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The Boston Medical Products, Inc. Montgomery® Thyroplasty Implant is indicated for medialization thyroplasty in patients with unilateral vocal cord paralysis to improve voice quality.

The Montgomery® Thyroplasty Implant System consists of the Implant and associated accessory surgical instruments which are used for selection of implant size and for the surgical thyroplasty procedure.

The Montgomery® Thyroplasty Implant is a one-piece device consisting of a threetiered base and an obtuse triangular top. It is provided in five sizes for males and five for females. The difference in size relates to the height of the triangular portion of the Implant. There is a single base size for all five male implants and a smaller base size for all five female implants.

Accessories to the System include the sterile, single use Measuring Kits for selection of the correct implant size at the time of surgery, the Procedure Kit for determining the correct position of the Implant and marking the window in the thyroid cartilage, and various elevators, hooks, etc. which are provided to facilitate both the surgical procedure and the placement of the Implant.

The provided document, K97223/7, is a 510(k) summary for the Montgomery® Thyroplasty Implant System. It describes the device, its intended use, and claims substantial equivalence to legally marketed predicate devices. The section on "CLINICAL STUDIES" briefly mentions a clinical study, but it does not provide detailed acceptance criteria or a comprehensive report of device performance against specific metrics.

Here's an analysis of the information available and what is missing based on your requested format:

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

Missing Information:

• Specific numerical targets or thresholds for "low number of complications" (e.g., complication rate < X%).
• Specific metrics and thresholds for "improvement of voice quality" (e.g., a specific percentage increase in a voice quality score, a certain change in acoustic parameters, or a defined improvement in stroboscopic findings). Without these, it's impossible to quantitatively assess if the device "meets" the criteria.

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

• Sample Size for Test Set: 44 patients
• Data Provenance: Not specified (e.g., country of origin).
• Study Type: The summary states "Clinical data for a cohort of 44 patients treated...", implying a prospective cohort study, but it doesn't explicitly state "prospective" or "retrospective." This type of study would typically be prospective to evaluate a new device directly.

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)

Missing Information: The document mentions "acoustic analysis, and stroboscopy," which would typically be assessed by qualified professionals (e.g., otolaryngologists, speech-language pathologists). However, it does not specify the number of experts, their qualifications, or their role in establishing "ground truth" (e.g., for what constitutes improved voice quality) for the clinical study.

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

Missing Information: The document does not describe any adjudication method for the clinical study's outcomes.

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 an implant, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant or described.

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

Not Applicable: This device is a medical implant, not a software algorithm. Therefore, "standalone" algorithm performance is not relevant.

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

• For Safety: Clinical observation of complications (outcomes data).
• For Effectiveness ("Improvement of voice quality"):
  • Patient survey responses (patient-reported outcomes data).
  • Acoustic analysis (objective measurement data, likely interpreted by experts but the process isn't detailed).
  • Stroboscopy (imaging/visual assessment, likely interpreted by experts but the process isn't detailed).

Missing Information: While types of data are mentioned, the process by which "ground truth" for "improvement" was established (e.g., expert consensus on what constitutes significant improvement based on these measures) is not detailed.

8. The sample size for the training set

Not Applicable/Missing: This device is a physical implant, not an AI algorithm that requires a training set. If the question implicitly refers to pilot studies or early development, that information is not provided.

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

Not Applicable/Missing: As above, this is not an AI algorithm with a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document briefly describes a clinical study involving a cohort of 44 patients.

• Purpose: To demonstrate the safety and effectiveness of the Montgomery® Thyroplasty Implant System.
• Safety Assessment: Based on a "low number of complications." (No specific numerical criteria provided).
• Effectiveness Assessment: Based on "improvement of voice quality," supported by:
  • Patient survey responses.
  • Acoustic analysis.
  • Stroboscopy.
  • (No specific numerical criteria or methods for defining "improvement" are provided).

The determination of "substantial equivalence" for 510(k) clearance primarily relies on a comparison to predicate devices, and while clinical data for this type of device is often included, it usually aims to confirm that the differences from predicates do not raise new questions of safety or effectiveness. The study described is an internal study presented to the FDA as part of the 510(k) submission. However, the provided text does not offer the level of detail typically found in a full clinical study report, particularly regarding detailed acceptance criteria and quantitative results.

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