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The SurgiSure™ Tissue Removal System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous and open surgical procedures whenever access to the surgical site is limited.

The SurgiSure™ Hysteroscopic Tissue Removal System consists of the following procedural components:

• SurgiSure™ Tissue Removal Device
• SurgiSure™ Control Unit
• SurgiSure™ Foot Pedal
  The SurgiSure™ Control Unit contains an electric motor and firmware motor controller that drives the SurgiSure Tissue Removal Device. The Control Unit motor is activated and deactivated by the SurgiSure Foot Pedal. The SurgiSure Tissue Removal Device is a tissue morcellator that is connected to the Control Unit via a flexible drive cable. The SurgiSure Tissue Removal Device features a rotating/reciprocating (2mm OD) cutter blade encased in a (3 mm OD) outer tube. The device's cutter blade is controlled by a drive system that enables simultaneous rotation and reciprocation of the cutter is also connected to a vacuum source which aspirates resected tissue through a side-facing cutting window in the device's outer tube. Distension fluid and resected tissue are transported from the SurgiSure Tissue Removal Device to a tissue trap and vacuum canister via a tube protruding from the proximal end of the Tissue Removal Device. The SurgiSure Tissue Removal System is compatible with commercially available fluid management systems and may be used with endoscopes that have a straight ≥3 mm working channel.

The provided document is a 510(k) summary for the SurgiSure™ Tissue Removal System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.

However, based on the information provided, we can extrapolate and infer some aspects related to acceptance criteria and the "study" (performance testing) that supports it.

Here's a breakdown of the requested information:

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

Since specific numerical acceptance criteria (e.g., minimum tissue removal rate, maximum power consumption) and direct reported performance values are not explicitly stated in the document, we must infer the criteria based on the comparison to predicate devices and the general safety and performance claims. The acceptance criterion is essentially "equivalent to or performs similarly to the predicate devices" in the specified aspects.

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 mentions "in-vitro testing" for tissue cutting rate. It does not specify the sample size, data provenance (country of origin), or whether it was retrospective or prospective. It is highly likely to be prospective data generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the performance testing described is "in-vitro" and does not involve human readers/experts evaluating device output. The ground truth for functional performance like tissue cutting rate would be established by objective measurements (e.g., mass of tissue removed per unit time) during the in-vitro tests, rather than expert evaluation.

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

Not applicable. As described in point 3, the testing is objective and in-vitro, not relying on subjective expert judgment or adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes a submission for a tissue removal system, which is a physical surgical device, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance.

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

Yes, a form of standalone performance testing was done. The "in-vitro testing" for tissue cutting rate, electrical safety, and biocompatibility are all standalone tests performed on the device itself without human intervention in the performance measurement. The device's motor, firmware, and mechanical components are assessed directly.

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

For the in-vitro tests:

• Electrical Safety & EMC: Ground truth is defined by the objective pass/fail criteria of the relevant international standards (e.g., IEC 60601 series).
• Biocompatibility: Ground truth is defined by the objective pass/fail criteria of ISO 10993-1.
• Tissue Cutting Rate: Ground truth would be objective measurements of tissue mass removed over time, or a similar quantitative metric, compared against the predicate device's measured performance.

8. The sample size for the training set

This is not applicable. The SurgiSure™ Tissue Removal System is a mechanical device, not a machine learning or AI algorithm that requires a training set.

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

This is not applicable, as there is no training set for this type of device.

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MyoSure™ Single Use Seals are a component / accessory to the MyoSURE™ Rod Lens Hysteroscope and are used to prevent distension fluid leakage from the proximal ends of the MyoSure™ Rod Lens Hysteroscope and removable outflow channel.

The MyoSure™ Rod Lens Hysteroscope incorporates a 3 mm ID working channel and a proximal seal. Additionally, the MyoSure™ Rod Lens Hysteroscope utilizes a removable 3.0 mm OD outflow channel which also includes a seal to prevent distension fluid leakage from its proximal end. The seal also provides an insertion pathway for handheld instruments or cautery probes.

MyoSure™ Rod Lens Scope Seals are comprised of white-tinted silicone.

