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3DMatrix DynaFlex (DynaFlex) is indicated for the reinforcement of soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery. Examples of applications where DynaFlex may be used include:

• Suture line reinforcement including for hernia repair
• Muscle flap reinforcement
• General tissue reconstructions

3DMatrix DynaFlex ("DynaFlex") is a single-use, fully absorbable, colorless, non-woven, 3D-printed, macroporous, polymeric surgical mesh made entirely of uncolored and undyed polydioxanone (PDO). DynaFlex is provided in three sizes, 6 cm x 5.5 cm, 6 cm x 14.5 cm, and 5 cm x 17 cm, that can be cut to the desired shape and size for each specific application at the time of use. DynaFlex is terminally sterilized by Ethylene Oxide validated to an SAL of 10-6 and intended to be used by prescription only in a healthcare facility or hospital.

Once implanted, DynaFlex acts as a mechanical support to soft tissues and provides a scaffold for tissue ingrowth. It is designed to fully degrade over six to seven months. DynaFlex provides temporary mechanical support and stabilization during the healing process. DynaFlex mesh is not isotropic so the mechanical properties of DynaFlex mesh are direction dependent.

The provided FDA 510(k) Clearance Letter for the 3DMatrix DynaFlex (DynaFlex) surgical mesh does not describe a study involving AI-driven diagnostic or assistive technology that would require ground truth adjudication, multi-reader multi-case studies, or specific acceptance criteria for a classification or regression task.

Instead, this document details the substantial equivalence of a medical device (a surgical mesh) to its predicate devices based on non-clinical performance and material characteristics. The "acceptance criteria" and "study proving the device meets acceptance criteria" here refer to the physical and biological properties of the surgical mesh as compared to a previously cleared device, not the performance of a software algorithm.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of device clearance.

Below, I will present the information that is available in the provided text, reinterpreting the "acceptance criteria" and "study" in the context of a physical medical device.

Device Description and Intended Use

• Device Name: 3DMatrix DynaFlex (DynaFlex)
• Device Type: Surgical Mesh
• Intended Use: Reinforcement of soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery. Examples include suture line reinforcement (including for hernia repair), muscle flap reinforcement, and general tissue reconstructions.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" are implicitly met by demonstrating "substantial equivalence" to a predicate device (3DMatrix Surgical Mesh, K232602) and several reference devices, based on various non-clinical tests. The performance is reported in terms of equivalence to or comparison with these predicate/reference devices.

Table 1: Acceptance Criteria (as demonstrated through equivalence) and Reported Device Performance

Study Proving the Device Meets Acceptance Criteria

The study conducted was a non-clinical performance evaluation to demonstrate substantial equivalence to legally marketed predicate and reference devices.

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

   • This inquiry is relevant for studies involving patient data or images (e.g., AI/Dx devices). For a physical medical device like a surgical mesh, "test set" refers to the samples of the device itself undergoing various physical and chemical tests. The document does not specify the exact number of samples used for each test (e.g., number of mesh pieces tested for tensile strength or degradation).
   • Data Provenance: Not applicable in the sense of patient data. The "data" comes from laboratory and biocompatibility testing of the manufactured mesh samples.

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

   • This is not applicable as the "ground truth" for a surgical mesh involves standardized physical, chemical, and biological testing methods (e.g., ASTM standards, ISO 10993). While experts design and interpret these tests, there isn't a "consensus" process like for annotating medical images.

3. Adjudication Method for the Test Set:

   • Not applicable. This is a concept for reconciling disagreements in human annotations for AI/Dx ground truth.

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

   • No. This type of study is for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging.

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

   • No. This is an AI/software performance metric, not relevant for a physical surgical mesh.

6. The Type of Ground Truth Used:

   • The "ground truth" for this device's performance is established through standardized non-clinical laboratory testing (e.g., tensile strength, tear strength, burst strength, degradation rates, biocompatibility) according to recognized international and industry standards (e.g., ASTM D6797-15, ASTM D2261-13, ASTM D5035-11, ISO 10993-1). This includes in vitro and in vivo (animal) biocompatibility studies.

7. The Sample Size for the Training Set:

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

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

   • Not applicable.

Summary of Non-Clinical Tests

The non-clinical tests performed to demonstrate substantial equivalence covered:

• Mechanical Performance:
  • Ball Burst Strength/Force (ASTM D6797-15)
  • Suture Pull-Out Strength (Internal Test Method)
  • Tear Strength (ASTM D2261-13)
  • Tensile Strength (ASTM D5035-11)
• Degradation:
  • Mechanical degradation kinetics
  • Mass degradation kinetics
• Bioabsorption:
  • In vivo bioabsorption
• Biocompatibility:
  • All endpoints required for long-term implant devices with tissue and bone, in accordance with ISO 10993-1, including hemolysis. These studies were conducted in compliance with GLP regulations (21 CFR Part 58) and FDA Guidance for Use of ISO 10993-1.

