Search Results

Black Diamond is intended as Treatment of Dental Hypersensitivity. For use in adults over the age of 21.

Black Diamond is a two-part liquid intended as a treatment for dentin hypersensitivity, for use in adults over the age of 21. The product does not need light cured and will provide occlusion of dentinal tubules preventing or reducing dentin hypersensitivity.

The formula has two liquid steps, each provided in an individual dropper bottle. A drop of each product is placed in a mixing well/dappen dish and applied sequentially to the tooth using a standard flock tip applicator bush such as a microbrush. The mixing pad, and applicator may or may not be included in the product package. These are standard items in dental offices and numerous types of each will work.

This document (K222323) is a 510(k) Premarket Notification from the FDA regarding "Black Diamond," a medical device intended for the treatment of dental hypersensitivity. It primarily focuses on demonstrating the substantial equivalence of Black Diamond to predicate devices based on intended use, technological characteristics, and safety information.

However, this document does NOT contain information about acceptance criteria for a study demonstrating device performance against specific metrics, nor does it detail a clinical study with human or even animal subjects that would typically be used to prove a device meets performance claims through clinical endpoints.

Instead, the document references physical tests and biocompatibility assessments to support the device's technical equivalence and safety.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert ground truth, and comparative effectiveness studies are not present in this document.

Here's an analysis of what is and is not available based on the provided text:

Based on the provided document (K222323), here's an attempt to address your request, highlighting the information that is not present as it's a 510(k) submission focused on substantial equivalence rather than a clinical trial report:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance in this 510(k) document. The document's acceptance criteria are implicit in demonstrating "substantial equivalence" to predicate devices based on similar indications for use, technological characteristics, and safety.
• Reported Device Performance:
  • Hydraulic Conductance Test: "A hydraulic conductance test was completed showing the efficacy of Black Diamond in occlusion of dentinal tubules in comparison to the predicate device." However, specific numerical results or the methodology for "efficacy" comparison (e.g., percentage reduction in conductance, statistical significance) are not provided.
  • SEM Images: "Additionally, SEM images were taken of untreated dentin treated with the predicate and subject device to show dentin tubule occlusion, and no other effect on healthy dentin." This indicates qualitative visual evidence but no quantitative performance metric.

2. Sample sizes used for the test set and the data provenance

• Test Set Sample Size: Not specified for the hydraulic conductance test or SEM imaging. These are typically bench-top or in vitro tests, not clinical test sets in the traditional sense of patient data.
• Data Provenance: The tests are described as completed by the company ("A hydraulic conductance test was completed... SEM images were taken..."). The document does not specify the country of origin of this test data or whether it was retrospective or prospective. Given these are bench tests often performed on extracted teeth, the concepts of "retrospective" or "prospective" as applied to clinical data are not relevant here.

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

• Not Applicable. For a device for hypersensitivity, clinical studies would involve patient reported outcomes or objective measurements by dental professionals. The tests described (hydraulic conductance, SEM) are physical/material characterization tests that do not typically involve human "experts" establishing a "ground truth" through consensus on images or clinical assessments in the way an AI-driven diagnostic device would.

4. Adjudication method for the test set

• Not Applicable. This concept is relevant for clinical studies involving human interpretation or multi-reader reviews, not for the physical/bench tests 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

• No. This document does not describe any MRMC study. Black Diamond is a physical dental product (cavity varnish), not an AI-assisted diagnostic or treatment planning software.

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

• Not Applicable. Black Diamond is not an algorithm or software. It is a physical dental varnish applied by a human.

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

• Proxy Ground Truth for Equivalence: For this 510(k), the "ground truth" for performance is effectively demonstrated through physical property testing (hydraulic conductance, SEM imaging) and comparison to the known performance/composition of legally marketed predicate devices. The ground truth for safety is based on biocompatibility testing (ISO 10993-1) and risk assessment (ISO 14971), as well as the long-standing safety history of its components.
• For a device like this, clinical outcomes data (e.g., reduction in patient-reported hypersensitivity scores) would be the ultimate ground truth for clinical efficacy, but such clinical trial data is typically not required for a 510(k) submission seeking substantial equivalence based on established predicate devices and bench performance. The document only mentions "a significant safe history of use as well as a published body of literature" for the components.

8. The sample size for the training set

• Not Applicable. This device is not an AI/ML product requiring a "training set."

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

• Not Applicable. This device is not an AI/ML product.

