Search Results

CD Horizon™ Astute™ Spinal System: The CD Horizon™ Astute™ Spinal System is intended to provide for posterior, supplemental fixation when used with an interbody fusion cage for patients diagnosed with degenerative disc disease (DDD- defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

CD Horizon™ Fenestrated Screw Set: When used without cement, CD Horizon™ Fenestrated Screws (with or without Sextant™ or Longitude™ instrumentation) are intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD- defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tumor and/or trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis), pseudarthrosis, and/or failed previous fusion. Additionally, CD Horizon™ Fenestrated Screws may be used for immobilization when used for trauma (e.g. fracture or dislocation) with the usage of bone graft material left to the surgeon's discretion. When used in conjunction with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion™ Fenestrated Screws augmented with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

CD HORIZON™ Growth Rod Conversion Set: The CD Horizon™ Growth Rod Conversion Set is indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency including early-onset scoliosis. The CD Horizon™ Growth Rod Conversion Set may be used with any cleared traditional CD Horizon™ Spinal System rod construct ranging in diameter from 3.5mm to 5.5mm, with the exception of PEEK Rod constructs. The CD Horizon™ Growth Rod Conversion Set may not be used with PEEK rods, Spire™ Spinous Process Plates, or Shape Memory Alloy (SMA) Staples.

CD HORIZON™ Spinal System: The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion. With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below. When used for posterior non-cervical pedictic patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, and congenital scoliosis, Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach. The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (12 - S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use. The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor. To achieve additional levels of fixation, CD Horizon™ Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of the Vertex™ indications of use.

GDLH™ Posterior Spinal System: The GDLH™ Posterior Spinal System, when using TSRH™ variable angle screws, is intended only for patients (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) receiving fusions using autogenous bone graft only; (c) having the device fixed or attached to the lumbar and sacral spine: and (d) having the device removed after the development of a solid fusion mass. When properly used. this system is intended to assist stabilization until a solid spinal fusion develops. Except for situations where screws are attached to the lumbar and sacral spine via a posterior surgical approach in a GDLH™ construct for the treatment of severe spondylolisthesis (Grade 4) at the L5-S1 vertebral joint, the specific indications for the GDLH™ Posterior Spinal System are the following: Degenerative disc disease (DDD - as defined by instability in the presence of one or more of the following: osteophyte formation, decrease in disc space height, endplate sclerosis, disc herniations, facet joint changes, and scarring and/or thickening of the annulus fibrosis, ligamentum flavum, or facet joint capsule). Pseudoarthrosis. Stenosis. Spondylolisthesis. Spinal deformities such as scoliosis, kyphosis, and lordosis. Fracture. Unsuccessful previous attempts at spinal fusion. Tumor resection. Nota bene: the GDLH™ Posterior Spinal System is limited to non-cervical use. TSRH™ variable angle with the GDLH™ Posterior Spinal System, are intended for sacral/iliac attachment only. GDLH™ hooks and Crosslink™ bars are intended for posterior thoracic and/or lumbar use only.

COLORADO 2™ Spinal System: When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Colorado 2™ Spinal System is indicated for one or more of the following: ( ) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (5) kyphosis, (6) spinal tumor, and/or (7) pseudarthrosis. In addition, when used as a pedicle screw fixation system, the Colorado 2™ Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5 S1) vertebral joint, (2) receiving fusions using autogenous bone graft only, (3) having the device fixed or attached to the lumbar and sacral spine (L3 and below), and (4) having the device removed after the development of a solid fusion mass. When used as a posterior, non-cervical, non-pedicle screw fixation system, the Colorado 2™ Spinal System is intended for the following indications: (1) degenerative disc disease (DDD - as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e. scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, and/or (7) tumor resection. When used as an anterolateral thoracic/lumbar system, the Colorado 2™ Spinal System is intended for the following indications: (1) DDD (as defined by back pain of discogenic origin with degeneration of the disc confirmed b patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e. scoliosis, kyhosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, and/or (7) tumor resection.

SHILLA™ Growth Guidance System: The Shilla™ Growth Guidance System is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth who require surgical treatment for correction and maintenance of the correction of severe, progressive, life-threatening early-onset seculiosis, which are associated with or at risk of thoracic insufficiency syndrome. The Shilla™ Growth Guidance System is intended to be removed after skeletal maturity.

