MRMC studies, training sets), cannot be extracted from the provided text.

Here is the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biomechanical performance per ASTM F1717-96	The polyaxial screw has been shown to have acceptable biomechanical performance per ASTM F 1717-96 and to function in an equivalent manner to predicate polyaxial screws.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document refers to biomechanical testing, which typically involves a set number of test specimens (e.g., screws, rods) rather than patient data.
Data Provenance: Not specified, but given the nature of biomechanical testing, it would involve engineered test samples rather than patient data. The company is based in Germany, so if there were any clinical aspects not detailed, it might have European origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Biomechanical testing adherence to ASTM standards does not involve expert-established ground truth in the way clinical or image-based AI studies do. The "ground truth" is typically defined by the test parameters and failure modes according to the ASTM standard.

4. Adjudication method for the test set

Not applicable. Biomechanical testing results are typically objective measurements against a standard, not subject to adjudication by multiple human experts.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/software in diagnostic or interpretive tasks, not for physical medical devices undergoing biomechanical testing.

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

Not applicable. This device is a physical spinal fixation system, not an algorithm. The reported "standalone" performance is the biomechanical performance of the device's components.

7. The type of ground truth used

Ground Truth: Adherence to defined biomechanical performance standards and metrics outlined in ASTM F1717-96.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not a machine learning algorithm.

9. How the ground truth for the training set was established

Not applicable. This device is a physical medical device, not a machine learning algorithm.

Summary

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510(k) Notification #K021275 01/2 Micomed Posterior Doublerod System (MPDS) July 9, 2002

JUL 1 8 2002

Attachment 2

Micomed -- Posterior Doublerod System 510(K) Summary

Prepared July 1, 2002 Micomed Posterior Doublerod System Tradename: Spinal Fixation Device System Generic Name Classification: Class II MNI and MNH, 21CFR888.3070 KWP, 21CFR888.3050 Micomed Ortho GmbH & Co. KG Company: Schorndorfer Strasse 96 Schorndorf 73614 Germany Phone: 011 49 71 81 48 99 85 87 Fax: 011 49 71 81 48 99 84 info@micomed.com Corrine M. Taflinger, RAC Contact: RA Consultant (858) 481-1638 Predicate Cross Medical SynergyTM Spinal System, 510(k) # K974749 Depuy Inc. Moss® Spinal System, 510(k) #984378 Devices The Micomed Posterior Doublerod System is a low profile, top loading Description: spinal fixation system available in titanium and stainless steel. The system consists of pedicle screws, polyaxial screws, open and closed hooks, and fluted and threaded rods. A set of instruments is available for use with the Micomed Posterior Doublerod System. polyaxial screws are only available in titanium The components of the Micomed Posterior Doublerod System are available Material: in titanium in conformance with ASTM F136 as well as Stainless Steel in conformance with ASTM F1314. Polyaxial Screws are only available in titanium.

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510(k) Notification #K021275 842 Micomed Posterior Doublerod System (MPDS) r July 9, 2002 - -

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	510(K) Summary - continued
Indications:	The Micomed Posterior Doublerod System is a pedicle screw systemindicated for the treatment of severe spondyloisthesis (Grades 3 and 4) atthe L5-S1 vertebra in skeletally mature patients receiving fusion byautologous bone graft having implants after the attainment of a solid fusion.The Micomed Posterior Doublerod System is a pedicle screw systemintended to provide immobilization and stabilization of spinal segments inskeletally mature patients as an adjunct to fusion in the treatment of thefollowing acute and chronic instabilities of deformities of the thoracic.lumbar, and sacral spine: degenerative spondyloisthesis with objectiveevidence of neurological impairment, fracture, dislocation, scoliosis,kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).When used as a non-pedicle screw fixation system, the Micomed PosteriorDoublerod System is also intended for scoliotic, lordotic, or kyphotic
	deformities such as scoliosis, Scheuermann's disease, degernerative diskdisease defined as back pain of discogenic origin with degeneration of thedisk confirmed by patient history and radiographic studies, and fractures ofthe posterior thoracolumbar spine from levels T4 to S1.
Testing andPerformance:	The polyaxial screw, to be used with the Micomed Posterior DoublerodSystem. has been shown to have acceptable biomechanical performance perASTM F 1717-96 and to function in an equivalent manner to the polyaxialscrews currently used in the predicate device systems.
SubstantialEquivalence:	The Micomed polyaxial screw for use with the Posterior Doublerod Systemis substantially equivalent with respect to intended use, design, andperformance to the Cross Medical polyaxial screw (as part of the SynergySpinal System) cleared for market entry under 510(k) # K974749 on March13, 1998, and the Depuy Moss® Spinal System cleared for market entryunder 510(k) #984378 on December 30, 1998.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration · 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2002

Micomed Ortho GmbH & Co. KG c/o Corrine M. Taflinger, RAC Regulatory Affairs Consultant 13195 Seagrove Street Lake Forest, California 92130

Re: K021275

Trade/Device Name: Micomed Posterior Doublerod System Regulatory Number: 21 CFR 888.3070. 21 CFR 888.3050 Regulation Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: MNH, MNI, KWP Dated: April 17, 2002 Received: April 22, 2002

Dear Ms. Taflinger:

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 mav 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 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.

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Page 2 - Corrine M. Taflinger, RAC

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 M Millerson

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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510(k) Notification #K021275 Micomed Posterior Doublerod System (MPDS) July 9, 2002

Attachment 3

Statement of Indication for Use

510(k) Number: K021275

Device Name: Micomed Posterior Doublerod System

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR
Over-The Counter Use

Mark n Mill
(Optional Format 1-2-96)

(Division Sign-Off) Division of General, Restorative and Neurological Devices

Micomed Ortho GmbH

510(k) Number K0212

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Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.