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Montage-XT Settable, Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries. Montage-XT is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.

MONTAGE-XT Settable. Resorbable Hemostatic Bone Putty is a sterile, biocompatible, resorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The single use MONTAGE-XT device contains two separate components of putty-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the MONTAGE-XT device form a resorbable putty-like material that can be applied directly to bleeding bone. The resulting hardening material is primarily comprised of calcium phosphate. MONTAGE-XT must be mixed immediately prior to use.

When applied to surgically cut or traumatically broken bone, MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).

This FDA 510(k) summary is for a medical device called MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty. The submission is to add a new indication for use: "in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy." The new device is compared to a previously cleared predicate device, Orthocon, Inc. MONTAGE Settable, Resorbable Hemostatic Bone Putty (K213418).

Here's the breakdown of the acceptance criteria and supporting studies as described in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" in a quantitative format for the new sternotomy indication. Instead, it relies on demonstrating substantial equivalence to the predicate device, Montage, and leveraging clinical data from the Montage device. The core argument is that the devices are nearly identical, with the only clinically meaningful difference being an extended working time for Montage-XT.

The comparison table provided focuses on similarities and differences between the subject device (Montage-XT) and the predicate device (Montage). The "performance" for the new indication is implied by the clinical efficacy shown for the predicate device in a sternotomy setting.

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

• Test Set Sample Size: The document states that "A human clinical evaluation was conducted that supports the use of Montage during sternotomy procedures." However, it does not specify the sample size of this clinical evaluation.
• Data Provenance: The document implies the clinical data is from a prospective study ("A human clinical evaluation was conducted"). The country of origin is not explicitly stated. It refers to "clinical data obtained from a sternotomy study" relevant to the Montage 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 in the document. The description of the clinical evaluation does not detail the methodology for establishing ground truth or the involvement of experts beyond the general statement of a "human clinical evaluation."

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

• No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance. This device is a hemostatic bone putty, not an AI-powered diagnostic or assistive tool. The clinical evaluation described would likely be a direct clinical trial evaluating the putty's efficacy, not a reader study.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not applicable. This device is a physical medical product (bone putty), not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is irrelevant. Its performance is directly tied to its physical application and biological interaction.

7. Type of Ground Truth Used

• For the clinical study on the predicate device (Montage) used to support the new indication for Montage-XT, the ground truth would have been based on clinical observation of hemostasis (cessation of bleeding) during sternotomy procedures. This would fall under outcomes data (i.e., successful control of bleeding).

8. Sample Size for the Training Set

• Not applicable. This product is a physical medical device. It does not employ machine learning algorithms that require a "training set" of data.

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

• Not applicable for the same reason as point 8.

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MONTAGE Settable, Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries. MONTAGE is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.

MONTAGE Settable. Resorbable Hemostatic Bone Putty is a sterile, biocompatible, resorbable material for use in the control of bleeding from bone surfaces. The MONTAGE device comprises two separate components of putty-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the MONTAGE device form a cohesive putty-like material that adheres to the bleeding bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate. MONTAGE components must be mixed immediately prior to use. When applied to surgically cut or traumatically broken bone, MONTAGE Settable, Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).

The provided text describes the Montagne Settable, Resorbable Hemostatic Bone Putty. The document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo performance data.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific, quantitative acceptance criteria for the device's hemostatic performance (e.g., time to hemostasis, success rate within a defined timeframe). Instead, it states more general performance outcomes.

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

The document mentions "A human clinical evaluation was conducted that supports the use of Montage during sternotomy procedures." However, it does not specify the sample size for this clinical evaluation, nor does it explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature of the study).

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

The document does not provide any information about the number or qualifications of experts used to establish ground truth for the test set of the clinical evaluation.

4. Adjudication Method for the Test Set:

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

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

The document does not mention or describe a MRMC comparative effectiveness study, nor does it discuss human improvement with or without AI assistance. This is expected as the device is a medical device (putty), not an AI-powered diagnostic tool.

