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The MTF Pre-Sutured Tendon is intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction.

The MTF Pre-Sutured Tendon is for single patient use only.

The MTF Pre-Sutured Tendon is a construct consisting of a single tendon pre-sutured with UHWMPE non-absorbable surgical suture. The device may include a semitendinosus tendon. bilateral anterior and posterior tibialis tendon, or bilateral peroneus longus tendon., The Pre-Sutured Tendon passes USP sterility testing and is provided for a single patient use.

The provided text does not contain detailed information about acceptance criteria for a medical device's performance, nor does it describe a study specifically designed to prove that the device meets those criteria with statistical rigor in the way one might expect for an AI/diagnosis device.

Instead, the document is a 510(k) summary for the MTF Pre-Sutured Tendon, a device that is compared to predicate devices to establish substantial equivalence. The "performance testing" section describes a comparison study and a cadaveric knee study to demonstrate equivalence or superiority to the predicate devices, rather than meeting pre-defined quantitative acceptance thresholds for accuracy, sensitivity, or specificity.

Here's an analysis based on the information provided, addressing your specific questions where possible. Many questions cannot be fully answered from this document because it's not a study report for an AI or diagnostic device with explicit acceptance criteria and performance metrics:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance in qualitative terms of "equivalence to or better than" predicate devices rather than specific numerical acceptance criteria.

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

• Tensile Strength/Pull Testing: Not specified.
• Cadaveric Knee Study: Not specified. The study involved "a cadaveric knee study," implying multiple cadaveric knees but no specific number is given. The provenance is implied to be cadaveric donations for research, but country of origin is not specified. It is a prospective study in the sense of comparing the novel device to a control construct in a controlled experimental setting.

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

• Cadaveric Knee Study: The study involved orthopedic surgeons for implanting the construct. It compares the device to a "quadruple bundled construct sutured by a surgeon at the time of surgery." It does not explicitly state experts establishing "ground truth," but rather performing the control intervention and assessing implantability ("traditional clinical methods by an orthopedic surgeon"). No specific number or qualifications are provided beyond "orthopedic surgeon."

4. Adjudication Method for the Test Set:

Not applicable or not specified. This type of device does not involve subjective interpretations requiring adjudication for ground truth. The assessments are biomechanical and objective (tensile strength, pull out strength).

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

No, an MRMC study was not done. This device is not an AI or diagnostic tool that involves human readers interpreting cases.

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

Not applicable. This is a physical medical device (pre-sutured tendon), not an algorithm or AI.

7. Type of Ground Truth Used:

• Biomechanical Performance: Measured physical properties (tensile strength, suture pull-out strength, knot pull strength, ultimate load strength), and biomechanical outcomes in a cadaveric model.
• Biological Safety: Endotoxin levels and sterility testing.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable.

Summary of the Study that Proves the Device Meets the (Implied) Acceptance Criteria:

The substantial equivalence of the MTF Pre-Sutured Tendon was demonstrated through a series of performance tests and a cadaveric knee study.

• Comparison Study: Visual characteristics and tensile strength of the pre-sutured tendon were evaluated and compared to the Arthrex Suture Grafting Kit (K041553). The suture's ability to resist pull-out and failure, along with its knot pull strength, were assessed against USP standards. The results indicated that the MTF Pre-Sutured Tendon was "equivalent to or better than" the predicate and USP standards.
• Cadaveric Knee Study: This study assessed the clinically relevant biomechanical performance of the construct when implanted with its intended fixation methods. It compared the MTF Pre-Sutured Tendon to a quadruple-bundled construct sutured by an orthopedic surgeon in an operating room setting. The study found "no statistical difference either acutely or post-cycling" between the two constructs. It also confirmed that the device could be implanted using traditional clinical methods.
• Biological Testing: The device's endotoxin levels were measured (less than 20 EU/device) and it passed USP and USP for sterility.
• Ultimate Load Strength: Comparison testing confirmed that the MTF Pre-Sutured Tendon is "equivalent in ultimate load strength" to its predicates (Allosource ReConnex K170957 and Arthrex Suture Grafting Kit K041553).

