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The Kepler II is indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. These patients should have had 6 weeks of non-operative treatment. The Kepler II implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The Kepler II Cervical Cage is to be used with supplemental fixation.

The Kepler II Cervical Cage consists of cervical spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Kepler II Cervical Cage is manufactured from PEEK-OPTIMA LT1 polymer and contains tantalum radiopaque markers. The Kepler II Cervical Cage is for single level anterior spinal use from the C2-C3 to C7-T1 disc levels.

This document is a 510(k) premarket notification for the Kepler II Intervertebral Body Fusion Device, manufactured by Orbbo Surgical, LLC. The FDA has determined the device to be substantially equivalent to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The document refers to "mechanical testing" and "performance testing" of the device itself and its material, not a "test set" of patient data.
• Data Provenance: Not applicable as no clinical data or patient test sets were used. The testing was mechanical and material-based.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. Mechanical and material testing standards (e.g., ASTM, ISO, USP) establish the 'ground truth' for performance rather than expert consensus on clinical cases.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical intervertebral body fusion device, not an AI or imaging diagnostic tool that would typically undergo such a study.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

• Not applicable. The Kepler II is a physical medical implant, not a software algorithm.

7. Type of Ground Truth Used

• The ground truth used was established engineering and material science standards (e.g., ASTM, ISO, USP) for mechanical performance, biocompatibility, and sterilization. These standards objectively define acceptable performance for the device.

8. Sample Size for the Training Set

• Not applicable. The Kepler II is a physical medical device, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable. No training set was used.

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The Kepler I Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The Kepler I Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, lordosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions.

This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.

The Kepler I Cervical Plate System is a system that includes titanium alloy (per ISO 5832-3) plates and screws that are intended to stabilize the spine during the fusion process. The plates and screws are available if various sizes to accommodate patients' anatomy. The plates are contoured to follow the curves of the cervical spine.

The provided text describes the Kepler I Cervical Plate System, a medical device for spinal fixation, and its substantial equivalence determination by the FDA. However, the input explicitly asks for details related to acceptance criteria and performance studies that are typically associated with artificial intelligence/machine learning (AI/ML) medical devices, particularly regarding diagnostic or predictive accuracy.

The document provided is for a traditional medical device (a cervical plate system) and does not involve AI/ML. Therefore, most of the requested information regarding acceptance criteria for device performance, ground truth, expert adjudication, sample sizes for test/training sets, or AI/ML specific studies (like MRMC or standalone performance) is not applicable to this submission.

Here's a breakdown of what can be extracted and why other parts are not present:

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

• Not applicable in the context of AI/ML performance. This device is a mechanical implant. Its performance is evaluated through mechanical testing (static and dynamic compression, static torsion) against established ASTM standards, not against diagnostic accuracy metrics. The document states that these tests were not required to be repeated for the Kepler I system because it is identical to a predicate device that had already demonstrated compliance with these mechanical standards.
  • Acceptance Criteria (Mechanical): Conformity to ASTM F1717-10 for static and dynamic compression, and static torsion testing (implied by substantial equivalence to predicate).
  • Reported Device Performance: By demonstrating "substantial equivalence" to the predicate device (Blue Mountain Cervical Plate System, K150036) which already passed these mechanical tests, the Kepler I system is considered to meet the performance requirements without needing new tests.

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

• Not applicable. There is no "test set" in the context of data for an AI/ML model for this mechanical device. The "testing" refers to mechanical stress tests of the physical device.

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. No expert ground truth establishment is mentioned for this type of mechanical device submission.

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

• Not applicable. No adjudication process as described for AI/ML models is mentioned.

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 a mechanical implant, not an AI/ML diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would be relevant or performed.

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

• Not applicable. There is no algorithm or AI component in this device.

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

• Not applicable. Ground truth, in the AI/ML sense, is not relevant for this mechanical device. Its "ground truth" relates to material properties and structural integrity as assessed by engineering standards.

8. The sample size for the training set

• Not applicable. There is no training set for an AI/ML model here.

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

• Not applicable. No training set exists.

Summary based on the provided document:

The device, Kepler I Cervical Plate System, is a mechanical implant made of titanium alloy. Its substantial equivalence to a predicate device (Blue Mountain Cervical Plate System, K150036) was demonstrated because of identical:

• Indications for Use
• Materials of manufacture
• Structural support mechanism
• Technological characteristics (materials, screw types/diameters/lengths, plate widths/thickness/lengths, screw locking mechanism).

Because of these identical characteristics, "Mechanical testing (static and dynamic compression testing and static torsion testing per ASTM F1717-10), which characterized the performance of the predicate was not required to be repeated. There are no changes in design, materials or manufacturing processes." This means the acceptance criteria were met by the predicate device's prior successful testing against the ASTM F1717-10 standard, and the Kepler I system is considered to perform equivalently.

