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The Signum Surgical BioHealx Anal Fistula Device is indicated for closure of the internal opening of mature, cryptogenic, transsphincteric, non-branching fistulas in ano via tissue apposition.

Device Description

The BioHealx Anal Fistula Device comprises the BioHealx Implant and the Delivery System. The BioHealx implant is designed as a sterile, single use helical, barbed bioabsorbable implant intended to promote healing by primary intention. The BioHealx delivery device is a sterile single-use, disposable delivery device that rotates the implant into the soft tissue surrounding the internal opening of the fistula tract. The BioHealx implant apposes the internal opening of the fistula channel and is held in position by its design geometry. The implant is fully enclosed in the anal sphincter muscle tissue and is not exposed to the ano-rectal canal. The implant retains adequate strength to compress the tissue of the internal opening of a fistula for 4 - 6 weeks and is absorbed within 6 - 12 months.

AI/ML Overview

Please note that the provided text is a regulatory submission for a medical device (BioHealx Anal Fistula Device) and not a study describing an AI/ML algorithm. Therefore, many of the requested points related to AI/ML specific studies (e.g., MRMC studies, standalone algorithm performance, number of experts for ground truth, adjudication methods, training set details) are not applicable and thus will be marked as "N/A" (Not Applicable).

However, I can extract information related to the device's acceptance criteria and the studies performed to demonstrate its safety and effectiveness, as outlined in the document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported "results" are directly extracted from the "SUMMARY OF NONCLINICAL/BENCH STUDIES" table provided in the input text.

