Search Results

DB-EZ Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The device provides a bone void filler that resorbs and is replaced by bone during the healing process.

DB-EZ Bone Void Filler is a pre-mixed moldable and biocompatible putty/paste bone void filler. DB-EZ consists of a mixture of calcium phosphate powder in a bioinert polyethylene glycol (PEG) based polymer that resorbs and is replaced with bone during the healing process.

The provided document is a 510(k) Premarket Notification for the DB-EZ Bone Void Filler. This type of submission establishes substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through novel clinical trials. Therefore, the information typically associated with acceptance criteria and a study proving device performance (like sensitivity, specificity, or AUC) for diagnostic AI/ML devices is not applicable here.

The device is a resorbable calcium salt bone void filler, which is a Class II medical device. The submission establishes substantial equivalence by demonstrating that the DB-EZ Bone Void Filler has the same intended use, technological characteristics, and performance characteristics as the predicate device, Skeletal Kinetics SKaffold NMX (K132211).

Instead of "acceptance criteria" related to diagnostic performance metrics, the document focuses on demonstrating equivalence through various physical, chemical, and biological tests.

Here's a breakdown of the information requested, tailored to the context of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, "acceptance criteria" are implied by the predicate device's established performance and the demonstration that the subject device meets or is equivalent to those characteristics. The reported device performance is presented as being identical or substantially equivalent to the predicate.

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

This is a materials science and engineering equivalence study, not a diagnostic performance study with a "test set" in the typical sense of a human-read or AI-analyzed dataset. The "testing" referred to in the document consists of various in-vitro and physical/chemical characterization tests.

• Sample Size: The document does not specify the exact number of samples used for each individual test (e.g., Working Time, Setting Time, FTIR, etc.). It refers to "test samples" without providing specific counts for each parameter.
• Data Provenance: The tests described were performed on the predicate device (K132211) and the results were provided in that earlier submission. For the subject device (DB-EZ Bone Void Filler), the submission states, "The following testing was performed on the predicate device and presented in the K132211 documentation." It further indicates that the subject device is composed of the same material and is manufactured and packaged by the same processes. New specific test results for the subject device are not independently presented for each parameter, but rather a claim of "identical" or "similar" performance based on the shared specifications and manufacturing process. The provenance of the original predicate testing data (K132211) is not detailed in this current submission. Given the nature of these tests, they would be lab-based, likely performed in a controlled environment.

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

This information is not applicable. The "ground truth" for this type of device is established through scientific and engineering principles, material characterization, and established standards (e.g., ASTM, USP), not through expert consensus on interpreting medical images or clinical outcomes in the same way as an AI diagnostic device. The performance is objectively measured by the tests listed.

4. Adjudication Method for the Test Set

This is not applicable. There is no "adjudication" in the sense of resolving discrepancies among experts for diagnostic interpretation. The tests are designed to yield objective, measurable results against predetermined specifications or comparisons to the predicate.

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

This is not applicable. An MRMC study is relevant for diagnostic devices that involve human interpretation, often assisted by AI. The DB-EZ Bone Void Filler is a biomaterial device, not a diagnostic AI/ML device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable. This question pertains to AI/ML algorithm performance. The DB-EZ Bone Void Filler is a physical biomaterial.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• Material Science and Engineering Standards: Compliance with established physical, chemical, and mechanical properties (e.g., working time, setting time, solubility, crystal structure, porosity, density, pH, temperature profile) measured through validated test methods (e.g., ASTM F1185-03, USP, USP).
• Biocompatibility Standards: Demonstration of biocompatibility through compliance with relevant standards. The document states, "No new biocompatibility studies were needed... because no changes to the product were made from the identical predicate device."
• Sterility and Shelf-Life Testing: Verification against established sterilization (SAL 10-6) and shelf-life requirements.

8. The Sample Size for the Training Set

This is not applicable. There is no AI/ML algorithm involved, and therefore no "training set" in this context.

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

This is not applicable, as there is no training set for an AI/ML algorithm.