The conclusion drawn from these non-clinical tests was that the DynaFlex device is substantially equivalent to its predicate and reference devices in terms of intended/indications for use, design, materials, function, biocompatibility, and sterilization, and performs as well as them.

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DynaFlex ® Clear Bracket & Buttons is indicated for alignment of teeth during orthodontic treatment.

DynaFlex ® Clear Brackets & Buttons is a series of clear, lightweight, ceramic brackets, and buttons. DynaFlex ® Clear Brackets & Buttons are used in the alignment of teeth through orthodontic treatment of misalignment and malocclusion in patients by moving teeth progressively to a final, treated state.

DynaFlex ® Clear Brackets & Buttons are designed to move teeth to improve their alignment. Ceramic brackets are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position. Ceramic brackets are intended for use in affixed to a tooth so that pressure can be exerted on the teeth. Bonding supplies are used to bond the bracket on to a tooth. Ceramic brackets are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position.

DynaFlex ® Clear Brackets & Buttons may be adjusted by the dentist. The appliance is provided as a non-sterile device and is single use. DynaFlex® Clear Bracket & Buttons is for prescription only.

The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device performance study. The document is a 510(k) summary for DynaFlex Clear Brackets & Buttons, which are orthodontic physical devices, not an AI/ML software.

The document discusses performance characteristics based on bench testing for bond strength and other non-clinical performance tests for overall design, biocompatibility, and manufacturing process validation. It then establishes substantial equivalence to a predicate device (Carriere SLX 3D Clear) based on similar design, materials, manufacturing methods, intended use, and similar technological characteristics.

Therefore, many of the requested elements pertaining to AI/ML device performance studies (such as sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI) are not applicable or available in this document.

However, I can extract the relevant information regarding the performance characteristics and the non-clinical testing performed to establish substantial equivalence for this specific medical device.

Here's the information derived from the provided text, focusing on the available details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Bond Strength Testing: "all samples tested" (specific number not provided).
• Other Non-Clinical Testing: Not specified.
• Data Provenance: Not specified, but generally, bench test data is generated in-house by the manufacturer.

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

• Not applicable as this is not an AI/ML device performance study requiring expert ground truth for image/data interpretation. Performance is based on physical property measurements and adherence to standards.

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

• Not applicable. Performance is based on direct measurement against defined physical or material standards, not interpretive human judgments.

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 as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

7. The type of ground truth used

• For bond strength: Quantitative measurement of physical breaking point against a specified minimum.
• For other properties (In/Out, Torque, Angulation, Rotation): Quantitative measurement of dimensions and angles against a specified range (derived from the predicate device).
• For biocompatibility: Compliance with ISO 10993 series through laboratory testing.
• For manufacturing process: Adherence to internal technical specifications and standards.

8. The sample size for the training set

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

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DynaFlex® Clear Aligner is a series of clear, lightweight, plastic retainers indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion in patients by moving teeth progressively to a final, treated state.

DynaFlex ® Clear Aligner Appliance is a series of clear, lightweight, plastic retainers indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion in patients by moving teeth progressively to a final, treated state.

The device will be patient-specific and will be sold by prescription. The device is manufactured with medical grade thermo plastic that is standard throughout the industry.

Aligners are fabricated from .030 thermoformed plastic. The mechanism of force application to the teeth is via intentional distortion of the plastic as the aligners are seated in the mouth. Each subsequent aligner in the overall progressive series is made from a mold of the patient's teeth which reflect subtle changes in the teeth from the previous aligner. The positional changes are introduced into each aligner in the laboratory by moving the teeth on the construction model and then forming the aligner on the same model. The overall treatment is prescribed by the dentist to the laboratory where they are fabricated.

Aligners may be adjusted by the dentist. Aligners are completely removable by the patient and treatment may be discontinued at any time. The appliance if provided as a non-sterile device and single use.

The provided text is a 510(k) Summary for the DynaFlex Clear Aligner. It primarily demonstrates substantial equivalence to predicate devices and does not describe AI/ML device performance or a clinical study that proves the device meets specific acceptance criteria in the context of an AI-powered medical device.