The overall conclusion was that the MTF Pre-Sutured Tendon is substantially equivalent to the predicate devices based on its materials, indications, function, and performance, with any differences not raising new questions of safety or effectiveness.

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The MTF New Bone Void Filler is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. The MTF New Bone Void Filler is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. The MTF New Bone Void Filler must be used in the posterolateral spine with bone marrow aspirate or autograft.

The MTF New Bone Void Filler is for single patient use only.

The MTF New Bone Void Filler (BVF) is processed human bone that has been demineralized and combined with gelatin and sodium hyaluronate, which are naturally derived materials that are biocompatible and biodegradable. The sodium hyaluronate used in the manufacturing of BVF is not of animal origin. BVF comes in the form of a mixture of demineralized bone with gelatin and sodium hyaluronate, and a spatula that is necessary to mix the components. A hydrating agent, such as blood and saline, can be used with BVF. Upon addition of a hydrating agent, BVF will achieve a flowable or moldable consistency. The resultant putty can then be manipulated by a surgeon into various shapes for ease and flexibility of use during surgical application.

Here's an analysis of the provided text regarding the MTF New Bone Void Filler, focused on acceptance criteria and supporting studies:

It's important to note that this 510(k) submission is for a bone void filler, which is a medical device and not an AI/ML powered diagnostic or screening tool. Therefore, many of the typical acceptance criteria and study aspects related to AI (e.g., sensitivity, specificity, reader performance, ground truth establishment by experts, training set size, adjudication methods) are not applicable or described in this document.

The "acceptance criteria" for this device are focused on demonstrated substantive equivalence to predicate devices and meeting specific material properties and biological performance in animal models.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as a numerical sample size in the context of typical "test sets" for AI/ML. The primary "test" to demonstrate substantial equivalence was an animal study. The document does not specify the number of animals or the design of this animal study.
• Data Provenance: The animal study is the key performance data. The document does not specify the country of origin but implies it was conducted to support FDA submission in the USA. It is a prospective study (for the animal model) designed to evaluate the new device.

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

• Not Applicable. For this bone void filler, "ground truth" as understood in AI/ML for image interpretation (e.g., disease presence/absence determined by human experts) is not relevant. The performance is assessed through biological outcomes in an animal model and adherence to material and processing standards.

4. Adjudication Method for the Test Set

• Not Applicable. No human-expert adjudication is described, as the evaluation method is not dependent on subjective human interpretation of diagnostic data.

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

• No. This is not an AI/ML powered diagnostic or screening device that uses human readers for interpretation. Therefore, a MRMC study is not relevant.

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

• Not Applicable. This is a physical medical device (bone void filler), not an algorithm or AI system.

7. Type of Ground Truth Used

• The "ground truth" for this device's performance is established through:
  • Biological Outcomes in an Animal Model: Specifically, osteoinductive potential in an athymic mouse model.
  • Material Properties Testing: Sterility (USP ), viral clearance and inactivation.
  • Compliance with Regulations: Donor suitability (21 CFR Part 1271).
  • Comparison to Predicate Devices: Demonstrating no new safety or effectiveness concerns based on the animal study.

8. Sample Size for the Training Set

• Not Applicable. This is not an AI/ML system that requires a "training set" in the computational sense.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Study Summary:

The primary study referenced to demonstrate the MTF New Bone Void Filler meets its acceptance criteria for substantial equivalence is an animal study. This study showed the new device was substantially equivalent to its predicate devices, implying similar safety and effectiveness profiles in that model. Additionally, routine lot release testing confirms osteoinductive potential in an athymic mouse model. Other "studies" or testing involve laboratory analyses for sterility, viral clearance, and adherence to regulatory standards for donor tissue processing.

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MTF Fascia is intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

MTF Fascia is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.

MTF Fascia is for single patient use only.

