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Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 mm) Tattoo Removal: Dark ink (blue and black) (1064 nm) Tattoo Removal: light ink (red, sky blue, green) (532 nm) telangiectasias (532 nm) spider nevi (532 nm) solar lentiginos, senile lentiginos, becker's nevi, freckles (532 nm) nevus of ota (1064 nm)

The ACTIVO is based on the Nd:YAG(1064nm) and KTP Nd: YAG(532nm) laser technology. It is indicated for the incision, ablation, vaporization of soft tissues for general dermatology. Three basic elements of operations are as follows: 1) A Nd:YAG crystal is used as a gain medium which produces a laser beam. 2) A resonator then amplifies the beam. 3) A lamp that contains Xe gas is used, as a pumping light source. The lamp requires a high-pressure power source device for operation. When the electric energy generated from the high-pressure power source is induced into the electrode of the lamp, it converts into light energy(1064nm). This converted light energy pumps the Nd: YAG crystal - a gain medium - and the light exhausted from the crystal is amplified into a specific wavelength light(532nm). As it passes between the resonant gases, laser beam radiates to an output unit. The regulation of laser output and repetition rate can be set by the user via GUI (Graphic User Interface) and controlled by microprocessor, which interfaces with the power supply.

This FDA 510(k) summary is for the ACTIVO laser surgical instrument. It relies on non-clinical testing for substantial equivalence, as no clinical testing was performed or required. Therefore, the device does not have acceptance criteria defined by an effectiveness study that proves its performance against clinical endpoints. Instead, its acceptance criteria are based on meeting design specifications and demonstrating substantial equivalence to a predicate device through non-clinical performance and safety standards.

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

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

Since this filing is based on substantial equivalence through non-clinical testing, the "acceptance criteria" are the standards and design specifications met by the device, and the "reported device performance" is that it successfully met these standards.

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

• Sample Size for Test Set: Not applicable. No clinical test set involving human or animal subjects was used as the submission relies solely on non-clinical testing and comparison to a predicate device.
• Data Provenance: Not applicable for clinical data. For non-clinical testing, the tests were conducted at facilities presumably in the country of manufacture or a certified testing laboratory, but this specific detail is not provided. The device manufacturer is DAEJU MEDITECH ENGINEERING CO., LTD. in Seoul, Republic of Korea.

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. There was no clinical test set requiring expert ground truth establishment. The document refers to compliance with international standards and internal verification for non-clinical aspects.

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

• Not applicable. No clinical test set requiring adjudication was used.

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. No MRMC study was conducted. This device is a laser surgical instrument, not an AI-assisted diagnostic or treatment planning system that would involve human readers.

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

• Not applicable. This is a physical medical device (laser surgical instrument), not a standalone algorithm.

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

• Not applicable for clinical ground truth. For non-clinical testing, the "ground truth" equivalent would be the established specifications and parameter tolerances of the device, and the established limits and requirements of the referenced international standards (e.g., IEC 60601-1, ISO 10993).

8. The sample size for the training set

• Not applicable. This device is a physical laser instrument, not an AI/ML-based device that requires a training set.

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

• Not applicable. No training set was used.

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The Activ Ortho Continuous Compression Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of small bones and small bone fragments.

The ActivOrtho Continuous Compression Screw System is a cannulated Nitinol bone screw having various sizes to accommodate a variety of applications. The screws are headed, cannulated, and partially threaded. The continuous compression screw incorporates a helical expansion section in the smooth shaft of the screw which elongates as the distal thread engages bone to produce a continuous compression force across the fracture site.

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The provided text is an FDA 510(k) clearance letter for the ActivOrtho Continuous Compression Screw System, which establishes substantial equivalence to previously marketed devices. This type of submission relies on comparisons to existing devices rather than new clinical outcome studies with predefined acceptance criteria.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment based on the provided text.

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The ActivOrtho Nitinol Compression Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of small bones and small bone fragments.

The ActivOrtho Nitinol Compression Screw System includes cannulated, partially threaded bone screws having a 4mm diameter in a variety of lengths to accommodate various applications.

This is a 510(k) premarket notification for a medical device, not a study evaluating device performance against acceptance criteria using AI or human readers. Therefore, much of the requested information regarding acceptance criteria, study design, expert ground truth, and AI-related metrics is not applicable to this document.

However, I can extract the relevant information available:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the format of a table with numerical targets. Instead, it describes performance testing conducted to demonstrate substantial equivalence to predicate devices. The "reported device performance" is described qualitatively as meeting the standards.