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

The document does not describe a standalone performance study in the context of an algorithm. This is not applicable to a physical medical device like bone putty.

7. Type of Ground Truth Used:

For the "human clinical evaluation" mentioned, the ground truth would implicitly be clinical outcomes (e.g., successful hemostasis, absence of re-bleeding, safety events) as observed and documented by the operating surgeons and medical staff. However, the document does not explicitly state the specific ground truth used. For other performance tests (biocompatibility, sterility, etc.), the ground truth would be established through standardized testing protocols and laboratory measurements as per ISO 10993 and other relevant standards.

8. Sample Size for the Training Set:

The document does not specify a training set sample size. As a physical medical device (bone putty) undergoing a 510(k) submission, the concept of a "training set" in the context of machine learning algorithms is not directly applicable. Performance is typically established through a combination of bench testing, animal studies (if applicable), and clinical evaluation.

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

Since there is no "training set" in the context of an algorithm, this question is not applicable. The performance characteristics for the device were likely established through the aforementioned laboratory tests and clinical evaluation, with ground truth based on observed biological or physical responses to the device.

In summary, the provided document is a 510(k) summary focused on substantial equivalence for a medical device. It briefly mentions performance testing and a clinical evaluation but lacks specific details typically found in summaries for AI/ML-powered devices, such as sample sizes, expert qualifications, or detailed performance metrics. The main purpose of this 510(k) was to add a new indication for use (sternotomy procedures) based on demonstrated equivalence to the previously cleared version of the same device and a predicate device.

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Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is a sterile, biocompatible, resorbable material for use in the control of bleeding from bone surfaces. The single use device contains two separate components of paste-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols, a mixture of a lactide-diester and polyester-based polymers and barium sulfate. When mixed together, the components of the device form a resorbable paste-like material that can be applied directly to bleeding bone by means of a single-use applicator (delivery device). The resulting hardening paste is primarily comprised of calcium phosphate. Montage Flowable XRO is mixed immediately prior to use.

When applied to surgically cut or traumatically broken bone. Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste achieves local control of bleeding by acting as a mechanical barrier (tamponade).

The provided text is a 510(k) summary for a medical device called "Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste." This document aims to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

However, the 510(k) summary does not contain information about acceptance criteria or a study that rigorously proves the device meets specific acceptance criteria in the manner you've outlined for AI/diagnostic devices.

This type of document for a conventional medical device (like a hemostatic bone paste) primarily focuses on demonstrating substantial equivalence to a predicate device through comparisons of:

• Intended Use: The new device has the same intended use as the predicate.
• Technological Characteristics: The new device has similar technological characteristics to the predicate. Any differences do not raise new questions of safety or effectiveness.
• Performance Data: This typically involves bench testing, biocompatibility, and sometimes animal studies to show that the device performs as intended and is safe.

Therefore, for your specific request regarding acceptance criteria and a study proving performance, I must state that the provided text does not contain the requested information in the format or detail typically associated with AI/diagnostic device performance studies.

Here's why and what the document does provide:

1. Table of Acceptance Criteria and Reported Device Performance: This is not present for specific diagnostic metrics (e.g., sensitivity, specificity, AUC). The document lists comparisons of technological characteristics between the subject device and a predicate. The "performance" section describes general types of testing (bench, biocompatibility, animal) but no quantitative results against predefined acceptance criteria for diagnostic accuracy.

2. Sample Size Used for the Test Set and Data Provenance: No test set is described in terms of human subjects or data for diagnostic evaluation. The document mentions "animal testing," but not in the context of a diagnostic test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable as there's no diagnostic test set with ground truth established by experts.

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating human performance with and without AI assistance for diagnostic tasks.

6. Standalone (Algorithm Only) Performance: Not applicable. This device is a physical paste, not an algorithm.

7. Type of Ground Truth Used: Not applicable. No diagnostic ground truth mentioned.

8. Sample Size for the Training Set: Not applicable. This device is not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established: Not applicable.

