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1064nm mode is indicated for the removal or lightening of unwanted facial or body hair, for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery, benign pigmented lesions (dermal melanocytosis) and tattoo removal for dark and blue inks.

The 1064nm fractional mode is indicated for the treatment of wrinkles in Fitzpatrick Skin Types I-IV.

532 nm mode is indicated for tattoo removal including red, blue and light blue and green inks, for the treatment of benign vascular lesions including telangiectasias, spider angiomas, cherry angiomas, spider nevi and the treatment of benign pigmented lesions including Cafe-au-lait birthmarks, solar lentigines, Becker's nevi, freckles nevus spilus and nevus of ota. 532nm mode is also indicated for incision, excision, ablation and vaporization of soft tissue in general dermatology.

The Iris Diode is intended for use for vascular lesions, spider veins, spider naevi, teleangiectasis, red superficial veins of the legs and face, pigmented lesions (e.g. cafe-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.

Not Found

I am sorry, but the provided FDA 510(k) clearance letter for the Alma Harmony Laser Device (K243044) does not contain the detailed information required to answer your request regarding acceptance criteria and the study that proves the device meets those criteria.

The letter primarily focuses on:

• Confirming the substantial equivalence determination for the device based on its indications for use.
• Listing relevant regulations and requirements for medical device manufacturers.
• Providing contact information for regulatory inquiries.
• Stating that the submitter will make information on safety and effectiveness available upon request.

Here's what is missing from the provided text that would be necessary to answer your specific questions:

• Acceptance Criteria: The document does not define any specific performance metrics (e.g., sensitivity, specificity, accuracy, precision, power output tolerances, treatment efficacy rates) that the device must meet, nor does it list numerical targets for these metrics. Laser devices typically have performance specifications related to wavelength, energy, pulse duration, spot size, etc., but these are not present as acceptance criteria in this document.
• Study Design and Results: There is no mention of a clinical or technical study conducted to prove the device meets performance criteria. The letter doesn't include:
  • Performance data: No tables of reported device performance.
  • Sample size and data provenance: No details on test sets, training sets, or where data came from.
  • Ground truth establishment: No information on how ground truth was determined (e.g., expert consensus, pathology, outcomes).
  • Expert qualifications or adjudication: No details on experts, their number, or adjudication methods.
  • MRMC or standalone studies: No mention of these types of studies or their outcomes.
  • Effect size of AI assistance: Not applicable as this is a laser device, not an AI diagnostic tool.

In summary, to answer your questions, I would need a different type of document, such as:

• The 510(k) summary document itself: Submissions typically include a summary of the data and methods used to demonstrate substantial equivalence, which might contain some of this information.
• Clinical study reports: Detailed reports of any studies conducted.
• Performance testing protocols and results.

Without this information, I cannot fulfill your request.

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The Alma Harmony is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery).

Clear Skin Pro 1540nm Applicator:
The ClearSkin Pro 1540nm is indicated for : Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.

SupErb 2940nm Applicator:
The 2940 nm Er.Y AG Laser Module handard and scanner accessory tips (with and without contactcooling) is indicated for use in soft tissue (skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.
Dermatology and Plastic Surgery: Skin resurfacing, Treatment of wrinkles, Epidermal nevi, Telangiectasia, Spider veins, Actinic chelitis, Keloids, Verrucae, Skin tags, keratoses, Scar revision (including acne scars), Debulking benign tumors, Debulking cysts, Superficial skin lesions, Diagnostic biopsies, Decubitus ulcers.
General Surgery: Surgical incision, vaporization, ablation, and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation, and/or vessel coagulation may be indicated.
Genitourinary: Treatment of: Lesions of the external genitalia, urethra and anus, penis, scrotum, and urethra (includes condyloma acuminate, giant perineal condyloma, and verrucous carcinoma), vulvar, lesions, polyps, and familiar polyps of the colon.
Gynecology: Treatment of: Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts, and condyloma.
Oral/Maxiofacial: Treatment of: Benign oral tumors, oral and glossal lesions, and gingivectomy.
Otothrynolaringology / Head and Neck (ENT): Treatment of: Ear, nose and throat lesions, polyns, cysts, hyperkeratosis, Excision of carcinogenic tissue and oral leukoplakia.
Ophthalmology : Treatment of: Soft tissue surrounding the eye and orbit.
Podiatry: Treatment of: Warts, plantar verrucae, large mosaic verrucae, Matrixectomy.