Ask a specific question about this device

DB-Composite Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. DB-Composite is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

DB-Composite Bone Void Filler is a moldable and biocompatible calcium sulfate/calcium phosphate bone void filler. The DB-Composite kit is comprised of two components: A calcium sulfate/calcium phosphate powder mix and a mixing solution in premeasured quantities, which will be mixed together prior to implantation. The 3cc, 5cc, and 10cc DB-Composite Bone Void Filler Kits are provided sterile to SAL 10-6 and are for single use only.

The provided text describes a 510(k) premarket notification for a medical device called DB-Composite Bone Void Filler. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or meeting specific performance criteria through new clinical studies. Therefore, the information typically requested in your prompt (e.g., acceptance criteria, detailed study results, AI performance, ground truth establishment) is not present here.

Instead, the submission focuses on comparing the new device's characteristics and performance to those of a predicate device (Skeletal Kinetics Callos ProModel Bone Void Filler). The "performance testing" section outlines a summary of tests performed on the predicate device (K112383) to demonstrate its safety and effectiveness, and the DB-Composite device is deemed substantially equivalent based on having identical materials, manufacturing processes, and indications for use.

Here's an attempt to answer your questions based on the available information, noting where specific details are not provided:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for the DB-Composite device as part of a new study designed to prove its performance against such criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device whose performance has already been accepted by the FDA. The performance testing outlined was primarily conducted on the predicate device, and the DB-Composite is considered equivalent due to identical characteristics.

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

The document does not provide specific sample sizes for the "test set" or information on data provenance. The performance testing section describes general test methods performed, primarily on the predicate device. It does not refer to a "test set" in the context of clinical or comparative studies on the DB-Composite 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)

No clinical "test set" requiring expert ground truth is described for the DB-Composite device within this 510(k) summary. The evaluation relies on substantial equivalence to the predicate device and non-clinical performance testing.

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

No clinical "test set" or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was performed or is relevant here, as this device is a bone void filler, not an AI-powered diagnostic tool.

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

This refers to AI performance, which is not applicable to this medical device.

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

For the non-clinical performance tests mentioned (e.g., pH profile, FTIR Analysis, Bacterial Endotoxins, etc.), the "ground truth" would be established by the standardized methods and instrument readings defined by the test protocols (e.g., ASTM F1185-03, USP, USP, mineralogic standards). No clinical ground truth (like pathology or outcomes data from new studies) was used for the DB-Composite device, as no new clinical studies were conducted or required.

8. The sample size for the training set

This is not applicable as this is not an AI/machine learning device.

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

Not applicable.

Ask a specific question about this device

DB-Orthopedics Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. DB-Orthopedics is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

DB-Orthopedics Bone Void Filler is a moldable, injectable and biocompatible calcium phosphate bone void filler. The DB-Orthopedics kit is comprised of two components: a calcium-phosphate powder and a mixing solution in premeasured quantities, which will be mixed together prior to implantation. The 3 cc, 5 cc, and 10 cc DB-Orthopedics Bone Void Filler kits are provided sterile to SAL of 10-6 and are for single use only.

The provided text is a 510(k) premarket notification for a medical device called DB-Orthopedics. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its performance in a clinical or AI-assisted setting.

Therefore, many of the requested details, such as acceptance criteria for AI performance, sample sizes for test sets, expert adjudication, MRMC studies, standalone AI performance, and ground truth establishment for AI models, are not applicable to this document. This submission is for a material (bone void filler) and relies on physical, chemical, and biocompatibility testing, along with comparison to a predicate device, to demonstrate safety and effectiveness.

However, I can extract information related to the device's technical specifications and the tests performed to support its substantial equivalence, which can be presented in a similar format to what you requested for acceptance criteria and performance data.

Here's the closest representation of the requested information based on the provided text:

Acceptance Criteria and Device Performance for DB-Orthopedics (based on provided 510(k) Summary)

This 510(k) submission for DB-Orthopedics focuses on demonstrating substantial equivalence to a predicate device (Callos™ Bone Void Filler, K051123) and expanding the indications for use of a previously cleared device (DB-Cranial Bone Void Filler, K182742). The "acceptance criteria" here refer to meeting established standards and demonstrating similar performance characteristics to the predicate, rather than an AI-driven performance metric.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test, but standard material testing involves multiple samples to ensure reproducibility and statistical significance.
• Data Provenance: The tests are described as in vitro and ex vivo (simulated physiological conditions). The data would be derived from laboratory experiments conducted by Dimensional Bioceramics, LLC. No country of origin for the specific testing data is mentioned, but the company is based in Santa Cruz, CA, USA.
• Retrospective/Prospective: The testing described appears to be prospective, performed specifically for this 510(k) submission to characterize the device.

