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The Demi Ultra is a Light Emitting Diode (LED) visible light curing device used for the polymerization of light-cured materials by dental professionals.

The Demi Ultra is a Light Emitting Diode (LED) visible light curing device used for the polymerization of light-cured materials by dental professionals. The Demi Ultra consists of a handpiece, LED light curing attachment, and charging dock. The aluminum and plastic molded handpiece contains two (2) ultracapacitors (electric double-layer capacitors), printed circuit boards containing the electronics and user interface buttons, receptacle for retaining the LED light curing attachment, and receptacle for interfacing with the charging dock. The LED light curing attachment contains the curing LED, clear lens and two (2) copper head spreaders, all over molded in plastic. The charging dock contains printed circuit boards containing electronics to support charging the handpiece and built-in LED radiometer functionality. For the handpiece, a digital circuit and microprocessor is utilized to control three (3) different curing modes (5, 10 and 20 seconds). Each mode specifies LED curing output and optional audible beep timing. The handpiece uses one button to activate the LED curing output and another to select the curing time mode. For the charging dock, a digital circuit and microprocessor is utilized to monitor the charging of the handpiece ultracapacitors, as well as respond to light at the radiometer input by illuminating lights on a radiometer meter. Demi Ultra is required to be used with an FDA cleared barrier sleeve.

The provided text describes a 510(k) premarket notification for a dental light-curing device called Demi Ultra. The submission asserts substantial equivalence to a previously cleared predicate device, the Demi Ultra (K123468).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative format for specific performance metrics that the device needs to meet. Instead, it lists performance tests that were conducted and compares the technological characteristics of the proposed device to a predicate device. The core argument for acceptance is substantial equivalence to the predicate device.

The document explicitly states: "The nonclinical performance testing demonstrates that the Demi Ultra performs as well as the predicate device Demi Ultra." This implies that the acceptance criteria for these tests were to demonstrate comparable performance to the predicate and compliance with relevant standards.

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

The document does not provide details on specific sample sizes for the performance tests (e.g., number of cure samples for depth of cure, number of units for charge/run time). The data provenance is not explicitly stated beyond the fact that the tests were performed by Sybron Dental Specialties as part of their product lifecycle and design validation. It is implied to be prospective testing for the proposed device.

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

This information is not provided. The performance tests (e.g., depth of cure, irradiance) are objective measurements based on standards, not expert interpretation of data points.

4. Adjudication Method for the Test Set

This information is not provided. Given that the tests are objective physical measurements, a traditional adjudication method for subjective assessments would not be applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study typically assesses the impact of a device (often AI-driven) on human reader performance, which is not applicable to a dental light-curing device.

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

No, a standalone algorithm performance study was not done. The Demi Ultra is a physical medical device, not an AI/software algorithm, so this type of study is irrelevant.

7. The Type of Ground Truth Used

For the performance tests, the "ground truth" would be the physical measurements obtained from testing the device against established international and national standards (ISO 10650:2015, ANSI/ADA 48-2:2010, ISO 10993, IEC 60601). For instance, the "ground truth" for depth of cure would be the actual measured depth under standardized conditions.

8. The Sample Size for the Training Set

This information is not applicable. The Demi Ultra is a hardware device, not an AI/machine learning algorithm that requires a "training set."

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

This information is not applicable, as there is no training set for this type of device.

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OsteoSelect® PLUS DBM Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoSelect® PLUS DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect® PLUS DBM Putty can be used as follows:

• Extremities ●
• . Pelvis
• Posterolateral spine ●

OsteoSelect® PLUS DBM Putty is processed human bone that has been demineralized and combined with an absorbable carrier that is biocompatible and biodegradable. The combination of demineralized bone and the absorbable carrier results in a putty-like consistency for ease and flexibility of use during surgical application. The carrier material is a mixture of carboxymethylcellulose (a wax-like material) and phosphate buffered saline (a dispersing agent). OsteoSelect® PLUS DBM Putty is virtually odorless, tan in color and can be spread easily with minimal adhesion to surgical gloves.

This document is a 510(k) premarket notification for the OsteoSelect® PLUS Demineralized Bone Matrix Putty. It does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and studies for an AI/ML medical device. This is a traditional medical device (bone void filler) and not an AI/ML device, therefore, many of your questions related to AI/ML specific evaluations (e.g., human-in-the-loop performance, effect size of AI assistance, training set details) are not applicable.

However, I can extract the relevant information regarding the device's acceptance criteria (based on the documented performance testing) and the studies that support it.