The "Acceptance Criteria" here are inferred from the description of the performance data section, which lists the types of testing performed and the ASTM standards followed. The "Reported Device Performance" summarizes the findings as described in the document, without providing specific numerical results, but asserting that the tests demonstrate equivalency.

Study-Specific Information:

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

   • The document states "Torsional properties, driving torque and axial pullout strength testing was performed on a worst case device according to ASTM F543." This implies a very small sample size, potentially N=1, for each mechanical test, focusing on the most challenging configuration. The exact number of devices tested is not specified beyond "a worst case device."
   • Data Provenance: Not specified, but generally, such bench testing would be conducted in a laboratory environment, likely within the manufacturer's or a contracted testing facility. No information on country of origin of data or whether it was retrospective or prospective in a clinical sense.

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

   • This information is not applicable to this type of regulatory submission. The "ground truth" for mechanical testing is established by the specified ASTM test methods and a pass/fail criterion based on pre-defined engineering specifications or comparison to predicate device performance. It does not involve human expert interpretation of device performance in a clinical context.

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

   • This is not applicable. Mechanical and corrosion testing adheres to predefined standard protocols (ASTM F543, ASTM F2129). The results are quantitative measurements, not subjective interpretations requiring adjudication.

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:

   • This is not applicable. This document describes the substantial equivalence of a physical medical implant (Nitinol Compression Screw System) through bench testing. It does not involve AI, image analysis, or human readers.

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

   • This is not applicable. This device is a physical implant, not an algorithm.

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

   • The "ground truth" for this submission is based on engineering specifications and established ASTM standards for mechanical and material properties. The device's performance is compared against these standards and the known performance of predicate devices to establish substantial equivalence. It is not based on expert clinical consensus, pathology, or outcomes data, as this is a 510(k) for an implantable device, not a diagnostic or prognostic tool.

7. The sample size for the training set:

   • This is not applicable. This device submission does not involve machine learning or a "training set."

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

   • This is not applicable. This device submission does not involve machine learning or a "training set."

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OTC: For minor wounds, ulcerations and burns, abraded skin, and irritated areas.

Professional: Intended in the management of:

• diabetic foot ulcers;
• leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology);
• pressure ulcers/sores (partial and full thickness);
• 1st and 2nd degree partial thickness burns;
• grafted and donor sites and traumatic and surgical wounds.

Activon Tulle is a sterile wound care dressing for use in moist wound management. Activon Tulle is offered as 2x2 inch and 4x4 inch non-adherent knitted viscose primary dressing impregnated with 100% Manuka honey for effective wound treatment.

The provided text does not contain information about acceptance criteria or a study proving that the device (Activon Tulle) meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

Instead, the document is a 510(k) summary for a medical device (Activon Tulle) and its FDA clearance letter. It focuses on demonstrating substantial equivalence to an existing predicate device (Medihoney Dressings With Active Manuka Honey) for its intended use, rather than presenting a performance study against predefined acceptance criteria for the device's efficacy.

Here's a breakdown of what the document does include, and why it doesn't fit the requested format:

• Device Description and Intended Use: Clearly defines what Activon Tulle is and what types of wounds it is intended to manage.
• Technological Characteristics and Substantial Equivalence: Compares Activon Tulle's characteristics to its predicate device, highlighting similarities and minor differences (e.g., 100% Manuka honey in Activon Tulle vs. Manuka honey with calcium alginate in the predicate). This is the core of a 510(k) submission.
• Assessment of Performance Data and Safety: Mentions "Biocompatibility testing (cytotoxicity, sensitization and irritation) performed with Activon Tulle demonstrates that the dressing is safe for its intended use." This is about safety, not performance against clinical efficacy metrics.
• FDA Clearance Letter: Confirms that the FDA has reviewed the 510(k) submission and determined the device to be substantially equivalent to previously cleared devices.

Therefore, I cannot provide the requested table and study information because it is not present in the provided text. The document describes a regulatory submission pathway (510(k)) that focuses on substantial equivalence for market clearance, which typically does not require extensive clinical efficacy studies with predefined acceptance criteria as would be expected for novel or high-risk devices.

To summarize, for each of your requested points:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on substantial equivalence rather than performance metrics.
2. Sample sized used for the test set and the data provenance: Not provided. No clinical performance study data is included. Biocompatibility testing is mentioned, but no details on sample size or data provenance are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. No clinical performance study requiring expert ground truth is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not 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/Not provided. This device is a wound dressing, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/Not provided.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable/Not provided.
8. The sample size for the training set: Not applicable/Not provided.
9. How the ground truth for the training set was established: Not applicable/Not provided.

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