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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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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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The subject device is intended for the evacuation of biological fluids from wounds or body cavities. Closed wound drainage systems have been used by various surgical specialties, including: orthopedic, general, reconstructive, neurological, gynecological, head and neck, thoracic / cardiovascular, and plastic surgery.

The Elutia ™ Coated Closed Surgical Wound Drain is a radiopaque, single-use silicone wound drain with extension tubing for use with available drain reservoirs that include an anti-reflux valve. The drain is channeled for its entire length. It is available in round or flat configurations and in multiple sizes. A low profile connector joins the drain to clear silicone extension tubing. The drain is packaged sterile in a double pouch and is non-pyrogenic. The hydrogel coating containing silver sulfadiazine has been shown to reduce bacterial contamination on the surface of the wound drain by greater than 99.99% over a 7 day period as tested under USP conditions against the following microorganisms: S. aureus, P. aeruginosa, E. coli, and C. albicans. The clinical significance of this finding is unknown. The subject device is composed of materials that have been successfully used in medical devices including the predicate devices. The subject device is composed of medical grade silicone (indwelling catheter, connector, and external tubing). The device is coated with silver sulfadiazine. USP grade silver sulfadiazine is used. The active drug substance is chemically synthesized and does not contain any animal or cell cultures derived from products or additives such as albumin or serum. The materials used in the subject device have been subjected to and passed biocompatibility testing. Additionally, the materials have been successfully used in other medical devices including the predicate devices. The subject devices are sterile single-use devices. Sterilization was performed.

Here's a breakdown of the requested information based on the provided 510(k) summary for the Elutia™ Coated Closed Surgical Wound Drain:

1. Acceptance Criteria and Reported Device Performance

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

The 510(k) summary does not explicitly state the sample size for the bacterial contamination reduction test or other performance tests (biocompatibility, packaging, etc.).

• Test Set Sample Size: Not explicitly stated.
• Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission, this data would typically be generated by the manufacturer during product development and testing, likely in a laboratory setting. No country of origin for the data is specified, nor is it described as retrospective or prospective clinical data. The primary test mentioned (USP ) is a standard in vitro microbiological method.

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

N/A. This type of information (expert consensus for ground truth) is not typically applicable or reported for a device like a surgical drain, especially for the in vitro performance tests described. The "ground truth" for the bacterial reduction test is the measurable reduction in bacterial count against controls in a laboratory setting.

4. Adjudication Method for the Test Set

N/A. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or patient outcomes, often with multiple human readers. This is not relevant to the in vitro and laboratory-based performance testing described for this device.

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

No. The 510(k) summary does not mention any MRMC comparative effectiveness study. The submission focuses on substantial equivalence to predicate devices based on technological characteristics and performance testing.

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

N/A. This device is a physical medical device (surgical drain), not a software algorithm or AI-based diagnostic tool. Therefore, the concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used

For the key performance claim:

• Bacterial Reduction: The ground truth was established through laboratory-based microbiological assays (USP ) comparing the coated drain's performance against control samples or expected bacterial growth.
  For other tests:
• Biocompatibility, Pyrogenicity, Physiochemical: Ground truth was based on standardized test methods and associated acceptance criteria (e.g., ISO 10993, USP ).
• Packaging Tests: Ground truth was based on standardized engineering and packaging test methods and associated acceptance criteria (e.g., ASTM 2096-04, ISO 11607, ASTM F1140-00).

8. The Sample Size for the Training Set

N/A. This device is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

N/A. As there is no training set for an AI/ML algorithm, this question is not applicable.

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