Here's the breakdown of what can be inferred from the provided text:

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

• Handling Characteristics: Maintained consistent characteristics for the duration of shelf life.
• Performance Under Irrigation: Tested.
• Cohesiveness: Showed cohesiveness while packing into void spaces.
• Adhesion: Handled without sticking to surgical gloves. |
  | Osteoinductive Potential | Each lot tested in a rodent model after gamma sterilization as part of release criteria. The document implies it meets the criteria for osteoinductivity. |
  | Shelf Life | Tested to maintain consistent handling characteristics. |
  | Chemical/Physical Testing | Comprehensive battery of non-clinical chemical and physical testing referenced and relied upon. |

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

• Sample Size: Not explicitly stated for any of the performance tests. The text indicates "each lot of OsteoSelect® PLUS DBM Putty is also tested for osteoinductive potential in a rodent model." This implies ongoing lot-release testing, but the specific number of samples or animals per test is not detailed.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• This device is not an AI/ML device and does not involve human interpretation of outputs that would require establishing a "ground truth" by human experts in the context of diagnostic accuracy.
• The "ground truth" for the osteoinductive potential is established through the rodent model, which is a biological assay. The interpretation of these assays is typically done by qualified laboratory personnel, but the number or specific qualifications are not detailed in this submission.

4. Adjudication method for the test set

• Not applicable as this is not an AI/ML diagnostic or prognostic device requiring expert adjudication of outputs.

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 is not an AI-assisted diagnostic or prognostic device.

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

• Not applicable. This is a physical medical device (bone void filler), not an algorithm.

7. The type of ground truth used

• Osteoinductive Potential: The ground truth is established through a rodent model (animal study/biological assay).
• Biocompatibility: Established through compliance with ISO 10993 standards, which may involve various in vitro and in vivo tests.
• Viral Inactivation: Established through validation studies using model viruses.
• Mechanical/Handling: Established through in-house testing against predefined specifications (though the specific specifications are not detailed, only the categories of assessment).

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/ML model that undergoes "training."

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

• Not applicable.

Summary of Studies that Prove the Device Meets Acceptance Criteria:

The document mentions that the device's performance against the acceptance criteria is demonstrated through:

• Prior Comprehensive Biocompatibility Testing: Conducted on the predicate device in accordance with ISO 10993. This testing supports the biocompatibility of OsteoSelect® PLUS DBM Putty.
• Viral Inactivation/Clearance Validation: Studies that validated the process used to make Demineralized Bone Matrix for its ability to inactivate and/or clear a panel of model human viruses. This included specific validation for the modified particle size formulation of the PLUS version.
• Performance Testing (for DBM particle size change): Due to a change in DBM particle size distribution, specific tests were conducted on OsteoSelect® PLUS DBM Putty to evaluate:
  • Extrusion from a syringe.
  • Maintenance of consistent handling characteristics over shelf life.
  • Performance under irrigation.
  • Cohesiveness when packing into void spaces.
  • Handling without sticking to surgical gloves.
• Lot Release Osteoinductive Potential Testing: Each lot of OsteoSelect® PLUS DBM Putty is tested in a rodent model after gamma sterilization to confirm osteoinductive potential.
• Referenced Non-Clinical Testing (Chemical, Physical, Animal): The submission references and relies upon a "comprehensive battery" of such tests previously conducted for the OsteoSelect® DBM Putty (predicate device).

In essence, the acceptance criteria are met through a combination of biocompatibility and viral inactivation studies inherited from the predicate device, specific performance testing for the new formulation (especially handling characteristics), and ongoing lot-release testing for osteoinductivity.

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OsteoSelect® DBM Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony strtucture. OsteoSelect® DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect® DBM Putty can be used as follows: - Extremities . - Posterolateral spine - Pelvis

OsteoSelect® DBM Putty is processed human bone that has been demineralized and combined with an absorbable carrier that is biocompatible and biodegradable. The combination of demineralized bone and the absorbable carrier results in a putty-like consistency for ease and flexibility of use during surgical application. The carrier material is a mixture of carboxymethylcellulose (a wax-like material) and phosphate buffered saline (a dispersing agent). OsteoSelect® DBM Putty is virtually odorless, tan in color and can be spread easily with minimal adhesion to surgical gloves. OsteoSelect® DBM Putty is intended for use as a filler for voids or gaps that are not intrinsic to the stability of the bony structure. The putty will be absorbed within a period of 90 days.

The provided text describes a 510(k) summary for a medical device, OsteoSelect® Demineralized Bone Matrix Putty. It primarily focuses on demonstrating substantial equivalence to predicate devices based on manufacturing procedures, physical test results, shelf-life testing, functionality (efficacy testing), and biocompatibility.