What the document does describe as "Performance Testing" includes:

• Bench Testing:

  • Evaluations: Relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, dissolution, and swelling.
  • Purpose: To verify handling properties, characterize performance over a range of temperatures, and evaluate dissolution properties.
  • Results: Stated as demonstrating substantial equivalence to predicate devices, but no quantitative acceptance criteria or specific results are provided.

• Biocompatibility Testing:

  • Evaluations: Irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, systemic toxicity, hemolysis, endotoxicity, and pyrogenicity.
  • Standards: Conducted in accordance with ISO 10993 and GLP requirements.
  • Results: Stated as demonstrating substantial equivalence.

• Animal Testing:

  • Purpose: To demonstrate intraoperative in vivo hemostasis and resistance to irrigation.
  • Results: Stated as demonstrating substantial equivalence.

• Sterility:

  • Validation: Gamma sterilization process validated to provide a SAL (Sterility Assurance Level) of 10^-6.
  • Lot Release: Each lot tested for bacterial endotoxin.

In summary, the provided FDA 510(k) letter and summary are for a physical medical device (hemostatic bone paste) and demonstrate substantial equivalence based on similar intended use, technological characteristics, and general performance testing (bench, biocompatibility, animal studies). It does not contain the detailed diagnostic performance metrics, acceptance criteria, or study designs typically requested for AI/diagnostic devices.

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MERIL - BONEWAX™ is intended to be used in the control of bleeding from bone surfaces during surgical operations.

MERIL - BONE WAX™ is ivory white, intended to aid mechanically in the control of bleeding of bone injuries, whether attributable to trauma or surgical intervention. It is composed of refined beeswax with Iso propyl myristate added as softening agent, and is supplied sterile in thin sheets. It is opaque and has a waxy odor. It is available as 2 or 2.5gm bone wax per pack. MERIL - BONE WAX™ achieves local hemostasis of bone by acting as a mechanical (tamponade) barrier. It does not act biochemically and is nonabsorbable.

This document, K200452, pertains to the FDA 510(k) premarket notification for MERIL-BONEWAX™. As a 510(k) submission, it aims to demonstrate substantial equivalence to a predicate device rather than providing extensive clinical study data that would be typical for a new device requiring a PMA.

Therefore, the information regarding acceptance criteria and a study proving the device meets these criteria is limited to performance tests designed to establish substantial equivalence.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of precise quantitative acceptance criteria with corresponding performance values for parameters like sensitivity, specificity, or quantifiable clinical outcomes. Instead, the acceptance criteria are generally qualitative or based on demonstrating equivalence to predicate devices and adherence to established standards.

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MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

MONTAGE-XT Settable. Resorbable Hemostatic Bone Putty is a sterile. biocompatible, resorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The single use MONTAGE-XT device contains two separate components of putty-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the MONTAGE-XT device form a resorbable putty-like material that can be applied directly to bleeding bone. The resulting hardening material is primarily comprised of calcium phosphate. MONTAGE-XT must be mixed immediately prior to use.

When applied to surgically cut or traumatically broken bone. MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).

The FDA document describes the MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty, which is a medical device for controlling bone bleeding. The submission seeks to prove the substantial equivalence of the new device (MONTAGE-XT) to a previously cleared predicate device (MONTAGE) by Orthocon, Inc. The primary difference highlighted is an extended working time for MONTAGE-XT.

Here's an analysis of the provided text in relation to the requested information:

Acceptance Criteria and Study for MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty

The acceptance criteria for this device are based on demonstrating substantial equivalence to a predicate device (MONTAGE Settable, Resorbable Hemostatic Bone Putty, K141502 and K152005). The studies conducted primarily revolve around characterizing the new device's properties and comparing them to the predicate, especially regarding the extended working time. This is not a study proving clinical effectiveness through outcome measures in an AI/software context, but rather a characterization and comparison study for a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not provide specific sample sizes for the performance tests.

