When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone Ascent POCT System is indicated for:
a) degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies:
b) spondylolisthesis:
c) fracture/dislocation:
d) spinal stenosis:
e) atlanto-axial fracture with instability;
f) occipito-cervical dislocation:
g) tumors;
h) revision of previous cervical spine surgery

The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic conditions only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (T1-T3). The hooks are intended to be placed from C1 to T3. The Songer Cable (titanium) System to be used with the Blackstone Ascent POCT System allows for wire/cable attachment to the posterior cervical spine.

The Blackstone Ascent POCT System can also be linked to the Blackstone Spinal Fixation System using the Blackstone Ascent Axial or Parallel Connector.

Device Description

The Blackstone Ascent POCT System is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The Ascent POCT System consists of an assortment of rods, setscrews, cross connectors, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, bone screws, and Songer Cables.

AI/ML Overview

The provided 510(k) notification for the Blackstone™ Ascent POCT System (K080394) describes a spinal implant system, not a medical device that would have performance metrics like sensitivity, specificity, or image quality. Therefore, most of the requested information regarding acceptance criteria and studies that prove the device meets these criteria in the context of an AI/imaging device is not applicable.

This submission is for a modification to an existing device (plate and rod modifications) and primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices. The "performance" of such a device is typically assessed through mechanical testing to ensure it meets established standards for strength, durability, and biocompatibility, rather than diagnostic accuracy.

Here's an attempt to answer the questions based on the provided document, noting when information is not applicable or available:

Acceptance Criteria and Device Performance

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

Given that this is a spinal implant system and a modification, the "acceptance criteria" are generally related to mechanical properties, biocompatibility, and meeting design specifications. The document does not provide a table of quantitative acceptance criteria or detailed test results. Instead, it asserts substantial equivalence based on the device description and intended use aligning with predicate devices.

Not Applicable in the traditional sense for a diagnostic device. For a spinal implant, acceptance criteria would typically involve:

Mechanical Integrity: Withstanding specified forces (e.g., bending, torsion) without fracture or permanent deformation.
Dimensional Accuracy: Conforming to design specifications.
Biocompatibility: No adverse tissue reaction, assessed through materials testing and history of use of similar materials.
Sterilization: Ability to be sterilized without degradation (if applicable, though this device is described as non-sterile).

The document implicitly "reports performance" by claiming substantial equivalence, which means its performance is expected to be comparable to the predicate devices based on design and materials.

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. This type of information is generally for diagnostic devices or those involving clinical studies. Mechanical testing of implants does not involve "test sets" of patient data.

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 this device would relate to engineering specifications and mechanical testing standards, not clinical diagnostic accuracy assessed by experts.

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

Not Applicable. This concept applies to expert review processes for diagnostic studies, not mechanical testing or design comparisons for implants.

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 specific to AI-assisted diagnostic devices.

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

Not Applicable. This is specific to AI/diagnostic algorithms.

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

For a spinal implant modification, the "ground truth" for demonstrating substantial equivalence is typically:

Engineering Standards: Conformance to established ASTM/ISO standards for spinal implants (strength, fatigue, etc.).
Material Specifications: Compliance with material properties for titanium alloy.
Predicate Device Performance: The known, clinically accepted performance and safety profile of the predicate devices.
Design Intent: Whether the modified components still fulfill the same functional requirements as the original device.

The document states the basis of substantial equivalence is that the modified components "are substantially equivalent to the identified predicate systems, which have been cleared by FDA for the purpose of building a spinal implant construct in the occipito-cervico-thoracic spine." This implies the "ground truth" is adherence to the established safety and effectiveness of the predicates and relevant engineering principles.

8. The sample size for the training set

Not Applicable. This is relevant for machine learning models, not mechanical devices.

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

Not Applicable. This is relevant for machine learning models, not mechanical devices.

In summary, the K080394 document is a 510(k) for a device modification to a spinal implant system. The regulatory pathway relies on demonstrating substantial equivalence to predicate devices. This involves showing that the modified device has the same intended use, technological characteristics, and performance (e.g., mechanical properties, biocompatibility) as a legally marketed device. The document does not describe a study involving diagnostic accuracy, expert review, or AI performance, as it is for a physical implant. The "proof" relies on engineering principles, materials science, and a comparison to previously cleared devices.

