When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the MIS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The MIS Pedicle Screw 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 is intended to be removed after solid fusion is attained.

The Spine Wave MIS Percutaneous Instruments are intended to be used with the MIS Pedicle Screw System Implants. The percutaneous instruments when used with the percutaneous cannulated screws and percutaneous rods, are intended to provide the surgeon with a percutaneous approach for posterior spinal surgery for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). As well as, 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 is intended to be removed after solid fusion is attained.

Device Description

The MIS Pedicle Screw System consists of a selection of non-sterile, single use titanium alloy rod and screw components that are assembled to create a rigid spinal construct. The rod and screw components of the MIS Pedicle Screw System are attached to the non-cervical spine in order to stabilize the spine during fusion of the vertebral bodies, and are intended to be removed after spinal fusion is achieved.

AI/ML Overview

Here's an analysis of the provided text regarding the MIS Pedicle Screw System, focusing on acceptance criteria and the study conducted.

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel safety and efficacy through extensive clinical trials. Therefore, the "acceptance criteria" and "study" described are primarily engineering-based and comparative to predicates.

Acceptance Criteria and Device Performance

The document does not explicitly state numerical "acceptance criteria" for the device's performance in a diagnostic or AI context. Instead, it describes mechanical testing conducted to demonstrate substantial equivalence to predicate devices. The "acceptance criteria" are implicitly met if the device performs comparably to or within the established safety envelope of these predicate devices as determined by the specified ASTM standards.

The device performance is reported as having undergone mechanical testing to support its equivalence.

Acceptance Criteria (Implicit)	Reported Device Performance
Substantial Equivalence to Predicate Devices: Performance comparable to the CapSure® PS Spine System and the DePuy Spine VIPER System.	"The MIS Pedicle System is substantially equivalent in intended use, design, materials, and construction to the predicate CapSure® PS Spine System devices. The proposed product, intended for percutaneous as well as minimally invasive placement is also equivalent to the DePuv Spine VIPER System..."
Mechanical Strength and Durability (ASTM F1717 Compliance):	"Testing was performed to support the equivalence of the proposed pedicle screw system in accordance with FDA Guidance 'Guidance for Industry and FDA Staff: Spinal System 510(k)s.' The following testing was performed in accordance with ASTM F1717: Static Compression Bending, Static Torsion and Dynamic Compression Bending."
Surgical Technique Verified: Practical applicability and safety of the percutaneous approach.	"In addition, the technique was verified in cadaveric testing."

Study Details

The primary "study" mentioned is a mechanical and cadaveric testing program designed to support substantial equivalence, not a clinical study to evaluate diagnostic performance or AI effectiveness.

Sample size used for the test set and the data provenance:
- Mechanical Testing: The document states that testing was performed in accordance with ASTM F1717, which is a standard for in vitro static and fatigue mechanical testing of spinal implant constructs. ASTM standards typically specify the number of samples required for robust testing (e.g., 5-6 samples per test condition for static tests, and a larger number for fatigue tests to establish a run-out limit). However, the specific number of samples (fixtures or constructs) used in this particular submission is not explicitly stated in the provided text.
- Cadaveric Testing: The sample size for cadaveric testing is not specified.
- Data Provenance: The mechanical testing is in vitro (laboratory-based). Cadaveric testing uses human cadaver specimens. The country of origin for these tests is not explicitly stated, but given the submitter information (Shelton, CT), it is likely within the US, or conducted by a contract lab adhering to US regulations. Both are retrospective in the sense that they are engineering tests performed before market clearance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. The "ground truth" for mechanical testing is defined by the physical forces applied and the resulting deformation/failure, measured by calibrated instruments. For cadaveric testing, the "ground truth" is typically the successful and safe execution of the surgical technique as assessed by the surgeons performing the cadaveric procedures. No "experts" in the sense of image readers or diagnosticians were involved in establishing ground truth for a test set in the way an AI/diagnostic device would.
Adjudication method for the test set:
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in reading medical images). The studies performed here are mechanical and cadaveric, not involving such expert interpretations.
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-powered diagnostic or assistive devices, not for mechanical spinal implants. There is no AI component mentioned in this device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Mechanical Testing: The "ground truth" is the physical properties and failure characteristics of the components and construct under defined loads, measured by laboratory instrumentation according to ASTM F1717 standards. This also includes comparison to the performance of predicate devices under the same test conditions.
- Cadaveric Testing: The "ground truth" for cadaveric testing would relate to the feasibility, ease of use, and surgical accuracy of the percutaneous instrument technique. This is typically assessed by successful placement of implants, anatomical relationships, and absence of iatrogenic damage, observed directly by the performing surgeons and potentially reviewed by other surgical experts.
The sample size for the training set:
- This question is not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.
How the ground truth for the training set was established:
- This question is not applicable for the same reason as point 7.

Summary

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KIDOROS Page 1 of 2

510(k) Summary MIS Pedicle Screw System

1. Submitter Information

Spine Wave, Inc. Three Enterprise Drive Suite 210 Shelton, CT 06484 Telephone: 203-712-1847 Telefax: 203-944-9493

JUN - 4 2010

Contact:	Denise Duchene
Date Prepared:	May 28, 2010

2. Device Information

Trade Name:	MIS Pedicle Screw System
Common Name:	Pedicle Screw Spinal System
Classification:	Class II per 21 CFR 888.3070
Classification Name:	Pedicle Screw Spinal System
Product Code:	MNH, MNI

3. Device Information

4. Intended Use

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The Spine Wave MIS Percutaneous Instruments are intended to be used with the MIS Pedicle Screw System Implants. The percutaneous instruments when used with the percutaneous cannulated screws and percutaneous rods, are intended to provide the surgeon with a percutaneous approach for posterior spinal surgery for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). As well as, for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-$1 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 is intended to be removed after solid fusion is attained.

5. Substantial equivalence

The MIS Pedicle Screw System is substantially equivalent to the CapSure® PS Spine System (K081228 and K083353), the DePuy Spine VIPER System (K061520 and K071860) and the Medtronic CD Horizon System for use with Sextant Instrumentation (K032033 and K032265).

The MIS Pedicle System is substantially equivalent in intended use, design, materials, and construction to the predicate CapSure® PS Spine System devices. The proposed product, intended for percutaneous as well as minimally invasive placement is also equivalent to the DePuv Spine VIPER System, which is intended for percutaneous placement in the spine. As such. the MIS Screw System does not raise any new issues of safety and efficacy when compared to these legally marketed devices.

Testing was performed to support the equivalence of the proposed pedicle screw system in accordance with FDA Guidance "Guidance for Industry and FDA Staff: Spinal System 510(k)s." The following testing was performed in accordance with ASTM F1717: Static Compression Bending, Static Torsion and Dynamic Compression Bending. In addition, the technique was verified in cadaveric testing.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Spine Wave, Inc. % Ms. Denise Duchene Three Enterprise_Drive - Suite_210 Shelton, Connecticut 06484

Re: K100605

Trade/Device Name: MIS Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH Dated: May 28, 2010 Received: June 01, 2010

Dear Ms. Duchene:

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.

JUN - 4 2010

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

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Page 2 - Ms. Denise Duchene

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

sincerely yours,

Mark A. Millkens

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and · Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

MIS Pedicle Screw System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

KI00605

And / Or

Over-The-Counter-Use (21 CFR 801 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 Surgical. Orthopedic,

and Restorative Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

CONFIDENTIAL

0000012

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.