• Bench Testing: Performed on the device to characterize properties like stiffness, spreadability, stickiness, working time, etc. No specific count of samples is given.
• Biocompatibility Testing: Conducted on a "representative device." No specific sample size (e.g., number of animals for toxicity tests) is provided within this summary.
• Animal Testing: Included "animal studies" to demonstrate intraoperative in vivo hemostasis and resistance to irrigation. The specific number or details of animals used are not provided.

The provenance of this data is from the manufacturer, Orthocon, Inc., as part of their 510(k) submission to the FDA. The studies appear to be prospective as they were conducted specifically for this submission to characterize the new device. The country of origin for the data generation is not explicitly stated, but it's generated by a US-based company for FDA submission, implying US-based or internationally accepted GLP/ISO standards were followed.

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

This submission is for a physical medical device, not an AI/Software as a Medical Device (SaMD). Therefore, the concept of "ground truth" established by experts (like radiologists for imaging data) is not directly applicable in the same way. The "ground truth" here is established by validated laboratory methods and animal models to measure physical properties, biocompatibility, and hemostatic efficacy.

The relevant "experts" would be the scientists, engineers, and veterinarians conducting the bench and animal studies, following established protocols (e.g., ISO, GLP). Their qualifications are implied by their ability to conduct such studies according to regulatory standards, but specific numbers or qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Not applicable as this is not an expert-driven AI/SaMD ground truth establishment process. Performance is objectively measured through defined test methods.

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

Not applicable. This is not a study involving human readers and AI assistance for diagnostic or interpretative tasks. It's a characterization of a physical medical device.

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

Not applicable. This is not an AI/SaMD. The device is a physical bone putty. Its performance is inherent to its physical and chemical properties and how it interacts with the biological environment.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation comes from:

• Bench Test Results: Quantifiable measurements of physical properties (e.g., working time, stiffness, spreadability).
• Biocompatibility Study Results: Standardized tests (e.g., ISO 10993) assessing biological responses.
• Animal Study Results: Direct observation and measurement of hemostatic efficacy and resistance to irrigation in a live biological model.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning model, so there is no "training set."

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

As there is no training set, this question is not applicable.

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HBP7 Settable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

HBP7 Settable Hemostatic Bone Putty is a sterile, biocompatible, nonabsorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The single use HBP7 device contains two separate components of putty-like consistency comprised of granular calcium phosphate, paraffin oil, vitamin E acetate, a triglyceride, and a mixture of nonabsorbable, polyetherbased polymers. When mixed together, the components of the HBP7 device form a nonabsorbable putty-like material that can be applied directly to bleeding bone. The resulting material is primarily comprised of calcium phosphate. HBP7 must be mixed immediately prior to use.

When applied to surgically cut or traumatically broken bone. HBP7 Settable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).

This document describes the HBP7 Settable Hemostatic Bone Putty, a medical device indicated for controlling bleeding from cut or damaged bone by acting as a mechanical barrier. The device's substantial equivalence to predicate devices is established through a series of performance tests.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for HBP7 Settable Hemostatic Bone Putty in the format of a table with specific thresholds. Instead, it describes various performance tests conducted to demonstrate substantial equivalence to predicate devices. The "reported device performance" is largely qualitative, indicating that the device "demonstrates" or "verifies" certain properties or functions similar to the predicates.

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

The document does not specify the sample sizes for the "test set" in terms of how many devices, animals, or specimens were used for the bench, biocompatibility, or animal studies. It states that tests were "conducted" and "demonstrate" substantial equivalence.
The data provenance (country of origin, retrospective/prospective) is not mentioned.

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 information is not provided in the document. The studies performed (bench, biocompatibility, animal) do not typically rely on expert consensus for "ground truth" in the way an AI diagnostic device would. Instead, their "ground truth" comes from established scientific methods, laboratory observations, and medical standards.

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

This information is not applicable and is not provided. Adjudication methods like "2+1" are relevant for expert review of images or data, typically in diagnostic AI studies. The tests described here are physical, chemical, and biological evaluations, not requiring such adjudication.

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

A multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The HBP7 is a physical medical device (bone putty) and not an AI-powered diagnostic tool, so such a study would not be applicable.

