The Pitch-Patch is a single use device intended to be used for reinforcement of the rotator cuff following or during repair by suture or suture anchors, where weakness exists in the soft tissue.

The Pitch-Patch is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the repair.

Device Description

The Pitch-Patch is a permanent implantable device for reinforcement of rotator cuff tears. It is constructed from a warp knitted fabric with integral eyelets. It is reinforced around its perimeter and around each eyelet to increase the security of suture attachment. The Pitch-Patch is available in two sizes, to cover different tear sizes without trimming (30 x 20 mm and 35 x 25 mm). It should not be cut to size. The device is supplied sterile.

The Pitch-Patch is made from Polyethylene Terephthalate (PET) also referred as polyester. This a nonabsorbable material that has a long history of use in the orthopedic market.

AI/ML Overview

The provided text describes the 510(k) clearance for the Pitch-Patch Tissue Reinforcement Device. This device is a surgical mesh intended to reinforce the rotator cuff during or after repair.

The information provided focuses on the performance testing conducted to demonstrate the device's substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving the device meets them in the context of an AI/software device. The document describes a medical device, not an AI/software device. Therefore, many of the requested points related to AI/software performance criteria (e.g., sample size for test/training set, expert ground truth, MRMC study, standalone algorithm performance) are not applicable or extractable from this document.

However, I can extract information related to the performance studies done for this physical medical device.

Here's an analysis based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the typical sense for an AI/software device (e.g., minimum sensitivity, specificity). Instead, it lists the types of performance tests conducted and concludes that the results demonstrate the device's mechanical properties are appropriate and that differences from predicates do not affect safety and efficacy.

Type of Performance Test	Reported Device Performance and Conclusion
Bench Testing:
- Simple Stitch Pull-Out Testing	• Successfully completed in accordance with FDA Guidance for Surgical Mesh.
- Burst Testing	• Successfully completed in accordance with FDA Guidance for Surgical Mesh.
- Tensile Testing of base material	• Successfully completed in accordance with FDA Guidance for Surgical Mesh.
- Tear Testing	• Successfully completed in accordance with FDA Guidance for Surgical Mesh.
- Density and Pore Size Testing	• Successfully completed in accordance with FDA Guidance for Surgical Mesh.
- Biocompatibility	• Successfully completed in accordance with FDA Guidance for Surgical Mesh.
Overall Bench Testing Conclusion	"The results demonstrate that the Pitch-Patch provides appropriate mechanical properties for its use in soft tissue repair." "The performance data benefit/risk analysis concluded that the differences encountered do not affect the safety and efficacy of the new device in relation to the predicate."
Clinical Performance (Cohort Study):
- Constant-Murley Score	• Increased significantly from 36.5 (pre-op) to 81.2 (midterm, P < .0001) and 83.4 (final follow-up).
- Subjective Shoulder Value (SSV)	• Increased significantly from 40.3 (pre-op) to 89.2 (midterm, P < .0001) and 89.6 (final follow-up).
- Re-ruptures	• 7 complete re-ruptures (14%) observed.
- Revision Surgery	• 8 patients underwent revision surgery. Main reason was frozen shoulder or arthrofibrosis with intact reconstruction and patch (6 cases), not necessarily due to patch failure. Re-ruptures did not correlate with revision surgery.

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

Test Set Sample Size: For the clinical study, the sample size was 50 patients.
Data Provenance: The document states it was a "prospective cohort study," implying prospective data collection. The country of origin is not explicitly stated for the patients, but the submitter (Xiros Ltd) is based in the United Kingdom.

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

This question is not applicable as this is a physical medical device. "Ground truth" in the context of diagnostic AI is not relevant here. The clinical outcomes (Constant-Murley score, SSV, re-ruptures, revisions) are direct patient data.

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

Not applicable for a physical medical device and clinical outcome study of this nature. Clinical outcomes were measured directly.

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 as this is a physical medical device, not an AI diagnostic tool.

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

Not applicable as this is a physical medical device, not an AI algorithm.

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

The "ground truth" equivalent for the clinical performance was patient outcomes data, specifically:
- Constant-Murley score (a standardized functional outcome measure for the shoulder).
- Subjective Shoulder Value (SSV).
- Incidence of complete re-ruptures (diagnosed clinically).
- Incidence and reasons for revision surgery.

8. The sample size for the training set:

Not applicable as this is a physical medical device; there is no "training set" in the AI sense.

