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The SpectraScience™ Reusable Biopsy Forceps are designed specifically to provide adjunctive illumination while collecting tissue endoscopically for bistological examination. The instruments are intended for endoscopic gastrointestinal and urologic biopsy and should not be used for any purpose other than their intended function.

The current biopsy forceps design has not changed during its long course of past clinical utility. The standard hinged design utilizes cup-shaped jaws to bite or pinch off tissue with minimal complications while providing a viable tissue sample. The cup-shaped jaws also serve to hold the biopsy sample within the forceps until the tissue can be transferred to a biopsy container. The proposed SpectraScience™ Reusable Biopsy Forceps uses the most basic of standard design. The mechanism of action of the SpectraScience™ design is identical to predicate devices in that the same standard mechanical design, materials and sizes are utilized. Using essentially identical mechanisms of action and materials results in identical clinical performance. The SpectraSciences design employs an adjunctive technological characteristic. The SpectraScience design incorporates an optical illumination fiber. The optical illumination fiber is intended to provide the endoscopist with additional light from a different angle compared to the endoscope's light source. In various anatomies under certain circumstances, the endoscope's light angle may not reveal critical structural contours which should be considered before a biopsy is performed. The intent of the SpectraSciences device is to enhance visualization and thus result in more accurate and precise identification and location of the tissue to be sampled.

The document provided is a 510(k) Notification for SpectraScience™ Reusable Biopsy Forceps, dated September 17, 1997. It describes the device, its intended use, and its substantial equivalence to predicate devices. The notification emphasizes the addition of an optical illumination fiber as an "adjunctive technological characteristic" to enhance visualization during endoscopic biopsy without changing the core mechanism of action.

Based on the provided information, here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not describe a test set or any specific clinical studies involving human subjects or collected data from a particular country. The approval is based on a claim of substantial equivalence to predicate devices, supported by bench testing and material specifications, not clinical trial data.

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

This information is not applicable as there was no test set or expert-established ground truth described in the submission. The assessment relies on a comparison to existing, already-approved medical devices.

4. Adjudication Method for the Test Set:

This information is not applicable as there was no test set described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

No MRMC comparative effectiveness study was described. The device's enhancement is qualitative (improved visualization) rather than a quantitative measure of performance that would typically be assessed in an MRMC study.

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

This information is not applicable. This device is a physical medical instrument, not an AI algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is the established safety and effectiveness of the predicate devices and the accepted principles of medical device engineering and biocompatibility. For the enhanced visualization feature, the ground truth is the historical and accepted safety and utility of fiberoptic illumination in medical devices.

8. The Sample Size for the Training Set:

This information is not applicable as there is no mention of a training set for an AI algorithm.

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

This information is not applicable as there is no mention of a training set for an AI algorithm.

Summary of the Study and Device Proof:

The SpectraScience™ Reusable Biopsy Forceps gained clearance through a 510(k) submission, demonstrating substantial equivalence to existing predicate devices. The "study" described is primarily based on engineering analysis, material scientific data, and historical precedent. The manufacturer asserts that the new device shares the same fundamental design, materials, and mechanism of action as previously approved biopsy forceps. The key addition, an optical illumination fiber, is justified by its long history of safe and effective use in other medical contexts, and the claim is made that it enhances visualization without altering the core function or safety of the biopsy procedure. Therefore, the proof of meeting acceptance criteria is largely through comparison to established medical device standards and the known performance of predicate devices, rather than a novel clinical study with a specific test or training set.

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The SpectraScience Biopsy Forceps are designed specifically to provide adjunctive illumination while collecting tissue endoscopically for histologic examination. The instruments are intended for endoscopic gastrointestinal and urologic biopsy and should not be used for any purpose other than their intended function.

The current design of biopsy forceps has not changed during its long course of past clinical utility. The standard hinged design utilizes cup-shaped jaws to bite or pinch off tissue with minimal complications while providing a viable tissue sample. The cup-shaped jaws also serve to hold the biopsy sample within the forceps until the tissue can be transferred to a biopsy container. The proposed SpectraScience biopsy forceps uses the most basic of standard designs in that no teeth or spikes will be employed in the design. The mechanism of action of the SpectraScience design is identical to predicate devices in that the same standard mechanical design, materials and sizes are utilized. Using identical mechanisms of action and materials results in identical clinical performance. The SpectraScience design employs a different technological characteristic. The SpectraScience design incorporates a fiberoptic illumination fiber. The illumination fiber is intended to provide the endoscopist with adjunctive light directed at the tissue biopsy site in addition to the endoscope's light source.

This 510(k) summary describes a medical device, the SpectraScience Biopsy Forceps, for which the manufacturer is seeking clearance through a substantial equivalence pathway. As such, the document primarily focuses on establishing that the new device is as safe and effective as a legally marketed predicate device, rather than providing a detailed study proving performance against acceptance criteria in the way a novel device might.

Therefore, many of the typical elements of an AI/ML device study (like sample size for test sets, ground truth establishment, or human reader studies) are not present in this summary. The manufacturer's argument for substantial equivalence relies on the device sharing fundamental design, materials, and mechanisms with existing devices, with the addition of a fiberoptic illumination feature.

Here's an analysis based on the provided text, addressing the requested points where information is available or inferable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not applicable in the context of this 510(k) summary. This submission relies on demonstrating substantial equivalence to a predicate device through engineering and material comparisons, not a clinical trial with a "test set" of patient data for performance evaluation in the typical sense.
• Data Provenance: Not applicable. The "data" here primarily refers to engineering specifications, material certifications, and a comparison to the predicate device.

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

• Not applicable. There is no "ground truth" derived from expert consensus on a test set of cases as this is not an AI/ML device requiring clinical validation against ground truth.

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:

• No. This is not an AI/ML device, and no MRMC study was conducted or mentioned. The device's enhancement is a physical illumination feature, not an AI assistance tool.

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

• Not applicable. This is not an algorithm, so a standalone performance study as described would not be relevant.

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

• Not applicable. The "ground truth" equivalent would be established engineering standards, material properties, and the known performance of the predicate device. The claim of "identical clinical performance" is based on having "identical mechanisms of action and materials," implying that if the fundamental physical aspects are identical, the outcome (tissue sampling) will be identical.

8. The sample size for the training set:

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

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

• Not applicable. No training set is involved.

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