Summary

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K080394

Premarket Notification Special 510(k) Blackstone Medical, Inc. Blackstone™ Ascent* POCT System Plate and Rod Modifications (System Modification) Confidential

510(K) SUMMARY

Name of Firm:	Blackstone Medical, Inc.1211 Hamburg TurnpikeWayne, NJ 07470	MAR 13 2008
510(k) Contact:	Whitney Törning, Senior Director of Regulatory Affairs &Quality Assurance
Submitter:	Martin Sprunck, Regulatory Affairs Manager
Trade Name:	Blackstone™ Ascent® Posterior Occipital Cervico-Thoracic (POCT) System
Common Name:	Rod and screw spinal instrumentation
Device Classification:	Class II
Classification Product Code:	KWP – 888.3050 – Spinal Interlaminal Fixation Orthosis

Substantially Equivalent Devices:

Blackstone™ Posterior Cervical System (K030197 SE 6-12-03) Blackstone™ Ascent POCT System Lateral Offset Adaptors (K040034 SE 2-11-04) Blackstone™ Ascent POCT System Hooks (K033980 SE 3-3-04) Blackstone™ Ascent POCT System 5.5mm/3.0mm Single Axial Connector (K042100 SE 9-20-04) Blackstone™ Ascent POCT System Parallel Rod Connectors (K073654 SE 1-24-08)

Device Description:

Description: The Blackstone Ascent POCT System is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The Ascent POCT System consists of an assortment of rods, setscrews, cross connectors, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, bone screws, and Songer Cables.

Levels of Use: When used in the occipito-cervico-thoracic spine, the Blackstone Posterior Cervical System may be used from the occiput to T3.

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Indications: When intended to promote fusion of the cervical spine and occipito-cervicothoracic junction (occiput-T3), the Blackstone Ascent POCT System is indicated for:

a) degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies:
b) spondylolisthesis:
c) fracture/dislocation:
d) spinal stenosis:
e) atlanto-axial fracture with instability;
f) occipito-cervical dislocation:
g) tumors;
h) revision of previous cervical spine surgery

The Blackstone Ascent POCT System can also be linked to the Blackstone Spinal Fixation System using the Blackstone Ascent Axial or Parallel Connector.

Basis of Substantial Equivalence:

The modified Blackstone™ Ascent Occipital Plate and Occipital-Transition Rod are substantially equivalent to the identified predicate systems, which have been cleared by FDA for the purpose of building a spinal implant construct in the occipito-cervico-thoracic spine.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure embracing a globe, symbolizing the agency's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2008

Blackstone Medical, Inc. % Ms. Whitney Törning Senior Director of Regulatory Affairs and Quality Assurance 1211 Hamburg Turnpike, Suite 300 Wayne, NJ 07470

K080394 Re:

Trade/Device Name: Ascent® Posterior Occipital Cervico-Thoracic (POCT) System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: February 11, 2008 Received: February 13, 2008

Dear Ms. Törning:

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 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); 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. Whitney Törning

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Millen

Mark N. Melkerson 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):

Device Name: Blackstone™ Ascent Posterior Occipital Cervical Thoracic System (POCT) System

Indications for Use:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone Ascent POCT System is indicated for:

degenerative disc disease (defined as neck pain of discogenic origin with degeneration of a) the disc confirmed by patient history and radiographic studies;
spondylolisthesis; b)
fracture/dislocation; c)
spinal stenosis; d)
atlanto-axial fracture with instability; e)
occipito-cervical dislocation; f)
tumors; g)
h) revision of previous cervical spine surgery

The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic conditions only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (T1-T3). The hooks are intended to be placed from C1 to T3. The Songer Cable (titanium) System to be used with the Blackstone Ascent Posterior Occipital Cervical Thoracic System allows for wire/cable attachment to the posterior cervical spine.

The Blackstone Ascent Posterior Occipital Cervical Thoracic System can also be linked to the Blackstone Spinal Fixation System using the Blackstone Ascent Axial or Parallel Rod Connector.

Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Page 1 of

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Dykman

Division of General, Restorative, and Neurological Devices

510(k) Number K080394

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.