The provided text is for a 510(k) Pre-market Notification for a medical device called "MyoSure™ Single Use Seals". This type of document is used to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, and thus does not require a full Pre-Market Approval (PMA).

The key takeaway from this document is that the study performed here is NOT a study to prove a device meets acceptance criteria in the sense of demonstrating a certain level of clinical performance (e.g., diagnostic accuracy, sensitivity, specificity). Instead, it's a demonstration of substantial equivalence based on material, dimensional, and functional similarity to a previously cleared device.

Therefore, many of the questions asked in the prompt are not applicable to the type of information presented in this 510(k) submission.

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

Acceptance Criteria and Device Performance

Study Details (Based on the provided 510(k) summary, which is a regulatory submission, not a detailed clinical study report)

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

   • The document implies bench testing was performed. Specific sample sizes for bench testing are not provided.
   • Data Provenance: Not explicitly stated as "country of origin." The company is Interlace Medical Inc., located in Framingham, MA, USA. The testing would have been conducted by them or a contracted laboratory. The testing appears to be retrospective in the sense that it's comparing a modified device to a previously approved predicate, but the bench tests themselves would be specific to the modified device.

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

   • Not applicable. This submission describes bench testing and a comparison to a predicate device, not a study evaluating human interpretation or clinical outcomes against a defined ground truth established by experts.

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

   • Not applicable. No adjudication method is mentioned as this is not a study assessing human reader performance.

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

   • No. This is a medical device (seals for a hysteroscope), not an AI diagnostic tool. Therefore, an MRMC study is not relevant or described.

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

   • Not applicable. This device is a physical component (seals). It does not involve an algorithm.

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

   • Bench Test Performance Requirements: The "ground truth" for the performance testing would be the pre-defined engineering specifications and performance limits for preventing fluid leakage, dimensional accuracy, and biocompatibility, as established by Interlace Medical, Inc. and relevant standards (ISO 10993-1). There is no "clinical ground truth" in the sense of pathology or outcomes.

7. The sample size for the training set:

   • Not applicable. This is not an AI/algorithm development, so there's no "training set."

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

   • Not applicable. (See point 7).

In summary, the K102686 submission is a 510(k) pre-market notification for a minor modification (seals) to an existing hysteroscope. The "study" described is primarily bench testing and a comparison of characteristics to demonstrate substantial equivalence to a predicate device, not a clinical trial or performance study against a complex ground truth involving human experts or AI algorithms.

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The MyoSure™ Hysteroscopic Tissue Removal System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.

The modified MyoSure Hysteroscopic Tissue Removal System consists of the following procedural components which are identical to those found in the predicate MyoSure System:

• MyoSure Control Unit O
• MyoSure Tissue Removal Device o
• MyoSure Foot Pedal o

The MyoSure Control Unit contains an electric motor and software controller that drives the MyoSure Tissue Removal Device. The Control Unit motor is activated and deactivated by the MyoSure Foot Pedal. The MyoSURE Tissue Removal Device is a tissue morcellator that is connected to the Control Unit via a flexible drive cable. The MyoSure Tissue Removal Device features a rotating/reciprocating (2.5 mm OD) cutter blade encased in a (3 mm OD) outer tube (i.e. morcellator). The morcellator's cutter-blade is controlled by a drive system that enables simultaneous rotation and reciprocation of the cutter. The cutter is also connected to a vacuum source which aspirates resected tissue through a side-facing cutting window in the device's outer tube. Distension fluid and resected tissue are transported from the MyoSure Tissue Removal Device to a tissue trap and vacuum canister via a tube protruding from the proximal end of the Tissue Removal Device. The MyoSure Hysteroscopic Tissue Removal System is compatible with commercially available fluid management systems and may be used with hysteroscopes that have a straight 3 mm working channel.

1. Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly list quantitative acceptance criteria in a table format. However, it indicates that the modified device's performance was evaluated against the predicate device. The conclusion states:

The study essentially aimed to prove equivalence to the predicate device (MyoSure Hysteroscopic Tissue Removal System, K091100) across these categories, rather than meeting specific numerical thresholds.

2. Sample Size for Test Set and Data Provenance:

The document describes "in-vitro testing" for performance evaluation. It does not specify the sample size of the test set used for this in-vitro testing. Furthermore, there is no information regarding the data provenance (e.g., country of origin of the data, retrospective, or prospective), as this was an in-vitro study, not a clinical trial with human data.