Test	Purpose	Method	Acceptance Criteria	Reported Device Performance/Results
Implant Verification Testing	Demonstrate that the BioHealx Implant maintains sufficient strength to support tissue healing for a minimum of 3 weeks post implant delivery (a strength equal to or greater than (b) (4)	The break strength was evaluated at T=0, 3, 4, 6 weeks following simulated in-vitro degradation in buffer solution at (b) (4)	Tensile (implant break) strength must be (b) (4) (T=0) and (b) (4) (T=3 weeks, 4 weeks, 6 weeks).	All testing passed the acceptance criteria.
Delivery Mechanism Verification	Demonstrate that the BioHealx delivery mechanism is capable of successful implant delivery. Determine the torque requirement to remove an implant from the drive coil assembly (implant lock testing).	Each test sample (Finished Device) was removed from the packaging and verified to meet specifications. The BioHealx implant was delivered to between (b) (4) into the simulated tissue surface.	a) The BioHealx Anal Fistula Device must be capable of consistent successful delivery of the BioHealx implant, to a controlled depth, being delivered to simulated tissue.
b) The drain capture mechanism must be capable of withstanding a (b) (4) load without failure and allow attachment of USP size 2-0 bioabsorbable suture via a secure knot.
c) The implant must maintain integrity and form (geometry) post implant delivery.	All testing passed the acceptance criteria.
Implant Migration	Demonstrate resistance to migration / extrusion of the BioHealx implant.	The BioHealx implant resistance to migration/extrusion was evaluated under the conditions of simulated rectal pressure cycling on BioHealx implant position. All bench testing was performed in an anatomically relevant model.	a) The applied force required to cause implant migration and extrusion force in the gel model must be (b) (4) axial force (b) (4)
b) The BioHealx implant final position (post pressure cycling) must remain within the required delivery depth specification of (b) (4) (b) (4)	All testing passed the acceptance criteria.
Drain Attachment	Demonstrate that the drain capture mechanism is: - Capable of withstanding anticipated loading - Allows attachment of 2-0 bioabsorbable suture using a secure knot. - When attached to suture (drain capture/suture assembly) can withstand anticipated loading while (i) retracting the lock and (ii) post retraction of lock.	Each test sample (Finished Device) was removed from the packaging and tested on the bench to ensure that the drain capture mechanism could withstand the anticipated loading.	a) Drain capture mechanism must withstand an applied load (b) (4) without failure.
b) Drain capture mechanism shall allow attachment of 2-0 bioabsorbable suture using a secure knot.
c) Drain capture/ suture assembly must withstand an applied (b) (4) load while (i) retracting the lock and (ii) post retraction of lock.	All testing passed the acceptance criteria.
Drain Release Force	Assessment of the force required to release the suture /drain from a delivered BioHealx implant.	BioHealx implants were delivered to a simulated fistula tract in a representative model. For each fistula tract/implant delivered, a simulated drain using suture material was created. A tensile load was applied to each drain to determine the force required to cause detachment.	This testing was used to collect representative data to determine the force required to release the suture/drain from a delivered BioHealx implant.	The average force (95%/95% confidence reliability) required to release the stop knot (3 throws of a figure 8) and to cause the drain to detach was (4) Kg equivalent.
In Vivo Performance Testing (GLP)	Evaluate the safety and performance of the BioHealx Anal Fistula Device for its intended use to appose tissues in the repair of anal fistulas using a porcine anal fistula model.	Cohort of six (6) pigs (species strain Sus scrofa scrofa/ domestic. Yorkshire cross – white) were treated in the study. - Four perianal fistulas, with a seton placed, were created at the 3,5,7 and 9 o'clock positions in each animal. - After 4-weeks recovery, a second surgical procedure was performed per the BioHealx implant procedure. This involved the creation of a small mucosal incision at the internal opening site, and partial fistulectomy as necessary followed by placement of the BioHealx device in each of the fistula tracts.	Animals were observed for any adverse clinical signs of disease or ill health. Fistula healing, as assessed by histopathology analysis. Determine that the BioHealx device does not adversely affect the incidence and rate of perianal healing nor have any detrimental effect as determined by histopathology).	All testing passed the acceptance criteria. Testing concluded that there was no evidence of adverse tissue reaction associated with the BioHealx device in any of the evaluated samples.
Human Factors/Summative Evaluation Testing	Demonstrate the components of the BioHealx system can be used by the intended users without serious use errors or problems. The specific objectives are: - Confirm that the BioHealx device can be safely delivered. - Confirm that the BioHealx device can be effectively delivered. - Confirm no unanticipated serious use errors attributable to the system user interfaces. - Evaluate the simulated model as an effective training tool for BioHealx system users.	Users: 7 x EU, 10 x US representative colorectal surgeons. 100% (17/17) participants performed several BioHealx implantations in an anatomically relevant simulated use bench top model. Clinical investigators (N=6) also completed an in vivo simulated use (porcine) animal model. Note: The human factors simulated use in vivo testing was for training effectiveness evaluation only and was a separate activity to the GLP in vivo performance testing (described above).	a) User must unpackage the device without causing damage to the device.
b) User must remove the device from the tray without damage to the device (e.g., drop device)
c) User feedback on the tissue stabilization features must not identify risks/complaints.
d) User must not cut gloves/cause self-injury during device use.
e) User must successfully attach suture to the device attachment loop.
f) User must successfully place speculum and must not complain about device interface experience with speculum.	All implanters successfully completed implant training and effectiveness evaluation. The objectives to confirm that the BioHealx device can be safely and effectively delivered were met. There were no close calls or use errors observed during the evaluation. The simulated use model was demonstrated to be an effective training tool.
Biocompatibility Testing - Implant	As described in the purpose column for each specific test (e.g., "To determine the potential hemolytic activity", "To determine the toxicity potential", etc.)	ASTM F756, ISO 10993-12, ASTM F619, ISO 10993-6, ISO 10993-11, OECD 408, ISO 10993-10, USP 141, ISO 10993-5, ISO 10993-3, ISO/TR 10993-33, OECD 471, OECD 490, USP 41, NF 36 (2018), Bacterial Endotoxins Test, USP	Acceptance criteria per relevant ISO, ASTM, and OECD standards as listed in the "Acceptance Criteria" column for each test.	All testing met the acceptance criteria. Specific findings are noted for each test (e.g., non-hemolytic, no local/systemic toxicity, non-reactive, non-pyrogenic, non-mutagenic).
BioHealx Delivery System Biocompatibility	As described in the purpose column for each specific test (e.g., "To evaluate the potential...to cause delayed dermal contact sensitization", "To determine the potential...to cause cytotoxicity", etc.)	ISO 10993-10 (2021), 10993-12 (2021), ISO 10993-5 (2009), 10993-23 (2009), USP , ISO 10993-11 (2017)	Acceptance criteria per relevant ISO and USP standards as listed in the "Acceptance Criteria" column for each test.	All testing met the acceptance criteria. Specific findings are noted for each test (e.g., not sensitizer, no cytotoxicity, no irritation, absence of pyrogens, no mortality or systemic toxicity).