However, the provided document DOES NOT contain information regarding:

• Acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy for an AI/algorithm).
• A "study" that proves the device meets these acceptance criteria in the context of an AI/algorithm for image analysis or diagnostics.
• Sample sizes for a test set or training set related to AI model evaluation.
• Details about ground truth establishment by experts, adjudication methods, or MRMC studies.
• Standalone performance (algorithm only) versus human-in-the-loop performance.

The "functionality (efficacy testing) results" mentioned refer to in vitro and in vivo biological tests for bone healing properties typical for a bone void filler, not an AI/ML diagnostic or predictive device. Specifically, it mentions:

• Viral inactivation potential: Evaluated with a panel of model viruses.
• Osteoinductive potential: Tested in an athymic rat model, with every final lot tested. The document explicitly states: "It is unknown how the osteoinductivity potential in the rat model correlates with human clinical performance."
• In vivo study: A report of an in vivo study was conducted to support use in the posterolateral spine. No details on this study's design, sample size, or outcomes are provided beyond its existence.

Therefore, it is not possible to fill out the requested table and answer the questions related to acceptance criteria and study proving device performance for an AI/ML device, as the provided text pertains to a traditional medical device (bone void filler) and not an AI/ML-driven product.

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The Demi Ultra is a Light Emitting Diode (LED) visible light curing device used for the polymerization of light-cured materials by dental professionals.

The Demi Ultra is a Light Emitting Diode (LED) visible light curing device used for the polymerization of light-cured materials by dental professionals. The Demi Ultro consists of a handpiece, LED light curing attachment, and charging dock. The aluminum and plastic molded handpiece contains two (2) ultracapacitors (electric double-layer capacitors), printed circuit boards containing the electronics and user interface buttons, receptacle for retaining the LED light curing attachment, and receptacle for interfacing with the charging dock. The LED light curing attachment contains the curing LED, clear lens and two (2) copper head spreaders, all over molded in plastic. The charging dock contains printed circuit boards containing electronics to support charging the handpiece and built-in LED radiometer functionality. For the handpiece, a digital circuit and microprocessor is utilized to control three (3) different curing modes (5, 10 and 20 seconds). Each mode specifies LED curing output and optional audible beep timing. The handpiece uses one button to activate the LED curing output and another to select the curing time mode. For the charging dock, a digital circuit and microprocessor is utilized to monitor the charging of the handpiece ultracapacitors, as well as respond to light at the radiometer input by illuminating lights on a radiometer meter.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Demi Ultra device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided submission does not explicitly list "acceptance criteria" in a quantitative, measurable format for the Demi Ultra. Instead, it relies on demonstrating substantial equivalence to a predicate device (Demi, K071251) through comparisons of technological characteristics and performance data. The implicit acceptance criterion is that the Demi Ultra performs comparably to the predicate device.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated. The submission mentions "depth of cure test data" and "irradiance data" for comparing the Demi Ultra to the predicate device, but does not provide details on the number of samples or trials used for these tests.
• Data Provenance: The data appears to be from internal testing conducted by the manufacturer, Sybron Dental Specialties, Inc./Kerr Corporation. The country of origin is not specified but implicitly assumed to be where the company operates, likely the USA based on the submission to the FDA. The tests are retrospective in the sense that they were conducted by the manufacturer as part of the submission process, but the testing itself would be prospective for the evaluated device properties.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is an LED curing light, not an AI/ML diagnostic or prognostic device that requires expert adjudication of images or data to establish ground truth. The "ground truth" here is the physical performance characteristics of the device (light output, depth of cure, etc.) measured using scientific instruments and established protocols.

4. Adjudication Method for the Test Set

Not applicable, as this is not a study assessing human reader performance or requiring subjective interpretation. The performance characteristics are measured objectively.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or prognostic tools where human interpretation plays a significant role. The Demi Ultra is a medical device for polymerization of materials, not a diagnostic tool requiring interpretation by human readers.

6. Standalone Performance Study (Algorithm Only)

Not applicable directly in the AI/ML sense. However, the "Non-Clinical Test Data" section describes standalone performance evaluations of the Demi Ultra in terms of:

• Biocompatibility: Materials designed to be in contact with a patient were tested and passed.
• Depth of Cure: Data was collected to evaluate the Demi Ultra's performance.
• Irradiance: Data was collected to demonstrate light intensity and peak wavelength.
• Software Validation: The software was successfully validated to confirm device performance.

These can be considered standalone performance evaluations of the physical device and its embedded software. The performance was then compared to the predicate device.