Summary of Device Performance Proof in this 510(k) Context:

For Black Diamond, demonstrating "substantial equivalence" is the primary means of "proving" it meets regulatory requirements for marketing. This is achieved by:

• Similar Indications for Use: Directly compared and shown to be identical to the predicate and reference devices.
• Similar Technological Characteristics: Contains silver and fluoride, similar two-part liquid application, and similar mechanism of action (silver deposition for tubule occlusion).
• Bench Testing:
  • Hydraulic Conductance Test: Used to show ability to occlude dentinal tubules, implying efficacy for hypersensitivity. (Details lacking on specific quantitative results).
  • SEM Images: Visual confirmation of tubule occlusion.
• Safety Assessments: Biocompatibility testing (ISO 10993-1), risk assessments (ISO 14971), and ion elution tests.
• Long History of Use: Mention of commercial availability in other countries with a safe history for its components.

Ask a specific question about this device

The Black Diamond™ POCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (Cl to C7) and the upper thoracic spine (TI-T3); traumatic spinal fractures and/or traumatic dislocations: instability or deformity: failed previous fusion (e.g., pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin, as confirmed by radiographic studies, and degenerative disease with instability. The Black Diamond™ POCT Spinal System is also intended to restore the integrity of the spinal column even in the absences of fusion for a limited time period in patients with advanced stage tumors in whom if e expectancy is of insufficient duration to permit achievement of fusion. To achieve additional levels offixation, the Black Diamond™ POCT Spinal System may be comected to the Osseus Black Diamond™ Pedicle Screw System using transition rods or anatomically-bent rods.

The Black Diamond™ POCT Spinal System is a posterior cervico-thoracic fixation system intended to provide stabilization to promote fusion of the cervical spine and upper thoracic spine. The Black Diamond™ system contains rods in multiple shapes and sizes, polyaxial screws, set screws, rod connectors and transverse connectors. Connecting components can be locked to the rod in various configurations to accommodate individual patient anatomy.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is an FDA 510(k) clearance letter for the "Black Diamond™ POCT Spinal System," which is a posterior cervical screw system.

It discusses:

• The FDA's review and determination of substantial equivalence to predicate devices.
• The device's indications for use.
• A summary of its technological characteristics.
• Non-clinical testing performed (mechanical testing per ASTM F1717).

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test sets, data provenance, or ground truth establishment for software/AI performance evaluation.
• Information on expert panels, adjudication methods, or multi-reader multi-case studies, as these are typically applicable to diagnostic imaging or AI/ML-based medical devices, not to mechanical spinal implants.
• Information about a standalone (algorithm only) performance study.
• Ground truth types for software performance.
• Training set sample sizes or how training set ground truth was established.

Therefore, I cannot fulfill your request based on the provided input.

Ask a specific question about this device

The Black Diamond Navigation Instruments are intended to be used during the preparation and placement of Black Diamond pedicle screws during spinal surgery to aid the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Black Diamond Navigation Instruments are specifically designed for use with the Medtronic Stealth Station System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Black Diamond Navigation Instruments are non-sterile, reusable instruments; including probes, bone taps, and inserters that are operated manually. These instruments are intended to be used within the context and limitations of the indications for use for Osseus Fusion System's FDA-cleared Black Diamond system and the Medtronic Synergy Experience StealthStation System S7 (v2.1.0). Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement.

The Black Diamond Navigation Instruments are non-sterile, reusable instruments (probes, bone taps, and inserters) intended for use during the preparation and placement of Black Diamond pedicle screws in spinal surgery. The device aims to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures, specifically designed for use with the Medtronic Stealth Station System.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or detailed reported device performance in a table format. It mentions that "nonclinical testing was performed to show that the subject Black Diamond Navigation Instruments are substantially equivalent to the predicate device" and lists the types of testing: Accuracy testing, Compatibility testing, and Performance testing. It concludes that "The results of these evaluations indicate that the Black Diamond Navigation Instruments are equivalent to predicate devices."

Without specific numerical thresholds or performance metrics for acceptance, a table cannot be fully constructed.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Nonclinical testing was performed to show that the subject Black Diamond Navigation Instruments are substantially equivalent to the predicate device." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective).

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications. The testing mentioned is non-clinical, suggesting that expert human assessment in a clinical context for ground truth may not have been the primary method.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

The document explicitly states: "No clinical studies were performed." Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a set of "Navigation Instruments" used with the Medtronic Stealth Station System. This implies it's a tool for surgeons, not a standalone AI algorithm. The document mentions "Accuracy testing" and "Performance testing" among the non-clinical tests. While these tests evaluate the device's inherent capabilities (e.g., how accurately it tracks, how it performs mechanically), they are likely evaluating the instrument's standalone performance within the context of the navigation system, rather than an AI algorithm's standalone performance. The text does not explicitly refer to an "algorithm only" standalone performance study.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the non-clinical testing. Given that the device is a navigation instrument for surgery, "Accuracy testing" would likely compare the instrument's reported position/orientation against a known, precise physical reference (e.g., measured by a coordinate measuring machine or similar highly accurate metrology equipment). Such a ground truth would be objective, physical measurements rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This further supports the interpretation that the device is a physical instrument rather than a machine learning algorithm that undergoes a training phase.