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

A standalone performance study of an algorithm was not done. The HBP7 is a physical medical device, not an algorithm, so this concept does not apply.

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

For the bench testing, the "ground truth" would be objective measurements and observations against pre-defined engineering and material science standards (e.g., stiffness measurements, dissolution rates).
For biocompatibility testing, the "ground truth" is derived from established biological assays and observation protocols outlined in ISO 10993, assessed by scientists/toxicologists.
For animal testing, the "ground truth" for hemostasis is direct observation of bleeding control and resistance to irrigation in a live animal model, assessed by veterinary surgical staff and researchers.
There is no "expert consensus" or "pathology" in the typical sense of diagnostic ground truth. Outcomes data for patients is not mentioned, as this is a premarket notification, not a large-scale clinical trial.

8. The sample size for the training set

This information is not applicable and is not provided. The HBP7 is a physical medical device, not an AI model, therefore it does not have a "training set" in the context of machine learning.

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

This information is not applicable as there is no "training set" for this physical device.

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The HBP6 Settable, Resorbable Hemostatic Bone Paste is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

The HBP6 Settable, Resorbable Hemostatic Bone Paste is a sterile, biocompatible, resorbable material for use in the control of bleeding from bone surfaces. The single use HBP6 device contains two separate components of paste-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the HBP6 device form a resorbable paste-like material that can be applied directly to bleeding bone by means of a single-use applicator (delivery device). The resulting hardening paste is primarily comprised of calcium phosphate. HBP6 is mixed immediately prior to use.

When applied to surgically cut or traumatically broken bone, HBP6 Settable, Resorbable Hemostatic Bone Paste achieves local control of bleeding by acting as a mechanical barrier (tamponade).

The provided document is a 510(k) summary for a medical device cleared by the FDA. It does not describe an AI/ML powered device, nor does it detail acceptance criteria and a study that proves the device meets those criteria in the context of an algorithm's performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested categories (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this document's content, as it pertains to a physical medical device (hemostatic bone paste), not an AI algorithm.

However, I can extract the information relevant to the device's performance testing and how it demonstrates "acceptance" in the context of a 510(k) submission.

Device: HBP6 Settable, Resorbable Hemostatic Bone Paste

Acceptance Criteria & Device Performance (as demonstrated for Substantial Equivalence):

The "acceptance criteria" in the context of a 510(k) for a physical device like this are framed around demonstrating substantial equivalence to a legally marketed predicate device, largely through showing similar technological characteristics and comparable performance in relevant tests. The performance is "accepted" if it falls within expected ranges for the device type and is consistently similar to the predicate.

Information Not Applicable or Not Provided in this Document (due to the nature of the device and submission type):

1. Sample size used for the test set and the data provenance: Not specified for bench or animal testing, as this typically isn't a statistical study to prove a diagnostic algorithm's performance on human data. The "test set" here refers to the actual samples or animals used in the physical properties and biological tests. Data provenance (country, retrospective/prospective) is not mentioned for animal or bench studies.
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 a physical hemostat is established via objective physical measurements (e.g., set time, dissolution rate) and observed biological effects (e.g., hemostasis in an animal model, toxicity in biocompatibility tests). There are no "experts" interpreting diagnostic images or clinical outcomes in this context.
3. Adjudication method: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is for diagnostic or AI-assisted devices, not a physical hemostat.
5. If a standalone performance was done: Not applicable in the context of an algorithm. For a physical device, "standalone performance" is implicitly demonstrated through the bench and animal tests, showing the device functions as intended on its own.
6. The type of ground truth used:
   • Bench Testing: Mechanical properties (e.g., stiffness, set time, dissolution rates) are measured directly based on established testing standards.
   • Biocompatibility Testing: Results are determined based on standardized ISO 10993 biological endpoints (e.g., cell viability, irritation scores, genetic mutations).
   • Animal Testing: In vivo hemostasis and resistance to irrigation are direct observations in animal models.
7. The sample size for the training set: Not applicable; there is no "training set" for a physical medical device.
8. How the ground truth for the training set was established: Not applicable.