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

• Not applicable. This submission does not involve an AI diagnostic device requiring expert interpretation of medical images. Ground truth for material characteristics is established through established scientific methods and instrumentation (e.g., ICP-MS for elemental analysis, XRD for crystallography).

4. Adjudication Method for the Test Set

• Not applicable. No expert adjudication process is described as it's not a diagnostic study.

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

• No. This is a bone void filler product, not a diagnostic imaging device, so MRMC studies are not relevant.

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

• Not applicable. This device is a material, not an algorithm.

7. The Type of Ground Truth Used

• For the physical and chemical tests, the "ground truth" is based on:
  • Scientific Standards: Adherence to established ASTM or ISO standards (e.g., ASTM F1185-03, ISO 11137-2:2013).
  • Instrumental Analysis: Data directly from scientific instruments (e.g., ICP-MS, FTIR, XRD, SEM).
  • Comparison to Predicate: Performance alignment with the already cleared predicate device (Callos™ Bone Void Filler).
• For biological aspects (biocompatibility, pyrogenicity), the "ground truth" relies on prior successful validation and routine testing, ensuring the material itself does not elicit harmful biological responses.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device. The "training" for this device comes from the established knowledge of the materials science for bone void fillers and the manufacturing processes validated through quality systems.

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

• Not applicable. As above, no training set in the AI sense applies here. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and regulatory requirements (e.g., Good Manufacturing Practices, ISO standards). The device is stated to be composed of "identical material" and manufactured by "identical processes" as a previously cleared reference device (DB-Cranial, K182742), indicating that prior validation and historical data serve as the "ground truth" for its production.

Ask a specific question about this device

DB-Cranial is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes or other cranial bone defects and craniotomy cuts with a surface area no larger than 25 cm2. DB-Cranial may be used in the restoration or augmentation of bony contours of the cranial bone skeleton.

DB-Cranial Bone Void Filler is a moldable and biocompatible calcium phosphate bone void filler. DB-Cranial kit is comprised of two components: a calcium-phosphate powder and a mixing solution in premeasured quantities, which will be mixed together prior to implantation. The 3 cc, 5 cc, and 10 cc DB-Cranial Bone Void Filler kits are provided sterile to SAL of 10-6 and are for single use only. The sterilization method is gamma radiation. Sterilization validation is based on ISO 11137-2:2013 (VDMax25). DB-Cranial Bone Void Filler will be labeled with a shelf life of 30 months.

The document provided is a 510(k) summary for the DB-Cranial device. It describes various performance tests conducted to demonstrate substantial equivalence to a predicate device, OsteoVation® Impact (K162864).

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

Important Note: This document does not describe a study that uses AI or machine learning. It is a submission for a medical device (a calcium phosphate bone void filler) that undergoes physical and chemical performance testing to demonstrate substantial equivalence. Therefore, many of the requested bullet points regarding AI/ML studies (e.g., sample size for test set, data provenance, ground truth, experts, MRMC, standalone performance, training set) are not applicable to this type of device submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for DB-Cranial were established by comparing its performance to that of the predicate device, OsteoVation® Impact (K162864). The "Results" column essentially serves as the reported device performance and also confirms that the device meets the implied acceptance criteria of being substantially equivalent to the predicate.

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: The document does not specify the exact number of samples used for each test (e.g., number of specimens for tensile testing, number of batches for chemical analysis). The tests are typically conducted on a sufficient number of samples to ensure statistically sound results for material characterization.
• Data Provenance: The data provenance is generally from laboratory bench testing (in vitro simulations). The country of origin of the data is not explicitly stated, but it would typically be where the manufacturer (Dimensional Bioceramics, LLC, Santa Cruz, CA) or their contracted laboratories are located. The testing is prospective for the device being submitted, although it involves comparison to an already marketed predicate.

