MOSS MIAMI SPINAL SYSTEMS by DEPUY ACROMED

The Moss Miami Spine 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 or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Moss Miami Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of 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 Moss Miami Spine System is also a hook and sacral/illiac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

Device Description

The CrossOver Cross Connector is designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes the torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement.

AI/ML Overview

The provided 510(k) summary for the Moss Miami Spinal System does not include information about acceptance criteria or a study proving the device meets said criteria in the way typically found for AI/ML-driven devices (e.g., performance metrics against a clinical standard).

Instead, the documentation describes a traditional medical device submission for a spinal implant system. The "performance data" mentioned refers to engineering tests to characterize the physical properties and functionality of the device components, rather than clinical efficacy measured against specific performance metrics like sensitivity or specificity.

Therefore, many of the requested bullet points, particularly those related to clinical performance, ground truth, expert review, and sample sizes for AI/ML models, are not applicable to this type of submission.

Here's a breakdown of the information that is available, and why other requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document in the format requested for AI/ML devices.

For this device (a spinal implant):

Acceptance Criteria (Implied): The device (CrossOver Cross Connector) would need to meet biomechanical performance standards and demonstrate equivalence in design and materials to its predicate devices (MOSS MIAMI Spinal System Transverse Connector and EZ-Link Transverse Connector). This would involve tests for strength, fatigue, torsional forces, and material compatibility. These specific numerical criteria are not detailed in the summary.
Reported Device Performance: The summary states: "Performance data were submitted to characterize the CrossOver Cross Connector." However, the actual results of these characterization tests (e.g., specific load capacities, fatigue cycles, torque resistance) are not reported in this summary document. The summary only confirms that such data "were submitted."

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

Not Applicable in the traditional sense for a clinical performance study. For a mechanical device, "test set" refers to physical samples of the manufactured device components. The specific number of physical units tested is not mentioned in this summary.
Data Provenance: Not applicable in the context of clinical data for AI/ML. The "performance data" would have been generated in engineering labs, likely within the manufacturer's facilities or accredited testing labs, characterizing the mechanical properties of device components.

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

Not Applicable. "Ground truth" in this context refers to clinical diagnoses or outcomes, which is relevant for AI/ML devices analyzing medical images or data. For a spinal implant, "ground truth" might relate to established engineering standards or material science properties, which would be validated by engineers and metallurgists rather than clinical experts.

4. Adjudication method for the test set

Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human reviewers (e.g., radiologists) when establishing ground truth for AI/ML performance studies. This is not relevant for the mechanical testing of a physical implant.

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. This is a type of study specifically for AI/ML diagnostic or assistive devices, comparing human performance with and without AI aid. The Moss Miami Spinal System is a physical implant, not an AI/ML diagnostic tool.

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

Not Applicable. This refers to the performance of an AI/ML algorithm independently. The Moss Miami Spinal System is a physical implant, not an algorithm.

7. The type of ground truth used

Not Applicable in the clinical sense. For this device, "ground truth" would derive from established engineering principles, material science specifications (e.g., ASTM F-136 for titanium alloy), and biomechanical testing standards. This would not be "expert consensus, pathology, or outcomes data" in the clinical AI/ML context.

8. The sample size for the training set

Not Applicable. There is no "training set" for a physical spinal implant device in the AI/ML context. The device design is based on engineering principles, predicate device designs, and material science, not machine learning from a dataset.

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

Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary of what can be gleaned from the document regarding "performance":

The submission included "Performance data... to characterize the CrossOver Cross Connector." This implies a series of mechanical and material tests.
The device is "Manufactured from ASTM F-136 implant grade MATERIALS: titanium alloy," indicating adherence to a recognized standard for implant materials.
The FDA's 510(k) clearance (K013296) indicates that the device was found "substantially equivalent" to predicate devices (K983583, K001372, K001470). This substantial equivalence is based on similar intended use, technological characteristics, and safety and effectiveness, which includes evaluation of the submitted performance data.

In conclusion, the provided document describes a much earlier and different type of device submission than one for an AI/ML medical device, and therefore the requested information categories are largely not applicable.

