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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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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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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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The Harmony Lite is intended for use in aesthetic, cosmetic, and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery, and aesthetic applications.

Specific indications for use are listed for the following handpieces:

• 500-600 nm Dye VL Pro Module AFT Hand piece: Treatment of benign cutaneous vascular lesions and use on Fitzpatrick skin types I-V.
• 540-950 nm VP PRO AFT Hand piece: Treatment of benign pigmented epidermal lesions, cutaneous lesions, benign cutaneous vascular lesions, and use on all skin types (Fitzpatrick I-VI).
• 570-950 nm SSR Pro Module AFT Hand piece: Treatment of benign pigmented epidermal lesions, face and body vascular and pigmented lesions, cutaneous lesions, benign cutaneous vascular lesions, and use on all skin types (Fitzpatrick I-VI).
• 590 nm LED Module Handpiece: Provide topical heating to promote increased blood flow for temporary relaxation of muscle and relief of pain, and provide topical heating for the purpose of elevating and/or maintaining tissue temperature.
• 780-950 nm SHR PRO AFT Module Hand piece: Treatment of pseudofolliculitis barbae (PFB), removal of unwanted hair and to effect stable long-term or permanent hair reduction, and use on all skin types (Fitzpatrick I-VI), including tanned skin.
• NIR Large and Small Modules: Temporary relief of minor muscle pain and stiffness, temporary relief of minor joint pain associated with arthritis, temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscle back pain.
• Thermoelectric Cooler (TEC): Cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to reduce pain, discomfort, minimize thermal injury, allow the use of higher light or laser fluences, and reduce potential side effects.

The Alma Lasers Harmony Lite Multi-Application Platform is comprised of the following main components:

• The main console unit that incorporates the touch-screen control panel, power supply modules, cooling system, switching module, service panel and isolating transformer.
• Variety of handpieces, including IPL, LED and NIR modules
• Footswitch.

The provided document is a 510(k) premarket notification from the FDA for a medical device called "Alma Harmony Lite." This type of document is for demonstrating substantial equivalence to a predicate device, not typically for reporting on a new device's acceptance criteria and related studies in the same way one would find for a novel device.

The "study" described here is primarily a comparative study against previously cleared (predicate) devices to establish substantial equivalence. It's not a study proving novel acceptance criteria for the new device itself, but rather demonstrating that the new device meets the performance and safety profiles of the predicate devices.

Therefore, the information you've requested regarding acceptance criteria and a study proving the device meets those criteria is framed within the context of establishing substantial equivalence to predicate devices, rather than an independent validation against pre-defined, standalone acceptance thresholds for a novel device.

Here's the breakdown of the information based on the provided text, interpreted in the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

In a 510(k) submission, "acceptance criteria" are implicitly derived from the technical characteristics and indications for use of the predicate devices. The "reported device performance" is the characteristics of the new device that are being demonstrated to be substantially equivalent.

Note on Acceptance Criteria: For a 510(k), the primary "acceptance criterion" is proving substantial equivalence to a predicate device in terms of indications for use, technological characteristics, and safety/effectiveness. The table above reflects this comparison, rather than an independent performance metric set for a novel device.

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

The document explicitly states:

• "Collateral animal data was presented on a pig study performed at the University of California for the Dye VL Pro handpiece."
• This study compared results from IPL experiments to acquired pulsed dye laser (PDL) data from a previous study.
• It does not specify the sample size (number of pigs or specific test cases) used for this study.
• Data Provenance: The study was performed at the University of California. The nature of the study (comparing IPL results to previous PDL data) suggests it's a prospective animal study for the IPL component, with historical (presumably retrospective) data used for comparison.

For other handpieces/modules: The submission primarily relies on comparing the technical characteristics and indications for use of the new device (Alma Harmony Lite) to those of the predicate devices (K072564 Alma Harmony XL Platform, K140009 The Modified Alma Lasers Soprano XL Family of Multi-Application and Multi-Technology Platforms). This implies that efficacy and safety for these other components are covered by the established profile of the predicate devices, rather than new human or animal test data being presented for every component.

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

The document does not mention human experts establishing ground truth for the animal study or any clinical test set. The animal study compares physiological effects (vascular shutdown) to previously acquired data. For the 510(k), equivalence is established by comparing technical specifications and intended uses, which does not typically involve human expert adjudication of a test set in the same way an AI diagnostic device would.

4. Adjudication Method for the Test Set

Not applicable, as there is no mention of a clinical or expert-adjudicated test set in the conventional sense for the Alma Harmony Lite's submission. The pig study's "ground truth" was likely derived from objective physiological measurements and comparison to historical data.