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 study involves physical and chemical property testing of a biomaterial, not subjective interpretation by medical experts. The "ground truth" for these tests comes from established scientific and engineering principles (e.g., ASTM/ISO standards for material testing, analytical chemistry techniques).

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

Not applicable, as there is no subjective adjudication required for quantitative and qualitative material property tests.

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/ML-driven diagnostic or assistive device.

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

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

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

The "ground truth" for the performance tests is derived from:

• Established material science and engineering principles.
• Quantitative measurements made by validated analytical equipment (e.g., ICP-MS, XRD, mechanical testers).
• Qualitative observations based on scientific methodologies (e.g., FTIR, SEM).
• The performance of the legally marketed predicate device, used as a benchmark for "substantial equivalence."

8. The sample size for the training set

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

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

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

Ask a specific question about this device

Dimensional Bioceramics™ (DB) Calcium Sulfate Device (CSD) is a bone graft substitute that is intended for use as a bone void filler for voids and gaps and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from a traumatic injury to the bone. DB-CSD is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities and pelvis). DB-CSD is a bone graft substitute that resorbs and replaced with bone during the healing process. DB-CSD is biodegradable and biocompatible and may be used in an infected site.

Dimensional Bioceramics (DB) Calcium Sulfate Device (CSD) [DB-CSD] Bone Void Filler Kit is provided sterile for single patient use. The Kit contains medical grade calcium sulfate powder and mixing solution in pre-measured quantities. When mixed together in a sterile mixing bowl, the resultant paste may be injected, digitally implanted, or applied to a mold to produce pellets. DB-CSD resorbs and is replaced with bone during the healing process. DB-CSD is a moldable, biocompatible, biodegradable, and resorbable calcium sulfate material that is to be applied directly to the intended sites. It may be used within an infected site. The critical specifications are chemistry, crystallinity, physical form, porosity, and solubility.

The provided text describes a 510(k) premarket notification for a medical device, the Dimensional Bioceramics Calcium Sulfate Device (DB-CSD), which is a bone void filler. It details the device's characteristics, indications for use, and a summary of testing performed to demonstrate substantial equivalence to a predicate device.

However, the provided text does not describe:

• Acceptance criteria in the context of a statistical study with specific numerical thresholds for performance metrics (e.g., sensitivity, specificity, F1-score).
• Performance metrics for an AI/algorithm-based device.
• Details about a test set, including its sample size, data provenance, ground truth establishment by experts, or adjudication methods.
• Multi-Reader Multi-Case (MRMC) studies or comparative effectiveness studies involving human readers and AI assistance.
• Standalone algorithm performance.
• Training set details (sample size, ground truth establishment).

The "Summary of Testing" section primarily focuses on:

• Laboratory Testing: Comparison of critical specifications (chemistry, crystallinity, physical form, porosity, solubility) of DB-CSD with a predicate device through various analytical techniques (FTIR, XRD, SEM, Mercury Intrusion Porosimetry, ICP-AES). The acceptance criterion here is substantially equivalent to the predicate device.
• Biocompatibility Testing: Demonstrated DB-CSD met the requirements of ISO 10993-1. The acceptance criterion is meeting these ISO standards.
• Pyrogenicity Testing: ISO Materials Mediated Rabbit Pyrogen testing showed DB-CSD is non-pyrogenic. The acceptance criterion is non-pyrogenic.
• Sterilization and Shelf-Life Testing: Validated radiation dose in accordance with ISO 11137-2006 to a Sterility Assurance Level (SAL) 10-6. The acceptance criterion is achieving SAL 10-6.
• Animal Testing: An ovine model study analyzed biocompatibility, implant resorption, bone formation, and surgical handling. The results indicated biocompatibility, complete resorption, and normal bone healing. The acceptance criteria relate to these biological outcomes being comparable to the predicate device.
• Clinical Testing: Explicitly states "N/A: This product type does not require clinical testing."

Therefore, I cannot populate the table or answer the specific questions related to AI/algorithm performance and clinical study design for an AI device because this document pertains to a resorbable calcium salt bone void filler device, which is a physical medical device, not an AI or imaging diagnostic device.

If you have a document describing an AI/algorithm-based medical device study, I would be happy to analyze it according to your criteria.

Ask a specific question about this device