Summary

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K013296

510(k) Summary

SUBMITTER:	DePuy AcroMed, Inc.325 Paramount DriveRaynham, MA 02780
CONTACT PERSON:	Lisa A. Gilman
DATE PREPARED:	August 28, 2001
CLASSIFICATION NAME:	Appliance, Fixation, Spinal InterlaminalOrthosis, Spinal Pedicle Fixation
PROPRIETARY NAME:	Moss Miami Spine System
PREDICATE DEVICES:	MOSS MIAMI Spinal System Transverse Connector(K983583)EZ-Link Transverse Connector (K001372, K001470)
DEVICE DESCRIPTION:	The CrossOver Cross Connector is designed totransversely connect two rods used in spinalinstrumentation constructs. The connector minimizesthe torsional forces on the construct, thus reducingthe micromotion and the probability of the constructshifting after placement.
INTENDED USE:	The Moss Miami Spine System is a pedicle screwsystem intended to provide immobilization andstabilization of spinal segments in skeletally maturepatients as an adjunct to fusion in the treatment of thefollowing acute and chronic instabilities or deformitiesof the thoracic, lumbar, and sacral spine:degenerative spondylolisthesis with objectiveevidence of neurological impairment, fracture,dislocation, scoliosis, kyphosis, spinal tumor, andfailed previous fusion (pseudarthrosis).The Moss Miami Spine System is also indicated forpedicle screw fixation for the treatment of severespondylolisthesis (Grades 3 and 4) of the L5-S1vertebra in skeletally mature patients receiving fusionby autogenous bone graft having implants attached tothe lumbar and sacral spine (L3 to sacrum) withremoval of the implants after the attainment of a solidfusion

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Manufactured from ASTM F-136 implant grade MATERIALS: titanium alloy.

PERFORMANCE DATA:

Performance data were submitted to characterize the CrossOver Cross Connector.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized symbol resembling an abstract bird or wing design, composed of three curved lines. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 9 2001

Mr. Frank Maas Manager, Regulatory Affairs DePuy Acromed, Inc. 325 Paramount Drive Raynham, Massachusetts 02767

K013296 Re:

Trade/Device Name: Moss Miami Spinal System Trade/Device Name: Moss Max.3070, 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis, Spondylolisthesis Spinal Fixation Device System Regulatory Class: II Product Code: MNH, MNI, KWP Dated: October 2, 2001 Received: October 2, 2001

Dear Mr. Maas:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have teviewed your became or substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the encreasary to active Amendments, or to devices that have been reclassified in enacificin cate of the Medical Dorter Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, market the devices casyone to equirements for annual registration, listing of devices, Controls provisions of the receiners and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 childing your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good 099. It substannally of equirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to Inspections, the Food and Drag realiting action. In addition, FDA may publish comply with the GMT Togalaxis in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Frank Maas

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed noutheation. The I Driving of easification 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 If you desire specific acvices in the subscric devices), please contact the Office of Compliance at additionally 607.10 for in True allestions on the promotion and advertising of your device, (201) 594-4639. prease conding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mionitation on your responsionate and more (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Susan Walker, MD

Image /page/3/Picture/5 description: The image contains a handwritten symbol or character that appears to be a stylized letter or signature. It features a curved line at the top, resembling a loop, connected to a shorter, horizontal stroke at the bottom right. The overall impression is that of a quick, fluid stroke, possibly representing the initials or a unique mark of an individual.

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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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Moss Miami Spinal System Device Name:

Indications For Use:

The Moss Miami Spine System is a pedicle screw system intended to provide i ne Moss Miami Opine System is spinal segments in skeletally mature patients immobilization and Studilization of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative instablimes or deformiato of the evidence of neurological impairment, fracture, dislocation, scollosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Moss Miami Spine System is also indicated for pedicle screw fixation for the The Moss Miami of severe sponding sis (Grades 3 and 4) of the L5-S1 vertebra in treathern of sover or sevents 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 Moss Miami Spine System is also a hook and sacral/iliac screw fixation The Moss Miam Opinical spine indicated for degenerative disc disease (defined as system of the norformeration of the disc confirmed by history and ulslogenic back pain with dogolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

(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: _____________________________________________________________________________________________________________________________________________________

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

510(k) Number K013296

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.