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

Not applicable. This was an in-vitro study comparing a modified device to a predicate device. Ground truth, in the sense of expert human assessment of medical images or conditions, was not established for this type of test. The performance was likely measured against objective physical or mechanical parameters relevant to tissue removal.

4. Adjudication Method for the Test Set:

Not applicable, as there were no human readers or expert panels involved in establishing ground truth for a test set in the traditional sense. The evaluation was based on in-vitro measurements and comparisons.

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

No, an MRMC comparative effectiveness study was not done. The document describes an in-vitro study focused on demonstrating equivalence to a predicate device, not a comparative study involving human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance:

Not applicable. The device described, the MyoSure™ Hysteroscopic Tissue Removal System, is a mechanical medical device for tissue removal, not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not relevant to this submission. The performance assessment focused on the device's mechanical and material characteristics.

7. Type of Ground Truth Used:

The "ground truth" for the in-vitro performance testing would have been objective measurements of physical parameters relevant to the device's function (e.g., cutting efficacy, tissue morcellation efficiency, fluid dynamics, material integrity under stress, etc.) compared against the performance of the predicate device under the same conditions. It was not based on expert consensus, pathology, or outcomes data in the context of human patients.

8. Sample Size for the Training Set:

Not applicable. This device is a mechanical system, not an AI/machine learning model that requires a "training set."

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

Not applicable, as there was no training set for an AI/machine learning model.

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The MyoSURE™ Hysteroscopic Tissue Removal System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.

The MyoSURE Hysteroscopic Tissue Removal System consists of the following procedural components: MyoSURE Control Unit, MyoSURE Tissue Removal Device, MyoSURE Foot Pedal. The MyoSURE Control Unit contains an electric motor and software controller that drives the MyoSURE Tissue Removal Device. The Control Unit motor is activated and deactivated by the MyoSURE Foot Pedal. The MyoSURE Tissue Removal Device is a tissue morcellator that is connected to the Control Unit via a flexible drive cable. The MyoSURE Tissue Removal Device features a rotating/reciprocating (2mm OD) cutter blade encased in a (3 mm OD) outer tube (i.e. morcellator). The morcellator's cutter blade is controlled by a drive system that enables simultaneous rotation and reciprocation of the cutter. The cutter is also connected to a vacuum source which aspirates resected tissue through a sidefacing cutting window in the device's outer tube. Distension fluid and resected tissue are transported from the MyoSURE Tissue Removal Device to a tissue trap and vacuum canister via a tube protruding from the proximal end of the Tissue Removal Device. The MyoSURE Hysteroscopic Tissue Removal System is compatible with commercially available fluid management systems and may be used with hysteroscopes that have a straight 3 mm working channel.

The provided text describes the MyoSURE™ Hysteroscopic Tissue Removal System and its comparison to a predicate device for 510(k) clearance. However, the document does not contain specific acceptance criteria, a detailed study protocol for performance evaluation against these criteria, or information about sample sizes (beyond "in-vitro testing"), expert involvement, or adjudication methods in the way a typical AI/software device submission would.

This submission is for a physical medical device, not a software or AI-driven diagnostic device. Therefore, the concepts of "acceptance criteria," "test set," "ground truth," "MRMC study," and "training set" as they relate to AI performance metrics are not applicable in this context. The performance testing described focuses on safety, biocompatibility, and functional equivalence to a predicate device.

Here's an attempt to structure the available information based on your request, even though it doesn't fit neatly into an AI device framework:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a physical device and not an AI/software product, the "acceptance criteria" are not framed as performance metrics (e.g., sensitivity, specificity) but rather as compliance with standards and equivalence to a predicate device.

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

• Sample Size: The document mentions "in-vitro testing" but does not specify the sample size (e.g., number of devices tested, number of tissue samples processed).
• Data Provenance: The testing was "in-vitro," meaning it was conducted in a laboratory setting. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these terms typically apply to clinical studies with human or patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This concept is not applicable. The "ground truth" for a physical device in this context would be its ability to safely and effectively resect tissue. This is evaluated through engineering testing (e.g., material properties, electrical safety, mechanical function) and functional in-vitro tests, not by expert consensus on diagnoses or images.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations (e.g., reading images). This is not relevant for the type of testing described for this physical device.