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

Since no training set is mentioned (as the device is not an AI algorithm requiring one in the traditional sense), this information is not applicable and not provided.

Ask a specific question about this device

The Black Diamond Pedicle Screw System, with or without MIS instrumentation, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Black Diamond Pedicle Screw System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Black Diamond Pedicle Screw System is intent patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatic pedicle screw fixation is limited to a posterior approach.

The Black Diamond Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, and cross links. All the components are available in a variety of sizes to match more closely the patient's anatomy

The provided text describes a 510(k) premarket notification for a medical device called the "Black Diamond Pedicle Screw System." This document focuses on demonstrating substantial equivalence to previously marketed predicate devices, primarily through non-clinical mechanical testing, rather than a clinical study involving human patients or complex AI algorithms. Therefore, much of the information requested about acceptance criteria for AI/ML performance, sample sizes for test sets, expert adjudication, MRMC studies, and ground truth establishment is not applicable to this specific submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" presented in this submission are not expressed as specific performance metrics and thresholds (e.g., accuracy > X%, AUC > Y%) typical for AI/ML devices. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through various comparisons, primarily mechanical testing.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not applicable in the context of human data or image data for AI/ML. The "test set" here refers to the Black Diamond Pedicle Screw System components themselves undergoing non-clinical mechanical testing. The specific number of physical components tested is not detailed, but standard mechanical testing involves multiple samples to ensure statistical validity.
• Data Provenance: Not applicable in the context of human data. The "data" comes from mechanical testing of the device components.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not human expert interpretation.

4. Adjudication Method:

Not applicable.

5. MRMC Comparative Effectiveness Study:

Not applicable. No clinical studies involving human readers or AI assistance were performed.

6. Standalone Performance Study:

Not applicable. This is a physical medical device, not an AI algorithm. The performance evaluation is based on mechanical testing of the device itself.

7. Type of Ground Truth Used:

Ground truth for this submission is based on engineering standards and direct physical measurements derived from non-clinical mechanical testing (e.g., static and dynamic compression per ASTM F1717, static torsion per ASTM F1717).

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML model and does not have a "training set" in that context.

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

Not applicable.

Ask a specific question about this device

The Osseus Black Diamond Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

The Osseus Black Diamond Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

The Osseus Black Diamond Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

This is a 510(k) summary for a spinal implant system and as such, it does not involve AI/ML device performance testing. The 'acceptance criteria' and 'device performance' in this context refer to mechanical and material performance rather than diagnostic accuracy or classification metrics.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "The results of this testing indicate that the Osseus Black Diamond Pedicle Screw System is equivalent to predicate devices." This implies that the device met the performance standards established by the predicate devices through these ASTM tests. The specific numerical acceptance criteria (e.g., maximum load, fatigue life) are not detailed in this summary document but would have been part of the full submission.

2. Sample Size Used for the Test Set and Data Provenance

Given this is a mechanical engineering test of a physical device, not an AI/ML system:

• Sample Size for Test Set: The document does not specify the exact number of units or replicates tested for each static and dynamic test. These would typically be defined by the ASTM F1717 standard and the test protocol.
• Data Provenance: The tests are non-clinical, meaning they were performed in a laboratory setting on manufactured devices, not on human patients or data derived from them. The data is generated from physical mechanical testing.

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

• This question is not applicable to this type of device submission. Ground truth, in the context of device performance described here, is established by adherence to ASTM standards for mechanical testing, not by expert interpretation of data or images.

4. Adjudication Method for the Test Set

• This question is not applicable. Mechanical tests according to ASTM standards do not involve adjudication by multiple experts in the same way clinical or AI/ML studies do. The results are quantitative measurements against predefined engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant to diagnostic imaging devices or AI systems where human readers interpret medical images. This submission is for a physical orthopedic implant.
• Effect Size: Not applicable as no such study was performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• This question is not applicable. This device is a physical pedicle screw system, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by engineering standards and specifications (specifically ASTM F136 for materials and ASTM F1717 for mechanical performance). The device's performance is compared against the known performance of legally marketed predicate devices through these standardized mechanical tests.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" in the context of a pedicle screw system's mechanical testing. This concept applies to AI/ML devices.

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

• This question is not applicable. As there is no training set, there is no ground truth establishment for it.

In summary, the provided 510(k) summary describes a traditional medical device (a spinal implant) and its non-clinical mechanical testing, not an AI/ML-driven diagnostic or therapeutic device. Therefore, many of the questions related to AI/ML study design, readers, and ground truth are not relevant to this specific document. The "study" referenced is a series of mechanical tests to demonstrate substantial equivalence to predicate devices.

Ask a specific question about this device