Clear Lift Pro Q-Switched Cr: Nd: YAG 1064 / 532 nm Applicator
1064mm mode is indicated for the removal or lightening of unwanted facial or body hair, for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery, benign pigmented lesions (dermal melanocytosis) and tattoo removal for dark and blue inks.
532 nm mode is indicated for tattoo removal including red, blue and green inks, for the treatment of benign vascular lesions including telangiectasias, spider angiomas, spider nevi and the treatment of benign pigmented lesions including Café-au-lait birthmarks, solar lentigines, Becker's nevi, freckles nevus spilus and nevus of ota. 532mm mode is also indicated for incision, ablation and vaporization of soft tissue in general dermatology.

ClearVas Nd:YAG 1064nm
For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stams, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins.
Treatment of wrinkles.
Removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB).
The ClearVas Nd: YAG 1064nm is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

Iris VL / PL Applicator:
Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology.
The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait macules.
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations. Use on all skin types (Fitzpatrick I- VI).

Iris Dye VL / Dye SVL Applicator:
The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus of Ota, and Becker's Nevi. • The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques. • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. • Use on skin types (Fitzpatrick I-V).

Iris SHR Applicator:
The Advanced Fluorescence Technology (AFT) 650-950 nm handpiece (with and without contact-cooling) is indicated for: The treatment of tattoos, the treatment of moderate inflammatory acne vulgaris, the treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait, the treatment of cutaneous lesions including warts, scars and striae, the treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Use on all skin types (Fitzpatrick I-VI), including tanned skin

Iris Acne Applicator:
Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical special and plastic surgery and dermatology.
The Advanced Fluorescence Technology (AFT) 420-950 nm Acne Module Applicator (with and without contact-cooling) is indicated for:
The treatment of moderate inflammatory acne vulgaris.
The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles).
The treatment of cutaneous lesions including warts, scars and striae.
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civate, leg veins and venous malformations.
Use on all skin types (Fitzpatrick I-VI).

Iris NIR Applicator: Intended to emit energy in the infra-red spectrum to provide topical heating for the purpose of elevating the tissue temperature.
For the temporary relief of minor muscle pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Iris Diode Applicator
The Iris diode is intended for use for vascular lesions, spider naevi, teleangiectass, red superficial veins of the legs and face, pigmented lesions (e.g. cafe-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.

The Alma Harmony is a Class II Medical Device that combines multiple technologies into one platform for use in dermatologic, aesthetic procedures and pain management procedures. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics, and the user interface. It has 10 applicators that are attached to the console, which can be selected for use in treatment through the user interface.
In addition, this submission will add the Smart Clinic Software that was previously cleared in the Soprano Titanium (K210371).

This document is a 510(k) Premarket Notification from the FDA, evaluating the substantial equivalence of the Alma Harmony device to previously cleared predicate devices. It describes the device, its intended use, and a comparison of its technological characteristics with the predicate devices. The document references performance testing and animal studies. However, it does not describe acceptance criteria for an AI/ML powered medical device, nor does it detail a study proving such a device meets those criteria.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on demonstrating the substantial equivalence of the Alma Harmony, which is a laser and light-based medical device, to existing laser and light-based devices. There is no mention of AI or machine learning components with specific performance criteria or studies in the context of diagnostic accuracy, human-in-the-loop performance, or standalone algorithm performance.

The section titled "Software verification and validation testing was conducted, and documentation provided as recommended by the FDA's 'Guidance for the Content of Premarket Submissions Contained in Medical Devices." is the only mention of software, and it's a general statement about V&V testing, not specific to AI/ML or its performance metrics. The statement "this submission will add the Smart Clinic Software. This software was previously cleared in the Alma Titanium K230371" confirms that any software component is previously cleared, implying it's not a novel AI/ML component being tested for new performance criteria.

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Harmony is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye as well as in management of patient data, clinical information, reports from ophthalmic diagnostic instruments through either a direct connection with the instruments or through computerized networks.

Harmony is a modification to the existing Harmony cleared in K182376. The differences between the new version and the currently cleared version are modifications to the graphical user interface consisting of PixelSmart Technology, Internationalization support, Analytical thickness grids, Hanging protocols, and Automatic image smoothing while zooming in.

Harmony is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye, as well as for management of patient data, diagnostic data, clinical information, reports from ophthalmic diagnostic instruments through either a direct connection with the instruments or through computerized networks.