7. Type of Ground Truth Used

The "ground truth" in this context refers to objectively measured physical and chemical properties:

• Biocompatibility: Established through standard biocompatibility tests (e.g., ISO 10993 series) performed by material manufacturers.
• Depth of Cure: Likely measured in a laboratory setting using standardized dental materials and techniques to assess the extent of polymerization.
• Irradiance: Measured using radiometers or spectroradiometers to quantify light intensity and spectral distribution.
• Software Functionality: Verified through validation testing against defined software requirements.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that learns from a training set of data. It is a hardware device with embedded software where performance is determined by its design and manufacturing.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device.

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DBX Putty is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX Putty is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.

DBX Putty can be used alone in the pelvis and extremities. DBX Putty can also be used as an extender in the pelvis and extremities with autograft or allograft. DBX Putty can be used with bone marrow. DBX Putty is for single patient use only.

DBX Inject is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.

DBX Inject can be used alone in the pelvis and extremities. DBX Inject can also be used as an extender in the pelvis and extremities with autograft or allograft. DBX Inject can be used with bone marrow. DBX Inject is for single patient use only.

DBX Putty is composed of Demineralized Bone Matrix and sodium hyaluronate. The demineralized bone allograft in this product is prepared from tissue procured from a deceased donor using aseptic surgical techniques. The bone used in DBX Putty is cortical bone. Sodium hyaluronate is a naturally derived material that is biocompatible and biodegradable. The sodium hyaluronate is mixed in a phosphate buffered saline and is added to the demineralized bone to aid in maintaining physiological pH as well to improve the handling characteristics of demineralized bone.

DBX Inject is composed of Demineralized Bone Matrix and sodium hyaluronate. The demineralized bone allograft in this product is prepared from tissue procured from a deceased donor using aseptic surgical techniques. The bone used in DBX Inject is cortical bone. Sodium hyaluronate is a naturally derived material that is biocompatible and biodegradable. The sodium hyaluronate is mixed in a phosphate buffered saline and is added to the demineralized bone to aid in maintaining physiological pH as well to improve the handling characteristics of demineralized bone.

The provided text describes two medical devices, DBX® Demineralized Bone Matrix Putty and DBX® Demineralized Bone Matrix Inject. Both are bone void fillers containing human demineralized bone matrix (DBM) and sodium hyaluronate. The 510(k) submission (K103784) was for an expansion of their indications for use in the pelvis and extremities, specifically allowing their use with autograft or allograft.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The text mentions "Recent in vivo studies conducted by MTF" for the equivalence assessment of the expanded indications. However, it does not provide the sample size for these in vivo studies.

The data provenance for these in vivo studies is not explicitly stated in terms of country of origin, nor whether they were retrospective or prospective. Given that they are described as "recent in vivo studies conducted by MTF," it implies a prospective study design primarily for this submission.

For the osteoinductive potential testing, the "test set" is described as "Every lot of final DBX Putty/Inject product." This is a continuous quality control measure rather than a single study with a fixed sample size. The testing is done in an "athymic mouse model" or an "alkaline phosphatase assay."

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for the in vivo equivalence studies. For the osteoinductive potential, the "ground truth" is defined by the outcome of the athymic mouse model or alkaline phosphatase assay, which are objective biological tests rather than expert interpretation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the in vivo equivalency studies or for the osteoinductive potential testing. These processes appear to rely on direct measurement or observation rather than subjective review requiring adjudication.

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

No MRMC comparative effectiveness study was done as this device is a bone void filler, not an imaging or diagnostic device that would typically involve human readers interpreting cases. Therefore, there is no discussion of human readers improving with or without AI assistance.

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

This question is not applicable. The device is a physical bone void filler, not a software algorithm or AI-based diagnostic tool. The performance evaluation focuses on its biological and physical properties in in vivo models, not on an algorithm's performance.

7. The Type of Ground Truth Used

• For Equivalence for expanded indications: The ground truth is established by the outcome of the "in vivo studies" demonstrating equivalence to the predicate (DBX Putty/Inject alone). The specific metrics or "ground truth" criteria for equivalence (e.g., bone formation, histological assessment) are not detailed in the provided text.
• For Osteoinductive Potential: The ground truth is the outcome of the "athymic mouse model" or the "alkaline phosphatase assay." These are biological assays that provide a quantitative or qualitative result indicative of osteoinduction.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. These devices are regulated based on their physical and biological properties and performance in in vivo models, not on machine learning algorithms that require training data.

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

This question is not applicable as there is no "training set" for these types of medical devices.

Ask a specific question about this device

DBX Putty is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX Putty is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.