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MONTAGE-QS Settable, Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

MONTAGE-QS Settable. Resorbable Hemostatic Bone Putty is a sterile. biocompatible, resorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The single use MONTAGE-QS device contains two separate components of putty-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the MONTAGE-QS device form a resorbable putty-like material that can be applied directly to bleeding bone. The resulting material is primarily comprised of calcium phosphate. MONTAGE-QS must be mixed immediately prior to use.

When applied to surgically cut or traumatically broken bone. MONTAGE-QS Settable, Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).

This document (K191140) is a 510(k) Premarket Notification for a medical device called "MONTAGE-QS Settable, Resorbable Hemostatic Bone Putty." It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific performance acceptance criteria via a clinical study with a detailed test set, ground truth, and expert evaluation as would be the case for a diagnostic AI/ML device.

Therefore, the information requested for acceptance criteria and a study proving the device meets those criteria (especially points 1 through 9 pertaining to diagnostic performance, expert review, MRMC studies, etc.) cannot be fully extracted or accurately described from the provided text.

Here's a breakdown of what can be extracted and why other points cannot be addressed:

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

This document does not present acceptance criteria for diagnostic performance outcomes (e.g., sensitivity, specificity, accuracy) or statistical thresholds for improved human reader performance with AI. Instead, it focuses on performance testing to demonstrate substantial equivalence to a predicate device in terms of physical properties, biocompatibility, and functionality.

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

• Sample Sizes: Not explicitly stated for specific tests. The document refers to "bench studies," "biocompatibility studies," and "animal studies" without specifying the number of samples or animals used in each.
• Data Provenance: Not specified. These are engineering and preclinical tests, not clinical data from patients.

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

This information is not applicable. The "ground truth" for this device's evaluation is based on objective physical/chemical measurements (bench testing), biological reactions (biocompatibility), and observed in-vivo effects in animal models, not on human expert radiologist or clinician interpretations.

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

Not applicable, as this testing does not involve human interpretation or adjudication of diagnostic findings.

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 hemostatic putty, not an AI/ML diagnostic tool meant to assist human readers.

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

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

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

The "ground truth" for this device's performance is established through:

• Standardized physical and chemical property measurements (e.g., stiffness, dissolution rates).
• Validated biocompatibility assays (ISO 10993 series).
• Direct observation of hemostatic efficacy and resorption in animal models.

8. The sample size for the training set:

Not applicable. This device does not involve machine learning or a "training set."

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

Not applicable. This device does not involve machine learning or a "training set."

Summary of Device and Evidence Presented:

The MONTAGE-QS Settable, Resorbable Hemostatic Bone Putty is a sterile, biocompatible, resorbable material intended to control bleeding from cut or damaged bone by acting as a mechanical barrier. The 510(k) submission successfully demonstrated substantial equivalence to a predicate device (MONTAGE Settable, Resorbable Hemostatic Bone Putty K152005) through:

• Bench Testing: Verifying handling properties (stiffness, spreadability, stickiness), temperature sensitivity, electrocautery compatibility, dissolution, and swelling.
• Biocompatibility Testing: According to ISO 10993 recommendations (cytotoxicity, irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, systemic toxicity, hemolysis, endotoxicity, pyrogenicity).
• Animal Testing: Demonstrating intraoperative in vivo hemostasis, resistance to irrigation, local tissue response, and characterizing resorption time.
• Technological Characteristics Comparison: Showing the device is "nearly identical" in configuration, formulation (with one exception for faster setting time), materials (primarily calcium phosphate), and principle of action (mechanical tamponade) to the predicate.

The FDA clearance (K191140) implies that based on these non-clinical tests, the device is considered as safe and effective as the legally marketed predicate device for its stated Indications for Use.