Harmony is used together with a number of computerized digital imaging devices, including:

• Optical Coherence Tomography devices .
• Mydriatic retinal cameras .
• Non-mydriatic retinal cameras .
• Biomicroscopes (slit lamps)

In addition, Harmony collects and manages patient demographics, image data, and clinical reports from a range of medical devices, including:

• Scanning Laser Ophthalmoscope images and videos .
• Non Radiometric Ultrasound devices ●
• Video image sources ●
• TWAIN compliant imaging sources ●
• Compliant data sources placed in network accessible folders and directories
• . Images of known format from digital cameras and scanners
• . Printer files of known format form computerized diagnostic devices
• Electronic information complying to accepted DICOM formats
• Other devices connected in proprietary formats ●

There are 5 notable device modifications subject of this submission: PixelSmart Technology, International support, Analytical thickness grids, Hanging protocols, and Automatic image smoothing while zooming in, along with some minor modifications.

PixelSmart is an optional post-processing image enhancement algorithm performing a moving average across OCT B-scans, reducing speckle noise and improving contrast by applying smoothing.

International support adds the possibility to use the Harmony user interface and online user manual in Spanish, in addition to the standard English software.

Analytical thickness grids offer the same functionality as the existing, cleared thickness grids in Topcon's IMAGEnet 6, now also in Harmony. The grids show sectorial average thickness values as derived from OCT segmentation data.

Hanging protocols allows a customizable image display arrangement in the Harmony user interface, resembling the arrangement of physical images on a light box.

Automatic image smoothing while zooming in is an optional display feature that will cause OCT B-scan images on higher zoom levels to look less pixelated.

The provided text describes a 510(k) premarket notification for a device called "Harmony" by Topcon Healthcare Solutions. This submission is for modifications to an existing cleared device (K182376). As such, the focus is on demonstrating that the modifications do not introduce new safety or effectiveness concerns and that the device remains substantially equivalent to its predicate.

Therefore, the document does not contain the kind of detailed clinical study and performance data (e.g., acceptance criteria tables, sample sizes for test/training sets, expert ground truth establishment, MRMC studies) that would typically be required for the initial clearance of a novel AI/ML-driven device with diagnostic claims. Instead, it relies on demonstrating that the "modified Harmony" functions equivalently to the predicate Harmony, primarily through software validation and verification.

Based on the provided text, here's what can and cannot be answered:

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

• Cannot be provided. The document states: "Software validation and verification demonstrate that Harmony performs as intended and meets its specifications, using methods equivalent to the predicate device." However, it does not specify quantitative acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy, F1-score) or report specific performance values for the modified features. This is expected given that the modifications are primarily related to UI, image enhancement (PixelSmart), and display features, not fundamental diagnostic algorithms requiring extensive performance studies against clinical ground truth.

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

• Cannot be provided in detail. The document mentions "software validation and verification activities" and "non-clinical performance testing." These are typically done with internal test cases or simulated data rather than large, independent clinical test sets for a device of this nature (an image management and processing system with UI/display modifications). There is no mention of specific sample sizes of patient images or their provenance.

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/Cannot be provided. Since no formal clinical test set with a "ground truth" adjudicated by multiple experts is described for the modifications in this 510(k) summary, details about expert involvement are not present. The changes (PixelSmart, Internationalization, Analytical thickness grids, Hanging protocols, Automatic image smoothing) relate to image display, processing, and user interface, rather than directly generating a diagnostic output that would require expert-adjudicated ground truth.

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

• Not applicable/Cannot be provided. As no multi-expert ground truth establishment for a test set is described, there's no mention of an adjudication method.

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

• No, an MRMC study was not done. The document describes modifications to an image management and processing system. The "PixelSmart" technology is an optional post-processing image enhancement algorithm (moving average to reduce speckle noise and improve contrast). While this could hypothetically improve reader performance, the submission does not present an MRMC study to quantify such an effect. This type of study is more common for AI algorithms directly assisting in interpretation or detection, which is not the primary claim for these modifications.

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

• Not explicitly described as a formal validation study. The "PixelSmart" feature is an algorithm (moving average). Its performance would be evaluated internally for its intended effect (reducing speckle noise, improving contrast). However, the document does not present a standalone performance study with metrics like sensitivity/specificity for a specific clinical task. The assessment is that it "performs as intended" and "meets its specifications" as an image enhancement tool.

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

• Not applicable/Cannot be provided. The modifications are not addressing a diagnostic claim that would require ground truth from expert consensus, pathology, or outcomes data. The "ground truth" for verifying these changes would relate to software functionality (e.g., does PixelSmart correctly apply a moving average? Does the Spanish UI display correctly?).

8. The sample size for the training set

• Not applicable/Cannot be provided. The "Harmony" system itself is a software platform. While the PixelSmart feature is an algorithm, the document does not describe it as a machine learning model that undergoes a "training" phase with a large dataset. It's described as a "moving average across OCT B-scans," suggesting a rule-based or conventional image processing algorithm rather than a deep learning model. Therefore, there's no mention of a training set size.

