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 Connector or the Blackstone Ascent Parallel Rod 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 document from K073654 is a 510(k) Premarket Notification for a system modification to the Blackstone™ Ascent® POCT System. This is a spinal implant system and the submission is for the addition of a "Parallel Rod Connector."

Medical devices like the Ascent POCT System, particularly spinal instrumentation, are evaluated for substantial equivalence to existing legally marketed predicate devices, not typically against acceptance criteria in the same way an AI/software device would be. The "study" here refers to the engineering and design controls required to demonstrate that the modified device functions as intended and is as safe and effective as its predicate.

Therefore, the requested information elements (1-9) which are typically applied to AI/software performance studies, or clinical trials for novel devices, do not directly apply in the context of this 510(k) for a system modification to a spinal implant. The "acceptance criteria" for this type of submission are primarily around demonstrating mechanical integrity, biocompatibility (if new materials are introduced), and overall functional equivalence to predicate devices.

Here's how to interpret the request in the context of this 510(k):

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied for a system modification): The new Parallel Rod Connector must meet the same mechanical performance, material specifications, and design requirements as the predicate devices and other components of the Ascent POCT System. This would include tests for strength, fatigue, torsional stability, and compatibility within the construct. These are typically defined by recognized standards (e.g., ISO, ASTM for spinal implants).
- Reported Device Performance: The document does not provide specific test data or performance metrics for the Parallel Rod Connector. Instead, it states: "The additional Blackstone™ Ascent Parallel Rod Connector is 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 statement implies that the necessary testing was performed and demonstrated equivalence.
Sample size used for the test set and the data provenance:
- This is not a "test set" in the context of AI or clinical studies. For mechanical testing of medical devices, the "sample size" refers to the number of devices or components tested to ensure statistical significance for mechanical properties. This information is not provided in the public 510(k) summary. The data provenance would be in vitro laboratory testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable. "Ground truth" in this context would be engineering specifications and standards for spinal implants, and the expertise would come from biomechanical engineers and material scientists performing the testing and design verification.
Adjudication method:
- Not applicable for mechanical testing of a device modification.
If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No. This is not an imaging or diagnostic device requiring MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical spinal implant, not a software algorithm.
The type of ground truth used:
- Not applicable as "ground truth" for a spinal implant modification consists of adherence to validated engineering specifications, material standards, and biomechanical performance criteria.
The sample size for the training set:
- Not applicable. There is no concept of a "training set" for physical device modifications in this context.
How the ground truth for the training set was established:
- Not applicable.

Summary based on the provided document for K073654:

The 510(k) submission for the Blackstone™ Ascent® POCT System Parallel Rod Connector is a system modification to an existing spinal instrumentation system. The core of the submission is to demonstrate substantial equivalence to previously cleared predicate devices.

Acceptance Criteria (Implied): The Parallel Rod Connector must meet biomechanical and material specifications consistent with its intended use in spinal fusion and be equivalent in safety and effectiveness to the predicate devices. These criteria are typically derived from recognized standards for spinal implants.
Study Proving Acceptance: The document states that the device "is substantially equivalent to the identified predicate systems." This implies that internal design verification and validation testing (e.g., mechanical strength, fatigue, material compatibility) were performed to demonstrate that the new connector performs equivalently to previously cleared devices. Specific test data, sample sizes for mechanical testing, and detailed methodologies are not disclosed in the public 510(k) summary provided.
Data Provenance: The "data" would primarily be in vitro laboratory test results from the manufacturer.
Experts/Ground Truth: Not applicable in the context of expert consensus or pathology for clinical cases. The "ground truth" for a medical device modification relates to engineering specifications and performance standards established by regulatory bodies and industry best practices.
No clinical or AI studies: This submission does not involve clinical trials, AI algorithms, or human-reader performance studies.

Summary

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K073654

Premarket Notification Special 510(k) Blackstone Medical, Inc. Blackstone™ Ascent® POCT System Parallel Rod Connector (System Modification) Confidential

510(K) SUMMARY

JAN 2 4 2008

Name of Firm:	Blackstone Medical, Inc.1211 Hamburg TurnpikeWayne, NJ 07470
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 5.5mm/3.0mm Single Axial Connector (K042100 SE 9-20-04) DePuy Spine Summit and Mountaineer OCT Spinal Systems (K042508 SE 10-7-04)

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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Premarket Notification Special 510(k) Blackstone Medical, Inc. Blackstone™ Ascent® POCT System Parallel Rod Connector (System Modification) Confidential

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;
occipito-cervical dislocation; f)
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 Connector or the Blackstone Ascent Parallel Rod Connector.

Basis of Substantial Equivalence:

The additional Blackstone™ Ascent Parallel Rod Connector is 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles an eagle or bird with three wing-like shapes. The symbol is black and appears to be a simplified representation of a bird in flight.

Public Health Service

JAN 2 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K073654

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: December 21, 2007 Received: December 26, 2007

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 M. Milliman

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:

a) degenerative disc disease (defined as neck pain of discogenic origin with degeneration of 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 Blackstone Ascent POCT System can also be linked to the Blackstone Spinal Fixation System using the Blackstone Ascent Axial Connector or the Blackstone Ascent Parallel Rod Connector.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Mark A. Milliman

Division of General, Restorative, and Neurological Devices

510(k) Number K073654

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.