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For the management of hypertrophic and keloid scars

The NewGel Plus introduced by NewMedical Technology, Inc., is a device which substantially equivalent to other marketed silicone gel sheets. Indications for use are substantially the same, that is, topical treatment of scars. The advantages over other marketed devices from other vendors include the size of the strips in the package to enhance ease of use. In summary, the features incorporated into the NewMedical NewGel Plus have specific advantages over other substantially equivalent products to enhance ease of placement/ application along with the care and comfort of the patient. Neither one of the above features will raise any safety concern because they don't change any of the basic design concepts compared to other similar approved devices.

The provided text describes a 510(k) summary for the NewGel Plus device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria.

Therefore, many of the requested categories for a study proving device performance against acceptance criteria cannot be extracted from this document, as such a study was not conducted or reported in this format.

Here's an breakdown of what can be determined:

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

No explicit acceptance criteria or performance metrics are reported in this 510(k) summary. The document solely focuses on establishing substantial equivalence based on:

• Intended Use: Topical treatment of scars (hypertrophic and/or keloid). (Met by claiming similarity to predicate)
• Materials: Medical grade silicone gel and natural alpha-tocopherol (Vitamin E). (Met by claiming similarity to predicate and listing materials)
• Design: Adhesive methods of scar management, similar reinforcement materials, similar non-stick backings, similar transparent trays. (Met by claiming similarity to predicate)
• Operational Principles: Similar site preparation, method of application, ease of use and replacement, precautions, indications, and components. (Met by claiming similarity to predicate)

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

Not applicable. No formal "test set" or clinical study with data provenance is described as the basis for this 510(k) submission.

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)

Not applicable. No ground truth establishment by experts for a test set is mentioned.

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

Not applicable. No adjudication method is mentioned.

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 not an AI-assisted diagnostic tool, and no MRMC study was conducted.

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

Not applicable. This device is a physical product (silicone gel sheet), not an algorithm.

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

Not applicable. The basis of this submission is substantial equivalence to legally marketed predicate devices, not direct performance against a "ground truth" derived from patient outcomes or pathology for this specific device. The implicit "ground truth" is that the predicate devices are considered safe and effective for their intended use.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of device and submission.

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

Not applicable.

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indicated for use for pediatric as well adult Metacarpal-Phalangeal fractures. For external fixation of hand fractures or for distraction of osteotomies for the purpose of distraction osteogenesis as fractures.

The micro distractor/external fixator introduced by NewMedical Technology, Inc., is a device which is substantially equivalent to other marketed external fixators /distractors. Its indications for use are substantially the same, that is, external fracture fixation and/or distraction. The NewMedical Micro Distractor/External Fixator described here is completely identical to the NewMedical Micro Bone Distractor/Fixator that has already been approved by the (FDA/Dental Devices Committee) for use in external fixation of mandibular fractures or for mandibular distraction, referring to NewMedical Technology, Inc. product (K030485).

The main advantages over other marketed devices from other vendors include its' smaller profile and lightweight construction. The recessed distraction actuating screw is tamper resistant and hence better for use in pediatric patients. The device can only be actuated with the use of a custom actuator which is provided in the kit with the device. Hence, this tamper resistant design is useful when the device is used as an external bone fixation device for the treatment of fractures. Similarly, the conversion to a static from a dynamic fixator does not reguire any adjustment or addition of parts. The alloy metals used provide for excellent stability.

In summary, the features incorporated into the NewMedical Micro Distractor/External Fixator have specific advantages over other substantially equivalent products to enhance ease of placement along with the care and comfort of the patient requiring external fixation/distraction of the mandible or small bones. Neither one of the above features will raise any safety concern because they don't change any of the basic design concepts compared to other similar approved devices.

The provided text is a 510(k) summary for the NewMedical Micro Bone Distractor/Fixator. It focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a clinical or performance study with acceptance criteria.