TENOR™ Spinal System: The Tenor™ Spinal System, when used for pedicle screw fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar – first sacral (L5-S1) vertebral joint; (b) receiving fusions using autogenous bone graft only; (c) having the device fixed to the lumbar and sacral spine (levels of pedicle screw fixation may be from L3 to sacrum); and (d) having the device removed after the development of a solid fusion mass. Note: Tenor™ Plates are intended for the L5-S1 pedicle screw indication only. The Tenor™ Spinal System, when used as a posterior, non-pedicle screw fixation system, is intended for the following indications: Degenerative disc disease (DDD - as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). Pseudarthrosis. Stenosis. Spondylolisthesis. Spinal deformities such as scoliosis, kyphosis, and/or lordosis. Fracture. Tumor resection. When used for posterior non-pedicle screw fixation. the Tenor™ Spinal System is intended for thoracic, lumbar, and sacral (T1- Sacrum) fixation only.

CD HORIZON™ ASTUTE™ SPINAL SYSTEM: The CD Horizon™ Astute™ Spinal System consists of a variety of sizes of rods, as well as set screws, which are used with bone screws from the CD Horizon™ Solera™ Spinal System, to create a variety of rigidly locked configurations, with each construct being tailored to the individual case. CD Horizon™ Astute™ Spinal System implant components are fabricated from medical grade titanium alloy, tantalum, or polyetheretherketone (PEEK). Medical grade titanium, titanium alloy, or medical grade cobalt-chromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct. Only use set screws designed for use with CD Horizon™ Astute™ rods. PEEK implants may be used with titanium alloy or cobaltchromium-molybdenum alloy implants. CD Horizon™ Astute™ Spinal System rods are not to be used with Crosslink™M plates, fixed angle screws, sagittally adjusting screws, or in pediatric patients. To achieve best results, do not use CD Horizon™ Astute™ Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document.

CD HORIZON™ Growth Rod Conversion Set: The CD Horizon™ Growth Rod Conversion Set consists of a variety of inline connectors used with certain CD Horizon™ Spinal System components to create posterior pedicle screw and hook constructs intended for treatment of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The CD Horizon™ Growth Rod Conversion Set is used with CD Horizon™ Spinal System rods (ranging in diameter from 3.5mm to 5.5mm), pedicle screws, hooks, and connectors of various sizes. These implants are used to form a distinct spinal construct in growing children to correct spinal deformities in a non-fusion manner. Similar to CD Horizon™ implants used in fusion cases, these components are rigidly locked into a variety of configurations with each construct being tailor-made for the individual. As the patient grows, subsequent lengthening surgeries are performed periodically to reapply tension/distraction to the construct. These surgeries are repeated until the child has reached skeletal maturity, at which point the implants may be removed. Certain components within the CD Horizon™ Spinal System are excluded for use in pediatric patients and, therefore, are excluded for use with the CD Horizon™ Growth Rod Conversion Set. These include PEEK rods, Shape Memory Alloy Staples and Spire™ Plates. All screws used in pediatric cases are only cleared for use via a posterior approach. CD Horizon™ Growth Rod Conversion Set components are fabricated from medical grade stainless steel or titanium alloy. Compatible CD Horizon™ Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy. Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct. To achieve best results, do not use any of the CD Horizon™ Growth Rod Conversion Set implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document.

CD HORIZON™ SPINAL SYSTEM: The CD Horizon™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, Crosslink™ Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. A subset of CD Horizon™ Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, Crosslink™ plates, and connecting components. Similar to the CD Horizon™ implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Certain components within the CD Horizon™ Spinal System are specifically excluded for use in pediatric patients. These include PEEK rods, Spire™ plates. Screws used in pediatric cases are only cleared for use via a posterior approach. All components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, and medical grade cobalt-chromium-molybdenum alloy. Certain implant components from other Medtronic spinal systems can be used with the CD Horizon™ Spinal System in non- pediatric cases. These components include TSRH™ rods, hooks, screws, plates; Crosslink™ plates, connectors, staples and washers; GDLH™ rods, hooks, connectors; Crosslink™ bar and connectors and Medtronic multi-axial rods and screws. Note that certain components are specifically designed to connect to specific rod diameters, while other components can connect to multiple rod diameters. Care should be taken so the correct components are used in the spinal construct. CD Horizon™ hooks are intended for posterior use only. CD Horizon™ staples and associated screws are intended for anterior use only. However, for patients of smaller stature and pediatric patients, CD Horizon™ 4.5mm rods and associated components may be used posteriorly. CD Horizon™ Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, medical grade cobalt- chromium-molybdenum alloy, or medical grade PEEK Optima-LT1. Certain CD Horizon™ Spinal System components may be coated with hydroxyapatite. Never use stainless steel and titanium implant components in the same construct. Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct. PEEK Optima-LT1 implants may be used with titanium or cobalt-chromium-molybdenum alloy implants. CD Horizon™ PEEK rods are not to be used in pediatric patients. PEEK rods are only to be used with the associated pedicle screws as well as interbody fusion devices in the anterior spinal column. To achieve best results, do not use CD Horizon™ Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document.