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Orthocon HemasorbPlus Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

HEMASORBPLUS™ Resorbable Hemostatic Bone Putty is a sterile, biocompatible, resorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The material contains a mixture of alkylene oxide polymer based materials, vitamin E acetate, granular calcium phosphate and sodium carboxymethylcellulose. HEMASORBPLUS™ Resorbable Hemostatic Bone Putty is virtually odorless, off-white in color and can be spread easily onto bone with minimal adhesion to surgical gloves. The putty requires no kneading or warming prior to application. When applied to surgically cut or traumatically broken bone, HEMASORBPLUS™ Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). HEMASORBPLUS Resorbable Hemostatic Bone Putty has been shown to be mixable with autograft in a 1:1 volume ratio.

This document is a 510(k) summary for the Orthocon HemasorbPlus Resorbable Hemostatic Bone Putty. It describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance:

The document implicitly refers to acceptance criteria by stating that "Testing was conducted to verify the device's handling properties, to characterize the device's performance over a range of temperatures and to evaluate the device's dissolution and swelling properties." and that the "data presented demonstrate that the device is suitable for its indicated use." However, specific numerical acceptance criteria (e.g., "smearability shall be X," "dissolution rate shall be Y") and detailed reported device performance values are not explicitly provided in this summary.

The summary lists the following studies and their general findings:

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

• Test Set Sample Size: Not explicitly stated for bench, biocompatibility, or in vivo studies.
• Data Provenance: The studies were conducted by Orthocon, Inc. and are described as "bench studies," "biocompatibility testing," and "in vivo performance testing." The in vivo testing included "animal studies," implying the data provenance is from animals, rather than human patients. The country of origin is not specified but implicitly in the USA as it is for FDA approval in the US. The studies are assumed to be prospective as they were conducted to support the 510(k) submission.

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

Not applicable. The ground truth for bench, biocompatibility, and animal studies is typically established through direct measurement, laboratory assays, and observations by trained personnel, not through expert consensus in the same way clinical image interpretation might require.

4. Adjudication Method for the Test Set:

Not applicable. This type of device testing (bench, animal) does not typically involve adjudication methods like those used for human-in-the-loop diagnostic studies.

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 that involve human interpretation of medical images or data. The HemasorbPlus is a resorbable hemostatic bone putty and does not involve human readers interpreting data generated by the device itself in a diagnostic capacity.

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

Yes, the device performance tests described are inherently "standalone" in the sense that they evaluate the device's physical, chemical, and biological properties and direct effect on bleeding, independent of human interpretive input. The core functionality and safety of the putty were evaluated.

7. The Type of Ground Truth Used:

• Bench Studies: Objective measurements of physical properties (e.g., smearability metrics, stiffness measurements, temperature effects, dissolution rates, swelling properties).
• Biocompatibility Testing: Laboratory assay results (e.g., cytotoxicity assays, irritation scores, sensitization responses, acute systemic toxicity observations, pathology from implantation, hemolysis assays, pyrogenicity tests) against established biological safety standards (ISO 10993).
• In Vivo Performance Testing (Animal Studies): Direct observation and measurement of hemostasis, resistance to irrigation, ability to remove, and characterization of safety and absorption time in animal models. For the autograft study, histological analysis (pathology) would likely be the ground truth for "normal bone healing."

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML-based diagnostic or predictive algorithm that requires a "training set" in the conventional sense. The "training" for such a device comes from understanding material science, biocompatibility principles, and surgical hemostasis.

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

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

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ROP Bone Hemostasis Material is a water-soluble material indicated for use to control bleeding from bone surfaces.

The ROP Bone Hemostasis Material is a blend of water-soluble alkylene oxide copolymers. It contains no additives or colorants. The product is provided in a stick-like form, contained in a capped delivery tube. Each tube contains approximately 6.0 grams of the material. It is to be extruded from the container by rotation of the base of the tube for application to bleeding bone defect. The ROP Bone Hemostasis Material is, as the predicate, a water soluble wax-like substance and is slippery when wet. The delivery tube is a barrier between the surgeon's wet gloved hand and the material, permitting application to the boney defect in the manner similar to handling a crayon. ROP Bone Hemostasis Material is sterilized by a validated gamma irradiation process. It is labeled for single surgical use and is not to be resterilized. The tube is provided in a secondary wrap to permit delivery into a sterile field. The device is a resorbable material in contact with bone tissue for less than 30 days.

