The Spinal Elements Lotus Posterior Cervical/Thoracic Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Lotus Posterior Cervical/Thoracic Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Lotus Posterior Cervical/Thoracic Spinal System may be connected to the Mercury® Spinal System with the Lotus Posterior Cervical/Thoracic rod connectors. Transition rods with differing diameters may also be used to connect the Lotus Posterior Cervical/Thoracic Spinal System to the Mercury Spinal System. Refer to the Mercury Spinal System package insert for a list of the Mercury Spinal System indications for use.

Device Description

The Lotus Posterior Cervical/Thoracic Spinal System consists of a variety of fixation devices manufactured from Ti-6Al-4V that are attached to the spine. Screws may be placed from a posterior approach into the cervical and/or thoracic spine. Hooks may be placed on the posterior elements of the various vertebrae. Rods span the distance between the screws/hooks, and various other connectors may be used between rods or between rods and screws/hooks. The system achieves fixation by the mechanical joining of the rods, screws, hooks and connectors. A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the "Lotus® Posterior Cervical/Thoracic Spinal System." This document primarily focuses on demonstrating the substantial equivalence of the device to legally marketed predicate devices, rather than presenting a study that establishes acceptance criteria and then proves the device meets them through clinical or standalone performance studies against a ground truth.

Therefore, many of the requested elements (acceptance criteria, device performance, sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study details, standalone performance, type of ground truth, training set size, and training set ground truth establishment) are not present in the provided text.

The document discusses performance testing but these are typically mechanical tests to ensure structural integrity and safety, not clinical performance against acceptance criteria for diagnostic or therapeutic efficacy as would be seen in AI or drug approval processes.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Not found. This document doesn't define clinical acceptance criteria (e.g., sensitivity, specificity, accuracy, or a specific clinical outcome measure) for the device. The "performance data" mentioned refers to mechanical testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not found. This section is not applicable as there is no test set for clinical performance, only mechanical testing of components.

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)

Not found. This section is not applicable as there is no test set or ground truth established in the context of clinical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not found. This is not applicable.

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 found. This device is a surgical implant, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant to this device.

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

Not found. This device is a physical surgical implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not found. Not applicable for this type of device and submission. The "ground truth" for mechanical testing would be the engineering specifications and material properties, against which the physical tests are performed.

8. The sample size for the training set

Not found. Not applicable, as this device does not involve a training set for an algorithm.

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

Not found. Not applicable, as this device does not involve a training set for an algorithm.

What is provided regarding "Performance Data":

The document states under "Performance Data":
"Published literature and performance testing support substantial equivalence. Tests included:

Interconnection testing per ASTM F 1798
Dynamic Compression Bending per ASTM F 1717
All data indicates that the device will perform as intended."

Interpretation for your request:

Acceptance Criteria (Mechanical): The acceptance criteria for these tests would be the specifications outlined in the ASTM F 1798 (Standard Guide for Spinal Implant Material Selection) and ASTM F 1717 (Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model) standards. These standards define methods for testing the mechanical properties and fatigue life of spinal implant constructs. The device "meets" these acceptance criteria if it passes the specified tests according to the standard's requirements (e.g., withstands certain forces, lasts for a specified number of cycles without failure).
Reported Device Performance (Mechanical): The document generally states, "All data indicates that the device will perform as intended," implying it met the criteria of the ASTM standards. Specific numerical performance values (e.g., ultimate tensile strength, bending modulus, fatigue life in cycles) are not provided in this summary.
Study That Proves the Device Meets Acceptance Criteria: The study referred to is the "performance testing" based on the ASTM F 1798 and ASTM F 1717 standards. These are in vitro mechanical engineering studies, not clinical trials.
Sample Size for Test Set: For mechanical testing, this refers to the number of device constructs tested. This information is not specified in the document (e.g., "n=5 constructs were tested").
Data Provenance: The tests are in vitro laboratory tests, not human data.
Ground Truth: For mechanical testing, the "ground truth" would be the engineering specifications and material science principles, and the expectation that the device should not fail under conditions prescribed by the ASTM standards.

In summary, the provided document is a regulatory submission for a physical medical device (spinal system) focusing on substantial equivalence based on prior clearances and mechanical performance testing, not on clinical performance against a diagnostic or therapeutic ground truth as your questions imply for something like an AI device.

Summary

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

September 3, 2015

Spinal Elements, Incorporated Ms. Cecilia Silva Regulatory Affairs Specialist 3115 Melrose Drive; Suite 200 Carlsbad, California 92010

Re: K151705

Trade/Device Name: Lotus® Posterior Cervical/Thoracic Spinal System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: August 24, 2015 Received: August 25, 2015

Dear Ms. Silva:

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.

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 of medical 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.

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Page 2 – Ms. Cecilia Silva

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151705

Device Name

Lotus® Posterior Cervical/Thoracic Spinal System

Indications for Use (Describe)

The Spinal Elements Lotus Posterior Cervical/Thoracic Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fraumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radior myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Lotus Posterior Cervical/Thoracic Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Type of Use (Select one or both, as applicable)

	☑ Prescription Use (Part 21 CFR 801 Subpart D)
	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Spinal Elements, Inc. Premarket Notification - Lotus® Posterior Cervical/Thoracic Spinal System

510(k) Summary Lotus® Posterior Cervical/Thoracic Spinal System

510(k) Number K151705

Manufacturer IdentificationSubmitted by:	Spinal Elements, Inc.3115 Melrose Dr., Suite 200Carlsbad, CA 92010760-607-0121
Contact Information:	Cecilia SilvaRegulatory Affairs SpecialistSpinal Elements, Inc.3115 Melrose Dr., Suite 200Carlsbad, CA 92010760-607-1830csilva@spinalelements.com
Date Prepared:	August 24th, 2015
Proprietary Name :	Lotus® Posterior Cervical/Thoracic Spinal System
Regulatory Identification/Classification:	Orthosis, Cervical Pedicle Screw Spinal FixationProduct Code: NKGUnclassifiedAppliance, Fixation, Spinal InterlaminalProduct Code: KWP21 CFR Section 888.3050Class II

Purpose of this 510(k)

This 510(k) seeks clearance for expanded indications and line additions to the Lotus Posterior Cervical/Thoracic Spinal System previously cleared for use under K120467 and K131427.

Device Description

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rods and screws/hooks. The system achieves fixation by the mechanical joining of the rods, screws, hooks and connectors. A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient.

Indications for Use

The Spinal Elements Lotus Posterior Cervical/Thoracic Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3; traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Lotus Posterior Cervical/Thoracic Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Substantial Equivalence

The subject Lotus devices are substantially equivalent in indications for use, surgical technique, design features and instrumentation to the following predicate devices:

Primary Predicate

. Medtronic's VERTEX® Reconstruction System (K143471)

Reference Devices

Spinal Elements' Lotus Posterior Cervical/Thoracic Spinal System (K120467, . K131427).

Performance Data

Published literature and performance testing support substantial equivalence. Tests included:

Interconnection testing per ASTM F 1798 ●
Dynamic Compression Bending per ASTM F 1717 ●

All data indicates that the device will perform as intended.

Regulation Number and Section

§ 888.3075 Posterior cervical screw system.

(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.