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. The Alma Harmony Lite is a laser and light-based aesthetic/surgical platform, not an AI-powered diagnostic imaging device that would involve human "readers" or an "AI assistance" component in an MRMC study.

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

Not applicable. This device is not an algorithm, but a physical medical device (laser/light platform).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the animal study on the Dye VL Pro handpiece:
"Ground truth" was established by physiological observations (persistent vascular shutdown) in pigs and comparison to previously acquired pulsed dye laser (PDL) data, which would have its own established ground truth for efficacy. The methodology ("Monte Carlo simulations to investigate the relationship between absorbed energy, wavelength, and penetration depth") indicates a biophysical basis for evaluating the treatment effect.

For the substantial equivalence of the other modules, the "ground truth" is the established safety and efficacy profile of the predicate devices (K072564 and K140009), based on their previously approved indications and technical characteristics.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device (laser/light platform), not an AI algorithm that requires a "training set."

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

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

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The Harmony vLED Surgical Lighting System is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient and to provide video-visual procedural support for the hospital staff during surgical procedures.

The Harmony vLED Surgical Lighting System is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient and to provide video-visual procedural support for the hospital staff during surgical procedures.

The Harmony vLED Surgical Lighting System is designed to replace existing surgical lights, or to be installed as part of major renovations to existing facilities or in new facilities.

The Harmony vLED Surgical Lighting System accessories are as follows:

• STERIS ACT Interface o
• o Camera Module
• Dual or Single Flat Panel Monitors o
• o 24VDC Battery Backup support
• Remote Power Module Unit 0
• Sterile Disposable Handle Covers o

The provided text describes the STERIS® Harmony vLED Surgical Lighting System (K100395) and its performance testing to demonstrate substantial equivalence to a predicate device. However, this document does not contain the specific details required to complete your request for acceptance criteria and a study proving device conformance to those criteria.

The document states: "Performance testing was conducted to verify that the Harmony vLED Surgical Lighting System meets the requirements for Medical Electrical Equipment as defined in CEI/IEC 60601-1 and IEC 60601-2-41." This indicates that the device's performance was evaluated against these safety and performance standards for medical electrical equipment. However, the specific acceptance criteria within these standards for this particular device and the results of that testing demonstrating the device meets those criteria are not provided in the given text.

Therefore, I cannot populate the table of acceptance criteria and reported device performance, nor can I provide answers to the questions regarding sample size, ground truth, expert involvement, or comparative effectiveness studies based on the information given.

To answer your request, I would need access to the actual performance testing report, which would detail the specific tests conducted, the acceptance limits for each test, and the actual measurements obtained from the Harmony vLED Surgical Lighting System.

Based on the provided text, the following information is available (though insufficient for your request):

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

• Cannot be provided as the specific acceptance criteria and detailed performance results are not included in the text. The text only states that the device meets the "general requirements for safety as defined in CEI/IEC 60601-1 and IEC 60601-2-41 for Medical Electrical Equipment."

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

• Not provided. The document does not specify the number of devices or components tested. Data provenance is also not mentioned beyond the manufacturer being STERIS Corporation.

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

• Not applicable / Not provided. For a surgical light, "ground truth" and expert adjudication are typically not involved in performance testing for electrical and safety standards like CEI/IEC 60601-1 and IEC 60601-2-41. These standards involve objective measurements (e.g., light intensity, electrical leakage, temperature, etc.) against pre-defined limits.

4. Adjudication method for the test set:

• Not applicable / Not provided. See point 3.

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 surgical light, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI assistance are not relevant.

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

• Not applicable. This device is a surgical light; there is no algorithm for standalone performance to evaluate in this context.

7. The type of ground truth used:

• Not applicable. Performance testing for a surgical light against IEC standards relies on objective measurements against engineering specifications, not "ground truth" in the diagnostic sense (e.g., pathology, expert consensus).

8. The sample size for the training set:

• Not applicable. There is no "training set" for a surgical light being tested against electrical and safety standards.

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

• Not applicable. See point 8.

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The proposed Harmony LED-1 Surgical lighting System subjected in this submission is a variable pattern/ intensity surgical light designed to provide visible illumination of the surgical field and patient and to provide video-visual procedural support for the hospital staff during surgical procedures.

The proposed Harmony LED-1 Surgical Lighting System subjected in this submission is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient and to provide video-visual procedural support for the hospital staff during surgical procedures.

The proposed Harmony LED-1 Surgical Lighting System Lighthead is specifically designed to be the next generation lighthead which can be added to the existing center mounted suspension system supporting the horizontal arms, spring arms and yokes of the predicate device Amsco Harmony Surgical Lighting and Media System cleared for market on December 13, 2001 as K013242 (STERIS Corporation). Like the predicate device the system operates via an electronic controller.