The provided text describes a 510(k) premarket notification for the "ROP Resorbable Hemostasis Material" (K153095). However, the document does not present specific acceptance criteria in a quantifiable manner (e.g., a specific percentage of bleeding control or a fixed resorption rate within a certain timeframe that the device must meet).

Instead, the study aims to demonstrate substantial equivalence to a predicate device, Ostene® CT Soluble Bone Hemostasis Implant Material. The acceptance criteria for this type of submission are generally met by showing that the new device performs similarly to the legally marketed predicate device with respect to safety and effectiveness for its intended use.

Therefore, the "acceptance criteria" can be inferred as:

• Similarity in hemostatic performance to the predicate.
• Similarity in adherence to bone to the predicate.
• Similarity in resorption profile to the predicate.
• No negative impact on bone healing compared to the predicate.
• Biocompatibility according to ISO 10993 standards.
• Material and device characterization matching established specifications.
• Sterilization and shelf life validation.

Here's an attempt to structure the information based on the provided text, interpreting "acceptance criteria" as demonstrating similarity or compliance with established standards, and "reported device performance" as the study's findings regarding this similarity/compliance:

1. Table of Acceptance Criteria and Reported Device Performance

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:
  • Animal Testing (In vivo performance and ISO 10993-6 study): The document specifies "ISO Bone Implantation Study in the mid shaft femur of rabbits, 48 hours, 1 and 4 weeks." While the specific number of rabbits (sample size) is not explicitly stated in the provided text, "rabbits" is mentioned, implying a multi-animal study.
  • Biocompatibility Testing: Many tests listed use animal models (e.g., "ISO Modified Intracutaneous Irritation in the Rabbit," "Guinea Pig Maximization Sensitization Test," "Mouse Peripheral Blood Micronucleus Study," "Dose Range Finding Study with a Definitive Mouse Lymphoma Assay," "Systemic Toxicity in Mice," "ISO Systemic Toxicity in the Rat," "USP Rabbit Pyrogen Study"). The exact number of animals for each test is not detailed in this summary.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the studies are described as "Non-clinical testing" conducted in accordance with FDA guidance and standards, indicating laboratory and animal testing. This is typically 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)

• The document does not mention the use of human experts to establish "ground truth" for the test set in the traditional sense of medical image interpretation or clinical diagnosis. The studies described are primarily non-clinical laboratory and animal studies. The "ground truth" or evaluative criteria would be based on scientific and biological endpoints (e.g., histological analysis of tissue response, observation of hemostasis, measurement of resorption) as assessed by researchers or pathologists involved in the studies, rather than subjective expert consensus.

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

• Not applicable. The reported studies are non-clinical (laboratory and animal) and do not involve human reader interpretation or adjudication of results in the way a clinical imaging study would.

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. The device is a "Bone Hemostasis Material," not an AI diagnostic or assistive tool. The studies focus on the intrinsic properties and performance of the material itself.

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

• Not applicable, as this is a physical medical device, not a software algorithm. The "standalone" performance refers to the device's inherent function, which was evaluated through laboratory and animal testing.

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

• The ground truth for the non-clinical studies was established through:
  • Pathology/Histology: For tissue response, bone healing, and resorption evaluation in animal studies.
  • Physical and Chemical Measurements: For material and device characterization (e.g., melting point, pH, molecular weight, formaldehyde content, stiffness).
  • Biological Endpoints/Observations: For hemostasis, adherence to bone, and biocompatibility endpoints in animal models.
  • Comparisons: Performance was assessed relative to a legally marketed predicate device (Ostene).

8. The sample size for the training set

• Not applicable. This is a physical medical device, and the described studies are non-clinical evaluations for regulatory clearance, not a machine learning study requiring training data.

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

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

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