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

• Not applicable/Cannot be provided. As there's no description of a training set, the method for establishing its ground truth is not provided.

Summary of what is described regarding the study/validation:

• Type of Study: Software validation and verification, and non-clinical performance testing.
• Purpose: To demonstrate that the modified Harmony functions equivalently to the predicate Harmony and that the modifications do not introduce new safety or effectiveness concerns.
• Assessment: Risk assessment was conducted, and "newly identified risks or modified existing risks are mitigated, and no unacceptable risk was identified."
• Standards Followed: IEC 62304 (Medical Device Software Life Cycle Processes), NEMA PS 3.1-3.20 (DICOM), ISO IEC 10918-1 (JPEG), ISO 14971 (Risk Management).

In essence, this 510(k) relies on demonstrating the equivalence of a modified, already cleared, non-diagnostic software platform through robust engineering and software validation principles, rather than extensive clinical performance studies common for novel AI diagnostic devices.

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Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical special and plastic surgery, and dermatology.
The treatment of benign pigmented epidermal lesions including dyschromia. hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait macules.
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations. Use on all skin types (Fitzpatrick I- VI).
The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus of Ota, and Becker's Nevi. • The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques. • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. • Use on skin types (Fitzpatrick I-V).
The Advanced Fluorescence Technology (AFT) 650-950 nm handpiece (with and without contact-cooling) is indicated for: The treatment of tattoos, the treatment of moderate inflammatory acne vulgaris, the treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait, the treatment of cutaneous lesions including warts, scars and striae, the treatments vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Use on all skin types (Fitzpatrick I-VI), including tanned skin
Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical special and plastic surgery and dermatology The Advanced Fluorescence Technology (AFT) 420-950 nm Acne Module Applicator (with and without contact-cooling) is indicated for:
The treatment of moderate inflammatory acne vulgaris.
The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles).
The treatment of cutaneous lesions including warts, scars and striae.
The treatment of benign cutaneous vascular lesions including port wine stains hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
Use on all skin types (Fitzpatrick I-VI).
Intended to emit energy in the infra-red spectrum to provide topical heating for the purpose of elevating the tissue temperature.
For the temporary relief of minor muscle pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The Iris diode is intended for use for vascular lessons, spider naevi, teleangiectasis, red superficial veins o fthe legs and face, pigmented lesions (e.g. cafe-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.

The Alma Harmony is a Class II Medical Device that combines multiple technologies into one platform for use in dermatologic, aesthetic procedures and pain management procedures. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics and the user interface. It has 6 applicators that are attached to the console, which can be selected for use in treatment through the user interface.
There are 6 separate applicators. Each handpiece has its own indication for use.

• Iris VL / PL is an IPL handpiece operating in the wavelength range of 540nm-950nm ●
• Iris Dye VL and Dye SVL is an IPL handpiece operating in the wavelength range of ● 500nm-600nm
• Iris SHR is an IPL handpiece that operates in the wavelength range of 650nm-950nm
• Iris Acne is an IPL handpiece operating in the wavelength range of 420nm 950nm ●
• Iris NIR is near infrared with a wavelength of 1300nm ●
• Iris Diode is a 520nm diode laser.

The provided text is a 510(k) Premarket Notification from the FDA regarding Alma Lasers, Inc.'s Alma Harmony device. This document focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than proving that the device meets specific performance-based acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving the device meets them, particularly regarding AI-assisted performance, reader studies, or detailed performance metrics. The crucial sentence in Section VIII states: "Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no clinical studies were deemed needed to support this submission."

This means the submission relies on bench testing, software verification/validation, and comparison to predicate devices to demonstrate safety and effectiveness, rather than a clinical trial with acceptance criteria for performance.

Therefore, I cannot populate the requested information regarding acceptance criteria, study data, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/performance study, as this information is not present in the provided document.

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Harmony Referral System (Harmony RS) is a comprehensive software platform intended for use in importing, processing, viewing, measurement and storage of clinical images and videos as well as in management and communication of patient data, diagnostic and clinical information and reports from ophthalmic diagnostic instruments through either direct connection with the instruments or through computerized networks. The system neither performs any interpretations nor provides treatment recommendations.

Harmony Referral System is an internet-browser-based software platform that allows users to access examination data of a patient from different sources. Harmony Referral System may be used together with a number of computerized digital imaging devices and third party software. In addition. Harmony Referral System software collects and manages patient demographics, image data, and clinical reports from a range of approved medical devices. Harmony Referral System enables a real-time review of diagnostic patient information at a PC workstation. The software uses SSL encryption in network communication and secure network infrastructure with firewalls and additionally also VPN and IP-based access restrictions to ensure secure networking environment. The Harmony Referral System does not perform automated image analysis but provides measurements based on pixels of an image, which were marked by the user manually on the screen including cup-disk ratio and line and area measurements.