The proposed Harmony LED-1 Surgical Lighting System accessories are as follows:

• . Ambient Light System.
• . IR remote control for camera module.
• DeepSite Fiber Optic Light. .
• Fiber Optic Video Enabled Video. ●
• . STERIS ACT Interface.
• Camera Module.
• . Dual or Single Flat Panel Monitors.
• . CRT.
• . 24VDC Battery Backup support.
• . Secondary Spindle Mount.
• . Low Profile Wall Control Unit.
• . Remote Power Module Unit.
• . Sterile Disposable Handle Covers.

Here's an analysis of the provided text regarding the STERIS Harmony LED-1 Surgical Lighting System, specifically addressing the requested information about acceptance criteria and performance studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document cites performance testing to verify compliance with safety standards, but does not explicitly list specific acceptance criteria or quantitative performance metrics (e.g., lux levels, color temperature, etc.) for the Harmony LED-1 Surgical Lighting System within the given text.

It makes a general statement: "Performance testing was conducted to verify that the proposed Harmony LED-1 Surgical Lighting System meet the requirements for Medical Electrical Equipment as defined in CEI/IEC 60601-1 and IEC 60601-2-41."

Therefore, based on the provided text, the table would look like this:

Important Note: To get actual numerical acceptance criteria (e.g., minimum illumination levels, maximum heat generation, color rendering index), one would need to refer to the specific clauses of the CEI/IEC 60601-1 and IEC 60601-2-41 standards, which are not detailed in this submission. This document focuses on demonstrating conformance to these standards rather than detailing the specific performance results against each criteria.

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

The provided text does not mention any specific sample size for a "test set" in the context of clinical or performance data. The performance testing described refers to verification against technical standards, which typically involves testing the device itself, not a sample of patient data.

Therefore, this information cannot be extracted from the given document.

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

This is not applicable to the type of safety and performance testing described in the document. The "ground truth" here is established by the international safety standards (CEI/IEC 60601-1 and IEC 60601-2-41), and the testing verifies the device's adherence to these engineering and electrical safety requirements, not clinical efficacy or diagnostic accuracy that would require human expert adjudication.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated in point 3. The "test set" here is the physical device and its electrical/mechanical performance, which is assessed against objective technical standards, not through human adjudication of data.

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

No, an MRMC comparative effectiveness study was not conducted or mentioned in the provided text. This type of study is typically used for diagnostic or screening devices to assess the impact of AI on human reader performance for interpretation of images or other data. The STERIS Harmony LED-1 Surgical Lighting System is an illumination device, not a diagnostic tool that relies on human interpretation of outputs aided by AI.

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

This is not applicable. The device is a surgical light, not an algorithm. Therefore, there is no "standalone" algorithmic performance to report.

7. The Type of Ground Truth Used

The "ground truth" used for performance assessment is the technical requirements and specifications outlined in the international safety and performance standards CEI/IEC 60601-1 and IEC 60601-2-41. These standards define what constitutes a safe and functional surgical light. The device is tested to ensure it meets these engineering and electrical safety criteria.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical hardware product (surgical light), not an AI/ML algorithm that requires a "training set" of data.

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

This is not applicable for the reasons stated in point 8.

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To provide a self-locking mechanism to hold the edges of a wound open and allow for surgical exposure during general use and neurosurgical procedures.

The Harmony Port System includes the Harmony Port, which provides surgical exposure during minimally invasive procedures, along with accessory instruments designed to facilitate the use of the Port and rigidly fix the system during use.

The provided 510(k) notification summary for the Harmony™ Port System does not contain specific acceptance criteria or a study that proves the device meets such criteria. Instead, it indicates that the device's substantial equivalence to a predicate device was established through non-clinical testing.

Here's a breakdown of the information that is present and what is missing based on your requested categories:

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

• Acceptance Criteria: Not explicitly stated in the document.
• Reported Device Performance: "The results of non-clinical testing and evaluation demonstrate that the device is safe and effective." No specific performance metrics (e.g., accuracy, precision, duration of use) are provided.

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

• This information is not provided. The summary only mentions "non-clinical testing," which typically refers to bench testing, mechanical testing, or simulations, rather than human data.

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 provided, as the testing was non-clinical and did not involve human-derived data that would require expert ground truthing.

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

• This information is not applicable and not provided, as the testing was non-clinical.

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 applicable. The device is a surgical retractor, not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted or referenced.

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

• This information is not applicable. The device is a physical surgical tool, not an algorithm.