MTF Fascia is dehydrated, decellularized human allograft fascia minimally processed to preserve the extracellular matrix of the fascia. The fascia is reinforced with a resorbable Poly-L-Lactic Acid (PLLA) fiber woven into the fascia to enhance suture retention of the fascia. MTF Fascia is aseptically processed-no terminal sterilization is conducted. The device passes USP sterility testing and satisfies FDA requirements for LAL endotoxin limit for medical devices. The device must be rehydrated prior to use following the procedures described in the Instructions for Use.

This document is a 510(k) summary for the MTF Fascia device. It is a premarket notification for a medical device seeking clearance from the U.S. Food and Drug Administration (FDA) and is not a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would for a diagnostic device, for example.

The purpose of a 510(k) submission is to demonstrate that the device is "substantially equivalent" to a legally marketed predicate device. This means it is as safe and effective as another legally marketed device. The acceptance criteria in this context are related to demonstrating this substantial equivalence, rather than a quantifiable performance metric for a specific medical condition.

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

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

For a 510(k) submission for a surgical mesh, the "acceptance criteria" are implicitly defined by the requirements for demonstrating substantial equivalence to predicate devices regarding material composition, biocompatibility, and biomechanical properties. The "reported device performance" refers to the results of tests demonstrating these aspects.

• ISO 10993 testing of the PLLA fiber.
• Cytotoxicity Study Using the ISO Elution Method (demonstrated not cytotoxic).
• Risk Analysis for MTF Fascia.
• Subchronic toxicity tests (animal studies).
• Established history of using the material components. |
  | Biomechanical and Histologic Outcomes Equivalence | Demonstrated through:
• Clinical (cadaver) studies.
• Preclinical in vivo models.
• Data presented in peer-reviewed journals and submitted within the 510(k) supported substantial equivalencies between MTF Fascia and Synthasome X-Repair in these outcomes.
• Not intended to provide full mechanical strength, but for reinforcement; sutures provide biomechanical strength. |
  | Sterility | Aseptically processed. Passes USP Sterility Tests. Satisfies FDA requirements for LAL endotoxin limit. |
  | Intended Use Equivalence | Intended for reinforcement of soft tissues during tendon repair surgery (rotator cuff, patellar, Achilles, biceps, quadriceps, etc.). Stated to be substantially equivalent to OrthADAPT PR in indication for use. |

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 mentions "clinical (cadaver)" and "preclinical in vivo models" for biomechanical and histologic outcomes, and "animal studies" for subchronic toxicity. However, specific sample sizes for these tests are not provided in the summary.

• Test Sets: Cadaver studies, preclinical in vivo models (animals), and in-vitro tests (ISO 10993, Cytotoxicity).
• Data Provenance: Not explicitly stated, but typically these types of studies are conducted in laboratories or research institutions, potentially in the USA or internationally. The document does not specify if data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information (expert involvement in establishing ground truth) is usually found in clinical trials or diagnostic accuracy studies. For a 510(k) for a surgical mesh, "ground truth" is typically established through:

• Standardized testing procedures: e.g., ISO, USP standards.
• Histopathology analysis: Performed by qualified pathologists, but the number and qualifications are not specified here.
• Biomechanical testing protocols: Carried out by engineers or researchers in controlled environments.

This 510(k) summary does not mention a number of experts or their specific qualifications for establishing ground truth for any test sets.

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

Adjudication methods are typically associated with resolving discrepancies in expert interpretations, common in diagnostic imaging studies. For a surgical mesh, the "adjudication" (if any) would be embedded within the scientific rigor of the laboratory testing and pathology review processes. The document does not describe any specific adjudication method for the test sets.

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 or any study involving human readers/AI assistance was not done for this device. This type of study is relevant for diagnostic devices that interface with human interpretation (e.g., radiology AI). The MTF Fascia is a surgical implant.

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

This question is not applicable to a surgical implant device like MTF Fascia. "Standalone" performance with an algorithm relates to AI/software as a medical device (SaMD).