CD Horizon™ Fenestrated Screw Set: The CD Horizon™ Fenestrated Screw Set consists of a variety of cannulated screws. These screws contain a series of fenestrations which allows polymethylmethacrylate (PMMA) > bone > > cement (Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement) to be injected into the treated site. This cement is used to augment screw fixation into the pedicle in patients whose life expectancy is of insufficient duration to permit achievement of fusion. These implants may also serve as traditional pedicle screws when used without bone cement in patients. CD Horizon™ Fenestrated Screws are specifically designed to connect to appropriate rods and associated connecting components contained within the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package insert for information regarding those implants. Care should be taken so the correct components are used in the spinal construct. CD Horizon™ Fenestrated Screw Set implant components are fabricated from medical grade titanium and/or medical grade titanium alloy and/or medical grade cobaltchromium-molybdenum alloy. Never use stainless steel and titanium implant components in the same construct. To achieve best results, do not use CD Horizon™ Fenestrated Screw implants with components from any system other than the CD Horizon™ Spinal System.

COLORADO 2™ SPINAL System: The Colorado 2TM Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, and connecting components. Colorado 2TM implant components can be rigidly locked into a variety of configurations, with each construct being tailormade for the individual case. Colorado 2TM Spinal System implant components are fabricated from medical grade stainless steel. Alternatively, the entire system may be fabricated from medical grade titanium or titanium alloy. The titanium version of the Colorado 2TM Spinal System is used in conjunction with GDLHTM φ5.5 rods, TSRHTM Spinal System rods and TenorTM Spinal System rods. To achieve best results, do not use Colorado 2TM Spinal System implant components with components from any other system or manufacturer. Never use stainless steel and titanium implant components in the same construct.

GDLH™ POSTERIOR SPINAL SYSTEM: The GDLHTM Posterior Spinal System consists of a variety of shapes and sizes of rods, hooks, and connecting components. TSRHTM variable angle screws may also be used with the GDLHTM Posterior Spinal System. GDLHTM implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. GDLHTM Posterior Spinal System implant components are fabricated from medical grade stainless steel described by ASTM Standard F 138, Grade 2 (commonly called 316 LVM Stainless Steel) or ISO 5832-1 or ISO 5832-9. This material is not compatible with titanium, MP35NTM1 or any other alloy. Alternatively, GDLH TM Posterior Spinal System implant components are fabricated from titanium alloy (Ti-6Al-4V) such as described by ASTM F136 or ISO 5832-3. Implant components made from different metal alloys must not be used together in a construct. Medtronic expressly warrants these devices are fabricated from the foregoing material specifications. To achieve the best results, do not use GDLHTM Posterior Spinal System components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopaedic implants, none of the GDLH Posterior Spinal System components should ever be reused under any circumstances.

SHILLA™ Growth Guidance System: The Shilla™ Growth Guidance System consists of stainless steel components used to form a distinct spinal construct in growing children. The Shilla™ Growth Guidance System set screw provides attachment of a spinal pedicle screw to a spinal rod. Unlike a typical set screw, which rigidly locks the vertical rod inside the connector housing to the pedicle screw, the Shilla™ Growth Guidance System set screw captures the rod within the screw housing, but does not fix it rigidly to the pedicle screw. The Shilla™ Growth Guidance System consists of a construct that includes 4.5mm or 5.5mm diameter rods, fixed angle and multi-axial screws, and CrosslinkTM plates. Additionally, the construct may be supplemented with sublaminar wire. Shilla™ Growth Guidance System implants are provided non-sterile. Shilla™ Growth Guidance System implants are not to be used with implants from other systems. Never use stainless steel and titanium implant components in the same construct.

TENOR™ SPINAL SYSTEM: The Tenor™ Spinal System consists of a variety of shapes and sizes of rods, screws, bolts, clamps, connectors, plates, cross-connectors, washers, and nuts. The Tenor™ Spinal System may be used with GDLH™ 5.5mm rods, TSRHTM hooks and connectors, TSRH™ Low Profile Crosslink™ plates, CD Horizon™ Low Profile Multispan™ Crosslink™ plates, and/or Multi-axial Low Profile Multi-span™ Crosslink™ plates for attachment to the posterior thoracic and lumbar spine. All screws/bolts in this system are 5.5mm in diameter or larger. Implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Tenor™ Spinal System implants are fabricated from medical grade titanium alloy. Alternatively, the entire system may be manufactured from medical grade stainless steel. Never use stainless steel and titanium implant components in the same construct. To achieve best results, do not use Tenor™ Spinal System implants with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document.