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

• This information is not applicable. For non-clinical device testing, ground truth typically refers to engineering specifications, physical measurements, or established mechanical properties, rather than clinical outcomes or pathology. The document does not detail the specific "ground truth" or reference standards used for the non-clinical tests.

8. The sample size for the training set

• This information is not applicable. The device is a physical product, not a machine learning model.

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

• This information is not applicable. The device is a physical product, not a machine learning model.

Summary of Device and Evidence:

The Harmony™ Port System is a surgical retractor intended "to provide a self-locking mechanism to hold the edges of a wound open and allow for surgical exposure during general use and neurosurgical procedures."

The basis for its 510(k) clearance (K050706) is its substantial equivalence to a predicate device, The Bright Medical Dilation Retractor System (K992898). The submission states that the Harmony Port System "has the same intended use, is manufactured from similar materials using similar processes, and is similar in design when compared to the predicate device."

The only performance data mentioned is: "The results of non-clinical testing and evaluation demonstrate that the device is safe and effective." This statement indicates that bench or mechanical tests were performed to confirm the device's functionality and safety, consistent with its classification as a Class II surgical retractor. However, no specific details about these tests, the acceptance criteria, or the reported performance metrics are provided in the excerpt.

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The Harmony INR Monitoring System is indicated for the quantitative determination of prothrombin time (PT) in capillary whole blood by properly selected and trained patients or their caregivers, or in capillary or venous whole blood by health care professionals, as an aid in monitoring oral anti-coagulation therapy.

The Harmony System consists of a meter and test strip. When a drop of blood is placed on the test strip, the blood is drawn into the reaction cells and mixed with reagents that cause blood clotting to begin. The meter monitors the blood clotting process by passing a light beam through the blood sample being tested. The meter detects blood clot formation and, at the conclusion of the test, the prothrombin time is displayed in International Normalized Ratio (INR) units.

Here's an analysis of the provided text regarding the Harmony™ INR Monitoring System, focusing on acceptance criteria and the supporting study:

The provided text contains very limited information regarding detailed acceptance criteria and the specifics of the performance study. It states that "The study conducted to compare equivalency of the Rubicon 510(k) cleared device to the modified Harmony System met the performance requirements for accuracy and precision relative to the reference laboratory system." However, it does not explicitly list those performance requirements (acceptance criteria) or provide the detailed results that would allow for a table comparing them to the device's reported performance.

Therefore, many sections of your request cannot be fully answered based only on the provided text.

Here's what can be extracted and what remains unknown:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical or qualitative acceptance criteria for accuracy and precision are not detailed in the provided document.

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

• Sample Size: Not specified. The document only mentions "The study conducted to compare equivalency..." without detailing the number of participants or samples.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Not specified. The document refers to a "reference laboratory system" for comparison, implying expert-derived ground truth, but gives no details about the number or qualifications of experts.

4. Adjudication Method for the Test Set

• Not specified.

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

• No, this was not an MRMC comparative effectiveness study in the context of human readers improving with AI. This is a point-of-care device for measuring INR, not an AI or imaging diagnostic tool that would typically involve human reader improvement. The study was a comparison of the Harmony system to a predicate device and a reference laboratory system.

6. If a Standalone (Algorithm Only) Performance Study Was Done

• Yes, implicitly. The "Performance Testing" section states, "The study conducted to compare equivalency... met the performance requirements for accuracy and precision relative to the reference laboratory system." This refers to the device (meter and test strip) performing the measurement and generating the INR result, which is a standalone performance by the device's inherent mechanisms. There isn't a separate "algorithm" in the sense of a machine learning model, but rather the device's electrochemical and optical detection system.

7. The Type of Ground Truth Used

• Reference Laboratory System: The performance of the Harmony device was compared to a "reference laboratory system." This typically implies a highly accurate and precise laboratory method for measuring INR, often considered the gold standard for clinical ground truth in this context.

8. The Sample Size for the Training Set

• Not applicable/Not specified. This device is not an AI/machine learning system that requires a separate "training set" in the conventional sense. Its "training" would be its design, calibration during manufacturing, and internal parameters, which are not learned from data in the same way an AI model is.

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

• Not applicable/Not specified as there is no "training set" in the context of an AI model for this device. Its inherent performance is based on its physical/chemical design and calibration.

Summary of Limitations Based on Provided Text:

The provided document, a 510(k) summary, focuses on demonstrating substantial equivalence to a predicate device and broadly states that performance requirements for accuracy and precision were met. It does not delve into the detailed methodology, specific acceptance criteria values, sample sizes, or expert involvement in the way a scientific publication or a more detailed technical report would. This level of detail is often contained within the full 510(k) submission, which is not fully provided here.

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