The document states:

• "Bench testing of the Aligners has not been performed; however, there is sufficient information available from the scientific literature & other legally FDA cleared device of similar characteristics and material to demonstrate that the preformed aligner provides reasonable assurance of effectiveness." (Page 5)
• "The DynaFlex Clear Aligner passed all the testing in accordance with internal requirements, national standards, and international standards to support substantial equivalence of the subject device." (Page 5)
• "Manufacturing Process Flow validation was performed to ensure that the finished device matches the specification of the doctors' requirements. The output and work model and aligner were tested and compared. DynaFlex Clear Aligners met the specifications of this testing." (Page 5)
• "DynaFlex has completed biocompatibility testing per ISO 10993-1 and its applicable parts, as appropriate for the aligner contact and duration. The mechanical properties of the thermoformed plastic has been previously demonstrated by the manufacturer as appropriate for use with aligners, therefore no additional testing was required to demonstrate substantial equivalence." (Page 5)

This 510(k) summary focuses on demonstrating substantial equivalence based on material, design, manufacturing process, and intended use to existing predicate devices (Clear Image™ Aligner and Clear Correct). It does not involve AI/ML performance, diagnostic accuracy, or a clinical study in the typical sense of evaluating an AI model. Therefore, I cannot provide an answer that includes:

1. A table of acceptance criteria and reported device performance (in the context of AI metrics).
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study or related effect sizes.
6. Standalone performance (algorithm only).
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document is for a physical medical device (orthodontic aligner), not an AI/ML-powered diagnostic or assistive device. The "performance characteristics" detailed relate to material safety, manufacturing quality, and physical properties, not diagnostic or clinical accuracy determined by an AI algorithm.

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DynaFlex ® EZ-Align® Appliance is a series of up to four, clear, lightweight, plastic retainers intended to be used to correct minor (1.5mm or less to inter canine/cusped crowding) anterior tooth misalignment in patients in permanent dentition by moving teeth progressively to a final, treated state. DynaFlex EZ-Align® is for prescription only.

DynaFlex ® EZ-Align® Appliance is a series of up to four, clear, lightweight, plastic retainers intended to be used to correct minor (1.5mm or less to inter canine/cusped crowding) anterior tooth misalignment in patients in permanent dentition by moving teeth progressively to a final, treated state.

The device will be custom made for each patient and will be sold by prescription. The device is manufactured with medical grade thermo plastic that is standard throughout the industry.

Aligners are fabricated from .030 thermoformed polycarbonate plastic. The mechanism of force application to the teeth is via intentional distortion of the plastic as the aligners are seated in the mouth. Each subsequent aligner in the overall progressive series is made from a mold of the patient's teeth which reflect subtle changes in the position of the teeth from the previous aliener. The positional changes are introduced into each aligner in the laboratory by moving the teeth on the construction model and then forming the aligner on the same model. The overall treatment is prescribed by the dentist to the laboratory where they are fabricated.

Aligners may be adjusted by the dentist. Aligners are completely removable by the patient and treatment may be discontinued at any time. The appliance if provided as a non-sterile device and single use.

The DynaFlex® EZ-Align® device is a series of clear, lightweight, plastic retainers designed to correct minor anterior tooth misalignment. The available documentation does not describe a study with explicit acceptance criteria or reported device performance metrics in the way one might expect for an AI/CADe device. Instead, the submission focuses on demonstrating substantial equivalence to already legally marketed devices.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity thresholds) or device performance metrics (e.g., success rates of tooth movement) are stated in the document.

The "Performance Characteristics" section explicitly states: "Bench testing of the Aligners has not been performed due to the difficulty in evaluating this type of dental device in a laboratory setting. However, there is sufficient information available from the scientific literature & other legally FDA cleared device of similar characteristics to demonstrate that the preformed tooth positioner provides reasonable assurance of safety and effectiveness."

Instead of performance metrics against acceptance criteria, the document relies on comparing the device's technological characteristics and intended use to predicate devices. The implicit acceptance criterion is that the device is substantially equivalent to the predicate devices, thereby ensuring comparable safety and effectiveness.

The table below summarizes the comparison of characteristics for substantial equivalence. While not "performance," these are the aspects evaluated for acceptance.

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

No specific test set or clinical study demonstrating device performance is described. The submission relies on scientific literature and the established safety and effectiveness of predicate devices. Therefore, these details are not applicable.

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

Not applicable, as no described test set or ground truth establishment process is provided. The evaluation is based on a comparison of device characteristics rather than a clinical outcome study requiring expert-derived ground truth.

4. Adjudication Method

Not applicable, as no described test set or adjudication process is provided.