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

The types of "ground truth" used for demonstrating substantial equivalence for MTF Fascia primarily include:

• Standardized material properties: Measured against established industry standards (e.g., ISO for PLLA fiber).
• Biocompatibility test results: Based on standardized cytotoxicity assays and animal studies.
• Histologic outcomes: Likely assessed by comparing tissue responses in animal or cadaver models to known characteristics, implying pathology review (though not explicitly detailed regarding how it established ground truth).
• Biomechanical test results: Measured tensile strength, suture retention, etc., in cadaveric or in-vitro models.
• Compliance with FDA regulations: (e.g., USP sterility tests, LAL endotoxin limits).

8. The sample size for the training set

This concept (training set) is primarily relevant for machine learning/AI models. As MTF Fascia is a physical surgical implant and not an AI-driven diagnostic or therapeutic system, there is no "training set" in this context.

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

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

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The MTF New Bone Void Filler is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. The MTF New Bone Void Filler is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. It can be used in the pelvis and extremities. The MTF New Bone Void Filler can be used as an extender in the pelvis and extremities with autograft or allograft. The MTF New Bone Void Filler can be used with bone marrow aspirate, blood or saline.

The MTF New Bone Void Filler is for single patient use only.

The MTF New Bone Void Filler is processed human bone that has been demineralized and combined with gelatin and sodium hyaluronate, which are naturally derived materials that are biocompatible and biodegradable. The sodium hyaluronate used in the manufacturing of the MTF New Bone Void Filler is not of animal origin. The MTF New Bone Void Filler comes in the form of a mixture of demineralized bone with gelatin and sodium hyaluronate, and a spatula that is necessary to mix the components. A hydrating agent can be used with the MTF New Bone Void Filler. Upon addition of a hydrating agent, the MTF New Bone Void Filler will achieve a flowable consistency. The resultant putty can then be manipulated by a surgeon into various shapes for ease and flexibility of use during surgical application.

The provided text describes the MTF New Bone Void Filler and its substantial equivalence to predicate devices, focusing on safety and effectiveness information rather than specific acceptance criteria from a clinical study for device performance. It emphasizes the osteoinductive potential demonstrated in an athymic mouse model, but explicitly states that the correlation with clinical performance in human subjects is unknown.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics cannot be found in the provided document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not specified for any study mentioned.
• Data Provenance: The primary "study" mentioned for establishing osteoinductive potential is an "athymic mouse model." This indicates an animal study. No human data (retrospective or prospective) is described for device performance.

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

• Number of Experts: Not applicable. The "ground truth" for osteoinductive potential was based on observations in the athymic mouse model and for sterility on standard USP testing. The concept of expert consensus for ground truth as typically understood in diagnostic studies is not relevant here.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. The evaluations mentioned (e.g., osteoinductive potential in mice, sterility testing) are objective tests, not subjective interpretations requiring 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:

• MRMC Study: No. This device is a bone void filler, not an AI-powered diagnostic tool. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers and AI assistance is not relevant or described.

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

• Standalone Performance: No. This is a medical device (bone void filler), not an algorithm. The concept of standalone algorithm performance does not apply.

7. The type of ground truth used:

• Ground Truth for Osteoinductive Potential: Positive result in an athymic mouse model (animal study observation).
• Ground Truth for Sterility: Passing USP Sterility Tests (laboratory test result).
• Ground Truth for Viral Clearance: Demonstrated inactivation of model viruses (laboratory test result).
• Ground Truth for Substantial Equivalence: Comparison to predicate devices based on an "animal study" (details not provided) and material composition/intended use.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. The document describes a medical device, not a machine learning model that requires a training set. The "testing" referred to is for lot release and safety/equivalence rather than machine learning model development.

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

• Ground Truth for Training Set: Not applicable, as there is no training set mentioned for a machine learning model.

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The MTF New Bone Void Filler is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. The MTF New Bone Void Filler is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. It is for use in the posterolateral spine only, for posterolateral spine fusions. The MTF New Bone Void Filler must be used in the spine with bone marrow aspirate.

The MTF New Bone Void Filler is for single patient use only.

