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The Alma Diode Tabletop Laser is intended for use in dermatologic and general surgical procedures.
Indications for Use
The Alma Diode Tabletop Laser includes three possible diode laser modules depending on the customer order.
Diode Laser Modules:
The indications for use for the 810 nm Alma Diode Tabletop Laser include:
-The Alma 810 rm diode tabletop laser is indicated for endoluminal or endovenous laser surgery for saphenous incompetent veins.
The indications for use for the 980 nm Alma Diode Tabletop Laser include:
-The Alma 980 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980 mm diode tabletop laser assisted lipolysis.
The indications for use for the 1470 nm Alma Diode Tabletop Laser include:
-The Alma 1470 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470 nm diode tabletop laser is further indicated for laser assisted lipolysis.

The Diode Tabletop System is a small, tabletop laser console that can be sold with one of three wavelengths - 1470nm, 980mm or 810mm. It is comprised of 4 major components. The main console unit contains the laser moduler, cooling and user interface. The Footswitch is used to activate the laser. The diode laser modules are contained in the main console and emit laser energy in the required wavelength. All of the accessories connect via a fiber to the SMA connection port on the laser console. A single use, radial emitting fiber will be provided sterile by an OEM manufacturer. The fiber is sterilized using ETO. It is for prescription use only.

The provided text pertains to a 510(k) premarket notification for a medical device called the "Alma Diode Tabletop Laser." It describes the device, its intended use, comparison to a predicate device, and the non-clinical testing performed.

However, the document does not contain information related to acceptance criteria, device performance against those criteria, sample sizes for test or training sets, data provenance, expert involvement for ground truth, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance, as would be expected for a product relying on AI/ML or complex diagnostic capabilities.

The core of this 510(k) submission is for a laser surgical instrument, and the significant change described is the addition of a temperature sensing thermistor to a cannula used during laser lipolysis. The testing for this modification focused on bench testing to verify the performance of the temperature sensor and its accuracy in an ex vivo porcine model, rather than complex AI/ML performance metrics.

Therefore, many of the requested elements of your prompt are not applicable or cannot be extracted from this specific document.

Here's what can be extracted based on the provided text, and where gaps exist:

Acceptance Criteria and Study Details for the Alma Diode Tabletop Laser (K212073)

Summary of Device and Key Change:
The Alma Diode Tabletop Laser is a laser surgical instrument used in dermatologic and general surgical procedures, specifically for saphenous incompetent veins and laser-assisted lipolysis. The K212073 submission describes a modification to a previously cleared device (K160952), primarily the addition of a temperature-sensing thermistor to a cannula used during laser lipolysis procedures. This thermistor is designed to detect tissue temperature in near real-time and alert the user if a preset temperature is exceeded.

Study Type:
The study described is non-clinical bench testing to verify the performance of the modified device, particularly the added temperature sensing functionality.

Missing Information:

• This document does not describe the testing of an AI/ML component. Therefore, acceptance criteria regarding AI diagnostic performance (e.g., sensitivity, specificity, AUC) are not present.
• No human reader studies (MRMC) were conducted as the device's function does not involve diagnostic interpretation by human readers.
• No standalone algorithm performance metrics are provided as it's not an AI-driven diagnostic algorithm.
• Ground truth establishment methods (expert consensus, pathology, outcome data) are not relevant in the context of this device's functional testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria and corresponding reported performance values for properties like sensitivity, specificity, or similar metrics typically associated with AI/ML products. Instead, the performance testing described relates to the functionality of the new temperature sensor.

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

The document mentions "ex vivo porcine model" for performance testing of the temperature sensor.

• Sample Size: Not specified (e.g., number of porcine samples or measurements).
• Data Provenance: Ex vivo porcine model (experimental, not human clinical retrospective or prospective data). The country of origin for the data is not specified.

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

Not applicable. The ground truth for the performance of a temperature sensor is typically established by calibrated reference instruments, not expert human readers or consensus, especially in an ex vivo setting.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human readers in diagnostic studies, which is not relevant here.

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 conducted. This device is a surgical laser, and the testing described is not related to human diagnostic performance or AI assistance in interpretation.

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

No. This is not an AI/ML algorithm or diagnostic device tested for standalone performance. The testing involved the functional performance of a physical component (temperature sensor) within a laser system.

7. The Type of Ground Truth Used

The ground truth for the temperature sensor's performance would be derived from calibrated temperature measurement devices in the ex vivo porcine model, comparing the thermistor's readings against these reference measurements. This is a type of "bench testing" or "experimental setup" ground truth, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product that undergoes a training phase with a dedicated dataset.

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

Not applicable, as there is no training set for this device.

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Intended Use The Alma Diode Tabletop Laser is intended for use in dermatologic and general surgical procedures.

Indications for Use

laser assisted lipolysis.

