The HD Lumbar Interbody System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone and allograft bone comprised of cancellous and/or corticocancellous bone.

Device Description

The HD Lumbar Interbody System consists of interbody fusion cages made from Ti-6Al-4V implant-grade titanium using additive manufacturing technology. The implants of the HD Lumbar Interbody System are offered in a variety of lengths, widths and cross sectional geometries to accommodate patient anatomy and surgical approach. The implants of the HD Lumbar Interbody System are also offered in various lordotic configurations to ensure proper stability and alignment of the spine for differing patient anatomy. The implants are provided sterile.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "HD Lumbar Interbody System," a medical device used in spinal fusion. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving independent effectiveness through clinical studies with acceptance criteria for device performance in terms of accuracy or efficacy in diagnosing/treating disease.

Therefore, many of the requested items related to "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software as a medical device (SaMD) are not applicable to this submission. This is a traditional hardware medical device.

However, I can extract information related to the performance testing that was done to demonstrate substantial equivalence.

Here's a breakdown of what is and is not applicable based on the provided text:

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

Applicable, but not in the context of clinical accuracy: The acceptance criteria for this device relate to mechanical performance (strength, stability, etc.) rather than clinical outcomes or diagnostic accuracy.
Reported Device Performance: The document states: "The results of this non-clinical testing show that the strength of the Lumbar Interbody System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." Specific numerical results or direct comparisons to numerical acceptance criteria are not provided in this summary, but the conclusion of meeting these criteria is given.

Acceptance Criteria (Type of Test)	Reported Device Performance (Summary)
Static axial compression (ASTM F2077-14)	Sufficient for intended use and substantially equivalent to predicates
Static compressive shear (ASTM F2077-14)	Sufficient for intended use and substantially equivalent to predicates
Dynamic axial compression (ASTM F2077-14)	Sufficient for intended use and substantially equivalent to predicates
Dynamic compressive shear (ASTM F2077-14)	Sufficient for intended use and substantially equivalent to predicates
Static expulsion (ASTM Draft F-04.25.02.02)	Sufficient for intended use and substantially equivalent to predicates
Static subsidence (ASTM F2267-04)	Sufficient for intended use and substantially equivalent to predicates
Bacterial endotoxins (ANSI/AAMI ST72:2011, USP <161>, USP <85>, EP 2.6.14, JP 4.01)	Sufficient for intended use and substantially equivalent to predicates

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

Not applicable for clinical data: This information is not provided as the submission relies on mechanical testing rather than clinical data from human subjects. The "sample size" would refer to the number of devices tested in the lab, which is not specified in this summary.

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 applicable: Ground truth in the context of expert review is relevant for diagnostic or AI-based devices. This device is an implant, and its "ground truth" for performance is based on standardized mechanical testing rather than expert clinical assessment of patient data.

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

Not applicable: Adjudication methods are used to resolve discrepancies in expert labeling or diagnoses. This is not relevant for the mechanical testing performed on this device.

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 type of study is specific to AI-assisted diagnostic devices. The HD Lumbar Interbody System is a physical implant.

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

Not applicable: This refers to the standalone performance of an AI algorithm, which is not relevant for this device.

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

Applicable, but different context: The "ground truth" for this device's performance is defined by adherence to established ASTM (American Society for Testing and Materials) and other recognized standards for mechanical and biocompatibility testing. These standards define the acceptable range for forces, loads, and biological responses.

8. The sample size for the training set

Not applicable: There is no "training set" in the context of an implant device relying on mechanical testing for 510(k) clearance based on substantial equivalence. This concept is relevant for machine learning/AI models.

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

Not applicable: As there's no training set, this question is not relevant.

In summary: The provided document is for a traditional medical device (an interbody fusion cage) seeking 510(k) clearance based on "substantial equivalence" to existing predicate devices. The primary evidence presented relates to non-clinical (mechanical and biological) performance testing against recognized industry standards, rather than clinical efficacy studies, diagnostic accuracy, or AI model performance benchmarks. Therefore, most of the questions relating to AI/SaMD acceptance criteria and study design are not applicable.

Summary

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

HD LifeSciences LLC % Mr. Kenneth C. Maxwell Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918 July 13, 2017

Re: K170676

Trade/Device Name: HD Lumbar Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 25, 2017 Received: June 13, 2017

Dear Mr. Maxwell:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 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/ResourcesforYou/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.

Mark N. Melkerson -S

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) K170676

Device Name HD Lumbar Interbody System

Indications for Use (Describe)

The HD Lumbar Interbody System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone and allograft bone comprised of cancellous and/or corticocancellous bone.

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

[X] Prescription Use (Part 21 CFR 801 Subpart D)
[ ] Over-The-Counter Use (21 CFR 801 Subpart C)

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Submitter's Name	HD LifeSciences LLC
Submitter's Address	38 Montvale Ave Ste 380Stoneham, MA 02180
Submitter's Telephone	978.595.6625
Company Contact Person	Ian HelmarChief Product Officer, Director of Engineeringianhelmar@hdlifesciences.com
Contact Person	Kenneth C. Maxwell IIEmpirical Testing Corp.719.291.6874KMaxwell@empiricalconsulting.com
Date Summary was Prepared	10 July 2017
Trade or Proprietary Name	HD Lumbar Interbody System
Common or Usual Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Classification	Class II per 21 CFR §888.3080 Device Classification
Product Code	MAX
Classification Panel	Division of Orthopedic Devices

510(K) SUMMARY

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

The indications for use for the HD Lumbar Interbody System is similar to that of the predicates listed in Table 5-1.

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TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are the same between the subject and predicates:

. Principle of Operation
Indications for Use ●
Materials of manufacture ●

		Table 5-1: Predicate Devices
--	--	------------------------------	--

510kNumber	Trade or Proprietary orModel Name	Manufacturer	PredicateType
K072791	OPAL Spacer	Synthes	Primary
K072253	ALIF Spacer	Synthes	Additional
K160547	Cascadia Interbody System	K2M	Additional

PERFORMANCE DATA

The Lumbar Interbody System has been tested in the following test modes:

Static axial compression per ASTM F2077-14
Static compressive shear per ASTM F2077-14 ●
Dynamic axial compression per ASTM F2077-14
Dynamic compressive shear per ASTM F2077-14
Static expulsion per ASTM Draft F-04.25.02.02
. Static subsidence per ASTM F2267-04
Bacterial endotoxins test per ANSI/AAMI ST72:2011/(R) 2016, USP <161>, USP <85>, EP 2.6.14, and JP 4.01.

The results of this non-clinical testing show that the strength of the Lumbar Interbody System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Lumbar Interbody System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.