The MTF New Bone Void Filler is processed human bone that has been demineralized and combined with gelatin and sodium hyaluronate, which are naturally derived materials that are biocompatible and biodegradable. The sodium hyaluronate used in the manufacturing of the MTF New Bone Void Filler is not of animal origin. The MTF New Bone Void Filler comes in the form of a mixture of demineralized bone with gelatin and sodium hyaluronate, and a spatula that is necessary to mix the components. A hydrating agent can be used with the MTF New Bone Void Filler. Upon addition of a hydrating agent, the MTF New Bone Void Filler will achieve a flowable or moldable consistency. The resultant putty can then be manipulated by a surgeon into various shapes for ease and flexibility of use during surgical application.

The provided text does not contain detailed acceptance criteria, device performance data in a quantitative format, or descriptions of a study that would specifically prove the device meets such criteria in the manner typical of AI/medical imaging device submissions. The submission is for a "Bone Void Filler" and focuses on demonstrating substantial equivalence to predicate devices through material properties and in vitro or animal model testing, rather than human clinical trials with strict performance metrics.

Specifically, there is no mention of:

• A table of acceptance criteria with reported device performance for metrics like sensitivity, specificity, AUC, etc.
• Sample sizes for test sets (as there isn't a human clinical test set described in the context of device performance metrics).
• Data provenance for a test set.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Sample size or ground truth establishment for a training set (as this is not an AI/machine learning device).

However, I can extract the information that is present and frame it in a way that aligns with the spirit of your request, interpreting "acceptance criteria" as implicitly tied to the demonstration of substantial equivalence and safety/effectiveness for this type of device.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Given that K110003 is a 510(k) premarket notification for a Bone Void Filler, the primary "acceptance criterion" is demonstrating substantial equivalence to legally marketed predicate devices, along with evidence of safety and effectiveness. This is achieved by comparing the new device's technological characteristics, intended use, and performance to those of the predicate.

The key study mentioned is an animal model study, and lot release testing, to support the substantial equivalence claim.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Description: The primary "test set" in the context of demonstrating equivalence for this non-AI bone graft device is an in vivo animal study combined with in vitro testing.
• Sample Size: The specific sample size for the "Rabbit Model of Posterolateral Lumbar Fusion" study is not provided in the given text.
• Data Provenance: The study was conducted in a rabbit model, implying an animal study rather than human data. The geographical origin of the study is not specified, but it's presented by a US-based foundation (Musculoskeletal Transplant Foundation). It is inherently a prospective study if referring to the animal experimentation conducted to compare the new device to predicates.

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

• Number of Experts & Qualifications: This section is not applicable as the ground truth for an animal model study (e.g., fusion success, bone formation) would typically be established by veterinary pathologists, histologists, and/or radiologists specializing in animal models, not human medical experts in the context of clinical interpretation. The text does not provide these details.

4. Adjudication Method for the Test Set

• Adjudication Method: This is not applicable as the data presented is not based on expert interpretation of images or clinical outcomes in human subjects requiring an adjudication panel. Outcomes in an animal fusion model would typically be assessed objectively (e.g., imaging, histology, biomechanical testing).

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret patient cases with and without AI assistance to measure reader performance improvement. This device is a bone void filler, not a diagnostic imaging AI.

6. Standalone Performance Study (Algorithm Only)

• Standalone Study: No, a standalone performance study (algorithm only) was not done. This is also relevant for AI/machine learning algorithms. The device is a physical bone void filler.

7. Type of Ground Truth Used

• Ground Truth Type:
  • For Osteoinductive Potential: The ground truth is established by positive results in an athymic mouse model (likely histological evidence of ectopic bone formation).
  • For the Rabbit Model of Posterolateral Lumbar Fusion: The ground truth for fusion outcomes would typically be based on a combination of radiographic evidence, CT imaging, and potentially histopathological analysis of explanted spines after a defined healing period. The specific details are not provided in the summary.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

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

• Ground Truth for Training Set Establishment: Not applicable. As there is no AI/machine learning component, there is no training set or ground truth establishment for such a set.