The provided document, a 510(k) summary for the Topcon Harmony Referral System (Harmony RS), states that no performance data was required or provided for this device. Therefore, it is not possible to describe acceptance criteria or a study proving the device meets those criteria from this document.

The document explicitly states:

Performance Data

"No performance data was required or provided. Software validation and verification demonstrate that Harmony RS performs as intended and meets its' specifications."

And under the "Substantial Equivalence" section:
"The different technological characteristics of the devices do not raise new questions of safety and effectiveness. The differences in hardware requirements and system access are all system features that can be evaluated during software validation and verification and were primarily revised to allow the system to operate with newer hardware, browsers and operating systems."

This indicates that the FDA's clearance was based on demonstrating substantial equivalence to a predicate device (Topcon Harmony, K182376) and on software validation and verification, rather than a clinical performance study with defined acceptance criteria.

While the document details the device's intended use and technical specifications, it does not contain the information requested in the prompt regarding acceptance criteria, study design, sample sizes, expert ground truth, or adjudication methods for performance evaluation.

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The Harmony® Latex & the Harmony® Polyisoprene Dams are used as a barrier when engaging in oral/vaginal and oral/ anal sex to help reduce the transmission of bodily fluids, harmful pathogens and sexually transmitted infections.

The Harmony® Latex and Harmony® Polyisoprene Dams are rectangular shaped non-porous, intact polymer film that are placed over the vagina or anus during oral sexual contact. The dam provides coverage to the external female genitalia or to the anal acts as a physical barrier to infectious agents responsible for the transmission of sexually transmitted infections (STIs). Both Harmony® Latex and Harmony® Polyisoprene Dams are 152.4 mm (6") x 254 mm (10") and 0.12 mm thick. The Harmony® Latex Dam contains natural polyisoprene rubber and the Harmon® Polyisoprene Dam contains synthetic polyisoprene rubber. The dams are slightly scented with vanilla fragrance and are provided in natural color.

This document is a 510(k) summary for the Harmony® Latex Dams and Harmony® Polyisoprene Dams. It outlines the acceptance criteria and supporting studies for these devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the international standard ISO 29942:2011 Prophylactic dams -- Requirements and test methods and the 2020 FDA guidance Use of International Standard ISO 10993-1. The specific ranges or thresholds for these criteria are not provided in the document, but it states that "All test results were acceptable."

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

The document does not explicitly state the sample sizes for each test in the acceptance criteria section. The data provenance is also not specified in terms of country of origin or whether it was retrospective/prospective. The testing appears to be prospective bench testing performed on manufactured Harmony® Latex and Harmony® Polyisoprene Dams.

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

This section is not applicable as the device is a physical barrier (dam) and the testing involves non-clinical bench tests (mechanical, barrier, biocompatibility), not interpretation of medical images or patient data that would require expert consensus for ground truth.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as #3. Bench testing results are typically objectively measured against specified standards, not adjudicated by experts.

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

This section is not applicable. An MRMC study is relevant for diagnostic devices that involve human interpretation of results, especially in the context of AI assistance. The Harmony® Dams are physical barrier devices.

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

This section is not applicable. There is no algorithm or AI component in the Harmony® Dams. The performance evaluated is the physical and biological properties of the device itself.

7. Type of Ground Truth Used

The ground truth used for the non-clinical tests is established by international standards and FDA guidance. For example:

• ISO 29942:2011 specifies requirements and test methods for prophylactic dams.
• ISO 10993 series outlines biological evaluation of medical devices.
  The ground truth is therefore defined by the specifications and thresholds outlined in these recognized standards.

8. Sample Size for the Training Set

This section is not applicable. There is no "training set" as this device is not an AI/ML algorithm or a diagnostic tool that learns from data.

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

This section is not applicable for the same reason as #8.

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The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licensed medical practitioner.

It is intended to assist a licensed medical practitioner in the defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation.

-Elekta Synergy and Elekta Harmony are the default entry-level configurations. They are intended to be used for single or multiple fractions using standard dose fractionation, and hypofractionation in all areas of the body where such treatment is indicated.

-Elekta Infinity is the default mid-level configuration. It is intended to be used for single or multiple fractions using standard dose fractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy - SBRT; stereotactic ablative radiotherapy - SABR) in all areas of the body where such treatment is indicated.