This document, K221646, describes an MRI update for several Medtronic ThoracoLumboSacral Anterior & Posterior Spinal Fixation Systems. The stated intention of the submission is to harmonize language in certain sections (Visual Inspection, Packaging, Cleaning & Sterilization, Cleaning & Decontamination, and Sterilization) across all 8 package inserts, claiming these changes do not impact related specifications and therefore require no further verification or validation testing.

The performance data provided focuses entirely on MRI safety testing, indicating that the device's main "performance" in this context is its MRI compatibility rather than clinical effectiveness for spinal fixation.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly mentioned for the MRI testing samples. Typically, these tests involve a representative number of device components or assemblies, but the exact count is not provided.
• Data Provenance: Not specified. It's likely these tests were conducted in a laboratory setting, not necessarily involving human or animal data. The origin of the testing facility (country) is not provided. The study is prospective in the sense that the testing was performed specifically for this submission to demonstrate MRI compatibility.

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)

• This document describes physical product testing (MRI compatibility), not a clinical study involving human interpretation where "ground truth" would be established by experts. Therefore, this information is not applicable. The ground truth is determined by the objective measurements performed during the standardized engineering tests (ASTM standards).

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

• This document describes physical product testing, not a clinical study requiring adjudication of expert opinions. Therefore, this information 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

• No MRMC comparative effectiveness study was done. This submission focuses on the MRI compatibility of spinal implants, not diagnostic performance with or without AI assistance. Therefore, this information is not applicable.

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

• No standalone algorithm performance study was done. This submission is for spinal implants, not AI algorithms. Therefore, this information is not applicable.

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

• For the MRI safety testing, the "ground truth" is established by the physical phenomena and measurements defined by the ASTM standards (e.g., magnetic field strength, temperature measurements, image artifact measurements). It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• This submission describes physical product testing, not the development or training of an AI algorithm. Therefore, this information is not applicable.

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

• This submission describes physical product testing, not the development or training of an AI algorithm. Therefore, this information is not applicable.

Ask a specific question about this device

The SHILLATM Growth Guidance System is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth, who require surgical treatment for correction and maintenance of the correction of severe, progressive, life-threatening early-onset deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome. The SHILLA™ Growth Guidance System is intended to be removed after skeletal maturity.

The SHILLA™ Growth Guidance System is intended to treat severe, progressive multi-planar spinal deformities such as early-onset scoliosis while allowing for skeletal growth. Severe, progressive early-onset scoliosis is defined as a greater than 40° Cobb angle or a rib-vertebral angle difference greater than 20°. The SHILLATM Growth Guidance System consists of a variety of shapes and sizes of steel rods, hooks, screws, CROSSLINK® Plates, and connecting components, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. All SHILLATM components are manufactured from medical grade stainless steel.

The provided text is a 510(k) summary for the SHILLA™ Growth Guidance System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific acceptance criteria in a study to prove device performance. It doesn't detail a study with acceptance criteria in the way you've outlined.

However, I can extract the information provided about the supporting data that was submitted to the FDA for the SHILLA™ Growth Guidance System:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present a table of specific, pre-defined acceptance criteria (e.g., sensitivity, specificity, accuracy targets) and corresponding device performance values because it is a 510(k) summary. The "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device.

The reported "performance" is a general statement about clinical and mechanical equivalence:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated. The document mentions "Retrospective clinical data for the subject device compared to traditional growth rod devices were provided." It does not specify the number of patients or cases included in this dataset.
• Data Provenance: Retrospective clinical data. The country of origin is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. Since the clinical data is "retrospective," it likely refers to outcomes observed from standard clinical practice rather than a controlled study with a dedicated expert panel for ground truth establishment for a specific AI-assisted device.

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

This information is not provided.

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:

This is not applicable. The SHILLA™ Growth Guidance System is a physical surgical implant system, not a software device involving human readers or AI assistance. Therefore, an MRMC study related to interpretation accuracy with or without AI is not relevant to this device.

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

This is not applicable. The SHILLA™ Growth Guidance System is a physical surgical implant system, not an algorithm.

7. The type of ground truth used:

For the clinical data, the "ground truth" would be the observed patient outcomes (e.g., correction of deformity, continued growth, complications) obtained from standard clinical follow-up for patients treated with either the SHILLA™ system or traditional growth rods.

8. The sample size for the training set:

Not applicable. This device is a physical implant system, not an AI/ML algorithm that requires a training set.

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

Not applicable. As above, this device does not involve a training set for an AI/ML algorithm.

Ask a specific question about this device