The Alma Diode Tabletop Laser includes three possible diode laser modules depending on the customer order. Diode Laser Modules:

The indications for use for the 810 nm Alma Diode Tabletop Laser include: - The Alma 810 nm diode tabletop laser is indicated for endovenous laser surgery for saphenous incompetent veins.

The indications for use for the 980 nm Alma Diode Tabletop Laser include: -The Alma 980 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980 nm diode tabletop laser is further indicated for laser assisted lipolysis.

The indications for use for the 1470 nm Alma Diode Tabletop Laser include: -The Alma 1470 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470 nm diode tabletop laser is further indicated for

The Alma Diode Tabletop Laser is comprised of the following major components:

• The main console unit 1.
• 2. Pull-back
• 3. Footswitch
• Accessories 4.

The provided text is a 510(k) summary for the Alma Diode Tabletop Laser. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, the acceptance criteria and study data provided in this document pertain to the device's substantial equivalence to predicate devices based on technical characteristics and safety standards, NOT to the performance of an AI/ML algorithm or its clinical effectiveness.

Therefore, I cannot provide information on acceptance criteria for an AI/ML device, nor studies proving its performance, nor details about ground truth, expert adjudication, or MRMC studies for an AI/ML algorithm, as none of that information is present or relevant to this 510(k) submission.

The document discusses "Design Verification Testing" for the hardware component (pullback accessory) and software validation for the control software, but this is not equivalent to clinical performance studies for an AI/ML diagnostic or therapeutic algorithm.

Here's what can be extracted from the document regarding the device's (a laser system and its pullback accessory) "acceptance criteria" and "proof" of meeting them, within the context of substantial equivalence:

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

The document doesn't present "acceptance criteria" in the typical sense of quantitative performance metrics for a clinical task (like sensitivity/specificity for a diagnostic AI). Instead, it relies on demonstrating substantial equivalence to predicate devices by comparing technical characteristics and meeting safety standards.

The closest to "criteria" and "performance" described are:

• Technical Characteristics Comparison (Table 1 - Salient Characteristics of the 1470nm module and the Predicate Devices): This table implicitly serves as the "acceptance criteria" by showing that the proposed device's characteristics (e.g., laser wavelength, max power, operation mode, fiber size, user interface) are comparable or identical to the predicate devices. The "reported device performance" is essentially the listed characteristic itself, demonstrating it falls within the range/type of the predicates.

  Parameter (Implicit Acceptance Criteria)	New Device (Alma Diode Tabletop Laser - 1470nm)	Predicate Device (K13 Alma diode tabletop laser)	Predicate Device (K100558 Quanta Diode Laser Family)
  Laser Wavelength [nm]	1470	1470	1470
  Max power	15W	15W	15W
  Light/Laser Source	Diode	Diode	Diode
  Laser Delivery	Optical Fiber	Optical Fiber	Optical Fiber
  Operation Mode	Continuous wave, single pulse, pulsed	Continuous wave, single pulse, pulsed	Continuous wave, single pulse, pulsed
  Pulse Duration	10-990ms	3ms - 2.5s (Predicate used is K100558, not K13)	3ms - 2.5s
  Bare fiber size	200, 300, 320, 400, 600, 800, 1000	200, 300, 320, 400, 600, 800, 1000	200, 300, 320, 400, 600, 800, 1000
  User Interface	LCD touch screen	LCD touch screen	LCD touch screen
  Aiming beam	635nm	650nm (Predicate used is K100558, not K13)	650nm
  Electrical Requirements	100-240, V AC 50-60 Hz, 6.3 A	100-240, V AC 50-60 Hz, 6.3 A, single phase	100-240, V AC 50-60 Hz, 6.3 A, single phase
  Indications for Use	Matching predicate (listed)	Listed	Listed

• Design Verification Testing (Section VIII):

  • Criterion: Actual pullback speeds match requested speeds.
  • Reported Performance: "Performing mechanical tests to verify the actual pull back speeds matched the requested speeds." (No specific numerical results provided, only an assertion of matching).
  • Criterion: Software fully verified and validated according to IEC 62304 and FDA guidance.
  • Reported Performance: "the software controlling the Alma 1470nm diode tabletop laser with the pull-back accessory was fully verified and validated in accordance with IEC 62304 and the FDA guidance document entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"." (Again, an assertion of compliance rather than explicit test results).

• Electrical Safety and EMC Testing (Section VII):

  • Criterion: Compliance with IEC 60601-1 and IEC 60601-1-2.
  • Reported Performance: "Additional product electrical safety testing and EMC testing was successfully completed in accordance with the following standards: IEC 60601-1... IEC 60601-1-2..." (Assertion of successful completion).