-Versa HD is the default high-level configuration. It is intended to be used for single or multiple fractions using standard fractionation, hyperfractionation and stereotactic delivery (stereotactic body radiation therapy - SBRT; stereotactic ablative radiotherapy – SABR; stereotactic radio surgery - SRS) in all areas of the body where such treatment is indicated and for the treatment of functional disorders, such as trigeminal neuralgia.

The EMLA is indicated for the delivery of curative and palliative intent EBRT to Adult and Pediatic with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body.

The Elekta Medical Linear Accelerator (EMLA) system is an image guided Radiation Therapy device to assist a licensed practitioner in the delivery of ionizing radiation to a defined target volume. The system consists of components of the accelerator, such as, beam shaping, with imaging and accessories for patient positioning and set-up to deliver therapeutic treatments. The Elekta Harmony being introduced with this premarket notification submission.

The EMLA offers multiple treatment modalities including photon energies in the range of 4 – 25 MV and electron energies in the range of 4 – 22 MeV. Un-flattened and flattened photon energies are available. A treatment table, located in the treatment room, allows the patient to be accurately positioned to receive the prescribed radiotherapy and supports the patient during treatment. The table is capable of linear and rotational movements. The EMLA is equipped with a MV portal imaging subsystem, i.e. iViewGT, and an optional kV imaging sub-system, i.e. XVI. The user interface controlling devices are located partly in the treatment room and partly in the control room.

This 510(k) summary describes a premarket notification for the Elekta Medical Linear Accelerator (EMLA) system, including the new Elekta Harmony variant. This submission is for a medical device that assists in delivering external beam radiation therapy and is classified as a Class II device. The document does not contain acceptance criteria or a study demonstrating the device meets such criteria for performance. The non-clinical testing performed focuses on design, risk management, and compliance with various standards related to safety, essential performance, and software development.

Therefore, many of the requested details, such as a table of acceptance criteria, reported device performance, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth information are not available in the provided text.

Here's a breakdown of what can be extracted:

• Device Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD (all fall under Elekta Medical Linear Accelerator - EMLA)
• Regulation Number: 21 CFR 892.5050
• Regulation Name: Medical charged-particle radiation therapy system
• Regulatory Class: Class II
• Product Code: IYE

Summary of available information based on your request categories:

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

   • Not provided. The document states "The verification and validation non-clinical test results demonstrate compliance with the applicable consensus standards and that the functional and performance requirements defined by Elekta are met." However, it does not specify what those functional and performance requirements (acceptance criteria) are, nor does it quantify the reported device performance against them.

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

   • Not provided. The document mentions "non-clinical testing" and "formal validation of the clinical workflows has been performed on a clinically representative production equivalent system," but does not give sample sizes, data provenance, or whether the study 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):

   • Not provided. The document mentions "competent and professionally qualified personnel" performed validation but does not specify the number or qualifications of these individuals, nor their role in establishing a "ground truth" for a test set.

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

   • 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 linear accelerator for radiation therapy delivery, not an AI-assisted diagnostic or interpretation tool for human readers. No MRMC study is mentioned.

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

   • Not applicable/Not provided. While the device contains software, the testing described is of the integrated system and its components, focusing on safety, essential performance, and compliance with standards. It's not a standalone algorithm with a specific performance metric of clinical output in the context of diagnostic AI. The device's function is to deliver radiation, not to independently make diagnostic or treatment decisions without human input.

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

   • Not provided. The term "ground truth" in this context is generally for diagnostic or interpretive AI systems. For a linear accelerator, "ground truth" would relate to the accuracy of beam delivery, dose distribution, and patient positioning. The document states validation was done against "functional and performance requirements defined by Elekta" and "applicable consensus standards," which serve as the "ground truth" for engineering and safety performance, but not in the sense of a clinical diagnostic truth.

8. The sample size for the training set:

   • Not applicable/Not provided. This is not a submission for an AI/ML algorithm that is "trained" on a dataset in the typical sense of diagnostic AI. The software development and verification are described as following IEC 62304 for medical device software.

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

   • Not applicable/Not provided. See point 8.

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence through non-clinical testing regarding safety, essential performance, and compliance with regulatory standards for a medical linear accelerator system. It does not contain the detailed performance study information typically requested for diagnostic or interpretive AI/ML devices, such as specific acceptance criteria, quantitative performance metrics, test set characteristics, or ground truth methodologies for clinical outcomes.

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Harmony is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye as well as in management of patient data, diagnostic data, clinical information, reports from ophthalmic diagnostic instruments through either a direct connection with the instruments or through computerized networks.

Harmony is a modification to Synergy ODM cleared in K151952. The differences between the new version and the currently cleared version are modifications to the GUI using a responsive design and a change to the front end platform from Microsoft Silverlight to HTML5.