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The Hubble I System is indicated for use for noncervical pedicle fixation from the T1 to S1 vertebrae in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

The Orbbo Hubble I System is an implant device made from a titanium alloy Ti 6Al-4V ELI per ISO 5832-3 and Cobalt-Chrome per ISO 5832-12. The titanium alloy implants are provided sterile. The cobalt-chrome implants are provided non-sterile. It is to be implanted from the posterior approach. The screws are available as monobloc reduction (traction) screws and polyaxial and polyaxial reduction (traction) screws in diameters from 4.0 - 8.0 mm and in lengths from 25 - 55 mm and polyaxial illac screws of 7 and 8mm diameters with lengths from 55mm to 110mm. Rods are available in 5.5mm diameter in lengths from 40 - 500 mm. Hooks are available in various sizes to attach to the thoracic and lumbar spine. Transverse connectors are available in various sizes to attach to the two parallel rods. Associated instrumentation to complete the procedure is provided non-sterile.

The provided document is a 510(k) premarket notification for the Hubble I System, a thoracolumbosacral pedicle screw system. It declares substantial equivalence to a predicate device, the Mont Blanc Spinal System.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that the Hubble I System was evaluated to demonstrate equivalence to the predicate devices. It explicitly mentions that mechanical testing was performed for the predicate devices, which characterized their mechanical performance and fatigue endurance (Static Compression Bend, Static Torsion, and Dynamic Compression Bend per ASTM F1717-13). For the Hubble I System itself, "As there are no changes in design or materials or manufacturing processes, no new performance testing was required." This implies that the Hubble I System is expected to have the same performance as the predicate device because it is considered equivalent in design, materials, and manufacturing, and thus no new tests were performed to establish new acceptance criteria or new performance data for the Hubble I System specifically. The acceptance criteria for the Hubble I System are essentially the demonstrated performance of the predicate device.

Regarding other requested information, the document does not provide the following details, as the submission relies on substantial equivalence and does not report a separate clinical or AI study:

• Sample size used for the test set and the data provenance: Not applicable, as no new clinical or AI study with a test set was performed for the Hubble I System.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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 a surgical implant, not an AI diagnostic or assistive tool.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of what was done according to the document:

The Hubble I System's acceptance was primarily based on a declaration of substantial equivalence to existing predicate devices (Mont Blanc Spinal System, K150185 and K161387). The core of the "study that proves the device meets the acceptance criteria" is the assertion that the Hubble I System shares identical technological characteristics (indications for use, materials of manufacture, structural support mechanism) with its predicates.

Therefore, instead of new performance testing for the Hubble I System, the submission leveraged the existing mechanical performance and fatigue endurance data of the predicate devices, which were tested according to ASTM F1717-13 for Static Compression Bend, Static Torsion, and Dynamic Compression Bend. The rationale is that since there are no changes in design, materials, or manufacturing processes for the Hubble I System compared to the predicate, its performance is considered equivalent, and thus no new testing was deemed necessary.

The document explicitly states: "No clinical or animal studies were performed." This clarifies that no independent clinical validation or AI-specific performance study was conducted for the Hubble I System's 510(k) clearance process.

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The Hubble II Lumbar Interbody Fusion is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). Hubble II System implants are to be used with autogenous bone graft. Patients should be sketally mature and have at least six months of non-operative treatment. The Hubble II System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

The Hubble II Lumbar Interbody Fusion System consist of 3 designs, PLIF & PLIF BS, TLIF and OLIF. The PLIF and TLIF implants are available as a lordotic form, while the OLIF implants are provided with no lordosis. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile, and a set of instrument for implantation is provided to facilitate implantation. Two radiographic markers made of tantalum per ASTM F560 are included in the PLIF and OLIF PEEK implants, and three radiographic markers made of tantalum per ASTM F560 are included in the TLIF PEEK implant to allow radiographic visualization.

This document is a 510(k) Premarket Notification from the FDA for a medical device called Hubble II, an intervertebral body fusion device. It primarily discusses the device's substantial equivalence to predicate devices and does NOT contain information about acceptance criteria or a study proving device performance against such criteria.

The crucial sentence that indicates this is:

"As there are no changes in design or materials or manufacturing processes, no new performance testing was required. No clinical or animal studies were performed."

This means the submission relies on the established performance of the legally marketed predicate device (Twin Peaks) and does not present new performance data for Hubble II itself. Therefore, I cannot extract the requested information.

Reason for not providing the requested information: The provided document is a 510(k) Premarket Notification for a medical device. This type of submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving the subject device meets specific acceptance criteria based on new performance studies. The document explicitly states that "no new performance testing was required" and "no clinical or animal studies were performed" for the Hubble II device due to its identical design, materials, and manufacturing processes to its predicate.

Therefore, the document does not contain:

• A table of acceptance criteria and reported device performance.
• Details on sample sizes or data provenance for a test set.
• Information on experts used to establish ground truth.
• Adjudication methods.
• Results from multi-reader multi-case (MRMC) comparative effectiveness studies.
• Results from standalone (algorithm-only) performance studies.
• The type of ground truth used.
• Sample size for a training set or how its ground truth was established, as this device does not involve an algorithm or AI.

The "Performance Testing" section states that the predicate device was tested according to ASTM F2077 and ASTM F2267, including static and dynamic axial compression, static and dynamic compression shear, subsidence, and expulsion. However, these are tests performed on the predicate, not the Hubble II device itself as part of this submission, and no specific performance values are reported for Hubble II against acceptance criteria.

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