The 510(k) summary does not include information about:

1. A table of acceptance criteria and the reported device performance: This document does not establish specific performance criteria like accuracy, sensitivity, or specificity, as it's not a performance study. Its primary goal is to assert equivalence in intended use, materials, design, and operational principles.
2. Sample size used for the test set and the data provenance: No test set comprising patient data (e.g., images for an AI device) is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of experts establishing ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: No adjudication method is discussed as there's no test set in the sense of a clinical trial or performance study.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth, in the context of a performance study, is not applicable or discussed here.
8. The sample size for the training set: Not applicable as there is no AI algorithm being trained.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide is a claim of substantial equivalence based on mechanical and material properties compared to existing devices.

The key "criteria" for acceptance in this 510(k) process are:

• Intended Use Equivalence: "All of the named devices, and the NewMedical Micro Distractor/Fixator Device, are intended to be used as external fixation/ distraction devices for the stabilization/lengthening of bone and bone fragments." The device is indicated for "pediatric as well adult Metacarpal-Phalangeal fractures. For external fixation of hand fractures or for distraction of osteotomies for the purpose of distraction osteogenesis as fractures."
• Materials Equivalence: "The materials used... are two grades of Stainless steel. The material conforms to ASTM F 138-97." These are stated to be the same materials with a "long history of successful clinical usage" as predicate devices (Hoffman Mini Fixator, Synthes Mini-Lengthener and the Hand Bone Lengthener).
• Design Equivalence: "The basic design features... are substantially equivalent to the predicate devices. The subject device and the named derives accept various diameter pins. The subject device and the named devices operate using the same principle by utilizing screw mechanism that the surgeon adjusts to control the distraction/compression length. The subject device and the predicate devices use clamps attached to the distraction screw for holding the pins or threaded wires."
• Operational Principles Equivalence: "The basic operational principles for the named device and the subject device are similar - mainly in site preparation, pin placement and device operation. The bone distraction/compression is similar also."

The "study" referenced is the 510(k) submission itself, where the manufacturer asserts and documents these equivalences, rather than a clinical trial or performance study against specific, quantitative acceptance criteria. The FDA's role is to review this submission and concur with the claim of substantial equivalence, which they did in this case (indicated by the approval letter).

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For pediatric patients, for external fixation of mandibular fractures or for mandibular distraction.

The micro distractor/external fixator introduced by NewMedical Technology, Inc., is a device which is substantially equivalent to other external fixators /distractors. Its indications for use are substantially the same, that is, external fracture fixation and/or distraction.

There are many unique features that make this distractor an improvement over those currently available. The main advantages over other devices include its' smaller size and lightweight construction. The recessed distraction actuating screw is tamper resistant and hence better for use in pediatric patients. The device can only be actuated with the use of a custom actuator which is provided in the kit with the device. Hence, this tamper resistant design is useful when the device is used as an external bone fixation device for the treatment of fractures. Similarly, the conversion to a static from a dynamic fixator does not require any adjustment or addition of parts. The alloy metals used provide for excellent stability.

In summary, the features incorporated into the NewMedical Micro Distractor/External Fixator have specific advantages over other substantially equivalent products to enhance ease of placement along with the care and comfort of the patient requiring external fixation/distraction of the mandible or small bones.

The provided document is a 510(k) summary for the NewMedical Micro Bone Distractor/Fixator. It describes the device, its intended use, materials, design, and operational principles, and states its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria, device performance results, sample sizes for test or training sets, ground truth establishment, or clinical study design elements (like MRMC studies or expert qualifications).

Therefore, I cannot fulfill the request for information on acceptance criteria and the study that proves the device meets them based solely on the provided text.

The rejection letter from the FDA (pages 2-4) also reiterates the substantial equivalence determination but does not provide performance data.

The document focuses on demonstrating substantial equivalence to existing devices rather than presenting detailed performance data against specific acceptance criteria.

To provide the requested information, a different type of document, such as a full clinical study report or a detailed performance validation report, would be necessary.

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