Harmony is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye, as well as for management of patient data, diagnostic data, clinical information, reports from ophthalmic diagnostic instruments through either a direct connection with the instruments or through computerized networks.

Harmony is used together with a number of computerized digital imaging devices, including:

• Optical Coherence Tomography devices
• Mydriatic retinal cameras
• Non-mydriatic retinal cameras
• Biomicroscopes (slit lamps)

This document (K182376) is a 510(k) premarket notification for a software platform called Harmony. It primarily focuses on demonstrating substantial equivalence to a predicate device (Topcon Corporation Synergy ODM, K151952) rather than presenting new performance study data with acceptance criteria.

The key takeaway is that no performance data was required or provided to prove the device meets acceptance criteria as this submission is for a modification to an already cleared device. The manufacturer states that "Software validation and verification demonstrate that Harmony performs as intended and meets its' specifications." This implies that the acceptance criteria are related to the software's functional specifications, which were validated internally, but no detailed performance study meeting specific clinical or diagnostic metrics is presented here.

Therefore, many of the requested sections regarding a study that proves the device meets acceptance criteria cannot be extracted from this document because such a study was not deemed necessary for this particular submission.

Here's a breakdown of what can be inferred and what cannot:

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

• Acceptance Criteria: Not explicitly stated with specific numerical targets. Based on the "Performance Data" section, the acceptance criteria are implicitly tied to the software's functional specifications and its ability to perform as intended. These would likely include criteria such as:
  • Successful import, processing, measurement, analysis, and storage of clinical images and videos of the eye.
  • Proper management of patient data, clinical information, and reports from ophthalmic diagnostic instruments.
  • Successful connection (direct or network) with ophthalmic diagnostic instruments.
  • Correct execution of viewing operations (zoom, pan, contrast/brightness adjustment, drawing tools).
  • Accurate line and area measurement capabilities.
  • Accurate Cup to Disc ratio and MPS (Macular Photocoagulation Study) measurements.
  • Proper functioning of network and security features (web-based access, DICOM communication).
  • Correct printing, archiving, and backup functionality.
• Reported Device Performance: The document states, "Software validation and verification demonstrate that Harmony performs as intended and meets its' specifications." No specific performance metrics (e.g., accuracy, sensitivity, specificity, resolution, speed) are provided.

Table (based on inference):

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

• Sample Size: Not specified. As no performance study with a test set was required, this information is not provided. The "validation and verification" likely refer to internal software testing rather than a clinical study with a patient data test set.
• Data Provenance: Not specified.

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

• Not applicable/Not specified, as no clinical test set requiring expert ground truth establishment was described.

4. Adjudication method for the test set:

• Not applicable/Not specified, as no clinical test set requiring adjudication was described.

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:

• No MRMC comparative effectiveness study was done or reported. The device is described as a "comprehensive software platform" and "image management system," not an AI diagnostic tool designed to assist human readers in a diagnostic capacity that would typically warrant such a study.

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

• Not applicable/Not specified. The device is a "software platform intended for use in importing, processing, measurement, and storage...as well as in management of patient data, clinical information, reports." This describes an infrastructure and management tool, not an algorithm with standalone diagnostic performance.

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

• Not applicable/Not specified. The "ground truth" in this context would likely be the expected functional behavior and output of the software, verified through software testing, rather than clinical ground truth from patient data.

8. The sample size for the training set:

• Not applicable/Not specified. This device is not described as an AI or machine learning model that would require a training set in the typical sense. It is a software platform for managing images and data.

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

• Not applicable/Not specified, as there is no mention of a training set.

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The Dye VL Handpiece (500-600 nm) is indicated for:

• The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus spillus, nevus of Ota, and Becker's Nevi.
• The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques.
• The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
• Use on skin types (Fitzpatrick I-V).

The Harmony XL™ continues to be comprised of the identical console unit, footswitch, and a variety of handpieces. The main console of the Harmony XL™ continues to consist of the same control panel, system controller, power supply modules, cooling system, switching module, and isolation transformer.

The subject change is to add a version of the 515-950 nm SVL515 Module AFT handpiece ("SVL515") provided in the company's cleared Harmony XL™ (K072564) to the Harmony XL™ system. The modified handpiece has a narrowed wavelength range of 500-600 nm as compared to the SVL515 handpiece that has a wavelength of 515-950 nm. In addition, the modified handpiece is named the "Dye VL handpiece." Further, the identification color of the distal end of the handpiece is being changed from turquoise to light green.

The provided text is a 510(k) summary for the Alma Lasers Harmony XL™ Multi-Application Platform with the Dye VL Handpiece. This document is a regulatory submission to the FDA for demonstrating substantial equivalence to a predicate device, not a detailed scientific study on device performance against specific acceptance criteria. Therefore, the information required to fully answer your request regarding acceptance criteria and a study proving the device meets them is limited and largely not present in the provided text.