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

Not applicable. MRMC studies are used to assess the impact of AI on human reader performance, typically in diagnostic tasks. This device is a surgical tool, not a diagnostic imaging AI, and such a study would not be relevant.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device, not a standalone algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context refers to established standards and the performance of the predicate device. For example:

• Electrical Safety: Standards like IEC 60601 (implied by "EMC standards").
• Biocompatibility: ISO 10993-1.
• Functional Performance: Direct comparison to the established performance of the predicate Interlace Morcellator in an in-vitro setting. This would likely involve measuring tissue resection rates, cutting efficiency, or other mechanical aspects.

8. Sample Size for the Training Set

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

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

Not applicable. As there's no training set, there's no ground truth to be established for it.

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The MyoSURE™ Rod Lens Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

The MyoSURE™ Rod Lens Hysteroscope is comprised of an oval 6.0 mm x 6.4mm OD x 184 mm long stainless steel tube containing a series of rod lenses and a 3.0 mm working channel. At the distal end of the tube, an "objective" lens captures the image of the "object". The series of "rod" lenses relays the image along the length of the tube. The image is directed by a 45° prism to an offset eyepiece that also contains "rod" lenses which relay the image along the length of the eyepiece tube. At the proximal end of the eyepiece, an "ocular" lens forms the image for the human eye and/or camera. The hysteroscope features a 0° angle of view and an 80° field of view.

The MyoSURE™ Rod Lens Hysteroscope also incorporates an inflow channel with stopcock, glass fibers for illumination, a 3 mm working channel and a proximal seal. The 3 mm working channel is dimensionally compatible with the Interlace Medical Hysteroscopic Morcellator (K073690).

Additionally, the MyoSURE™ Rod Lens Hysteroscope utilizes a removable 3.0 mm OD x 283 mm length outflow channel which may be inserted through the hysteroscope's working channel. The outflow channel includes a seal to prevent distension fluid leakage from its proximal end. The seal also provides an insertion pathway for handheld instruments or cautery probes.

The MyoSURE™ Rod Lens Hysteroscope is autoclavable and will be sold as a non-sterile, reusable device.

The provided text describes a 510(k) summary for the MyoSURE™ Rod Lens Hysteroscope. This is a traditional medical device submission, primarily focused on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through extensive clinical studies like those for AI/ML-based devices.

Therefore, many of the requested categories for AI/ML device evaluations are not applicable to this submission. The "performance testing" section refers to compliance with standards and validation protocols typical for mechanical/optical devices, not statistical performance metrics derived from large datasets.

Here's the breakdown of the information available in relation to your request:

1. Table of acceptance criteria and the reported device performance

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 as this is a traditional medical device submission for a hysteroscope, not an AI/ML device relying on a "test set" of clinical data in the conventional sense. Performance was demonstrated through engineering testing and substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. There was no "test set" requiring expert-established ground truth for an AI/ML algorithm.

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

• Not applicable.

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 is not an AI/ML device.

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

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

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

• Not applicable in the context of AI/ML device evaluation. The "ground truth" for this device's performance relies on engineering standards, material specifications, and functional demonstrations typical for medical instruments. For example, sterilization efficacy is validated against microbiological sterility standards, and biocompatibility against ISO 10993.

8. The sample size for the training set

• Not applicable. There is no AI/ML component or "training set."

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

• Not applicable.

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Interlace Medical Operative Hysteroscopy System is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

The Interlace Medical Operative Hysteroscopy System is intended for use in visualizing the uterine cavity and performing operative hysteroscopy procedures. The Operative Hysteroscopy System includes an obturator, a sheath and a hysteroscope. The obturator is used to facilitate introduction of the sheath into the uterine cavity. The single use sheath includes a working channel to permit the introduction of instrumentation. The reusable fiber optic hysteroscope is designed with optical lenses for visualization and optical fibers for illumination. The obturator is inserted into the working channel of the sheath and the hysteroscope is inserted into a designated lumen of the sheath. The Operative Hysteroscopy System can be combined with a hysteroscopic fluid management system (not the subject of this submission) to provide continuous flow hysteroscopy capability. The hysteroscope can be used with standard O.R. camera couplers.

