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The RESPONSE BandLoc Spinal Fixation is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

• · Spinal trauma surgery, used in sublaminar or facet wiring techniques;
• · Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and spondylolisthesis;
• · Spinal degenerative surgery, as an adjunct to spinal fusions;
• · The RESPONSE BandLoc Spinal Fixation may also be used in conjunction with other medical implants made of titanium alloy or CoCr alloy whenever "wiring" may help secure the attachment of other implants.

The RESPONSE BandLoc Spinal Fixation implant consists of a titanium alloy tulip head clamp attached to a polyester band and includes a set screw for affixing the clamp to a rod used for spinal fusion. The polyester band is available in two configurations-single and double (DUO) band. Both band configurations include a tip portion with an internal titanium insert enclosed in the band to enable the user to more easily pass the tip through the spinal anatomy. The final implanted devices are identical. Combinations of 5.5 and 6.0 diameter rods offered in titanium alloy, and/or cobalt chromium alloy can be utilized.

All implants are made from implantable grade materials and provided sterile and are single use only; the implants should not be re-used or re-sterilized under any circumstances.

This submission adds an additional implant configuration to the system, describes a modification to a system-specific (Class II) instrument, and adds MR conditions to the labeling.

The system is implanted using general (Class I, 510(k) exempt) and system-specific (Class II) instruments.

The provided text describes a 510(k) premarket notification for the OrthoPediatrics Response BandLoc Spinal Fixation device. It highlights the device's indications for use, comparison to a predicate device, and performance data from mechanical testing, electromagnetic compatibility, and biocompatibility. However, it does not include information about specific acceptance criteria or an analytical study comparing the device's performance against those criteria in a format applicable to AI/ML devices, or detailed clinical study information with human readers, sample sizes for test/training sets, or methods for establishing ground truth as requested in the prompt.

The information provided pertains to a traditional orthopedic implant, not an AI/ML device. Therefore, many of the requested fields are not applicable to the content of this document.

Here's an attempt to answer the questions based only on the provided text, while noting the limitations due to the nature of the device:

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

   Acceptance Criteria	Reported Device Performance
   Withstand anticipated loads during sublaminar passage	The BandLoc DUO assembly passed an internal tensile strength test. "The subject device met the pre-determined acceptance criteria for all tests."
   Mechanical performance of fusion construct	Mechanical testing data from predicate K161267 leveraged to support static and dynamic compression testing of a spine construct (ASTM F1717). No specific performance results for the current device are provided, but leverage implies equivalence.
   Corrosion susceptibility	Mechanical testing data from predicate K161267 leveraged to support corrosion susceptibility (ASTM F2129) of the tulip head. No specific performance results for the current device are provided, but leverage implies equivalence.
   BandLoc Tensioner modification	"The modified instrument met pre-determined acceptance criteria" following life cycle testing to simulate worst-case use.
   MR-Conditional Status	Determined to be MR-Conditional in accordance with ASTM F2052 (Magnetic Induction Displacement), ASTM F2213 (Magnetically Induced Torque), ASTM F2182 (RF Induced Heating), and ASTM F2119 (MR Image Artifacts). This implies meeting the requirements of these standards for "MR-Conditional" labeling.
   Biocompatibility	Supported by leveraging information from predicate K161267 per ISO 10993-1. Implies the device is biocompatible based on similar materials and manufacturing.

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

   • Mechanical Testing (tensile strength): The document states "an internal method." No sample size is specified.
   • Mechanical Testing (fusion construct, corrosion): Leveraged from predicate K161267. No sample sizes specified in this document for the predicate's tests.
   • Electromagnetic Compatibility: No specific "test set" sample size for patients/cases is applicable since these are device-specific engineering tests. The tests were performed on the device itself.
   • Biocompatibility: Leveraged from predicate K161267. This typically involves material testing, not patient data in the context described.
   • Provenance: "internal method" suggests in-house testing.

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 to this type of device and testing. The ground truth for mechanical, EMC, and biocompatibility tests is established by published test standards and engineering principles, not expert medical opinion on images or clinical data.

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

   • Not applicable to this type of device and testing.

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 device is an orthopedic implant, not an AI/ML medical device designed to assist human readers.

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

   • Not applicable. This device is an orthopedic implant, not an AI/ML algorithm. The performance tests (mechanical, EMC, biocompatibility) are standalone for the device itself against established standards.

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

   • Mechanical Testing: Engineering test standards (ASTM F1717, ASTM F2129), internal test methods, and pre-determined acceptance criteria based on mechanical properties and expected loads.
   • Electromagnetic Compatibility: Published ASTM standards (F2052, F2213, F2182, F2119) for determining MR-Conditional status.
   • Biocompatibility: ISO 10993-1, which provides guidelines for biological evaluation of medical devices.

8. The sample size for the training set

   • Not applicable. This device is an orthopedic implant, not an AI/ML device that requires a training set.

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

   • Not applicable. This device is an orthopedic implant, not an AI/ML device that requires a training set or associated ground truth.

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The RESPONSE BandLoc Spinal Fixation is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

• · Spinal trauma surgery, used in sublaminar or facet wiring techniques;
• Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis;
• Spinal degenerative surgery, as an adjunct to spinal fusions.
• The RESPONSE BandLoc Spinal Fixation may also be used in conjunction with other medical implants made of titanium alloy or CoCr alloy whenever "wiring" may help secure the attachment of other implants.

The Response BandLoc Spinal Fixation consists of a woven band, band clip, metal insert, tulip head and set screw. The metal insert, band, band clip and tulip head are assembled at the manufacturer and provided as a one piece assembly to the user. This tulip head/band assembly and the set screw are packaged in the same box but in separate peal packs. The tulip head assembly mates with a spine system rod and the set screw is tightened in the tulip head assembly securing it to the rod. Combinations of 5.5 and 6.0 diameter rods offered in titanium alloy, and/or cobalt chromium can be utilized. All implants are made from implantable grade materials and provided sterile and are single use only; the implants should not be re-used or re-sterilized under any circumstances. No accessories are offered with the system.

This document describes the 510(k) summary for the OrthoPediatrics Corp. Response BandLoc Spinal Fixation system. However, the provided text does not contain any information regarding AI/algorithm performance, human reader studies, or ground truth establishment relevant to an AI-powered device.

The document details the device's mechanical, material, and biocompatibility testing to demonstrate substantial equivalence to predicate spinal fixation devices. The acceptance criteria and testing described pertain to the physical medical device, not to an algorithm or AI system.

Therefore, I cannot fulfill your request for information on acceptance criteria and study details related to an AI device based on this input. The input describes a traditional medical device submission, not one that would involve the metrics you've requested.

To answer your request, the input would need to be a regulatory submission for an AI/ML-based medical device.

Ask a specific question about this device