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 sequential aligner for physical tooth movement, not an AI/CADe product intended to assist human readers (e.g., radiologists) in diagnostic tasks.

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

Not applicable. This device is a physical orthodontic appliance, not an AI algorithm. Its function inherently involves human intervention (dentist prescription, patient use).

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

Not applicable. The basis for acceptance is "substantial equivalence" to predicate devices, focusing on materials, design, intended use, and mechanism of action, rather than a direct performance evaluation against a defined ground truth for a specific medical outcome. The "ground truth" in this context is the regulatory acceptance of the predicate devices.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device requiring a training set.

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

Not applicable, as this is not an AI/ML device requiring a training set.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" presented is a substantial equivalence comparison to legally marketed predicate devices. The manufacturer, DynaFlex, did not conduct a new clinical trial or bench testing to establish the superior or equivalent performance of the EZ-Align® device in terms of clinical outcomes (e.g., percentage of successful tooth alignment).

Instead, they demonstrated substantial equivalence by detailing how the EZ-Align® device shares the same:

• Intended Use: Correcting minor anterior tooth misalignment in patients with permanent dentition (with specific thresholds for crowding).
• Technological Characteristics: Made from thermoformed polycarbonate plastic, custom-fabricated, non-sterile, single-patient multiple-use, worn at night, and applies force through intentional distortion of the plastic.
• Mechanism of Action: Basic mechanics follow conventional orthodontics, applies simple force for tipping, rotation, extrusion, and intrusion (with limited extrusive force).
• Materials: Thermoformed polycarbonate.
• Patient Population: Patients with permanent dentition.

The submission argues that because these key characteristics are "essentially identical" to those of multiple FDA-cleared predicate devices (Allesee Orthodontic Appliance Inc. - Red, White & Blue (K040874), Specialty Appliance Works, Inc. - Clear Image™ Aligner (K071970), and Clear Correct, Inc. - Clear Correct (K082556)), the EZ-Align® device can be presumed to be as safe and effective as those existing devices. The FDA's 510(k) clearance confirms this finding of substantial equivalence.

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DynaFlex® Anti-Snoring & Sleep Apnea Devices are intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The devices are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist, and is removable by the patient.

The proposed DynaFlex® Anti-Snoring & Sleep Apnea Devices are intraoral devices used for treating snoring and sleep apnea, and will consist of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable lugs, or by the industry standard Herbst mechanism which is a rod and tube type assembly that orientates the jaws in a predetermined relationship. These devices function as a mandibular re-positioner which acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep. The devices will be custom made for each patient and have the ability of the adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The devices will be sold by prescription only.

The LISA Appliance is a one piece, non-adjustable design. The LISA II Appliance is a dynamic, adjustable design. The Dorsal Appliance is a two-piece design with separate upper and lower acrylic portions that when engaged posture the mandible into protrusive position via acrylic fins built in the lower acrylic portion. The adjustable Herbst Appliance is a one piece construction held together by two adjustment mechanisms on the buccal or outer are of the upper and lower appliance.

The provided text describes a 510(k) summary for DynaFlex® Anti-Snoring & Sleep Apnea Devices. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria. Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria is largely not present in the provided text.

The document states: "It has been shown in this 510(k) submission that the differences between the DynaFlex® Anti-Snoring & Sleep Apnea Devices and the predicate devices do not raise any questions regarding their safety and effectiveness. DynaFlex® Anti-Snoring & Sleep Apnea Devices, as designed and manufactured, are therefore determined to be substantially equivalent to the referenced predicate devices."

This implies that the predicate devices have established safety and effectiveness, and the DynaFlex device is considered equivalent based on its similar intended use and technological characteristics (or differences that don't raise new questions). There is no standalone performance study described for the DynaFlex device with specific acceptance criteria.

However, based on the information provided, here's an attempt to answer the questions, noting where information is absent:

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

This information is not present in the provided text. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not on proving performance against specific quantitative acceptance criteria in a dedicated study.

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

This information is not present in the provided text. No specific test set or study data for the DynaFlex device is described.

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 present in the provided text. As no specific test set or study is detailed, there's no mention of experts establishing ground truth.

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

This information is not present in the provided text.

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

This information is not present in the provided text. The device is a physical intraoral device, not an AI software.

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

This information is not present in the provided text. The device is a physical intraoral device, not an algorithm.

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

This information is not present in the provided text.

8. The sample size for the training set

This information is not present in the provided text. As this is not an AI device, the concept of a "training set" in this context is not applicable.

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

This information is not present in the provided text.

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