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

• Not applicable for a clinical test set in the context of an AI/ML device. The "testing" mentioned is for hardware performance and software validation of the device's control system, not for an AI algorithm's performance on clinical data.
• The document implies lab-based mechanical and electrical tests. There is no information on sample size of patients or data, nor data provenance (country of origin, retrospective/prospective).

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

• Not applicable. This pertains to clinical ground truth for diagnostic AI. The "ground truth" for this device's testing would be precise measurements of speed, electrical parameters, and successful software operation, established by engineers and test equipment, not clinical experts.

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

• Not applicable. This pertains to expert review of clinical data, not mechanical or software validation.

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, not done. This is a laser surgical instrument, not a diagnostic AI system intended to assist human readers.

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

• Not applicable in the context of AI. The device itself is a standalone instrument. Its software controls its functions, but it's not a diagnostic algorithm.

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

• For the pullback accessory: The "ground truth" for pullback speed verification would be precise mechanical measurements from calibrated instruments.
• For electrical safety and EMC: The "ground truth" would be standardized test procedures and measured electrical parameters against defined thresholds in the IEC standards.
• For software: The "ground truth" for software validation would be software requirements specifications and its ability to consistently execute defined functions without errors.

8. The sample size for the training set:

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

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

• Not applicable. As above, no AI/ML training set is involved.

In summary: The provided document is a 510(k) submission for a traditional medical device (a laser and its accessory). It focuses on demonstrating substantial equivalence to existing devices through comparison of technical specifications and adherence to engineering safety and performance standards, rather than proving the clinical performance or validation of an AI/ML algorithm. Therefore, many of the questions related to AI/ML device performance studies are not applicable to this document.

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Intended Use The Alma Diode Tabletop Laser is intended for use in dermatologic and general surgical procedures.

Indications for Use The Alma Diode Tabletop Laser includes three possible diode laser modules depending on the customer order.

Diode Laser Modules:

The indications for use for the 810nm Alma Diode Tabletop Laser include:

• The Alma 810nm diode tabletop laser is indicated for endovenous laser surgery for saphenous incompetent veins.

The indications for use for the 980 nm Alma Diode Tabletop Laser include:

-The Alma 980nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980nm diode tabletop laser is further indicated for laser assisted lipolysis.

The indications for use for the 1470nm Alma Diode Tabletop Laser include:

-The Alma 1470nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470nm diode tabletop laser is further indicated for laser assisted lipolysis.

The Alma Diode Tabletop Laser is comprised of the following major components:

• 1. The main console unit
• 2. Footswitch.
• 3. Accessories

This is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with acceptance criteria in the way a de novo or PMA submission would. Therefore, the document does not contain the detailed performance study information requested for an AI/ML device.

Here's an analysis based on the provided text, highlighting what is and isn't available:

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

The document does not provide a table of acceptance criteria and reported device performance in the context of clinical efficacy or specific accuracy metrics from a study. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to the predicate device by matching technical characteristics and indications for use.

The tables in sections 8-VI (Tables 1, 2, and 3) compare the "Alma Diode Tabletop Laser" (K13) to the "Quanta Diode Laser Family" (K100558) across several technical parameters. The "reported device performance" in this context is the Alma device meeting these technical specifications and having similar indications for use.

Similar tables exist for the 980nm and 810nm modules, with minor differences in wavelength, max power (30W for 980nm/810nm), and aiming beam wavelength (635nm vs 650nm for predicate).

The study that proves the device meets the acceptance criteria:

The "study" cited is the comparison to predicate devices and adherence to recognized electrical and laser safety standards. There are no clinical performance studies, accuracy metrics, or AI/ML specific evaluations described in this 510(k) summary.

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

Not applicable. This is a 510(k) for a laser device, not an AI/ML diagnostic. There are no test sets of patient data mentioned for performance evaluation. The device was tested to meet specific safety and electrical standards.

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. This type of information is not relevant to this 510(k) submission, which focuses on substantial equivalence of a physical laser device.

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

Not applicable. No test set requiring adjudication in this context.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI/ML product designed to assist human readers.

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

Not applicable. This device is not an algorithm.

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

The "ground truth" for this submission is implicitly the established safety and performance profile of the predicate device and adherence to international electrical and laser safety standards.

The device was tested by a certified laboratory according to:

• IEC 60601-1: 1988+A1:1991+A2:1995: Medical Electrical Equipment Part 1: General Requirements for basic safety and essential performance
• IEC 60601-1-2: Medical electrical equipment: Part 1-2: General requirements for safety-Collateral Standard: Electromagnetic compatibility - Requirements and tests (2001 + A1(4))
• IEC 60601-2-22:1995 Medical electrical equipment- Part 2-22: Particular requirements for the safety of diagnostic and therapeutic laser equipment 1995.
• IEC 60825-1:2007 (2nd edition) Safety of Laser Products-Part 1: Equipment Classification and Requirements

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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