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

Not applicable as this is a physical medical device; there is no "training set" in the AI sense.

Summary

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August 13, 2021

Xiros Ltd Steve Curran Compliance Director Springfield House Lane, Whitehouse Lane Leeds. West Yorkshire LS19 7UE United Kingdom

Re: K211563

Trade/Device Name: Pitch-Patch Tissue Reinforcement Device Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: May 16, 2021 Received: May 20, 2021

Dear Mr. Curran:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Deborah Fellhauer Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211563

Device Name Pitch-Patch Tissue Reinforcement Device

Indications for Use (Describe)

The Pitch-Patch is a single use device intended to be used for reinforcement of the rotator cuff following or during repair by suture or suture anchors, where weakness exists in the soft tissue.

Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Pitch-Patch Tissue Reinforcement Device

Submitter Information

Submitter:	Xiros, Ltd
Address:	Springfield House
	Whitehouse Lane
	Leeds
	West Yorkshire
	LS19 7UE
	UK
Telephone:	+44(0)1132387200
Fax:	+44(0)1132387201
Contact:	Dr. Steve Curran
Date Prepared:	May 13, 2021

Device Information

Trade Name:	Pitch-Patch Tissue Reinforcement Device
Common Name:	Surgical Mesh
Classification:	Class II
Regulation:	21 CFR 878.3300
Classification Name:	Surgical Mesh Polymeric
Classification Panel:	General Plastic Surgery
Product Code:	FTL

Purpose of Submission

The purpose of this submission is to gain clearance for a new orthopedic surgical mesh for use during rotator cuff repair to reinforce the tissue during and following repair surgery.

Predicate Device Information

The Pitch-Patch Reinforcement device described in this submission is substantially equivalent to the following predicate devices:

Surgicraft Surgical Mesh System (K072370) BioMerix Surgical Mesh (K070961)

Device Description

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The Pitch-Patch is made from Polyethylene Terephthalate (PET) also referred as polyester. This a nonabsorbable material that has a long history of use in the orthopedic market.

Intended Use/Indications for Use

The Pitch-Patch is a single use device intended to be used for reinforcement of the rotator cuff, following or during repair by suture or suture anchors, where weakness exists in the soft tissue.

Comparison of Principles of Operation & Technological Characteristics

The Pitch-Patch has the same principles of operations as the predicate devices. They are all permanent implants intended to support the rotator cuff during and after a surgical repair.

Performance Data

The following performance testing has been completed for the Pitch-Patch:

Simple Stitch Pull-Out Testing ●
Burst Testing
Tensile Testing of the base material .
Tear Testing
Testing to determine the density and pore size ●
Biocompatibility ●

Performance Testing - Bench

A series of tests, listed above, has been conducted and successfully completed in accordance with the Guidance for the Preparation of a Premarket Notification for a Surgical Mesh; Guidance for Industry and/or for FDA reviewers/ Staff and/or Compliance. The results demonstrate that the Pitch-Patch provides appropriate mechanical properties for its use in soft tissue repair.

The performance data benefit/risk analysis concluded that the differences encountered do not affect the safety and efficacy of the new device in relation to the predicate.

Performance Testing - Clinical

The Pitch-Patch device was used in a prospective cohort study of 50 patients. Clinical outcome was evaluated using the Constant-Murley score and the subjective shoulder value. Mean clinical midterm and final follow-up was 22 months (9-35 months) and 52 months (25-74 months), respectively.

The mean Constant-Murley score increased significantly from 36.5 (+/-16.4 standard deviation [SD]) preoperatively to a midterm value of 81.2 (+/-9.6 SD: P < .0001) and further improved to a mean of 83.4 (+/-10.8 SD) at final follow-up. The mean subjective shoulder value increased

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from 40.3 (+/-24.3 SD) to 89.2 (+/-12.9 SD: P < .0001) at midterm and to 89.6 (+/-15.2 SD) at final follow-up. There were 7 complete re-ruptures (14%). However, re-ruptures did not correlate with revision surgery, which was per-formed in 8 patients. The main reason for revision was frozen shoulder or arthrofibrosis with an intact reconstruction and patch, which was performed in 6 cases.

Conclusion

Based on the above information the Pitch-Patch device is substantially equivalent to rotator cuff tissue re-enforcement predicate devices, Surgical Mesh System (K072370) and the BioMerix Surgical Mesh (K070961) for use in reinforcement of the rotator cuff following or during surgical repair with suture or suture anchors.

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.