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

Due to the nature of the device (a physical surgical implant), there isn't a "test set" in the traditional sense of an AI/ML algorithm that processes data. Instead, there are various studies conducted with different sample sizes:

Bench Testing: Sample sizes are not explicitly stated for all bench tests, but the results indicate that these tests were performed and "All testing passed the acceptance criteria."
Animal Performance Testing (GLP):
- Sample Size: 6 pigs (porcine model).
- Data Provenance: In vivo study, prospective (animals were treated and observed as part of the study).
Human Factors/Summative Evaluation Testing:
- Sample Size: 17 representative implanters (7 EU, 10 US colorectal surgeons).
- Data Provenance: Performance in simulated benchtop models and in vivo porcine models (for training effectiveness only, not clinical performance evaluation). Likely prospective.
Clinical Study:
- Sample Size: 32 patients.
- Data Provenance: Multi-center, prospective, non-randomized clinical study conducted at three investigational sites in Hungary (OUS - Outside United States).
- Follow-up: All 32 patients followed for a minimum of 12 months; 18 of 32 patients for up to 40 months (average 23.4 months).

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

This concept is not directly applicable to a physical surgical device's performance studies as described. Ground truth is established through direct observation, pathological analysis, and clinical outcomes.

Animal Study: "board-certified veterinary pathologist" assessed healing by histopathology. The number of pathologists is not specified (e.g., singular "pathologist" suggests one, but it's not confirmed).
Clinical Study: Clinical outcomes (fistula closure, drainage, pain scores, etc.) were assessed by treating physicians and follow-up visits. Specific numbers and detailed qualifications of these physicians establishing "ground truth" (e.g., number of expert radiologists annotating images) are not provided, as this is a medical device study and not an AI image analysis study. The implanters in Human Factors study were "practicing colorectal surgeons or general surgeons with specialty interest in colorectal/gastroenterological surgery" with varying experience (5-40+ years).

4. Adjudication Method for the Test Set

Not applicable in the context of these device performance studies. Clinical outcomes are typically assessed by the study investigators and reported, not by an independent adjudication panel in the way an AI model's performance on image annotations might be.

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 a medical device, not an AI/ML diagnostic tool. There were no human readers/AI assistance studies.

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

Not applicable. This is a medical device, not an AI/ML algorithm.

7. The Type of Ground Truth Used

Bench Testing: Mechanical measurements, visual inspections, functional tests against predefined specifications.
Animal Performance Testing (GLP): Histopathology analysis of tissue samples, observation of clinical signs by veterinary professionals.
Human Factors Testing: Observational assessment of user performance (ability to complete tasks, adherence to instructions) and user feedback surveys.
Clinical Study:
- Effectiveness: Absence of drainage from the external opening site (primary endpoint), "downgrading" of fistula type (secondary). While the FDA notes uncertainty regarding the "flush test" and prefers the definition of "closure of both the internal and external opening without drainage," the study's ground truth for success was based on clinical observation of drainage.
- Safety: Recording and tabulation of adverse events, patient-reported outcomes (pain scores, quality of life, incontinence scores), and clinical observations (e.g., absence of sphincteric damage, migration).
- Implicitly: Post-surgical healing (or lack thereof) determined by clinical examination.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML algorithm. There are no "training sets" in the AI/ML sense. For the human factors evaluation, users received training before performing tasks, but this isn't a data training set for an algorithm.

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

Not applicable, as this is not an AI/ML algorithm.

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