DBX Putty can be used alone in the posterolateral spine. DBX Putty can also be used as an extender in the spine with autograft or allograft. DBX Putty can be used with bone marrow. DBX Putty is for single patient use only.

DBX Inject is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.

DBX Inject can be used alone in the posterolateral spine. DBX Inject can also be used as . an extender in the spine with autograft or allograft. DBX Inject can be used with bone marrow. DBX Inject is for single patient use only.

DBX Putty is composed of Demineralized Bone Matrix and sodium hyaluronate. The demineralized bone allograft in this product is prepared from tissue procured from a deceased donor using aseptic surgical techniques. The bone used in DBX Putty is cortical bone. Sodium hyaluronate is a naturally derived material that is biocompatible and biodegradable. The sodium hyaluronate is mixed in a phosphate buffered saline and is added to the demineralized bone to aid in maintaining physiological pH as well to improve the handling characteristics of demineralized bone.

DBX Inject is composed of Demincralized Bone Matrix and sodium hyaluronate. The demineralized bone allograft in this product is prepared from tissue procured from a deceased donor using aseptic surgical techniques. The bone used in DBX Inject is cortical bone. Sodium hyaluronate is a naturally derived material that is biocompatible and biodegradable. The sodium hyaluronate is mixed in a phosphate buffered saline and is added to the demineralized bone to aid in maintaining physiological pH as well to improve the handling characteristics of demineralized bone.

The provided text is a 510(k) summary for two medical devices: DBX® Demineralized Bone Matrix Putty and DBX® Demineralized Bone Matrix Inject. It describes their intended use, device description, and safety/effectiveness information.

However, the document does not contain the acceptance criteria or a study proving that the device meets specific performance criteria in the way that would typically be presented for an AI/ML device (e.g., sensitivity, specificity, F1 score, etc.). Instead, this document focuses on the bio-compatibility, osteoinductive potential, and viral clearance of the bone matrix products, essentially demonstrating that they are safe and effective for their intended biological function as bone void fillers.

Here's an analysis of the provided information in relation to your request, acknowledging that much of the requested detail for an AI/ML device is not applicable or present in this type of submission.

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

Important Note: The document focuses on the biological and safety aspects of a medical device (demineralized bone matrix) rather than analytical performance associated with an AI/ML diagnostic or predictive tool. There are no performance metrics like sensitivity, specificity, or F1 score.

Given that this is a 510(k) summary for a bone void filler and not an AI/ML device, most of the remaining requested information is not applicable. I will address what can be inferred or state its non-applicability.

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

• Test Set Sample Size: Not explicitly stated for specific studies. The lot release testing for osteoinductive potential is conducted on "every lot of final DBX Putty product," implying continuous testing rather than a single pre-market test set. The "recent in vivo study" mentioned for the expanded indications does not specify a sample size.
• Data Provenance: The document does not specify the country of origin for the "recent in vivo study" or the "long history of safe and effective clinical use." The athymic mouse model is a laboratory model.
• Retrospective or Prospective: Not specified. The "long history of safe and effective clinical use" would imply retrospective data accumulation, but the "recent in vivo study" could be prospective.

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 is not applicable as the studies described are biological/in vivo and laboratory tests, not assessments requiring expert interpretation for ground truth establishment in the context of an AI/ML inference.
• For the osteoinductive potential in the athymic mouse model or alkaline phosphatase assay, the ground truth is established by the assay's biochemical or biological outcome.

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

• Not applicable. This concept relates to resolving discrepancies in expert interpretations, which is not relevant to the types of studies described (in vivo biological models, laboratory assays).

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 bone void filler, not an AI/ML diagnostic or assistive tool for human readers. Therefore, no MRMC study or AI assistance effect size is mentioned.

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

• Not applicable. There is no algorithm; this is a biological product.

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

• Biocompatibility: Established through adherence to ISO 10993 standards and a history of clinical use. This effectively uses a combination of established standards and historical outcomes data.
• Sterility: USP microbiological testing standards.
• Osteoinductive Potential: The positive outcome in an athymic mouse model or an alkaline phosphatase assay serves as the "ground truth" for lot release.
• Viral Clearance: Laboratory assessment of viral inactivation potential using model viruses.
• Expanded Indications: Based on "a recent in vivo study," implying direct biological outcomes in a living system (likely animal model as it's not a human clinical trial summary).

8. The sample size for the training set

• Not applicable. This medical device is not an AI/ML algorithm that requires a training set.

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

• Not applicable, as there is no training set for an AI/ML algorithm.