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

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

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

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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

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

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

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

Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

4. Adjudication Method for the Test Set:

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

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

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

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

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

7. The Type of Ground Truth Used:

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

8. The Sample Size for the Training Set:

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

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

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

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

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

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

DBX® Demineralized Bone Matrix is available in three forms: Paste, Putty and Mix. DBX® products are completely resorbable. DBX® Paste and Putty are composed of donor cortical bone; the DBX® Mix is composed of donor corticocancellous bone. The bone granules are mixed with sodium hyaluronate (Hy) in varying combinations to form the DBX® Putty, Paste, and Mix.

This 510(k) summary describes a change in the osteoinductivity assay for the DBX® Demineralized Bone Matrix Putty, Paste, and Mix. The device itself is a bone void filler containing human demineralized bone matrix (DBM). The primary focus of the provided document is on the validation of the new osteoinductivity assay as a surrogate for the previously accepted in vivo athymic mouse model, not a study of the overall clinical performance of the device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly provide a "test set" sample size in the traditional sense of a clinical study for device performance. Instead, it discusses the validation of an assay.

• Athymic Mouse Model (In Vivo): Used for original and ongoing validation.

  • Sample Size: Not specified (e.g., number of mice, number of lots tested).
  • Data Provenance: Not specified, but likely laboratory-based.
  • Retrospective/Prospective: Not specified for individual tests, but implies ongoing lot testing.

• BMP-2 ELISA (In Vitro): This is the new assay being validated against the athymic mouse model.

  • Sample Size: "Every final lot of DBX® Putty is tested" or "each lot of DBM incorporated into DBX® Putty is assayed." The number of lots used specifically for the correlation study between the ELISA and the athymic mouse model is not specified.
  • Data Provenance: Laboratory testing.
  • Retrospective/Prospective: The correlation study would have been prospective to establish the link between the new and old methods. Subsequent lot testing would be prospective for quality control.

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

This information is not provided. The "ground truth" here is the osteoinductive potential, as measured by either the athymic mouse model or the BMP-2 ELISA. These are laboratory assays, not interpretations by experts in a clinical context.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of clinical outcomes or image interpretations. The "adjudication" in this context is the comparison between the results of the in vitro ELISA and the in vivo athymic mouse model. The document states that "Results from this immunoassay were correlated to the athymic mouse model." The specific statistical method or criteria for this correlation are not detailed beyond the statement of correlation.

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

No, an MRMC study was not done. This device is a bone graft substitute, and the submission concerns a change in a laboratory assay for osteoinductivity, not a diagnostic imaging or clinical assessment device that would typically involve an MRMC study.

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

Yes, in a way. The "standalone" performance here refers to the new BMP-2 ELISA assay. The study establishes its correlation with the athymic mouse model, suggesting it can function as a standalone test for osteoinductivity in lot release.

7. The Type of Ground Truth Used

The ground truth for determining osteoinductive potential is:

• Biological Assay: The in vivo athymic mouse model. This model has a history of use for assessing osteoinductivity.
• Biochemical Assay: The BMP-2 ELISA, which is being proposed as a surrogate for the biological assay. The "ground truth" for the validation of the ELISA is therefore the athymic mouse model's results.

8. The Sample Size for the Training Set

The document does not explicitly refer to a "training set" in the context of machine learning or algorithm development. The "correlation" between the BMP-2 ELISA and the athymic mouse model implicitly involves a dataset of DBM lots for which both tests were performed. The size of this dataset (i.e., the number of lots used to establish the correlation) is not specified.

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

The "ground truth" for the training/correlation set (the lots used to compare the two assays) was established by:

• Athymic Mouse Model: Historically, this in vivo model was used to determine the osteoinductive potential of DBM. "Standard testing performed in an athymic mouse model... must prove positive for lot release."
• The BMP-2 ELISA results were then compared to these established athymic mouse model results to show correlation. The document implies that the positive/negative outcome of the athymic mouse model served as the gold standard for validating the ELISA's accuracy in predicting osteoinductivity.

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