Here's an analysis based on the available information:

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

The document does not provide a table with specific acceptance criteria (e.g., in terms of clinical efficacy metrics like lesion reduction percentage, or safety metrics like adverse event rates) and reported device performance against those criteria.

The "Performance Data" section states:

• "Software verification and validation was performed, and demonstrates that the software performs as intended."
• "Electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) was established."
• "Biocompatibility of patient-contacting components was established per ISO 10993."
• "In all instances, the subject device functions as intended and meets all the same acceptance criteria as the predicate devices."

This indicates that the acceptance criteria are based on fulfilling engineering and safety standards, and that device functions as intended. However, the specific quantitative or qualitative criteria are not detailed.

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

The document does not mention any clinical test set, sample size, or data provenance (country of origin, retrospective/prospective). The performance data cited refers to engineering verifications and validations (software, electrical safety, EMC, biocompatibility), which typically do not involve human subjects or clinical data in the same way as a clinical trial.

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 applicable and not available in the document, as no clinical test set requiring expert ground truth establishment is described.

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

This information is not applicable and not available, as no clinical test set requiring adjudication is described.

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

There is no mention of an MRMC comparative effectiveness study, nor is there any AI component described in the device. The device is a laser/light platform, not an imaging analysis or diagnostic AI device. Therefore, this question is not applicable to the provided document.

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 laser/light therapy platform, not an algorithm.

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

For the engineering performance data mentioned, the "ground truth" would be established by the relevant engineering standards (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility) and the functional specifications of the device. There is no mention of clinical ground truth (like pathology or outcomes data) because the document focuses on demonstrating substantial equivalence based on technological characteristics and safety, rather than presenting new clinical efficacy data.

8. The sample size for the training set

The document does not mention any training set. This device is not described as an AI/ML device that would require a "training set" in the context of machine learning.

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

Not applicable, as no training set for an AI/ML component is mentioned.

Summary of what is present:

The document is a 510(k) summary for a medical device (Harmony XL™ Multi-Application Platform with Dye VL Handpiece). It aims to demonstrate substantial equivalence to existing predicate devices, not necessarily to prove new clinical efficacy.

• Acceptance Criteria (Implied): The device is stated to meet the "same acceptance criteria as the predicate devices" for software, electrical safety, electromagnetic compatibility, and biocompatibility. These criteria are based on established engineering and safety standards (IEC 60601-1, ISO 10993) and the device's functional specifications. Specific quantitative or qualitative performance targets are not listed.
• Study: The "studies" conducted are non-clinical:
  • Software verification and validation.
  • Electrical safety testing (IEC 60601-1).
  • Electromagnetic compatibility testing (IEC 60601-1-2).
  • Biocompatibility testing (ISO 10993).
• Sample Size/Data Provenance/Experts/Adjudication/MRMC/Standalone Performance/Ground Truth (for clinical data or AI): These details are not provided because the 510(k) submission primarily relies on demonstrating that the modified device's technological characteristics and intended use are substantially equivalent to a cleared predicate, and that it conforms to relevant engineering and safety standards. It does not describe a clinical performance study using patient data and expert review.

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JMS Harmony® A.V.Fistula Needle Set is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment and for the removal of scabs that have developed over the constant site prior to cannulation. The device is intended for single use only and is used on 'developed constant site' access sites. This device is for use on developed 'constant site' access sites

Not Found

This document is a 510(k) premarket notification for a medical device called the JMS Harmony® A.V. Fistula Needle Set. It aims to demonstrate substantial equivalence to legally marketed predicate devices. The document explicitly states that "Performance Specification: Met established acceptance criteria" for the modified device and both predicates.

However, the document does not provide details about the specific acceptance criteria themselves, nor does it describe the study that proves the device meets these criteria. It only makes a general statement that the criteria were met.

Therefore,Based on the provided text, I cannot extract the detailed information requested in your prompt. The document is a regulatory submission for a medical device, and while it states that "Performance Specification: Met established acceptance criteria" for the modified device and its predicates, it does not elaborate on what those acceptance criteria are or describe the specific study (or studies) used to demonstrate that the device meets them.

The information requested, such as sample sizes, data provenance, number and qualifications of experts, adjudication methods, details of comparative effectiveness studies, standalone performance, type of ground truth, and training set information, is not present in this document. This kind of detailed study information is typically found in a separate section of a 510(k) submission, often within a "Performance Testing" or "Bench Testing" report, which is not provided in this extract.

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