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DBX® Inject is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used as follows:
Ridge augmentation
Filling of extraction sites
Craniofacial augmentation
Mandibular reconstruction
Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture
Filling resection defects in benign tumors, benign cysts, or other osseous defects in the alveolar ridge wall
Filling of cystic defect
Filling of lesions of periodontal origin
Filling of defects of endodontic origin
DBX® Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Inject can be used with bone marrow. DBX® Inject is for single patient use only.

DBX® Inject is osteoconductive, and has been shown to have osteoinductive potential in an athymic mouse model. Every lot of final DBX® Inject Paste will be assayed in vivo for osteoinductive potential. - Every lot of final DBX® Inject Putty product will be tested in an athymic mouse model or in an alkaline phosphatase assay, which has been shown to have a positive correlation with the athymic mouse model, to ensure the osteoinductive potential of the final product. Standard testing performed in an athymic mouse or alkaline phosphatase assay must prove positive for lot release. It is unknown how the osteoinductive potential, measured in the athymic mouse model or the alkaline phosphatase assay, will correlate with clinical performance in human subjects.
DBX® Inject is single-donor processed. The donor suitability criteria used to screen this donor are in compliance with the FDA regulations published in 21 CFR Part 1270 and Part 1271 Human Tissue Intended for Transplantation.

This 510(k) summary describes a traditional medical device (Bone Void Filler) and not an AI/ML powered device. As such, the requested information (sample sizes, ground truth establishment, expert qualifications, HRMC studies, etc.) is not applicable and is not present in the provided document.

However, I can extract the acceptance criteria and refer to the studies mentioned in the document that were performed to demonstrate the device meets these criteria.

Acceptance Criteria and Reported Device Performance

Every lot of final DBX® Inject Putty product must be tested in an athymic mouse model or in an alkaline phosphatase assay (which has a positive correlation with the athymic mouse model) to ensure osteoinductive potential, and prove positive for lot release.

Note: It is unknown how the osteoinductive potential, measured in these models, will correlate with clinical performance in human subjects. | DBX® Inject is osteoconductive and has been shown to have osteoinductive potential in an athymic mouse model. Standard testing will be performed in an athymic mouse or alkaline phosphatase assay for lot release. |
| Viral Clearance and Inactivation | The processing method for the demineralized bone matrix must provide significant viral inactivation potential for a wide range of potential viruses. | The DBM processing methods were determined to provide significant viral inactivation potential for a wide range of potential viruses, as evaluated with a panel of model potential human viruses representing various types, sizes, shapes, and genomes. |
| Donor Suitability | Donor suitability criteria used to screen donors must be in compliance with FDA regulations published in 21 CFR Part 1270 and Part 1271 Human Tissue Intended for Transplantation. | DBX® Inject is single-donor processed, and the donor suitability criteria used are in compliance with FDA regulations 21 CFR Part 1270 and Part 1271. |

Statements regarding AI/ML specific information (as it pertains to a traditional medical device):

1. Sample size used for the test set and the data provenance: Not applicable. The studies mentioned are laboratory tests, not clinical trials with human patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for osteoinductivity and viral inactivation is established through standardized laboratory assays.
3. Adjudication method for the test set: Not applicable. Laboratory assays follow predefined protocols.
4. 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 is not an AI-powered device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-powered device.
6. The type of ground truth used:
   • Osteoinductive potential: Athymic mouse model results or alkaline phosphatase assay results.
   • Viral clearance and inactivation: Results from standard viral inactivation assays using model viruses.
   • Donor suitability: Compliance with FDA regulations (21 CFR Part 1270 and Part 1271).
7. The sample size for the training set: Not applicable. This is not an AI-powered device.
8. How the ground truth for the training set was established: Not applicable. This is not an AI-powered device.

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DBX® Inject is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used as follows:

DBX® Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Inject Putty can be used as an extender in the spine with autograft. DBX® Inject can be used with bone marrow. DBX® Inject is for single patient use only.

DBX® Inject is completely resorbable and is composed of donated cortical and cancellous bone. The bone granules are mixed with sodium hyaluronate (Hy). DBX® Inject consists of DBX Putty or Paste with a separate, sterile plastic syringe for delivery directly into the operative site.

The provided text is a 510(k) summary for the DBX® Inject device, a bone void filler. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with specific acceptance criteria and performance metrics typically seen in studies for diagnostic or AI-powered devices.

Therefore, the information required to populate the requested table and answer the study-related questions for a device performance study as described in the prompt is not present in the provided document. The 510(k) summary describes regulatory compliance, device characteristics, and comparisons to predicate devices.

However, I can extract information related to the device's biological potential and safety testing, which are forms of performance evaluation for this type of medical device.