The provided text describes a 510(k) premarket notification for the Interlace Medical Operative Hysteroscopy System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo clinical study with specific acceptance criteria and performance metrics.

Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not directly applicable or available in this document. The document specifically states that "The Interlace Medical Operative Hysteroscopy System does not raise any new safety and efficacy concerns when compared to the similar legally marketed device." and relies on "descriptive characteristics" to demonstrate substantial equivalence.

Here's a breakdown of why each specific point you asked for cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. There are no performance criteria established for this clearance, as it is based on substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No dedicated "test set" or clinical study data is presented for performance evaluation in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. No ground truth establishment was conducted for a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication process for a test set 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: Not applicable. This device is a physical hysteroscopy system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical hysteroscopy system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth was established for a performance study.
8. The sample size for the training set: Not applicable. The device is not an AI/machine learning model needing a training set.
9. How the ground truth for the training set was established: Not applicable. The device is not an AI/machine learning model.

Summary of Device Rationale based on the provided text:

The Interlace Medical Operative Hysteroscopy System received 510(k) clearance by demonstrating substantial equivalence to the predicate device, the Smith and Nephew Hysteroscope and Accessories (K013870). The equivalence is based on:

• Same Intended Use: "to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures."
• Similar Technological Characteristics: "The Interlace Medical Operative Hysteroscopy System is substantially equivalent in design, materials, construction and intended use as that of the predicate. The principal of operation of both devices are exactly the same."
• No New Safety or Efficacy Concerns: The submission argues that due to the above similarities, the device "does not raise any new safety and efficacy concerns."
• Performance Testing: The only specific performance testing mentioned is that the system "meets electrical safety standards." This is a general safety requirement, not a clinical performance metric.

Therefore, the "study" that proves the device meets acceptance criteria in this context is the comparison to the legally marketed predicate device and the argument that no new safety or effectiveness questions are raised.

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The Interlace Medical Hysteroscopic Morcellation System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.

The system consists of the following components: Control Unit, Morcellator Handpiece, Single Use Morcellator, Footswitch. The Interlace Medical Hysteroscopic Morcellation System will be used with standard hysteroscopes and fluid management systems.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document mentions "an in-vitro test" but does not specify the sample size (e.g., number of morcellations, amount of tissue removed, or number of devices tested).
• Data Provenance: The study was "in-vitro," meaning it was conducted in a lab setting, not on human subjects. The country of origin of the data is not explicitly stated, but given the sponsor is Interlace Medical Inc. located in Framingham, MA, USA, and the FDA review, it is highly probable the testing was conducted in the USA. It was a prospective test, as it was conducted to demonstrate device performance for regulatory approval.

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

This information is not provided in the document. As the study was an in-vitro performance test comparing the device to a predicate, it likely involved objective measurements based on engineering or laboratory protocols rather than human expert interpretation of results.

4. Adjudication method for the test set:

This information is not provided. Given the nature of the in-vitro performance test, it's unlikely a human adjudication method (like 2+1, 3+1) was used. Performance would have been measured against technical specifications or direct comparison to the predicate device's measured performance.

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. A MRMC comparative effectiveness study was not done. The device is a medical instrument (Hysteroscopic Morcellation System), not an AI-powered diagnostic or interpretive tool. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

Yes, in essence. The "in-vitro test" mentioned in point 7 of the "Performance Testing" section can be considered a standalone performance evaluation of the device's mechanical function, without direct human-in-the-loop performance measurement for regulatory submission purposes. The device's operation is mechanical, and its performance was assessed in a controlled environment.

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

The ground truth for the in-vitro performance test would have been established by objective technical measurements and engineering specifications related to the device's ability to resect and remove tissue, compared directly against the performance of the predicate device under similar conditions. This is not comparable to ground truth derived from expert consensus, pathology, or outcomes data, which are typically used for diagnostic or screening devices.

8. The sample size for the training set:

Not applicable/Not provided. The Interlace Medical Hysteroscopic Morcellation System is a mechanical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data used to train an algorithm.

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

Not applicable. As stated above, there is no training set for this device.

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