Here's what can be gathered from the document, acknowledging the difference in scope from the prompt's implied request for clinical performance study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable in the context of a clinical study on device performance in humans. The testing mentioned is for lot release (biological properties) and viral inactivation.
  • For osteoinductive potential: "Every lot of final DBX® Inject Paste will be assayed," and "Every lot of final DBX® Inject Putty product will be tested." The specific number of samples per lot test is not provided, nor is the number of lots tested in the submission.
  • For viral clearance: A "panel of model potential human viruses" was evaluated. The specific number of virus types/samples used is not detailed.
• Data Provenance:
  • Osteoinductive potential: In vivo (athymic mouse model) and in vitro (alkaline phosphatase assay).
  • Viral clearance: In vitro (evaluated DBM processing methods).
  • Donor suitability: Refers to compliance with FDA regulations for human tissue donors.

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

• Not applicable. The ground truth here relates to biological activity (osteoinductivity) and viral inactivation, which are determined by laboratory assays and scientific protocols, not expert consensus on interpretations of images or clinical outcomes.

4. Adjudication Method for the Test Set:

• Not applicable. This concept applies to human expert adjudication in clinical or diagnostic studies. The tests mentioned are laboratory-based.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., images), and the device aims to assist or improve their performance. DBX® Inject is a bone void filler, not a diagnostic device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• No, a standalone performance study in the context of an algorithm or AI is not applicable. DBX® Inject is a physical medical device. The "performance" evaluated relates to its biological properties and manufacturing safety.

7. The Type of Ground Truth Used:

• Osteoinductive Potential: The "ground truth" is established by the qualitative result of the athymic mouse model (positive/negative for osteoinductivity) or the alkaline phosphatase assay, which is correlated to the mouse model. This is a scientific, biological assay result.
• Viral Clearance: The "ground truth" is the measured reduction/inactivation of various model viruses by the DBM processing methods. This is based on laboratory virology assays.
• Donor Suitability: Compliance with regulatory standards (21 CFR Part 1270 and Part 1271).

8. The Sample Size for the Training Set:

• Not applicable. This device is not an AI/ML algorithm that requires a "training set." The biological tests are on the final product lots.

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

• Not applicable, as there is no "training set" for this type of device submission.

In summary: The provided 510(k) summary for DBX® Inject addresses its safety and effectiveness through demonstrating substantial equivalence to predicate devices, biological activity (osteoinductive potential), and viral inactivation capabilities. It does not contain information on clinical trials with human subjects, device performance metrics, or reader studies that would typically apply to diagnostic or AI-powered devices. The "studies" described are primarily laboratory-based assessments of the product's inherent properties and manufacturing process safety.

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OsteoSelect™ (DBM) Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps in the extremities and pelvis that are not intrinsic to the stability of bony structure. It is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone.

OsteoSelect™ Demineralized Bone Matrix Putty is processed human bone that has been demineralized and combined with an absorbable carrier that is biocompatible and biodegradable. The combination of demineralized bone and the absorbable carrier results in a putty-like consistency for ease and flexibility of use during surgical application. The carrier material is a mixture of carboxymethylcellulose and phosphate buffered saline. OsteoSelect™ Putty is virtually odorless, tan in color and can be spread easily with minimal adhesion to surgical gloves.

The provided text describes a 510(k) premarket notification for the OsteoSelect™ Demineralized Bone Matrix Putty. It does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the manner typically associated with studies demonstrating AI or software device performance (e.g., sensitivity, specificity, or reader performance metrics).

However, the document does describe the "study" and "acceptance criteria" in the context of demonstrating substantial equivalence to predicate devices, focusing on the material's properties and biological activity.

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Viral Inactivation: A "panel of model potential human viruses" was used. The exact number of viruses is not specified.
  • Osteoinductivity: "an athymic rat model" for testing, and "Every final lot of OsteoSelect™ DBM Putty is tested in an in vivo rat model". The exact sample size (number of rats) for the initial testing or for lot release is not specified.
  • Physical/Biocompatibility/Absorption: Not specified, but likely involved laboratory testing of the material, not a "test set" in the sense of a clinical dataset.
• Data Provenance: The document does not specify country of origin for the data. The studies are described as pre-clinical (in vivo rat model, in vitro viral inactivation). They are not human clinical trials data.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable to the type of device and studies described. The ground truth for this medical device (a bone void filler) is established through laboratory and animal model testing, not through expert review of clinical images or data.

4. Adjudication Method

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving multiple human readers for diagnostic accuracy assessments. The described studies are pre-clinical (viral inactivation, animal models).

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

No. This type of study is not mentioned and would be irrelevant for this kind of medical device. MRMC studies are used to evaluate the performance of diagnostic tools (often AI-assisted) by comparing human reader performance with and without the tool on a set of cases.

6. Standalone Performance Study

Yes, in a way. The studies described (viral inactivation, osteoinductive potential in rats, physical properties, biocompatibility) are assessments of the device's inherent properties and performance without human-in-the-loop interaction for diagnostic purposes. These are "standalone" in the sense that they evaluate the device itself.

7. Type of Ground Truth Used

• Viral Inactivation: Laboratory assay results determining the reduction in viral titer.
• Osteoinductivity: Histological and/or other biological markers observed in the athymic rat model, indicating new bone formation.
• Biocompatibility: Results from standard biocompatibility tests (e.g., cytotoxicity, sensitization, irritation).
• Physical Properties: Laboratory measurements of consistency, color, adhesion, etc.

8. Sample Size for the Training Set

Not applicable. This device is a bone void filler, not an AI or software algorithm that requires a "training set" in the machine learning sense. The "training set" concept is irrelevant to the development of this device.

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

Not applicable, as there is no "training set" for this device.

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GRAFTON® II eDBM is intended for use as a bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis and extremities) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. GRAFTON®II eDBM is resorbed/ remodeled and is replaced by host bone during the healing process.

GRAFTON®II eDBM is a human bone allograft product containing human demineralized bone matrix (DBM) and surface demineralized cortical bone chips sealed in an absorbable mesh pouch for intraoperative handling. It is intended for use in filling bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. GRAFTON®II eDBM is provided ready-to-use in various package sizes by volume or dimension and is intended for single patient use.

GRAFTON®II eDBM is a demineralized bone product that is osteoconductive as well as osteoinductive in an athymic rat assay. It is prepared via a proprietary processing method of Osteotech, Inc. that has been shown to consistently produce DBM that is osteoinductive in an athymic rat assay. Product and process consistency are confirmed via ongoing testing of GRAFTON®II eDBM finished product for osteoinductivity in this validated athymic rat assay utilizing a five-point linear scale (0,1,2,3,4) to score bone formation at 28 days*. This bone forming activity exhibited by GRAFTON®II eDBM in the athymic rat surrogate assay should not be interpreted as a predictor of human clinical performance.

This document describes a 510(k) premarket notification for the GRAFTON®II eDBM device, a demineralized bone matrix allograft. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel AI/software function. Therefore, much of the requested information regarding AI device performance, sample sizes, ground truth establishment, and expert involvement is not applicable in this context.

Here's an analysis based on the provided text, addressing the relevant sections and indicating where information is not available due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a bone graft substitute, the "acceptance criteria" are primarily related to demonstrating substantial equivalence to legally marketed predicate devices and confirming the osteoinductive properties through an athymic rat assay. There isn't a table of quantitative performance metrics in the way one would see for a diagnostic AI device.

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

The primary performance data cited are from in vivo animal studies and an athymic rat assay.

• Athymic Rat Assay: Used for osteoinductivity testing. The sample size for this assay is not explicitly stated in the provided text, but it's referred to as "ongoing testing."
• In vivo Animal Studies: "The results of in vivo studies in animals showed that GRAFTON®II eDBM performs at least as well as, if not better than, predicate devices and/or autograft." The specific sample sizes for these animal studies are not provided.
• Data Provenance: The athymic rat assay is an in vivo animal model. The country of origin for the animal studies is not specified, but the submission is from a US company to the US FDA. The studies are prospective in the sense that they are conducted to demonstrate characteristics of the product.

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

Not applicable. The performance evaluation relies on biological assays (athymic rat model) and in vivo animal studies, not on interpretations of data by human experts in the context of setting a "ground truth" for a diagnostic algorithm. The osteoinductivity scoring (0-4 scale) would likely be performed by trained lab personnel, but they are not referred to as "experts" in the context of establishing ground truth for an AI/software device.

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

Not applicable. This is not a study requiring adjudication of expert opinions.

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 is not an AI/software device.

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

Not applicable. This is not an AI/software device.

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

The "ground truth" for the device's biological properties is established through:

• Biological Activity (Osteoinductivity): Demonstrated via the athymic rat assay, which is a recognized in vivo model for assessing bone formation potential of DBM. The outcome is assessed by scoring bone formation.
• In Vivo Performance: Demonstrated through animal studies comparing the device to predicate devices and autograft.

8. The sample size for the training set

Not applicable. This is not an AI/software device, so there is no "training set."

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

Not applicable. There is no training set.

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